Hepatitis B Vaccine

Class: Vaccines
ATC Class: J0BB04
VA Class: IM100
Brands: Comvax, Engerix-B, Pediarix, Recombivax HB, Twinrix

Introduction

Inactivated (recombinant) vaccine.^{132 133 213 281} Hepatitis B vaccine contains hepatitis B surface antigen (HBsAg) and is used to stimulate active immunity to hepatitis B virus (HBV) infection.^{132 133 213 281} Commercially available in the US as monovalent vaccines (HepB; Engerix-B, Recombivax HB).^{132 133} Also commercially available in a fixed-combination vaccine with Haemophilus influenzae type b (Hib) vaccine (Hib-HepB; Comvax),²⁵¹ in a fixed-combination vaccine with hepatitis A virus vaccine (HepA-HepB; Twinrix),²⁶² and in a fixed-combination vaccine that contains diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix).¹⁰⁴

Uses for Hepatitis B Vaccine

Prevention of Hepatitis B Virus (HBV) Infection

Prevention of HBV infection in neonates, children, adolescents, and adults.^{105 112 132 133 213 241 280 281 282}

Acute HBV infection may be self-limited resulting in production of antibody to HBsAg (anti-HBs) and immunity against reinfection; however, it may progress to chronic HBV infection (especially in infants or young children, immunocompromised individuals, patients with diabetes) or fatal, fulminant hepatitis.^{105 213 281 282} Case fatality rate is 0.5–1.5% among those with acute HBV infection;^{213 281 290} highest fatality rates are in adults >60 years of age.^{213 281} Chronic HBV infection develops in ≥90% of infants infected perinatally, 25–50% of children infected at 1–5 years of age, and <5% of those infected at ≥5 years of age.^{105 213 281 282 290 291} Chronic infection is associated with persistent HBV replication in the liver and may result in liver cirrhosis, liver cancer, liver failure, and death.^{105 213 281 282 290} HBV is transmitted by percutaneous or mucosal exposure to hepatitis B surface antigen-positive (HBsAg-positive) blood, serum, plasma, semen, or saliva^{105 130 213 269 281 282} and can be transmitted perinatally from mother to infant at birth, usually as the result of blood exposures during labor and delivery.^{105 213 282}

USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and American Academy of Family Physicians (AAFP) recommend that all neonates and infants and all previously unvaccinated children and adolescents through 18 years of age be vaccinated against HBV infection, unless contraindicated.^{105 112 213 241} (See Contraindications under Cautions.)

ACIP, AAFP, American College of Obstetricians and Gynecologists (ACOG), and American College of Physicians (ACP) recommend that all unvaccinated adults at risk for HBV infection be vaccinated against HBV.^{280 281} (See Preexposure Vaccination Against Hepatitis B Virus [HBV] Infection in High-risk Groups under Uses.) ACIP also states that any unvaccinated adult requesting protection from HBV can receive the vaccine, unless contraindicated.^{280 281} (See Contraindications under Cautions.)

For internationally adopted children whose immune status is uncertain, vaccinations can be repeated or serologic tests performed to confirm immunity.¹³¹ For hepatitis B vaccine (HepB vaccine), ACIP states initiate or complete the age-appropriate HepB vaccine series if vaccination history is uncertain or <3 doses were previously given.¹³¹ (See Dosage and Administration.) If child's records indicate ≥3 doses of HepB vaccine, ACIP states that additional doses not necessary if ≥1 dose was given at ≥24 weeks of age; if most recent dose was at <24 weeks, give an additional dose at ≥24 weeks.¹³¹ Regardless of vaccination status, test for HBsAg if individual was born in Asia, Pacific Islands, Africa, or other regions where HBV is highly endemic.¹³¹ AAP recommends serologic testing for HBsAg in all internationally adopted children and states that the HepB vaccine series should be given if such testing is not available and vaccination history is uncertain.¹⁰⁵

Combined active immunization with HepB vaccine and passive immunization with hepatitis B immune globulin (HBIG) is used to prevent perinatal HBV infection in neonates born to women known or suspected to be HBsAg-positive.^{105 112 132 133 213} (See Prevention of Perinatal Hepatitis B Virus [HBV] Infection under Uses.)

Active immunization with HepB vaccine with or without passive immunization with HBIG is used for HBV postexposure prophylaxis (PEP) in certain individuals exposed to HBV or HBsAg-positive materials (e.g., health-care personnel, sexual assault victims, sexual or intimate contacts of individuals with acute or chronic HBV infection).^{101 130 269 281 290} (See Postexposure Prophylaxis of Hepatitis B Virus [HBV] Infection under Uses.)

With the exception of hepatitis D virus (HDV) infection,^{105 133} monovalent HepB vaccine will not prevent hepatitis caused by other viruses known to infect the liver, including hepatitis A virus (HAV), hepatitis C virus (HCV), or hepatitis E virus (HEV).^{105 132 133} HDV occurs only as a coinfection or superinfection in patients with HBV infection; individuals immune to HBV also should be immune to HDV.^{105 133}

When a dose of HepB vaccine and a dose of Haemophilus influenzae type b (Hib) vaccine are both indicated in an infant 6 weeks to 15 months of age born to an HBsAg-negative woman, the commercially available fixed-combination vaccine containing Hib conjugate (meningococcal protein conjugate) vaccine and HepB vaccine (Hib-HepB; Comvax) can be used.^{213 251} ACIP states this fixed-combination vaccine also may be used to complete the HepB vaccine series in infants 6 weeks to 15 months of age born to HBsAg-positive women†.²¹³ Comvax should not be used for the initial (birth) dose of HepB vaccine that is indicated in neonates.^{105 213}

When there are no contraindications to any of the individual components, the commercially available fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix) can be used in infants and children 6 weeks through 6 years of age born to HBsAg-negative women.¹⁰⁴ ACIP states this fixed-combination vaccine also may be used to complete the HepB vaccine series in infants ≥6 weeks of age born to HBsAg-positive women†.²¹³ Pediarix should not be used for the initial (birth) dose of HepB vaccine that is indicated in neonates.^{104 105} Pediarix contains diphtheria, tetanus, and pertussis antigens identical to those contained in Infanrix DTaP vaccine and contains HBV antigen identical to that contained in Engerix-B HepB vaccine.¹⁰⁴

When vaccination against both HBV and HAV is indicated in adults ≥18 years of age, the commercially available fixed-combination vaccine containing hepatitis A virus vaccine inactivated and HepB vaccine (HepA-HepB; Twinrix) can be used.^{213 262 281}

Preexposure Vaccination Against Hepatitis B Virus (HBV) Infection in High-risk Groups

Preexposure vaccination in previously unvaccinated children, adolescents, or adults at risk of exposure to HBsAg-positive materials (e.g., blood, plasma, serum).^{130 132 133 233}

ACIP recommends preexposure vaccination for all unvaccinated adults in settings in which a high proportion of individuals are likely to be at risk for HBV infection.^{130 132 133 233} This includes health-care personnel, selected patients and patient contacts, populations with high risk of infection, individuals at risk because of their sexual practices, military personnel identified as being at increased risk, and other individuals at risk of exposure (e.g., injection drug abusers).^{130 132 133 233}

In settings in which a high proportion of individuals are likely to be at risk for HBV, ACIP recommends universal vaccination for all adults who have not completed the HepB vaccine series and suggests standing orders to administer the vaccine as part of routine services to all susceptible individuals who visit these settings.²⁸¹ This includes facilities that test and treat sexually transmitted diseases (STDs) and HIV, facilities that provide drug abuse treatment and prevention, health-care facilities targeting services for injection drug abusers or men who have sex with men, and correctional facilities.²⁸¹ In addition, because not all adults with HBV risk factors visit these settings, ACIP recommends that primary care and specialty medical settings (e.g., physician offices, community health centers, family planning clinics, liver disease clinics, travel clinics) implement standing orders to identify susceptible adults and provide HepB vaccine whenever indicated or requested as part of regular preventive care.²⁸¹

Health-care personnel at risk of exposure to blood, blood-contaminated body fluids, other body fluids, and/or needles that might be contaminated with HBsAg are at risk of HBV infection and should be vaccinated against HBV.^{180 181 182 183 185 206 233 269 282} ACIP and Hospital Infection Control Practices Advisory Committee (HICPAC) recommend HBV vaccination for all such health-care personnel (e.g., physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, phlebotomists, medical and laboratory technicians, hospital volunteers, administrative and support staff in health-care institutions).²³³ Ideally, the HepB vaccine series should be completed during medical, dental, nursing, laboratory technology, and other allied health professional training so that immunity is provided before exposure in high-risk environments.²³³ (For information on HBV postexposure prophylaxis in unvaccinated health-care personnel, see Postexposure Prophylaxis of Hepatitis B Virus [HBV] Infection under Uses.)

Individuals with hemophilia or other congenital bleeding disorders who are seronegative for HBV should be vaccinated against HBV.^{100 101 132 133 288} If immunization against HBV was not initiated at birth, initiate HepB vaccine series at the time hemophilia or other congenital bleeding disorders are diagnosed.²⁸⁸ Improved donor screening, more effective viral-inactivation procedures, and/or purification or filtration procedures have reduced, but not completely eliminated, the risk of transmission of blood-borne viruses (HBV, HCV, HIV) from plasma-derived clotting factors.²⁸⁸ The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) recommends postvaccination testing in individuals with hemophilia^{100 288} and states that nonresponders (i.e., those who do not respond to the primary HepB vaccine series) should receive ≥1 additional doses of the vaccine.¹⁰⁰ (See Pre- and Postvaccination Serologic Testing under Cautions.)

Patients and staff of hemodialysis, organ transplant, or oncology wards are at high risk of exposure to HBsAg-positive materials and should be vaccinated against HBV.^{101 220} Although seroconversion rates and anti-HBs titers induced by vaccination are lower in hemodialysis patients than in healthy individuals, vaccination provides protection against HBV infection in responders and reduces the need for frequent serologic screening.^{101 203 204 220} ACIP recommends identifying potential candidates as early as possible in the course of their renal disease; there is some evidence that higher seroconversion rates and anti-HBs titers are achieved in uremic patients if they are vaccinated before requiring dialysis.^{101 199 220}

Residents and staff of institutions for the developmentally disabled, including those in small (group) residential settings, are at high risk of exposure to HBsAg-positive materials and should be vaccinated.¹⁰¹ Residents discharged from residential institutions into community settings should be screened for HBsAg so that appropriate measures can be taken to prevent transmission in the community; such measures include both environmental controls and appropriate vaccination.¹⁰¹

Classroom contacts (teachers or classmates) of aggressive, deinstitutionalized developmentally disabled individuals are at high risk of exposure to HBsAg-positive materials.^{101 186} HBV vaccination of classroom contacts of HBsAg carriers is strongly encouraged when the carrier is aggressive or has special medical problems that increase the risk of exposure to their blood or serous secretions.^{101 186} In addition, staff of nonresidential day-care programs (e.g., schools, sheltered workshops for the developmentally disabled) attended by known HBsAg carriers have a risk of infection comparable to that among health-care personnel and should be vaccinated.^{101 200 205} Also consider vaccination of other enrollees in such day-care programs.^{101 205}

Spouses and nonsexual household and sexual contacts of HBsAg carriers are at high risk of exposure to HBsAg-positive materials.¹⁰¹ When carriers are identified through routine screening of donated blood, diagnostic testing in hospitals, prenatal screening, screening of refugees from certain areas, or other screening programs, they should be notified of their HBsAg status.¹⁰¹ Although some unvaccinated spouses and nonsexual household and sexual contacts of HBsAg carriers may develop immunity against HBV infection during continuous, long-term exposure, all such contacts should be tested and those who are susceptible should be vaccinated.¹⁰¹

Certain US population groups with high endemic rates of HBV (e.g., native Alaskans, Pacific Islanders, refugees from HBV-endemic areas) are at increased risk and should be vaccinated against HBV.^{101 105 213 222} Because transmission occurs principally during childhood in such populations, initiation of the HepB vaccine series at birth and completion of the series by 6–12 months of age is particularly important in these groups.^{105 213 222} Because of high rate of interfamily transmission among children in these populations, vaccination efforts should target all susceptible children and adolescents who have ≥1 parent born in a highly endemic area.^{105 281}

Individuals at high risk of HBV because of their sexual practices (e.g., men who have sex with men, individuals with >1 sexual partner in the previous 6 months, sexual partners of HBsAg-positive individuals,^{101 130 132 133 281} female prostitutes^{132 133} ) and individuals seeking evaluation or treatment for STDs should be vaccinated against HBV.^{101 130 132 133 281 282} HepB vaccine is recommended for all susceptible adolescent and adult men who have sex with men (homosexual, bisexual), regardless of age or duration of such sexual practices.^{130 132 133 282}

Travelers to areas with levels of endemic HBV that are intermediate (2–7%) or high (≥8%) are at risk of exposure to the disease.^{101 125 274} ACIP, CDC, and others recommend preexposure vaccination for previously unvaccinated travelers (neonates, infants, adolescents, adults) traveling to such areas.^{101 125 274} HBV prevalence is intermediate in South Central and Southwest Asia, Israel, Japan, Eastern and Southern Europe, Russia, and most areas surrounding the Amazon River basin, Honduras, and Guatemala; prevalence is high in Africa, Southeast Asia (including China, Korea, Indonesia, and Philippines), Middle East (except Israel), southern and western Pacific islands, interior Amazon Basin, and certain parts of the Caribbean (e.g., Haiti, Dominican Republic).^{125 274}

Morticians and embalmers are at high risk of exposure to HBsAg-positive materials; the manufacturers recommend use of HepB vaccine in these individuals.^{132 133}

Military personnel may be at increased risk of exposure to HBV; the manufacturers recommend use of HepB vaccine in these individuals.^{132 133}

Prisoners may be at increased risk of exposure to HBV; the manufacturers recommend use of HepB vaccine in these individuals.^{132 133}

Public-safety personnel (e.g., police, fire department personnel) may be at risk for occupational exposure to HBV (depending on tasks performed); those who have contact with blood or blood-contaminated body fluids should be vaccinated.²⁸¹

Individuals with chronic HCV infection may be at increased risk for HBV exposure and should be vaccinated.^{132 133} Optimal HepB vaccine regimen for such individuals has not been identified; response to HepB vaccine may be reduced in individuals with chronic HCV infection.^{267 268}

Individuals addicted to parenterally administered drugs are at high risk of exposure to HBsAg-positive materials and should be vaccinated against HBV as soon as their drug use is identified.¹³³

Individuals in casual contact with HBsAg carriers in settings such as schools, offices, and business environments are at minimal risk of HBV exposure.¹⁰¹ ACIP does not recommend routine use of HepB vaccine in these individuals.¹⁰¹ At child-care centers (other than those for the developmentally disabled), HBV transmission between children or between children and staff has rarely been documented.¹⁰¹ ACIP states that vaccination of contacts of HBsAg carriers in child-care settings is not necessary unless there are special circumstances that might facilitate transmission (e.g., behavior problems such as biting or scratching, medical conditions such as severe skin disease).¹⁰¹

Prevention of Perinatal Hepatitis B Virus (HBV) Infection

Prevention of perinatal HBV infection in neonates born to HBsAg-positive women.^{105 112 132 133 213}

A combined regimen that includes active immunization with HepB vaccine and passive immunization with HBIG is 85–95% effective in preventing acute and chronic HBV infection in infants born to women positive for both HBsAg and HBeAg.^{105 213}

ACIP and AAP recommend routine serologic screening of all pregnant women during an early prenatal visit (e.g., first trimester) to determine their HBsAg status, even if they were tested previously or have already been vaccinated against HBV.^{105 112 213} Women who were not tested prenatally, those who engage in behaviors that put them at high risk for HBV (e.g., >1 sex partner in the previous 6 months, HBsAg-positive sex partner, evaluation or treatment for STDs, recent or current injection drug abuse) and those with clinical hepatitis should be tested for HBsAg status when admitted to the hospital for delivery.^{105 213}

To prevent perinatal HBV infection, ACIP and AAP recommend that all neonates born to HBsAg-positive women receive a dose of HepB vaccine and a dose of HBIG as soon as possible after birth (within 12 hours of birth), regardless of gestational age or birthweight.^{105 112 213} For neonates <2 kg, do not count the birth vaccine dose toward completion of the HepB vaccine series; begin usual 3-dose vaccine series when infant is 1 month of age.^{105 213}

If maternal HBsAg status is unknown at birth, give infant the first dose of HepB vaccine (within 12 hours of birth).^{105 112 213} Determine mother's HBsAg status as quickly as possible and, if positive, give infant a dose of HBIG as soon as possible (no later than 7 days of age).^{105 112} For neonates weighing <2 kg, if the mother's HBsAg status cannot be determined within 12 hours of birth, give a dose of HBIG as soon as possible (within 12 hours of birth) and do not count the birth vaccine dose toward completion of the HepB vaccine series; begin usual 3-dose vaccine series when infant is 1 month of age.^{105 213}

Postexposure Prophylaxis of Hepatitis B Virus (HBV) Infection

HBV postexposure prophylaxis (PEP) in certain individuals exposed to HBV or HBsAg-positive materials (e.g., health-care personnel, sexual assault victims, sexual or intimate contacts of individuals with acute or chronic HBV infection).^{101 130 269 281 290}

Depending on exposure circumstances, PEP regimen may include combined active immunization with HepB vaccine and passive immunization with HBIG to provide both short- and long-term protection.^{101 130 269 281 290}

PEP may be indicated in susceptible, unvaccinated health-care personnel following occupational exposure to blood and other body fluids that might contain HBV.²⁶⁹ If an occupational exposure to HBV occurs, review vaccination status and vaccine-response status (if known) of exposed individual and HBsAg status of source.²⁶⁹ (See Table 1.)

If exposed individual was not previously vaccinated against HBV, initiate HepB vaccine series as soon as possible (preferably within 24 hours).²⁶⁹ In addition, if source is found to be HBsAg-positive, give a dose of HBIG as soon as possible (preferably within 24 hours).²⁶⁹

If exposed individual was previously vaccinated against HBV and is a known responder (serum anti-HBs ≥10 mIU/mL), PEP is not necessary.²⁶⁹ If exposed individual was previously vaccinated against HBV but is a known nonresponder (serum anti-HBs <10 mIU/mL), PEP is not necessary if source is HBsAg-negative.²⁶⁹ However, if source is HBsAg-positive or known to be high-risk for HBV, give exposed individual a dose of HBIG and initiate a second HepB vaccine series as soon as possible after exposure.²⁶⁹ A 2-dose regimen of HBIG (without HepB vaccine) is preferred in individuals who already previously failed to respond to a second vaccine series.²⁶⁹

If antibody status of exposed individual is unknown, test them for anti-HBs prior to initiation of PEP.²⁶⁹ If exposed individual is found to be a responder (serum anti-HBs ≥10 mIU/mL), PEP is not necessary.²⁶⁹ If exposed individual is found to be a nonresponder (anti-HBs levels <10 mIU/mL) and source is HBsAg-positive, give a dose of HBIG and a booster dose of HepB vaccine.²⁶⁹ If exposed individual is found to be a nonresponder and source is unknown or not available for testing, give a booster dose of HepB vaccine and recheck antibody titer in 1–2 months.²⁶⁹

Table 1. Postexposure Prophylaxis of HBV following Occupational (Percutaneous or Mucosal) Exposure to Blood269

	Treatment when Source Is:
Vaccination and Antibody Status of Exposed Individual	HBsAg-positive	HBsAg-negative	Source Unknown or Not Available for Testing
Unvaccinated	Single HBIG dose (within 24 hours) and initiate hepatitis B vaccine series (within 24 hours)	Initiate hepatitis B vaccine series	Initiate hepatitis B vaccine series
Previously vaccinated
Known responder (anti-HBs 10 mIU/mL or greater)	No treatment	No treatment	No treatment
Known nonresponder (anti-HBs less than 10 mIU/mL)	Single HBIG dose and initiate hepatitis B revaccination series or 2 HBIG doses (first dose as soon as possible; second dose 1 month later)	No treatment	If known high-risk source, treat as if source were HBsAg-positive
Antibody response unknown	Test exposed individual for anti-HBs	No treatment	Test exposed individual for anti-HBs
	1. If inadequate, single dose of HBIG and a booster dose of hepatitis B vaccine		1. If inadequate, give a booster dose of hepatitis B vaccine and recheck titer in 1–2 months
	2. If adequate, no treatment		2. If adequate, no treatment

ACIP and CDC recommend PEP with HepB vaccine for victims of sexual assault (adult, adolescent, child) who are susceptible to HBV.^{130 281} PEP after a sexual assault is not necessary in those who previously received the complete HepB vaccine series.¹³⁰ If victim is unvaccinated or incompletely vaccinated and perpetrator is HBsAg-positive, give a dose of HBIG within 14 days of the assault (preferably within 24 hours) and initiate or complete HepB vaccine series.^{130 281}

ACIP and CDC recommend PEP with HepB vaccine for sexual or needle-sharing partners and nonsexual household contacts of individuals with chronic HBV infection.^{130 281} Because most HBsAg-positive individuals are identified during routine screening (e.g., blood donation, prenatal evaluation) or clinical evaluation and it may be difficult to identify the time of last contact, use of HBIG is not considered necessary for PEP in contacts of such individuals.²⁸¹ A dose of HBIG may be indicated if the most recent sexual exposure to an HBsAg-positive individual occurred within the last 14 days.¹³⁰ Consider postvaccination serologic testing in sexual contacts of individuals with chronic HBV infection.²⁸¹ Although most are expected to respond to vaccination, initiate a second complete HepB vaccine series in nonresponders.²⁸¹ If there is no response to the second vaccine series, provide counsel about abstinence and use of other methods to protect themselves from HBV via sexual transmission.²⁸¹

ACIP and CDC recommend that previously unvaccinated sexual partners of individuals with acute HBV infection receive PEP with a dose of HBIG and the initial dose of the HepB vaccine series (within 14 days of the most recent sexual contact).^{130 281} Completion of the vaccine series confers long-term protection in case the individual with acute HBV infection becomes chronically infected.^{130 281} Consider prevaccination serologic testing of sexual partners, but only if it does not delay postexposure vaccination beyond 14 days.²⁸¹

AAP recommends that unvaccinated infants <12 months of age in close contact with a mother or other primary caregiver who has acute HBV infection receive combined passive immunization with HBIG and active immunization with HepB vaccine.¹⁰⁵ If the infant previously received a single dose of HepB vaccine, give the second vaccine dose if the interval is appropriate or, if it is too soon to give a vaccine dose, give a dose of HBIG.¹⁰⁵ HBIG is not required if, at the time of exposure, the infant has already received ≥2 doses of HepB vaccine.¹⁰⁵

Other nonsexual household contacts of individuals with acute HBV infection are not at increased risk for infection unless they have other risk factors or are exposed to the blood of the infected patient (e.g., by sharing a toothbrush or razor).^{105 130} However, encourage all household contacts of patients with acute HBV infection to receive HepB vaccine.^{105 130} If the patient with acute HBV infection becomes chronically infected (i.e., remains HBsAg-positive after 6 months), all household contacts should be vaccinated with HepB vaccine.¹³⁰

CDC recommends that individuals wounded in bombings or other mass casualty settings who are unvaccinated or have an uncertain vaccination history receive postexposure vaccination with HepB vaccine (without HBIG), unless contraindicated.²⁹⁰ HepB vaccine generally is warranted in such individuals if they have wounds (penetrating injuries), nonintact skin, or mucous membranes that may have been exposed to blood or body fluids from other individuals.²⁹⁰ If the vaccine is in short supply, consider that children <17 years of age and health-care personnel are more likely to have previously received the vaccine than other individuals.²⁹⁰ Responders and other personnel in mass casualty settings should be managed using PEP regimens recommended for occupational exposures to HBV.²⁹⁰ (See Table 1.)

PEP not necessary in individuals who previously received primary immunization with HepB vaccine and have serologic evidence of adequate levels of anti-HBs (≥10 mIU/mL).²⁶⁹

PEP not necessary in individuals previously infected with HBV; such individuals are immune to reinfection.^{269 282}

Hepatitis B Vaccine Dosage and Administration

Administration

IM Injection

Administer monovalent HepB vaccine (Engerix-B, Recombivax HB) by IM injection.^{132 133} May be administered by sub-Q injection when necessary in individuals at risk of hemorrhage following IM injection.^{132 133} (See Individuals with Bleeding Disorders under Cautions.) Do not administer IV or intradermally;^{101 132 133 251 262} there is evidence that intradermal administration may be associated with reduced immunogenicity.^{101 207 209}

Administer fixed-combination vaccine containing Hib vaccine and HepB vaccine (Hib-HepB; Comvax) by IM injection.²⁵¹ Do not administer sub-Q or IV.²⁵¹

Administer fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix) by IM injection.¹⁰⁴ Do not administer sub-Q or IV.¹⁰⁴

Administer fixed-combination vaccine containing HepA vaccine and HepB vaccine (HepA-HepB; Twinrix) by IM injection.²⁶² Do not administer sub-Q or IV.²⁶²

Shake vaccine well immediately prior to administration to provide a uniform, turbid, white suspension.^{104 133} Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.^{104 133}

Do not dilute.¹³³ Do not mix with any other vaccine or solution.¹⁰⁴

Depending on patient age, administer IM into the deltoid muscle or anterolateral thigh.^{101 104 105 131 132 133 213} To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.¹³¹

For neonates and young children (up to 12 months of age), IM injections should be made into the anterolateral thigh.^{101 104 105 132 133 213 282} For children 1–2 years of age, IM injections should preferably be administered into the anterolateral thigh; the deltoid muscle is an alternative if muscle mass is adequate.¹³¹ For adults, adolescents, and children ≥3 years of age, the deltoid muscle is preferred, although the anterolateral thigh is an alternative.^{101 104 105 131 132 133 282}

Generally do not administer vaccines into buttock muscle in children because of potential for injection-associated injury to sciatic nerve.¹³¹

Although some experts state that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) can be performed to ensure that a blood vessel has not been entered, ACIP and AAP state this procedure is not required because large blood vessels are not present at recommended IM injection sites.^{105 131}

Since syncope may occur following vaccination, observe vaccinee for approximately 15 minutes after the vaccine dose is administered.¹³¹ If syncope occurs, observe the patient until symptoms resolve.¹³¹ Syncope after vaccination occurs most frequently in adolescents and young adults.¹³¹

Monovalent HepB may be given simultaneously with HBIG (using different syringes and different injection sites) when passive immunization is considered necessary in addition to active immunization with the vaccine (e.g., in neonates born to HBsAg-positive women, PEP regimen in certain individuals exposed to HBV or HBsAg-positive materials).^{105 112 131 213 281}

May be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites).^{131 133 213} (See Interactions.)

When multiple vaccines are administered during a single health-care visit, each vaccine should be given with a different syringe and at different injection sites.^{131 213} Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.^{131 213} If multiple vaccines must be given into a single limb, the deltoid may be used in older children and adults, but the anterolateral thigh is preferred in infants and younger children.^{131 213}

Dosage

Dose and dosing schedule vary depending on the individual's age and specific vaccine administered, HBsAg status of the mother (for neonates), and presence of underlying disease.^{104 105 125 132 133 213 217} Follow dosage recommendations for the specific preparation used.^{101 105}

Currently available monovalent HepB vaccines (Engerix-B, Recombivax HB) generally are considered interchangeable; HepB vaccine series started with one monovalent vaccine may be completed using a different vaccine given in dosage recommended for the specific formulation.^{105 213}

Use only monovalent HepB vaccine (Engerix-B, Recombivax HB) for the initial (birth) dose in neonates or infants <6 weeks of age.^{105 112} Complete the vaccine series using monovalent or age-appropriate fixed-combination vaccines.^{105 112}

The complete HepB vaccine series must be administered to ensure optimal protection.^{105 213} Interruptions resulting in an interval between doses longer than recommended should not interfere with the final immunity achieved; it is not necessary to give additional doses or start the vaccine series over.^{104 105 213}

If the vaccine series is interrupted after the initial dose, give second dose as soon as possible (minimum interval between first and second dose is 4 weeks) and give third dose at least 8 weeks after the second dose (minimum interval between first and third dose is 16 weeks).^{112 213 269 281 282} If only the third dose is delayed, administer as soon as possible.^{213 269} Infants should receive the final dose at ≥24 weeks of age.^{112 213 282}

Pediatric Patients

Prevention of Hepatitis B Virus (HBV) Infection (Monovalent Vaccines)

Neonates and Infants (Engerix-B)

IM

Primary immunization consists of 3 doses.^{112 133 213} Use pediatric/adolescent formulation containing 10 mcg/0.5 mL.¹³³

Manufacturer recommends 10-mcg doses at 0, 1, and 6 months.¹³³ Alternatively, manufacturer recommends a 4-dose regimen consisting of 10-mcg doses at 0, 1, 2, and 12 months.¹³³

Full-term neonates born to HBsAg-positive women or women with unknown HBsAg status: Give initial dose of 10 mcg within 12 hours of birth.^{105 112 213} ACIP, AAP, and AAFP recommend that second and third 10-mcg doses be given at 1–2 and 6 months of age, respectively.^{105 112 213} Give third dose no earlier than 24 weeks of age.^{112 213} (See Prevention of Perinatal Hepatitis B Virus [HBV] Infection under Dosage and Administration.)

Full-term neonates born to HBsAg-negative women: Give initial dose of 10 mcg at birth (before hospital discharge).^{105 112 213} ACIP, AAP, and AAFP recommend that second and third 10-mcg doses be given at 1–2 and 6–18 months of age, respectively.^{112 213} If not given before hospital discharge, give initial d

Fosfomycin Tromethamine

Class: Urinary Anti-infectives
VA Class: AM900
Chemical Name: (1R,2S)-(1,2-Epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
Molecular Formula: C₃H₇O₄P•C₄H₁₁N O₁₃
CAS Number: 78964-85-9
Brands: Monurol

Introduction

Antibacterial; phosphonic acid derivative.¹

Uses for Fosfomycin Tromethamine

Urinary Tract Infections (UTIs)

Treatment of uncomplicated UTIs (acute cystitis) in women when UTIs are caused by susceptible Escherichia coli or Enterococcus faecalis (formerly Streptococcus faecalis).^{1 2 3 4 5}

Do not use for treatment of pyelonephritis or perinephric abscesses.¹

If persistence or reappearance of bacteriuria occurs after fosfomycin treatment, do not repeat treatment; select another anti-infective.¹

Fosfomycin Tromethamine Dosage and Administration

Administration

Oral Administration

Administer orally.¹

May be taken with or without food.¹

Prepare oral solution by adding contents of a single-dose packet (sachet) containing 3 g of the drug to 90–120 mL of water;¹ do not use hot water.¹ Ingest immediately after preparation.¹

Do not administer as dry granules.¹

Dosage

Available as fosfomycin tromethamine; dosage expressed in terms of fosfomycin.¹

Adults

Urinary Tract Infections (UTIs)

Uncomplicated UTIs

Oral

3 g as a single dose.¹

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.¹

Renal Impairment

Dosage adjustment not necessary.⁶ (See Pharmacokinetics.)

Geriatric Patients

Dosage adjustment not necessary.¹ (See Geriatric Use under Cautions.)

Cautions for Fosfomycin Tromethamine

Contraindications

• 
  

  Known hypersensitivity to fosfomycin or any ingredient in the formulation.¹

  
  

Warnings/Precautions

General Precautions

Retreatment

Do not use more than a single dose to treat a single episode of acute cystitis; repeated daily doses do not enhance efficacy and increase incidence of adverse events.¹

Selection and Use of Anti-infectives

Obtain urine specimens for culture and in vitro susceptibility testing before and after completion of therapy.¹

To reduce development of drug-resistant bacteria and maintain effectiveness of fosfomycin and other antibacterials, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether distributed into breast milk.¹

Potential for serious adverse reactions in nursing infants; discontinue nursing or do not administer drug.¹

Pediatric Use

Safety and efficacy not established in children ≤12 years of age.¹ Manufacturer make no specific dosage recommendations for pediatric patients.¹

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.¹ No evidence of substantial differences in safety and efficacy relative to younger adults.¹

Although dosage adjustment not usually necessary, select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.¹

Common Adverse Effects

Diarrhea.¹

Interactions for Fosfomycin Tromethamine

Drugs that Increase GI Motility

May decrease serum and urine concentrations of fosfomycin.¹

Specific Drugs

Drug	Interaction	Comments
Cimetidine	Pharmacokinetics of fosfomycin not affected1
Metoclopramide	Decreased serum concentrations and decreased urinary excretion of fosfomycin1

Fosfomycin Tromethamine Pharmacokinetics

Absorption

Bioavailability

Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin.¹ Peak serum concentrations attained within 2–4 hours.¹

Food

Food decreases oral bioavailability;¹ bioavailability is 37% and 30% under fasting and fed conditions, respectively.¹

Cumulative amount of drug excreted in urine is similar whether the drug is given with or without food.¹

Distribution

Extent

Distributed to kidneys, bladder wall, prostate, and seminal vesicles.¹

Crosses the placenta.¹

Plasma Protein Binding

Not bound to plasma proteins.¹

Elimination

Elimination Route

Eliminated unchanged in urine (38% of an oral dose) and feces (18% of an oral dose).¹

Peak urine concentrations achieved within 2–4 hours or 6–8 hours under fasting or fed conditions, respectively; cumulative amount excreted in urine is similar.¹

Half-life

5.7 hours.¹

Special Populations

Geriatric adults: Pharmacokinetics similar to that reported in younger adults.¹

Renal impairment: Decreased elimination and prolonged half-life.¹ Half-life ranges up to 50 hours in patients with renal impairment.¹

Stability

Storage

Oral

Powder

25°C (may be exposed to 15–30°C).¹

Actions and SpectrumActions

• 
  

  Phosphonic acid derivative,⁵ synthetic antibacterial agent.¹

  
  


• 
  

  Bactericidal in urine when administered in therapeutic doses.^{1 5}

  
  


• 
  

  Antibacterial activity results from interference with bacterial cell wall synthesis by inhibiting the enzyme enolpyruvyl transferase that catalyzes the formation of uridine diphosphate-N-acetylmuramic acid in the first step of bacterial cell wall synthesis.^{1 4 5} Also reduces adherence of bacteria to uroepithelial cells.^{1 5}

  
  


• 
  

  Active in vitro against a broad spectrum of gram-negative and gram-positive bacteria, including those commonly associated with uncomplicated UTIs.^{1 4 5} Active in vitro and in vivo against Escherichia coli and Enterococcus faecalis.¹

  
  


• 
  

  Cross-resistance generally does not occur between fosfomycin and other antibacterial agents (e.g., β-lactams, aminoglycosides).¹

  
  

Advice to Patients

• 
  

  Importance of diluting granules with water (not hot water) just prior to administration.¹

  
  


• 
  

  Advise patient that fosfomycin may be taken with or without food.¹

  
  


• 
  

  Importance of contacting clinician if UTI symptoms do not improve within 2–3 days after treatment.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Fosfomycin Tromethamine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For solution	3 g (of fosfomycin) per packet	Monurol Sachet	Forest

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Monurol 3GM Packet (FOREST): 1/$50.86 or 3/$139.89

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Forest Pharmaceuticals, Inc. Monurol (fosfomycin tromethamine) powder prescribing information. St. Louis, MO; 2004 May.

2. Elhanan G, Tabenkin H, Yahalom R et al. Single-dose fosfomycin trometamol versus 5-day cephalexin regimen for treatment of uncomplicated lower urinary tract infections in women. Antimicrob Agents Chemother. 1994; 38:2612-4. [IDIS 337800] [PubMed 7872756]

3. Selvaggi FP, Ditonno P, Traficante A et al. Fosfomycin trometamol (Monuril) versus norfloxacin in single dose for adult female uncomplicated UTIs: multicenter randomized, double-blind study. Chemotherapy. 1990; 36(Suppl 1):31-3. [IDIS 297402] [PubMed 2085986]

4. Reeves DS. Fosfomycin trometamol. J Antimicrob Chemother. 1994; 34:853-8. [IDIS 343321] [PubMed 7730229]

5. Patel SS, Balfour JA, Bryson HM. Fosfomycin tromethamine: a review of its antibacterial activity, pharmacokinetic properties and therapeutic efficacy as a single-dose oral treatment for acute uncomplicated lower urinary tract infections. Drugs. 1997; 53:637-56. [PubMed 9098664]

6. Forest Pharmaceuticals, Inc, St. Louis, MO: Personal communication.

More Fosfomycin Tromethamine resources

• Fosfomycin Tromethamine Side Effects (in more detail)
• Fosfomycin Tromethamine Use in Pregnancy & Breastfeeding
• Fosfomycin Tromethamine Drug Interactions
• Fosfomycin Tromethamine Support Group
• 2 Reviews for Fosfomycin Tromethamine - Add your own review/rating

Compare Fosfomycin Tromethamine with other medications

• Bladder Infection
• Transurethral Prostatectomy

Pulmicort Flexhaler

Generic Name: budesonide (Inhalation route)

bue-DES-oh-nide

Commonly used brand name(s)

In the U.S.

• Pulmicort


• Pulmicort Flexhaler


• Pulmicort Respules


• Pulmicort Turbuhaler

In Canada

• Pulmicort Nebuamp


• Rhinocort Turbuhaler

Available Dosage Forms:

• Suspension


• Powder


• Solution


• Aerosol Powder


• Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Pulmicort Flexhaler

Budesonide is used to help prevent the symptoms of asthma. When used regularly every day, inhaled budesonide decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Budesonide is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe. Inhaled budesonide may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs.

This medicine is available only with your doctor's prescription.

Before Using Pulmicort Flexhaler

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Respules® in children 12 months to 8 years of age. However, safety and efficacy have not been established in children younger than 12 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Flexhaler™ in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving inhaled budesonide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Boceprevir


• Bupropion


• Telaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin


• Itraconazole


• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute—Should not be used in patients with this condition.

• Bone problems (e.g., osteoporosis) or


• Cataracts or


• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox, including recent exposure or


• Measles or


• Herpes simplex virus infection of the eye or


• Infections (virus, bacteria, or fungus) or


• Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.

• Milk protein allergy, severe—Use with caution. The Pulmicort Flexhaler™ contains lactose (milk sugar with milk protein), which may cause side effects for patients with this condition.

Proper Use of budesonide

This section provides information on the proper use of a number of products that contain budesonide. It may not be specific to Pulmicort Flexhaler. Please read with care.

Inhaled budesonide is used to prevent asthma attacks. It is not used to stop an attack that has already started. For relief of an asthma attack that has already started, you or your child should use another medicine. If you do not have another medicine to use for an acute asthma attack or if you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor. This medicine usually begins to work in about 24 to 48 hours, but up to 2 to 6 weeks may pass before you feel the full effects.

Do not change your dose or stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

When using the Pulmicort Flexhaler™:

• This medicine comes as a powder that you breathe into the lungs with a special inhaler that is placed in the mouth. It is used by adults, teenagers, and children who are 6 years of age and older.


• The medicine comes with patient instructions. Read the instructions carefully before using this medicine. If you or your child do not understand the instructions or are not sure how to use the inhaler, check with your doctor.


• When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Before using this medicine, test or prime it.


• Hold the inhaler so that the white cover points up, then twist the cover and lift it off. Hold the inhaler upright (mouthpiece up) using the brown grip, then twist the middle of the inhaler fully in one direction as far as it will go, and then back again in the other direction. You will hear a click. Repeat this process one more time.


• You do not have to prime it again after this, even if you have not used it for a long time.


• After the inhaler is primed, twist the cover and lift it off.


• To load a dose, hold the inhaler in the upright position, then twist the grip fully in one direction as far as it will go, and then fully back again in the other direction. You will hear a click.


• Turn your head away from the inhaler and breathe out. Do not shake the inhaler.


• Place the mouthpiece between your lips and breathe in deeply and forcefully. You may not taste or feel the medicine.


• Do not chew or bite on the mouthpiece.


• Remove the inhaler from your mouth and breathe out. Do not blow or breathe into the inhaler.


• Repeat these steps if more than one dose is needed.


• When you are finished, place the cover back on the inhaler and twist shut. Rinse your mouth with water and spit out the water. Do not swallow the water. This helps prevent hoarseness, throat irritation, and infections in the mouth.


• Do not use the inhaler if it has been damaged or if the mouthpiece has become detached.


• Do not use a spacer with the Pulmicort Flexhaler™.


• Keep the inhaler clean and dry at all times. Follow the patient directions for cleaning and storing the inhaler.


• The inhaler has a dose indicator that keeps track of how many times you can use the inhaler before you need to open a new one. Check the dose indicator just below the mouthpiece. The dose indicator usually starts with either the number 60 or 120 when full.


• Discard the whole device when all doses have been used. The inhaler is empty when the number zero appears in the middle of the dose indicator window. You will be given a new inhaler each time you refill your prescription.

When using the Pulmicort Respules® liquid:

• This medicine comes as a liquid that you breathe into the lungs with a special breathing machine called a jet nebulizer. The nebulizer has a face mask or mouthpiece. It is used by children who are 12 months to 8 years of age.


• Your doctor will tell you which type of nebulizer to use with this medicine and will show you how to use the nebulizer. The medicine and nebulizer come with patient instructions. Read the instructions carefully before using the medicine or the machine. If you or your child do not understand the instructions or are not sure how to use the nebulizer, check with your doctor.


• Use this medicine at the same time each day, unless your child's doctor tells you otherwise.


• Do not mix this liquid with other medicines.


• Open the sealed aluminum foil envelope containing the medicine. Remove one container from the strip of five plastic containers with sealed caps. Write the current date on the back of the envelope when you open the foil pouch.


• Each container has one dose of medicine.


• Place the unused containers back in the foil pouch. This will protect the medicine from light.


• Shake the container in a circular motion before using it.


• Hold the container upright and open it by twisting off the cap.


• Slowly squeeze out all of the contents of the container into the nebulizer cup. Throw the empty container away.


• If your child is using a face mask, make sure that the mask fits tightly on the face to avoid getting the medicine in the eyes.


• Turn on the compressor to begin nebulizing the medication. The nebulizer turns the medicine into a fine mist that the child breathes into the lungs using the mouthpiece or mask.


• After the dose is completed, wash your child's face to prevent skin irritation.


• Rinsing your child's mouth with water after each dose may help prevent hoarseness, throat irritation, and infections in the mouth. Do not allow your child to swallow the water after rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For preventing an asthma attack:
  
  • For inhalation dosage form (powder inhaler):
    
    • Adults and children 6 years of age and older—At first, one or two puffs two times a day. Your doctor may increase your dose as needed.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For inhalation dosage form (suspension in a nebulizer):
    
    • Children 12 months to 8 years of age—0.5 to 1 milligram (mg) in a nebulizer once a day, or divided and given twice a day. Each container of liquid has one dose and a new container is used for each dose.
    
    
    • Infants younger than 12 months of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Pulmicort Flexhaler™ in a dry place at room temperature with the cover tightly in place.

Store the unused Pulmicort Respules® in an upright position at room temperature. Keep the medicine containers in the foil pouch until you are ready to use them. Do not freeze the containers. Once you have opened a foil pouch, the containers will only be good for 2 weeks. Throw away any unused containers if it has been longer than 2 weeks since you opened the pouch.

Precautions While Using Pulmicort Flexhaler

It is very important that your doctor check you or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects caused by this medicine.

You or your child should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor if you have any questions about this.

If your or your child's symptoms do not improve within one to two weeks, or if they become worse, check with your doctor.

This medicine may weaken your immune system. Avoid being around people who are sick or who have infections such as chickenpox or measles. Tell your doctor right away if you think you or your child have been exposed to chickenpox or measles.

If you or your child develop a skin rash, hives, or any type of allergic reaction (including anaphylaxis) to this medicine, stop using the medicine and check with your doctor as soon as possible.

This medicine may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you or your child have any signs of a throat infection.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.

This medicine may cause children to grow more slowly than normal. This would cause a child to not gain weight or get taller. Talk with your child's doctor if you think this is a problem or if you have any concerns.

This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist knows that you or your child are using this medicine. You might need to stop using this medicine several days before having surgery.

Your doctor may want you or your child to carry a medical identification card that says this medicine is being used. You or your child may need additional medicine during an emergency, a severe asthma attack, an illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Pulmicort Flexhaler Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain


• chills


• congestion


• cough


• diarrhea


• dryness or soreness of the throat


• fever


• general feeling of discomfort or illness


• headache


• hoarseness


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• pain or tenderness around the eyes and cheekbones


• shivering


• shortness of breath or troubled breathing


• sneezing


• sore throat


• stuffy or runny nose


• sweating


• tender, swollen glands in the neck


• tightness of the chest or wheezing


• trouble with sleeping


• trouble with swallowing


• unusual tiredness or weakness


• voice changes


• vomiting

Less common

• Bruising


• darkening of the skin


• depression


• dizziness


• earache


• excessive muscle tone


• fainting


• fractures


• large, flat, blue, or purplish patches in the skin


• lower back or side pain


• muscle stiffness


• muscle tension or tightness


• painful or difficult urination


• redness or swelling in the ear


• skin rash


• sore mouth or tongue


• white patches in the mouth or on the tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain

Less common

• Acid or sour stomach


• belching


• change in taste or bad, unusual, or unpleasant (after) taste


• difficulty with breathing


• difficulty with moving


• dry mouth


• ear congestion


• headache, severe and throbbing


• heartburn


• indigestion


• muscle cramping


• neck pain


• sleeplessness


• stomach discomfort, upset, or pain


• swollen joints


• unable to sleep


• unexplained runny nose or sneezing


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Pulmicort Flexhaler side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Pulmicort Flexhaler resources

• Pulmicort Flexhaler Side Effects (in more detail)
• Pulmicort Flexhaler Use in Pregnancy & Breastfeeding
• Pulmicort Flexhaler Drug Interactions
• Pulmicort Flexhaler Support Group
• 2 Reviews for Pulmicort Flexhaler - Add your own review/rating

• Pulmicort Flexhaler Concise Consumer Information (Cerner Multum)


• Pulmicort Flexhaler Prescribing Information (FDA)


• Pulmicort Flexhaler Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Budesonide Professional Patient Advice (Wolters Kluwer)


• budesonide Concise Consumer Information (Cerner Multum)


• Budesonide Monograph (AHFS DI)


• Entocort EC Prescribing Information (FDA)


• Entocort EC Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Pulmicort Respules Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Pulmicort Turbuhaler Powder MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Pulmicort Flexhaler with other medications

• Asthma, Maintenance

Kaletra

Pronunciation: loe-PIN-a-vir/rit-OH-na-vir
Generic Name: Lopinavir/Ritonavir
Brand Name: Kaletra

Kaletra is used for:

Treating HIV infection. It is used along with other medicines for HIV.

Kaletra is a combination of 2 HIV protease inhibitors. It works by stopping the HIV virus from multiplying.

Do NOT use Kaletra if:

• you are allergic to any ingredient in Kaletra


• you have a certain type of irregular heartbeat (congenital long QT syndrome) or low blood potassium levels


• you cannot swallow the tablet whole


• you are taking alfuzosin, astemizole, certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), cisapride, conivaptan, eletriptan, an ergot derivative (eg, ergotamine, methylergonovine), meperidine, oral midazolam, pimozide, rifampin, salmeterol, St. John's wort, terfenadine, tipranavir, or triazolam


• you are taking sildenafil to treat pulmonary arterial hypertension (PAH)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Kaletra:

Some medical conditions may interact with Kaletra. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have hepatitis, other liver problems, or abnormal liver function tests


• if you have high cholesterol or triglyceride levels, or hemophilia or another bleeding disorder


• if you have a history of kidney problems, pancreas problems (eg, pancreatitis), diabetes or high blood sugar (hyperglycemia), or low potassium or magnesium blood levels


• if you have a history of heart problems (eg, heart failure, conduction abnormalities), heart blood vessel problems, irregular heartbeat (eg, QT prolongation), or if you have a family member with a history of irregular heartbeat


• if you take another HIV protease inhibitor (eg, atazanavir, tipranavir)

Some MEDICINES MAY INTERACT with Kaletra. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Astemizole, cisapride, meperidine, pimozide, salmeterol, or terfenadine because serious side effects, such as seizures, blood problems, or heart problems (eg, irregular heartbeat), may occur


• Sildenafil (when used to treat PAH) because serious side effects, such as low blood pressure, prolonged erection, or vision changes, may occur


• Midazolam or triazolam because serious side effects, such as prolonged sedation or breathing problems, may occur


• Ergot derivatives (eg, ergotamine, methylergonovine) because serious blood flow problems may occur


• Rifampin, St. John's wort, or tipranavir because they may decrease Kaletra's effectiveness


• Alfuzosin, conivaptan, eletriptan, or certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin) because the risk of their side effects may be increased by Kaletra


• Many prescription and nonprescription medicines (eg, used for infections, HIV, inflammation, allergic reactions, allergies, asthma or other breathing problems, pain, birth control, blood thinning, cancer, enlarged prostate, gout, irregular heartbeat or other heart problems, high blood pressure, high cholesterol, immune suppression, erectile dysfunction, PAH, seizures, sleep disorders, smoking cessation, depression or other mood or mental problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) may interact with Kaletra, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Kaletra may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Kaletra:

Use Kaletra as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Kaletra comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Kaletra refilled.


• Take Kaletra by mouth with or without food.


• Swallow Kaletra whole. Do not break, crush, or chew before swallowing.


• Kaletra must be taken with other HIV medicines to be effective.


• If you are also taking didanosine, you may take it at the same time as Kaletra without food.


• Taking Kaletra at the same time each day will help you remember to take it.


• Continue to take Kaletra even if you feel well. Do not miss any doses. Do not stop taking Kaletra without checking with your doctor.


• If you miss a dose of Kaletra, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Kaletra.

Important safety information:

• Kaletra may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Kaletra.


• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Kaletra. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.


• If the patient is a child, tell the child's doctor if his or her weight changes. The dose of Kaletra may need to be changed.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Kaletra, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Kaletra is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.


• Kaletra does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Hormonal birth control (eg, birth control pills) may not work as well while you are taking Kaletra. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Hemophilia patients - Report all bleeding episodes to your doctor.


• Kaletra may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including cholesterol and triglyceride levels, viral load, and liver function, may be performed while you use Kaletra. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Caution is advised when using Kaletra in CHILDREN; they may be more sensitive to its effects, especially skin rash.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Kaletra while you are pregnant. It is not known if Kaletra is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Kaletra to the baby.

Possible side effects of Kaletra:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; mild stomach pain or upset; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dizziness or light-headedness; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; loss of consciousness; red, swollen, blistered, or peeling skin; severe or persistent nausea, vomiting, or stomach pain; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, unusual fatigue); unusual bleeding or bruising.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Kaletra side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Kaletra:

Store Kaletra between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Do not expose Kaletra to high humidity outside of the original container for longer than 2 weeks. Keep Kaletra out of the reach of children and away from pets.

General information:

• If you have any questions about Kaletra, please talk with your doctor, pharmacist, or other health care provider.


• Kaletra is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Kaletra. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Kaletra resources

• Kaletra Side Effects (in more detail)
• Kaletra Dosage
• Kaletra Use in Pregnancy & Breastfeeding
• Drug Images
• Kaletra Drug Interactions
• Kaletra Support Group
• 2 Reviews for Kaletra - Add your own review/rating

• Kaletra Prescribing Information (FDA)


• Kaletra Monograph (AHFS DI)


• Kaletra Advanced Consumer (Micromedex) - Includes Dosage Information


• Kaletra Consumer Overview

Compare Kaletra with other medications

• HIV Infection
• Nonoccupational Exposure

Sinemet CR Sustained-Release Tablets

Pronunciation: KAR-bi-DOE-pa/LEE-voe-DOE-pa
Generic Name: Carbidopa/Levodopa
Brand Name: Sinemet CR

Sinemet CR Sustained-Release Tablets are used for:

Treating symptoms associated with Parkinson disease and parkinsonism-like symptoms caused by other conditions. It may also be used for other conditions as determined by your doctor.

Sinemet CR Sustained-Release Tablets are an antidyskinetic combination. Levodopa is transformed by the body and the brain into a substance that helps to decrease tremors and other symptoms of Parkinson disease. Carbidopa helps levodopa to reach the brain.

Do NOT use Sinemet CR Sustained-Release Tablets if:

• you are allergic to any ingredient in Sinemet CR Sustained-Release Tablets


• you have narrow-angle glaucoma, undiagnosed skin growths, skin cancer, or a history of skin cancer


• you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sinemet CR Sustained-Release Tablets:

Some medical conditions may interact with Sinemet CR Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of heart problems (eg, irregular heartbeat) or heart attack, blood pressure problems, endocrine problems, fainting, lung problems (eg, asthma), kidney or liver problems, neuroleptic malignant syndrome (NMS), a severe muscle problem called rhabdomyolysis, glaucoma or increased pressure in the eye, stomach or intestinal problems (eg, ulcers, bleeding), or mood or mental problems (eg, depression)

Some MEDICINES MAY INTERACT with Sinemet CR Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• MAOIs (eg, phenelzine) because the risk of severe high blood pressure may be increased


• Tricyclic antidepressants (eg, amitriptyline) because the risk of high blood pressure or unusual muscle movements may be increased


• Metoclopramide because side effects may occur


• Blood pressure medicines or selegiline because the risk of severe dizziness when standing may be increased


• Butyrophenones, (eg, haloperidol), isoniazid, papaverine, phenothiazines (eg, chlorpromazine), phenytoin, or risperidone because they may decrease Sinemet CR Sustained-Release Tablets's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sinemet CR Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sinemet CR Sustained-Release Tablets:

Use Sinemet CR Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Sinemet CR Sustained-Release Tablets by mouth with or without food.


• Carefully follow the dosing schedule given to you by your health care provider. It may take several weeks to a few months to notice benefit from use because the dose is carefully adjusted over time.


• Swallow Sinemet CR Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some strengths of Sinemet CR Sustained-Release Tablets may be broken in half. If you have difficulty swallowing the tablet whole or if your doctor tells you to break the tablet in half, ask your pharmacist if your strength of medicine may be broken in half.


• If you are also taking iron salts (eg, ferrous sulfate), do not take them within 2 hours before or 2 hours after taking Sinemet CR Sustained-Release Tablets. Check with your doctor if you have questions.


• Take Sinemet CR Sustained-Release Tablets on a regular schedule to get the most benefit from it. Taking Sinemet CR Sustained-Release Tablets at the same times each day will help you to remember to take it.


• Diets that are high in protein may decrease your body's ability to absorb Sinemet CR Sustained-Release Tablets. Discuss any questions or concerns with your doctor. Tell your doctor if you have a diet that is high in protein, or if you will be changing your diet to include more protein.


• Continue to take Sinemet CR Sustained-Release Tablets even if you feel better. Do not miss any doses.


• If you have been taking levodopa, do not start taking Sinemet CR Sustained-Release Tablets until at least 12 hours after your final dose of levodopa.


• Do not suddenly stop taking Sinemet CR Sustained-Release Tablets without checking with your doctor. Side effects may occur. They may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating.


• If you miss a dose of Sinemet CR Sustained-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sinemet CR Sustained-Release Tablets.

Important safety information:

• Sinemet CR Sustained-Release Tablets may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Sinemet CR Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Sinemet CR Sustained-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Sinemet CR Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Tell your doctor or dentist that you take Sinemet CR Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - Sinemet CR Sustained-Release Tablets may cause the results of some tests for urine glucose or urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.


• Sinemet CR Sustained-Release Tablets may cause mental or mood changes. Contact your doctor at once if any new or worsening symptoms such as depressed mood; anxious, restless, or irritable behavior; or unusual changes in mood or behavior occur. Contact your doctor right away if any signs of suicidal thoughts or actions occur.


• You may experience an increase in involuntary movements while taking Sinemet CR Sustained-Release Tablets. Check with your doctor if this occurs.


• NMS is a possibly fatal syndrome that can be caused by Sinemet CR Sustained-Release Tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.


• Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if Sinemet CR Sustained-Release Tablets also increases the risk of melanoma. You may need to have skin exams while you are using Sinemet CR Sustained-Release Tablets. Tell your doctor if you notice any unusual skin growths or a change in the appearance of a mole. Discuss any questions or concerns with your doctor.


• Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while taking Sinemet CR Sustained-Release Tablets. Tell your doctor right away if you notice such effects.


• Do not suddenly stop taking Sinemet CR Sustained-Release Tablets. Some conditions may become worse when Sinemet CR Sustained-Release Tablets are suddenly stopped. Your dose may need to be slowly lowered by your doctor to avoid side effects.


• Gradually increase physical activity as your symptoms improve.


• A dark color (red, brown, or black) may appear in your saliva, urine, or sweat after taking Sinemet CR Sustained-Release Tablets. This is not harmful.


• The effects of Sinemet CR Sustained-Release Tablets might start to wear off between doses. Talk with your doctor if Sinemet CR Sustained-Release Tablets stops working well or if your condition worsens.


• Sinemet CR Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Sinemet CR Sustained-Release Tablets.


• Lab tests, including complete blood cell counts and liver function, may be performed while you use Sinemet CR Sustained-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Sinemet CR Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Sinemet CR Sustained-Release Tablets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Sinemet CR Sustained-Release Tablets while you are pregnant. It is not known if Sinemet CR Sustained-Release Tablets are found in breast milk. If you are or will be breast-feeding while you are taking Sinemet CR Sustained-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sinemet CR Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Confusion; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; taste changes; trouble sleeping; upset stomach; urinary tract infection; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in vomit; chest pain; confusion; depression; fast or irregular heartbeat; fever; hallucinations; mental or mood changes; muscle pain or unusual stiffness; new or increased involuntary movements; severe abdominal pain; severe lightheadedness or fainting; sore throat; thoughts of suicide; unexplained fever or sweating; unusual bruising or bleeding; unusual or painful movements or spasms of the face, eyelids, mouth, tongue, arms, hands, or legs; vision changes (blurred or double vision); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Sinemet CR side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Sinemet CR Sustained-Release Tablets:

Store Sinemet CR Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sinemet CR Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Sinemet CR Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Sinemet CR Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sinemet CR Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Sinemet CR resources

• Sinemet CR Side Effects (in more detail)
• Sinemet CR Use in Pregnancy & Breastfeeding
• Drug Images
• Sinemet CR Drug Interactions
• Sinemet CR Support Group
• 3 Reviews for Sinemet CR - Add your own review/rating

Compare Sinemet CR with other medications

• GTP-CH Deficiency
• Neuroleptic Malignant Syndrome
• Parkinson's Disease
• Restless Legs Syndrome

Guaifenex LA

Generic Name: guaifenesin (Oral route)

gwye-FEN-e-sin

Commonly used brand name(s)

In the U.S.

• Allfen


• Altarussin


• Amibid LA


• Antitussin


• Bidex 400


• Diabetic Siltussin DAS-Na


• Diabetic Tussin EX


• Drituss G


• Guaifenex G


• Guaifenex LA


• Mucinex


• Robitussin

In Canada

• Benylin-E


• Benylin E Extra Strength Chest Congestion


• Broncho-Grippex Expectorant


• Robitussin Extra Strength

Available Dosage Forms:

• Tablet, Extended Release


• Solution


• Capsule, Extended Release


• Packet


• Liquid


• Tablet


• Capsule


• Elixir


• Syrup

Therapeutic Class: Expectorant

Uses For Guaifenex LA

Guaifenesin is used to help clear mucus or phlegm (pronounced flem) from the chest when you have congestion from a cold or flu. It works by thinning the mucus or phlegm in the lungs.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Guaifenex LA

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of guaifenesin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. However, check with your doctor before using this medicine in children who have a chronic cough, such as occurs with asthma, or who have an unusually large amount of mucus or phlegm with the cough. Children with these conditions may need a different kind of medicine. Also, guaifenesin should not be given to children and infants younger than 2 years of age unless you are directed to do so by your doctor.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of guaifenesin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of guaifenesin

This section provides information on the proper use of a number of products that contain guaifenesin. It may not be specific to Guaifenex LA. Please read with care.

Drinking plenty of water while taking guaifenesin may help loosen mucus or phlegm in the lungs.

For patients taking the extended-release capsule form of this medicine:

• Swallow the capsule whole, or open the capsule and sprinkle the contents on soft food such as applesauce, jelly, or pudding and swallow without crushing or chewing.

For patients taking the extended-release tablet form of this medicine:

• If the tablet has a groove in it, you may carefully break it into two pieces along the groove. Then swallow the pieces whole, without crushing or chewing them.


• If the tablet does not have a groove, it must be swallowed whole. Do not break, crush, or chew it before swallowing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For regular (short-acting) oral dosage forms (capsules, oral solution, syrup, or tablets):
  
  • For cough:
    
    • Adults—200 to 400 milligrams (mg) every four hours.
    
    
    • Children 6 to 12 years of age—100 to 200 mg every four hours.
    
    
    • Children 4 to 6 years of age—50 to 100 mg every four hours.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  


• For long-acting oral dosage forms (extended-release capsules or tablets):
  
  • For cough:
    
    • Adults—600 to 1200 mg every twelve hours.
    
    
    • Children 6 to 12 years of age—600 mg every twelve hours.
    
    
    • Children 4 to 6 years of age—300 mg every twelve hours.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Guaifenex LA

If your cough has not improved after 7 days or if you have a fever, skin rash, continuing headache, or sore throat with the cough, check with your doctor. These signs may mean that you have other medical problems.

Guaifenex LA Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

• Diarrhea


• dizziness


• headache


• hives


• nausea or vomiting


• skin rash


• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Guaifenex LA side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Guaifenex LA resources

• Guaifenex LA Side Effects (in more detail)
• Guaifenex LA Use in Pregnancy & Breastfeeding
• Guaifenex LA Support Group
• 0 Reviews for Guaifenex LA - Add your own review/rating

• Allfen MedFacts Consumer Leaflet (Wolters Kluwer)


• Guaifenesin Monograph (AHFS DI)


• Guaifenesin Granules MedFacts Consumer Leaflet (Wolters Kluwer)


• Guaifenesin NR Prescribing Information (FDA)


• Hytuss Immediate-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex Prescribing Information (FDA)


• Mucinex Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex Consumer Overview


• Organidin NR Prescribing Information (FDA)


• Tussin Consumer Overview

Compare Guaifenex LA with other medications

• Bronchitis
• Cough
• Fibromyalgia

Claravis

Generic Name: isotretinoin (oral) (EYE so TRET i noyn)

Brand Names: Amnesteem, Claravis, Sotret

What is isotretinoin?

Isotretinoin is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

Isotretinoin is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

Isotretinoin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about isotretinoin?

Isotretinoin can cause severe, life-threatening birth defects. Never use isotretinoin if you are pregnant.

Women of child-bearing potential must agree in writing to use two specific forms of birth control and have regular pregnancy tests before, during, and after taking isotretinoin.

Isotretinoin is available only under a special program called iPLEDGE. It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States.

Do not take vitamin supplements containing vitamin A while you are taking isotretinoin. Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it.

What should I discuss with my healthcare provider before taking isotretinoin?

Isotretinoin is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.

It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States. The sale and distribution of isotretinoin outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.

Do not use this medication if you are allergic to isotretinoin or to parabens, or if you are pregnant or may become pregnant.

To make sure you can safely take isotretinoin, tell your doctor if you have any of these other conditions:

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  a personal or family history of depression or mental illness;

  
  


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  heart disease, high cholesterol or triglycerides;

  
  


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  osteoporosis or other bone disorders;

  
  


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  an intestinal disorder such as inflammatory bowel disease, ulcerative colitis, or Crohn's disease;

  
  


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  diabetes;

  
  


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  asthma;

  
  


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  an eating disorder (anorexia nervosa); or

  
  


• liver disease.

Isotretinoin can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy with oophorectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential.

Even women who have had their tubes tied are required to use birth control while taking isotretinoin.

You must have a negative pregnancy test 30 days before you start taking isotretinoin. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking isotretinoin and ending 30 days after you stop taking it. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

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  tubal ligation (tubes tied);

  
  


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  vasectomy of the male sexual partner;

  
  


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  an IUD (intrauterine device);

  
  


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  estrogen-containing birth control pills (not mini-pills); and

  
  


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  hormonal birth control patches, implants, injections, or vaginal ring.

  
  

Secondary forms of birth control include:

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  a male latex condom plus spermicidal foam or gel;

  
  


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  a diaphragm plus spermicidal foam or gel;

  
  


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  a cervical cap plus spermicidal foam or gel; and

  
  


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  a vaginal sponge containing spermicide.

  
  

Stop using isotretinoin and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.

It is not known whether isotretinoin passes into breast milk. Do not take isotretinoin without first talking to your doctor if you are breast-feeding a baby.

How should I take isotretinoin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Each prescription of isotretinoin must be filled within 7 days of the date it was prescribed by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.

Always take isotretinoin with a full glass of water to prevent the capsule from melting in your esophagus (food pipe), causing irritation. Do not chew or suck on the capsule. Swallow it as quickly as possible. Take isotretinoin with food or milk. Take this medication for the entire length of time prescribed by your doctor. Your acne may seem to get worse at first, but should then begin to improve.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

Never share this medicine with another person, even if they have the same symptoms you have. Store at room temperature away from moisture, heat, and light.

See also: Claravis dosage (in more detail)

What happens if I miss a dose?

Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling under the skin, swelling of the lips, and loss of balance or coordination.

What should I avoid while taking isotretinoin?

Do not take vitamin supplements containing vitamin A while you are taking isotretinoin. Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it. Donated blood that is later given to pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.

Do not use wax hair removers or have dermabrasion or laser skin treatments while you are taking isotretinoin and for at least 6 months after you stop taking it. Scarring may result.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Isotretinoin can make your skin more sensitive to sunlight and sunburn may result. Isotretinoin may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.

Isotretinoin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

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  depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;

  
  


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  sudden numbness or weakness, especially on one side of the body;

  
  


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  blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;

  
  


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  hearing problems, hearing loss, or ringing in your ears;

  
  


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  seizure (convulsions);

  
  


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  severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  
  


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  loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


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  severe diarrhea, rectal bleeding, black, bloody, or tarry stools;

  
  


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  fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding;

  
  


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  severe blistering, peeling, and red skin rash; or

  
  


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  joint stiffness, bone pain or fracture.

  
  

Less serious side effects may include:

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  joint pain, back pain;

  
  


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  feeling dizzy, drowsy, or nervous;

  
  


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  dryness of the lips, mouth, nose, or skin; or

  
  


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  cracking or peeling skin, itching, rash, changes in your fingernails or toenails.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect isotretinoin?

Tell your doctor about all other medicines you use, especially:

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  steroids (prednisone and others);

  
  


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  seizure medication such as phenytoin (Dilantin); or

  
  


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  a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Minocin), or tetracycline (Brodspec, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with isotretinoin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Claravis resources

• Claravis Side Effects (in more detail)
• Claravis Dosage
• Claravis Use in Pregnancy & Breastfeeding
• Drug Images
• Claravis Drug Interactions
• Claravis Support Group
• 55 Reviews for Claravis - Add your own review/rating

• Claravis Prescribing Information (FDA)


• Claravis Advanced Consumer (Micromedex) - Includes Dosage Information


• Claravis MedFacts Consumer Leaflet (Wolters Kluwer)


• Accutane Prescribing Information (FDA)


• Accutane Consumer Overview


• Amnesteem Prescribing Information (FDA)


• Isotretinoin Monograph (AHFS DI)


• Sotret Prescribing Information (FDA)

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Where can I get more information?

• Your pharmacist can provide more information about isotretinoin.

See also: Claravis side effects (in more detail)