Codeine Sulfate

Pronunciation: KOE-deen SUL-fate
Generic Name: Codeine Sulfate
Brand Name: Generic only. No brands available.

Codeine Sulfate is used for:

Treating certain types of severe pain.

Codeine Sulfate is a narcotic analgesic. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Codeine Sulfate if:

• you are allergic to any ingredient in Codeine Sulfate or to any codeine- or morphine-related medicine (eg, oxycodone)


• you have a lack of muscle movement in the bowel (paralytic ileus) or high levels of carbon dioxide in the blood


• you have a history of severe asthma or you are having an asthma attack


• you have slow or shallow breathing


• you are taking mixed agonist/antagonist analgesic medicines (eg, pentazocine, nalbuphine, butorphanol) or sodium oxybate (GHB)


• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or you have taken an MAOI within the past 14 days

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

Before using Codeine Sulfate:

Some medical conditions may interact with Codeine Sulfate. 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 or recently have had any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of heart problems, low blood pressure, stomach or bowel problems (eg, inflammation, ulcer), pancreas problems (eg, inflammation), gallbladder problems (eg, gallstones), an enlarged prostate gland or other prostate problems, a blockage of your bladder or bowel, kidney or liver problems, adrenal gland problems (eg, Addison disease), or an underactive thyroid


• if you have trouble breathing, a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), scoliosis, or chronic obstructive pulmonary disease (COPD), or a cough that occurs with large amounts of mucus


• if you are going through alcohol withdrawal or you have a history of alcohol or other substance abuse, mental or mood problems, or suicidal thoughts or behavior


• if you are dehydrated, are in very poor health, or have had recent abdominal surgery

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

• Anticholinergics (eg, scopolamine, bethanechol) because the risk of decreased bowel muscle movement and trouble urinating may be increased


• HIV protease inhibitors (eg, ritonavir), MAOIs (eg, phenelzine), other narcotic pain medicines, phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Codeine Sulfate's side effects, including low blood pressure and severe drowsiness


• Cimetidine or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, and seizures may be increased


• Mixed agonist/antagonist analgesic medicines (eg, pentazocine, nalbuphine, butorphanol), naltrexone, quinidine, or rifampin because they may decrease Codeine Sulfate's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Codeine Sulfate 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 Codeine Sulfate:

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

• Codeine Sulfate may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If Codeine Sulfate is no longer needed, check with your pharmacist for ways to properly dispose of Codeine Sulfate. Do not throw it in the trash.


• If you miss a dose of Codeine Sulfate and you are using it regularly, 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 Codeine Sulfate.

Important safety information:

• Codeine Sulfate may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Codeine Sulfate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


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


• Codeine Sulfate 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 take more than the recommended dose or use more often than prescribed without checking with your doctor.


• Codeine Sulfate may cause constipation. Check with your doctor to see if you should also take a stool softener or laxative to help decrease this effect.


• Tell your doctor or dentist that you take Codeine Sulfate before you receive any medical or dental care, emergency care, or surgery.


• Some patients may have a genetic trait that may cause Codeine Sulfate to enter their blood faster. This may increase the risk of side effects. Contact your doctor right away if you develop symptoms of overdose, even if you have not taken more than the recommended dose of Codeine Sulfate.


• Codeine Sulfate may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Codeine Sulfate.


• Use Codeine Sulfate with caution in the ELDERLY because they may be more sensitive to its effects, including severe drowsiness and breathing problems.


• Codeine Sulfate should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these 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 using Codeine Sulfate while you are pregnant. Codeine Sulfate is found in breast milk. If you are or will be breast-feeding while you use Codeine Sulfate, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Codeine Sulfate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Codeine Sulfate stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Codeine Sulfate. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Codeine Sulfate, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Codeine Sulfate:

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:

Constipation; dizziness; drowsiness; lightheadedness; nausea; sweating; tiredness; 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); chest pain; confusion; fainting; fast or irregular heartbeat; mental or mood changes; numbness or pain of an arm or leg; seizures; severe drowsiness or dizziness; severe or persistent constipation or stomach pain; shortness of breath; slow or shallow breathing; sudden, severe headache or vomiting; trouble urinating.

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: Codeine Sulfate 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. Symptoms may include blue lips or nails; cold and clammy skin; coma; confusion; hallucinations; limp muscles; loss of consciousness; mood or mental changes; seizures; severe dizziness or drowsiness; slow heartbeat; slow or shallow breathing; sluggishness; small or large pupils.

Proper storage of Codeine Sulfate:

Store Codeine Sulfate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Codeine Sulfate out of the reach of children and away from pets.

General information:

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


• Codeine Sulfate 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 Codeine Sulfate. 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 Codeine Sulfate resources

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

• Codeine Sulfate Monograph (AHFS DI)


• Codeine Professional Patient Advice (Wolters Kluwer)


• codeine Concise Consumer Information (Cerner Multum)


• codeine Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Codeine Sulfate with other medications

• Cough
• Diarrhea
• Pain

Clanza CR

Generic Name: aceclofenac

Dosage Form: tablet, film coated

DESCRIPTION

White, oblong, film-coated tablet, engraved with "UT" on one side and "CL CR" on the other side.

INDICATIONS

Clanza CR is indicated for Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism.

Dosage and Administration

Adults: The recommended dose is 200 mg daily, taken as one dose (every 24 hours).  However, the dose and dose frequency of Clanza CR can be modified under the supervison of physician or pharmacist.

CONTRAINDICATIONS

Patients with allergy to these drugs or other analogues (diclofenac). Patients with asthma. Like NSAIDS, acetylsalicylic acid and other drugs which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria. Patients with active peptic ulcer.

CAUTIONS

Patients with symptoms indicative of gastro-intestinal disorders, with a history of gastroulceration.  Patients with severe hepatic impairment or cardiac or renal impairment.  Patients under the medication of diuretics.  Patients in recovery after surgical treatment.

ADVERSE REACTIONS

The majority of side effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness.  To report suspected adverse reactions, call 1-800-FDA-1088.

GENERAL PRECAUTIONS

Patients suffering from dizziness, vertigo, or other central nervous system disorders while taking NSAIDS should refrain from driving or handling dangerous machinery.

DRUG INTERACTIONS

There has been no drug interactions reported, but close monitoring of patients on combination with lithium and digoxin, oral antidiabetic agents, anticoagulants, diuretics, and other analgesics.

USE IN PREGNANCY AND NURSING MOTHERS

Since there is no information on the safe use of Clanza CR during pregnancy and lactation, the use of Clanza CR should therefore be avoided in pregnancy and lactation.

USE IN CHILDREN

The dosage and indication is not established yet for children with less than 6 years old.

OVERDOSAGE

There are no human data available on the consequences of Clanza CR overdosage.  If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as hypotension, gastro-intestinal irritation, respiratory depression, and convulsions.

STORAGE

Preserve in tight containers.  Store at room temperature not exceeding 30oC.

SHELF LIFE

Three (3) years from manufacturing date.  Do not exceed the expiry date for use printed on the box.

PACKAGE

10 Blister Packs with 10 Tablets in each Blister Pack

Enter section text here

label test

CLANZA  CR aceclofenac  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65697-450 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aceclofenac (Aceclofenac) Aceclofenac 200 mg

Inactive Ingredients Ingredient Name Strength Lactose Monohydrate   Cellulose, Microcrystalline   Sodium Carbonate   Colloidal Silicon Dioxide   Crospovidone   Poloxamer 407   Magnesium Stearate   Alcohol   Hypromellose 2208 (15000 MPA.S)   Carbomer 941   Hypromellose 2910 (6 MPA.S)   Alcohol   Methylene Chloride   Hypromellose 2910 (5 MPA.S)   Titanium Dioxide   Ethylcelluloses   Diethyl Phthalate

Product Characteristics Color white Score no score Shape OVAL (Film-coated white oblong tablet) Size 15mm Flavor Imprint Code UT;CR;CT Contains

Packaging # NDC Package Description Multilevel Packaging 1 65697-450-20 1 TABLET In 1 PACKET None 2 65697-450-22 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK (65697-450-21) 2 65697-450-21 10 PACKET In 1 BLISTER PACK This package is contained within the CARTON (65697-450-22)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		05/12/2011

Labeler - United Douglas Pharm., Inc. (001444350)

Registrant - United Douglas Pharm., Inc. (001444350)

Establishment
Name	Address	ID/FEI	Operations
United Douglas Pharm., Inc.		001444350	pack, label

Establishment
Name	Address	ID/FEI	Operations
Korea United Pharm Inc.		688016534	manufacture

Revised: 11/2011United Douglas Pharm., Inc.

Zinecard

Pronunciation: dex-ra-ZOX-ane
Generic Name: Dexrazoxane
Brand Name: Zinecard

Zinecard is used for:

Reducing the incidence and severity of heart problems associated with the chemotherapy agent doxorubicin in women being treated for metastatic breast cancer.

Zinecard is a cardioprotective agent. Exactly how Zinecard works is unknown, but it works by interfering with harmful chemicals inside of cells that are thought to be partially responsible for heart problems caused by doxorubicin.

Do NOT use Zinecard if:

• you are allergic to any ingredient in Zinecard


• you are taking other chemotherapy that does not contain doxorubicin or a similar therapy

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

Before using Zinecard:

Some medical conditions may interact with Zinecard. 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 drug-induced bone marrow suppression or kidney or liver problems

Some MEDICINES MAY INTERACT with Zinecard. However, no specific interactions with Zinecard are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zinecard 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 Zinecard:

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

• Zinecard is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Zinecard at home, carefully follow the injection procedures taught to you by your health care provider.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• Wear gloves while handling this medication. If the powder or solution comes into contact with the skin wash thoroughly with soap and water or rinse eyes with water.


• If you miss a dose of Zinecard, contact your doctor right away.

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

Important safety information:

• LAB TESTS, such as kidney or liver function tests and blood tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Zinecard with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Zinecard during pregnancy. It is unknown if Zinecard is excreted in breast milk. Do not breast-feed while taking Zinecard.

Possible side effects of Zinecard:

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; difficulty swallowing; fever; general body discomfort; hair loss; infection (chills; sore throat); loss of appetite; nausea; pain or swelling at the injection site; streaking or flushing of the skin; swelling of the throat or tongue; tiredness; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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: Zinecard 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 Zinecard:

Once mixed, the solution can be stored for 6 hours at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), or in a refrigerator at 36 to 46 degrees F (2 to 8 degrees C). Throw away any unused solution. Store powder at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Zinecard out of the reach of children and away from pets.

General information:

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


• Zinecard 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 Zinecard. 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 Zinecard resources

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

• Zinecard Prescribing Information (FDA)


• Zinecard Monograph (AHFS DI)


• Zinecard Advanced Consumer (Micromedex) - Includes Dosage Information


• Dexrazoxane Prescribing Information (FDA)


• Dexrazoxane Professional Patient Advice (Wolters Kluwer)


• Totect Consumer Overview


• Totect Prescribing Information (FDA)

Compare Zinecard with other medications

• Cardiomyopathy Prophylaxis

Lidoderm Topical application

Generic Name: lidocaine (Topical application route)

LYE-doe-kane

Commonly used brand name(s)

In the U.S.

• Anestacon


• Burnamycin


• Burn-O-Jel


• Lida Mantle


• Lidoderm


• LMX 4


• LMX 5


• Senatec


• Solarcaine Cool Aloe


• Topicaine


• Xylocaine

In Canada

• Solarcaine First Aid Lidocaine Spray


• Solarcaine Lidocaine First Aid Spray

Available Dosage Forms:

• Foam


• Dressing


• Gel/Jelly


• Spray


• Cream


• Solution


• Pad


• Patch, Extended Release


• Ointment


• Lotion


• Aerosol Liquid

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Amide

Uses For Lidoderm

Lidocaine is used on different parts of the body to cause numbness or loss of feeling for patients having certain medical procedures. It is also used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

Lidocaine belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.

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

Before Using Lidoderm

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 lidocaine in children. However, because of this medicine's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

No information is available on the relationship of age to the effects of lidocaine in geriatric patients. However, because of this medicine's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

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.

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:

• Heart block or


• Shock, severe—Use with caution.

• Infection at or near the place of application or


• Large sores, broken skin, or severe injury at the area of application—Use with caution. The chance of side effects may be increased.

Proper Use of lidocaine

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

Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

A nurse or other trained health care professional will give you this medicine before having a medical procedure.

Wash your hands with soap and water before and after using this medicine.

Unless otherwise directed by your doctor, do not apply this medicine to open wounds, burns, or broken or inflamed skin.

This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Be careful not to get any of this medicine in your eyes, because it can cause severe eye irritation. If any of the medicine does get in the eyes, wash the eyes with water for at least 15 minutes and check with your doctor right away.

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 topical dosage form (ointment):
  
  • For pain and itching caused by minor skin conditions:
    
    • Adults—Apply to the affected area three or four times a day. The largest amount of ointment that should be used in a single application is 5 grams. If you use the 5% ointment, this is about 6 inches of ointment from the tube.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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.

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

Precautions While Using Lidoderm

It is very important that your doctor check you closely for any problems or unwanted effects that may be caused by this medicine.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. Lidocaine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

Stop using this medicine and check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation of your skin.

If you are using this medicine in the mouth or throat, do not eat or drink anything for one hour after using it. When this medicine is applied to these areas, it may cause swallowing and choking problems. Do not chew gum or food while your mouth or throat feels numb after you use this medicine. You may accidentally bite your tongue or the inside of your cheeks.

Do not use cosmetics or other skin care products on the treated skin areas.

Lidoderm 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 or nurse immediately if any of the following side effects occur:

Incidence not known

• Blurred vision


• chest pain or discomfort


• cold, clammy, or pale skin


• confusion


• cough


• difficult or troubled breathing


• difficulty with swallowing


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• false or unusual sense of well-being


• fast heartbeat


• fear


• hives or welts


• irregular, fast or slow, or shallow breathing


• itching


• lightheadedness, dizziness, or fainting


• mood or mental changes


• nervousness


• no blood pressure or pulse


• pale or blue lips, fingernails, or skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• redness of the skin


• seizures


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• skin rash


• sleepiness


• slow heart rate


• slow or irregular heartbeat


• stopping of heart


• swelling


• tightness in the chest


• trembling or shaking of the hands or feet


• twitching


• unconsciousness


• unusual tiredness or weakness


• weakness


• wheezing

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:

Incidence not known

• Cold or numbness


• continuing ringing or buzzing or other unexplained noise in the ears


• double vision


• hearing loss


• heat sensation

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: Lidoderm Topical application 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 Lidoderm Topical application resources

• Lidoderm Topical application Side Effects (in more detail)
• Lidoderm Topical application Use in Pregnancy & Breastfeeding
• Lidoderm Topical application Support Group
• 16 Reviews for Lidoderm Topical application - Add your own review/rating

Compare Lidoderm Topical application with other medications

• Anal Itching
• Anesthesia
• Burns, External
• Hemorrhoids
• Pain
• Persisting Pain, Shingles
• Pruritus
• Sunburn

Cymalon Cranberry Liquid

Cymalon

Cranberry Liquid (potassium citrate)

Important information about Cymalon Cranberry liquid

• This medicine is used to relieve the symptoms of cystitis and other minor urinary tract infections.


• It can be taken by adults, the elderly and children over 6 years.

Talk to your doctor

• If you still have symptoms after 2 days.


• This medicine is not an antibiotic. If your symptoms persist the doctor may need to prescribe antibiotics aswell.

Now read the rest of the leaflet before you use this medicine. It includes other information which might be especially important for you.

• Keep this leaflet. You may need to read it again.


• Ask your pharmacist if you need any more information or advice.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What the medicine is for

Cymalon Cranberry Liquid contains potassium citrate which makes the urine less acid. This helps relieve the symptoms of cystitis and other mild urinary tract infections.

Before you use this medicine

Do not use the medicine if you or your child have

• An allergy to potassium citrate or any of the ingredients listed in section 6.


• 
  High levels of potassium in your blood.
  


• 
  Kidney problems.
  


• 
  Irregular heart beat or heart problems.
  


• 
  Addison’s Disease (an adrenal gland problem).

Talk to your doctor if you or your child have

• Symptoms which carry on for more than 2 days after you start taking this medicine.


• Symptoms which keep recurring.


• Or are elderly, as elderly people can react differently to this medicine.

Talk to your doctor or pharmacist if you or your child are taking

• Nitrofurantoin or methenamine for a urinary or bladder infection.


• Cardiac glycosides (e.g. digoxin) for heart problems.


• Aspirin or other salicylates.


• Tetracycline (an antibiotic).


• Decongestants or drugs to help ease breathing (e.g. salbutamol, ephedrine, phenylephrine)


• Stimulant drugs (amphetamines).


• Barbiturates (e.g. phenobarbital).


• Other medicine containing potassium or medicine which may retain potassium in your body (e.g. drugs used for heart failure or cyclosporin) as these may be affected by taking this medicine.

Pregnant or breastfeeding

Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding.

Cymalon Cranberry Liquid should not be used in pregnancy unless the doctor has told you to do so.

Important information about some of the ingredients

• This product contains small amounts of ethanol (alcohol), less than 100mg per 10ml dose.


• It also contains 2.2g sucrose per 10ml dose. This should be taken into account in people with diabetes. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use this medicine

Take this medicine by mouth.

Adults, the elderly and children over 6 years:

• Shake the bottle thoroughly before use.


• Fill the dosing cup provided to the 10ml mark.


• Stir into a glass of water.


• Drink the diluted medicine 3 times a day after meals.

Children under 6 years

Do not give to children under 6 unless your doctor tells you to.

If you take too much

If you accidentally take too much, see a doctor straight away. Take the pack with you to show which medicine you have swallowed.

Possible side effects

Like all medicines, Cymalon Cranberry Liquid can have side effects, although these don’t affect everyone.

• Upset stomach.


• Nausea (feeling sick).


• Sickness.


• Abnormal heart rhythm due to high levels of potassium in the blood.

If you notice these or any other side effect not included above, stop use and tell your doctor or pharmacist. They will tell you what to do.

Storing this medicine

• Keep it out of the reach and sight of children.


• Store below 25°C.


• Keep the container tightly closed.


• Throw away any unused liquid 2 months after opening.


• Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.


• Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine. These measures will help to protect the environment.

Further information

What is in this medicine

The active ingredient per 5ml is:

Potassium Citrate 1.5g.

The other ingredients are: citric acid monohydrate, quillaia tincture, cranberry flavour, ethanol, chloroform, purified water and syrup.

What the medicine looks like

Cymalon Cranberry Liquid is a cloudy, thick yellow/brown liquid.

It is supplied in 60ml bottles.

Marketing authorisation holder

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjordur

Iceland

Manufacturer

Thornton and Ross Ltd.

Huddersfield

HD7 5QH

UK

This leaflet was revised in October 2008

Cymalon is a trade mark of Actavis Group PTC ehf.

THOPL007

Imiquimod

Pronunciation: im-I-kwi-mod
Generic Name: Imiquimod
Brand Name: Aldara

Imiquimod is used for:

Treating certain types of skin growths (actinic keratoses) or skin cancer (superficial basal cell carcinoma). It may also be used to treat external genital and perianal warts. It may also be used for other conditions as determined by your doctor.

Imiquimod is an immune response modifier. Exactly how it works is not known.

Do NOT use Imiquimod if:

• you are allergic to any ingredient in Imiquimod

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

Before using Imiquimod:

Some medical conditions may interact with Imiquimod. 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 other types of skin cancer; broken, damaged, or inflamed skin at the application site; rash at the application site; or warts in the areas of your body other than the genital or anal areas


• if you have a weakened immune system, an autoimmune disorder (eg, rheumatoid arthritis, lupus), or human papilloma virus (HPV) infection


• if your skin has not completely healed from surgery or other types of treatment

Some MEDICINES MAY INTERACT with Imiquimod. Because little, if any, of Imiquimod is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of interactions that may occur. Ask your health care provider if Imiquimod 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 Imiquimod:

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

• An extra patient leaflet is available with Imiquimod. Talk to your pharmacist if you have questions about this information.


• Imiquimod is usually not used every day. Be sure you know how many times per week you should use Imiquimod.


• A health care provider will teach you how to use Imiquimod. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not apply Imiquimod to any area of the body other than the treatment area. Do not apply it to open wounds or to scraped, blistered, infected, or sunburned skin without first checking with your doctor. Do not apply it inside the anus or vagina when treating genital or perianal warts.


• Apply Imiquimod just before bedtime, unless directed otherwise by your doctor.


• Wash your hands before and immediately after using Imiquimod.


• Wash your hands and the affected area with mild soap and water before using Imiquimod. Allow the area to completely dry (at least 10 minutes) before applying the medicine.


• Men who have not been circumcised and are treating warts under the foreskin should pull back the foreskin and clean the area just before treatment. Clean the area daily while you are using Imiquimod.


• Apply a thin layer of medicine to the affected area as directed by your doctor. Gently rub the medicine in until it is no longer visible.


• Do not wrap or cover the treated area with bandages unless directed by your doctor. Do not wear tight-fitting clothing over the affected area. Cotton underwear may be worn after applying medicine to the genital or anal area.


• Leave the medicine on the skin for the prescribed amount of time. Do not bathe or get the area wet until it is time to remove the medicine.


• Do not leave the medicine on the skin for longer than your doctor tells you. When it is time to remove it, use mild soap and water as directed by your doctor.


• Throw away any unused medicine that is left in the packet after the first use. Do not store Imiquimod in a packet for use at a later time. Throw away any unused medicine in a trash container, away from children and pets.


• Continue to use Imiquimod as directed even if your conditions improve. Do not miss any doses.


• If you miss a dose of Imiquimod, use 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 use 2 doses at once.

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

Important safety information:

• Imiquimod is for external use only. Do not get Imiquimod in your eyes, nose, or mouth, or on your lips. If you get it in any of these areas, rinse right away with cool water.


• Do not get Imiquimod in the vagina. Use care if applying the cream near the opening of the vagina. Pain, swelling, or trouble urinating may occur if you get it in the vagina.


• Imiquimod may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Imiquimod with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not apply Imiquimod to sunburned skin. Wait until your skin has healed before using Imiquimod.


• Imiquimod may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Imiquimod may cause minor redness, swelling, flaking, scabbing, or burning at or around the application site. If a severe reaction occurs, wash the medicine off with mild soap and water. Tell your doctor right away if you have a skin reaction that is severe, affects your daily activities, or makes you unable to use Imiquimod.


• Imiquimod may cause your skin to become lighter or darker. These effects may be permanent. Discuss any questions or concerns with your doctor.


• Imiquimod is not a cure for genital or perianal warts. Patients may still develop new warts during therapy. Remain under the care of your doctor.


• If you are using Imiquimod to treat genital or perianal warts, do not have any type of sexual contact while the medicine is on your skin.


• Imiquimod may decrease the effectiveness of condoms and diaphragms. If you are using Imiquimod to treat genital or perianal warts, use another form of birth control to prevent pregnancy.


• It is not known if Imiquimod will prevent you from spreading genital or perianal warts to others. Be sure to use safe sex practices to prevent the spread of genital or perianal warts. Talk with your doctor if you have questions about safe sex practices.


• Lab tests, including skin exams, may be performed while you use Imiquimod. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Imiquimod should be used with extreme caution in CHILDREN younger than 12 years old who have genital or perianal warts; safety and effectiveness in these children have not been confirmed.


• Imiquimod should be used with extreme caution in CHILDREN younger than 18 years of age with actinic keratoses or superficial basal cell carcinoma; safety and effectiveness in these 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 using Imiquimod while you are pregnant. It is not known if Imiquimod is found in breast milk after topical use. If you are or will be breast-feeding while you use Imiquimod, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Imiquimod:

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:

Back pain; changes in skin color; diarrhea; headache; itching, burning, mild pain, or tenderness at the application site; redness, dryness, flaking, swelling, or scabbing at the application site; small sores or mild drainage at the application site; thick or hardened skin at the application site; tiredness.

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, unusual hoarseness); chest pain; fever, chills, or sore throat; irregular heartbeat; muscle pain or weakness; nausea; oozing, blistering, or bleeding at the application site; severe irritation or pain at the application site; sores or ulcers at the application site; swollen lymph glands; trouble urinating; vaginal pain or swelling.

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: Imiquimod 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. Symptoms may include dizziness or fainting.

Proper storage of Imiquimod:

Store Imiquimod at room temperature, below 77 degrees F (25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Imiquimod out of the reach of children and away from pets.

General information:

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


• Imiquimod 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 Imiquimod. 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 Imiquimod resources

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

• Aldara Prescribing Information (FDA)


• Aldara Monograph (AHFS DI)


• Aldara Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Aldara Consumer Overview


• Zyclara Prescribing Information (FDA)


• Zyclara Consumer Overview

Compare Imiquimod with other medications

• Actinic Keratosis
• Basal Cell Carcinoma
• Condylomata Acuminata
• Human Papilloma Virus
• Molluscum Contagiosum

Phenylephrine/Carbetapentane/Guaifenesin

Pronunciation: FEN-il-EF-rin/ kar-bay-ta-PEN-tane/gwye-FEN-e-sin
Generic Name: Phenylephrine/Carbetapentane/Guaifenesin
Brand Name: Aquatab C

Phenylephrine/Carbetapentane/Guaifenesin is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Phenylephrine/Carbetapentane/Guaifenesin is a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and loosening mucus and lung secretions in the chest, making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Phenylephrine/Carbetapentane/Guaifenesin if:

• you are allergic to any ingredient in Phenylephrine/Carbetapentane/Guaifenesin


• you have uncontrolled high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you take droxidopa or have taken furazolidone or 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 Phenylephrine/Carbetapentane/Guaifenesin:

Some medical conditions may interact with Phenylephrine/Carbetapentane/Guaifenesin. 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 glaucoma or increased pressure in the eye, enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems (eg, pheochromocytoma), mental or mood problems (eg, depression), trouble sleeping, an overactive thyroid, seizures, or stroke


• if you have a chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus


• if you are in poor health or very overweight

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

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone , indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Phenylephrine/Carbetapentane/Guaifenesin's side effects


• Alpha-blockers (eg, prazosin) and bromocriptine because the risk of their side effects may be increased by Phenylephrine/Carbetapentane/Guaifenesin


• Guanadrel, guanethidine, mecamylamine, medicines for high blood pressure, methyldopa, or reserpine because their effectiveness may be decreased by Phenylephrine/Carbetapentane/Guaifenesin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine/Carbetapentane/Guaifenesin 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 Phenylephrine/Carbetapentane/Guaifenesin:

Use Phenylephrine/Carbetapentane/Guaifenesin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Phenylephrine/Carbetapentane/Guaifenesin by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow Phenylephrine/Carbetapentane/Guaifenesin whole. Do not break, crush, or chew before swallowing. Some brands of Phenylephrine/Carbetapentane/Guaifenesin may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.


• Take Phenylephrine/Carbetapentane/Guaifenesin with a full glass of water (8 oz/240 mL).


• Drink plenty of water while taking Phenylephrine/Carbetapentane/Guaifenesin.


• If you miss a dose of Phenylephrine/Carbetapentane/Guaifenesin, 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 Phenylephrine/Carbetapentane/Guaifenesin.

Important safety information:

• Phenylephrine/Carbetapentane/Guaifenesin may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Phenylephrine/Carbetapentane/Guaifenesin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Phenylephrine/Carbetapentane/Guaifenesin; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take appetite suppressants while you are taking Phenylephrine/Carbetapentane/Guaifenesin without checking with your doctor.


• Phenylephrine/Carbetapentane/Guaifenesin has phenylephrine, carbetapentane, and guaifenesin in it. Before you start any new medicine, check the label to see if it has phenylephrine, carbetapentane, or guaifenesin in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor or pharmacist.


• If cough persists for more than 1 week or is accompanied by a fever, headache, rash, or sore throat, contact your health care provider. A persistent cough could be a sign of a serious condition.


• Do not use Phenylephrine/Carbetapentane/Guaifenesin for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Phenylephrine/Carbetapentane/Guaifenesin may interfere with certain lab tests. Be sure that your doctor and lab personnel know you are taking Phenylephrine/Carbetapentane/Guaifenesin.


• Tell your doctor or dentist that you take Phenylephrine/Carbetapentane/Guaifenesin before you receive any medical or dental care, emergency care, or surgery.


• Use Phenylephrine/Carbetapentane/Guaifenesin with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Phenylephrine/Carbetapentane/Guaifenesin in CHILDREN; they may be more sensitive to its effects.


• Phenylephrine/Carbetapentane/Guaifenesin should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Phenylephrine/Carbetapentane/Guaifenesin can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Phenylephrine/Carbetapentane/Guaifenesin while you are pregnant. It is not known if Phenylephrine/Carbetapentane/Guaifenesin is found in breast milk. Do not breast-feed while taking Phenylephrine/Carbetapentane/Guaifenesin.

Possible side effects of Phenylephrine/Carbetapentane/Guaifenesin:

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; dizziness; drowsiness; excitability; headache; irritability; nausea; stomach upset; trouble sleeping.

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); difficulty urinating; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, anxiety, nervousness); paleness; seizures; severe or persistent dizziness, headache, or lightheadedness; tremor.

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: Phenylephrine/Carbetapentane/Guaifenesin 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. Symptoms may include bizarre behavior; blurred vision; confusion; difficulty urinating; fast or shallow breathing; hallucinations; paleness; restlessness; seizures; severe dizziness, headache, or lightheadedness; severe drowsiness; tremor; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Phenylephrine/Carbetapentane/Guaifenesin:

Store Phenylephrine/Carbetapentane/Guaifenesin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenylephrine/Carbetapentane/Guaifenesin out of the reach of children and away from pets.

General information:

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


• Phenylephrine/Carbetapentane/Guaifenesin 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 Phenylephrine/Carbetapentane/Guaifenesin. 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 Phenylephrine/Carbetapentane/Guaifenesin resources

• Phenylephrine/Carbetapentane/Guaifenesin Side Effects (in more detail)
• Phenylephrine/Carbetapentane/Guaifenesin Use in Pregnancy & Breastfeeding
• Phenylephrine/Carbetapentane/Guaifenesin Drug Interactions
• Phenylephrine/Carbetapentane/Guaifenesin Support Group
• 0 Reviews for Phenylephrine/Carbetapentane/Guaifenesin - Add your own review/rating

Compare Phenylephrine/Carbetapentane/Guaifenesin with other medications

• Cough and Nasal Congestion

Ultrase

Generic Name: pancrelipase (Oral route)

AM-i-lase, LYE-pase, PROE-tee-ase

Commonly used brand name(s)

In the U.S.

• Creon


• Palcaps


• Pancreaze


• Pancrelipase


• Pangestyme EC


• Panocaps


• Ultracaps


• Zenpep

In Canada

• Viokase

Available Dosage Forms:

• Capsule, Delayed Release


• Capsule


• Tablet


• Tablet, Chewable


• Powder

Therapeutic Class: Enzyme Replacement

Pharmacologic Class: Enzyme

Uses For Ultrase

Pancrelipase is used to help improve food digestion in certain conditions (e.g., cystic fibrosis) where the pancreas is not working properly.

Pancrelipase contains the enzymes needed for the digestion of proteins, starches, and fats.

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

Before Using Ultrase

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 pancrelipase in children.

Geriatric

No information is available on the relationship of age to the effects of pancrelipase in geriatric patients.

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.

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:

• Allergy to pork products—Use with caution. Pancrelipase contains pork proteins.

• Gout or


• Hyperuricemia (high uric acid in the blood) or


• Hyperuricosuria (high uric acid in the urine) or


• Intestinal (bowel) blockage, history of or


• Kidney disease or


• Pancreatitis (inflammation of the pancreas)—Use with caution. May make these conditions worse.

Proper Use of pancrelipase

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

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Take this medicine with meals or snacks and enough liquid to swallow it completely, unless otherwise directed by your doctor.

When prescribing this medicine for your condition, your doctor may also prescribe a personal diet for you. Follow the special diet carefully. This is necessary for the medicine to work properly. It is also important to drink plenty of water while you are on this medicine.

For patients taking the tablets:

• Swallow the tablets quickly with some liquid, without chewing, to avoid mouth irritation.

For patients taking the delayed-release capsules:

• Swallow the capsule whole.


• Do not crush, break, or chew before swallowing. Do not hold the capsule in your mouth.


• When given to children, the capsule may be opened and sprinkled on a small amount of soft food that can be swallowed without chewing, such as applesauce, gelatin, pureed bananas, or pears. This mixture must be swallowed immediately and followed with a glass of water or juice. This will ensure complete swallowing of the contents of the capsule and avoid mouth irritation.


• When given to infants, the contents of the capsule may be put directly into the infant's mouth or mixed with a small amount of applesauce, pureed bananas, or pears, and given before each feeding.


• Do not mix the contents of the capsule with alkaline foods, such as milk, breast milk, formula, or ice cream. This could reduce the effect of the medicine.

Do not change brands or dosage forms of pancrelipase without first checking with your doctor. Different products may not work in the same way. If you refill your medicine and it looks different, check with your pharmacist.

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.

• To help digestion:
  
  • For oral dosage form (capsules):
    
    • Older adults, adults, and teenagers—One to three capsules before or with meals and snacks. Your doctor may adjust your dose if needed.
    
    
    • Children—The contents of one to three capsules sprinkled on food at each meal. Your doctor may adjust your dose if needed.
    
    
  
  
  • For oral dosage form (delayed-release capsules):
    
    • Older adults, adults, teenagers, and children older than 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 500 lipase units per kilogram (kg) of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
    
    
    • Children older than 12 months and younger than 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 1000 lipase units per kilogram (kg) of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
    
    
    • Infants younger than 12 months—
      
      • Creon®: 3000 lipase units per 120 milliliters (mL) of infant formula or per breastfeeding.
      
      
      • Zenpep®: 3000 lipase units per 120 mL of infant formula or per breastfeeding.
      
      
      • Pancreaze™: 2000 to 4000 lipase units per 120 mL of infant formula or per breastfeeding.
      
      
    
    
  
  
  • For oral dosage form (powder):
    
    • Older adults, adults, and teenagers—1/4 teaspoonful (0.7 gram) with meals and snacks. Your doctor may adjust your dose if needed.
    
    
    • Children—1/4 teaspoonful with meals. Your doctor may adjust your dose if needed.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Older adults, adults, and teenagers—One to three tablets before or with meals and snacks. Your doctor may adjust your dose if needed.
    
    
    • Children—One to two tablets with meals.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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 medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store Creon® capsules at room temperature for 30 days. Throw away any unused medicine after 30 days.

Store the delayed-release capsules in a tightly-closed container to protect them from moisture. Putting desiccant pouches in the container may also help to keep the capsules from getting moist.

Precautions While Using Ultrase

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

For patients taking the capsules containing the powder:

• If the capsules are opened to mix with food, be careful not to breathe in the powder. To do so may cause harmful effects such as stuffy nose, shortness of breath, troubled breathing, wheezing, or tightness in the chest.

For patients taking the powder form of this medicine:

• Avoid breathing in the powder. To do so may cause harmful effects such as stuffy nose, shortness of breath, troubled breathing, wheezing, or tightness in the chest.

Check with your doctor right away if you or your child have unusual or severe abdominal or stomach pain, trouble passing stool, nausea, or vomiting. These may be symptoms of a rare but serious bowel disorder called fibrosing colonopathy.

This medicine is made from the pancreas of pigs. The risk of getting a virus from medicines made of pig organs has been greatly reduced in recent years. This is the result of required testing for certain viruses, and testing during manufacture of these medicines. Although the risk of transmitting certain viruses to people who will use the medicine is low, talk with your doctor if you or your child have concerns.

This medicine may cause a serious type of allergic reaction, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you or your child are using this medicine.

Ultrase 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:

Rare

• Skin rash or hives

With high doses

• Bowel blockage


• diarrhea


• nausea


• stomach cramps or pain

With very high doses

• Blood in the urine


• joint pain


• swelling of the feet or lower legs

With powder dosage form or powder from opened capsules - if breathed in

• Shortness of breath


• stuffy nose


• tightness in the chest


• troubled breathing


• wheezing

With tablets - if held in mouth

• Irritation of the mouth

Incidence not known

• Cough


• difficulty with breathing


• difficulty with swallowing


• dizziness


• fast heartbeat


• itching


• noisy breathing


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• redness of the skin


• severe stomach pain


• unusual tiredness or weakness


• wheezing

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

• Blurred vision


• dry mouth


• flushed, dry skin


• fruit-like breath odor


• headache


• increased hunger


• increased thirst


• increased urination


• sweating


• unexplained weight loss


• vomiting

Less common

• Abnormal feces


• anxiety


• bloated


• chills


• cold sweats


• coma


• confusion


• cool, pale skin


• depression


• excess air or gas in the stomach or intestines


• fever


• frequent bowel movements


• full feeling


• muscle aches


• nightmares


• passing gas


• runny nose


• seizures


• shakiness


• slurred speech


• sore throat

Incidence not known

• Difficulty having a bowel movement (stool)


• difficulty with moving


• muscle aching or cramping


• muscle pains or stiffness


• muscle spasm


• swollen joints

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: Ultrase side effects (in more detail)

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More Ultrase resources

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

• Pancrelipase Professional Patient Advice (Wolters Kluwer)


• Pancrelipase Prescribing Information (FDA)


• Pancrelipase Monograph (AHFS DI)


• Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon Prescribing Information (FDA)


• Creon Consumer Overview


• Creon MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Dygase MedFacts Consumer Leaflet (Wolters Kluwer)


• Pancreaze Consumer Overview


• Pancreaze Prescribing Information (FDA)


• Zenpep Prescribing Information (FDA)


• Zenpep Consumer Overview

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