Anadin Extra Tablets

1. Name Of The Medicinal Product

Anadin Extra / Powerin Tablets

2. Qualitative And Quantitative Composition

Active Ingredients:
Aspirin BP Paracetamol Ph Eur Caffeine Ph Eur	300 mg/tablet 200 mg/tablet 45 mg/tablet
For excipients see section 6.1

3. Pharmaceutical Form

Tablet for oral administration.

White, capsule shaped tablet with a break bar on one side, with the letter 'A' and 'E' debossed on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness, influenza, feverishness and feverish colds.

4.2 Posology And Method Of Administration

Adults, the elderly and young persons aged 16 and over:

2 tablets every 4 hours to a maximum of 8 tablets in 24 hours.

Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki's disease).

4.3 Contraindications

Hypersensitivity to the active ingredients or any of the other constituents. Peptic ulceration and those with a history of peptic ulceration; haemophilia, concurrent anti-coagulant therapy; children under 16 years and when breast feeding because of possible risk of Reyes Syndrome.

4.4 Special Warnings And Precautions For Use

Caution should be exercised in patients with asthma, allergic disease, impairment of hepatic or renal function (avoid if severe) and dehydration. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not take if you have a stomach ulcer.

Do not exceed the stated dose.

Do not take other paracetamol containing products.

If symptoms continue for more than 3 days or get worse consult your doctor.

Immediate medical advice should be sought in the case of an overdose, even if you feel well.

There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason aspirin should not be given to children under 16 years unless specifically indicated (e.g. Kawasaki's disease).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Aspirin:

Other NSAIDS and corticosteroids: Concurrent use of other NSAIDS or corticosteroids may increase the likelihood of GI side effects.

Diuretics: Antagonism of the diuretic effect.

Anticoagulants: Increased risk of bleeding due to antiplatelet effect.

Metoclopramide: Metoclopramide increases the rate of absorption of aspirin. However, concurrent use need not be avoided.

Phenytoin : The effect of phenytoin may be enhanced by aspirin. However, no special precautions are needed.

Valproate: The effect of valproate may be enhanced by aspirin.

Methotrexate: Delayed excretion and increased toxicity of methotrexate.

Paracetamol:

Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required.

Metoclopramide and Domperidone : The speed of absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.

Warfarin: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Chloramphenicol: Increased plasma concentration of chloramphenicol.

4.6 Pregnancy And Lactation

There is clinical and epidemiological evidence of safety of aspirin in pregnancy, but it may prolong labour and contribute to maternal and neonatal bleeding, and so should not be used in late pregnancy.

Aspirin appears in breast milk, and regular high doses may affect neonatal clotting. Not recommended while breast-feeding due to possible risk of Reye's Syndrome as well as neonatal bleeding due to hypoprothrombinaemia.

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of the doctor regarding its use. Paracetamol is excreted in breast milk but not in a significant amount. Available published data do not contraindicate breast feeding.

Caffeine appears in breast milk. Irritability and poor sleeping pattern in the infant have been reported.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Side effects are mild and infrequent, but there is a high incidence of gastro-intestinal irritation with slight asymptomatic blood loss. Increased bleeding time. Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions, such as skin reactions (including angioedema and face oedema) in susceptible individuals.

Aspirin may induce gastro-intestinal haemorrhage, occasionally major. It may precipitate gout in susceptible individuals. Possible risk of Reye's Syndrome in children under 16 years.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash (including angioedema and face oedema) may occur. There have been reports of blood dyscrasias including thrombocytopenia purpura and agranulocytosis, but these were not necessarily causality related to paracetamol.

High doses of caffeine can cause tremor and palpitations.

4.9 Overdose

This product contains both paracetamol and aspirin, and as such, any overdose events should be assessed using information available on both active substances.

Liver damage is possible in adults who have taken 10g or more of paracetamol. Adults who have consumed more than 5g of paracetamol, may experience liver damage if they have one of the following risk factors:

• long term treatment with either anti-infectives, anti-epileptics or St John's Wort, or any other drugs that induce liver enzymes

• regular consumption of ethanol in excess of recommended amounts

• likely to be glutathione deplete e.g. eating disorder, cystic fibrosis, HIV infection, starvation, cachexia.

Salicylate poisoning is usually associated with plasma concentrations>350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.

Symptoms

Common features exist for both active substances when taken in overdose, but these can be tabulated as follows:

Paracetamol	Aspirin	Caffeine
Within the first 24 hours: Pallor Nausea Vomiting Anorexia Abdominal pain After 12-48 hours: Liver damage Abnormalities of glucose metabolism and metabolic acidosis Severe poisoning: Hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. With or without severe liver damage: Acute renal failure with acute tubular necrosis strongly suggested by loin pain haematuria and proteinuria. Cardiac arrhythmias Pancreatitis	Common: Vomiting, Dehydration, Tinnitus Vertigo, Deafness, Sweating Warm extremities with bounding pulses Increased respiratory rate Hyperventilation Acid base disturbance Mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) in adults and children aged over 4 years. In children aged 4 years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis can increase salicylate transfer across the blood brain barrier. Uncommon: Haematemesis Hyperpyrexia Hypoglycaemia Hypokalaemia Thrombocytopenia Increased INR/PTR Intravascular coagulation Renal failure Non-cardiac pulmonary oedema Confusion, disorientation, coma and convulsions are more common in children than adults.	Other symptoms of overdosage, associated with the caffeine component, include: CNS stimulation; anxiety, nervousness, restlessness, insomnia, excitement, muscle twitching, confusion, convulsions Cardiac: tachycardia, cardiac arrhythmia Gastric: Abdominal or stomach pains Other: diuresis, facial flushing

Management

Paracetamol:

Immediate treatment is essential in the management of overdose due to the paracetamol content of the product.

There may be few or no initial symptoms, and these can be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour.

Plasma paracetamol concentrations should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).

Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol; however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.

Management of patients who present with serious hepatic dysfunction, or are under 10 years or over 70, beyond 24h from ingestion should be discussed with the National Poisons Information Service (NPIS) or a liver unit.

Salicylates:

Treatment with activated charcoal should be considered if salicylate plasma concentration is greater than 250mg/kg.

Plasma salicylate concentrations should be measured although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account.

Elimination of aspirin is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Metabolic acidosis should be corrected with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.

Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations>700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features.

Patients under 10 years or over 70 years of age may be at an increased risk of salicylate toxicity and may require dialysis at an earlier stage.

Caffeine:

Treatment of caffeine overdose is primarily symptomatic and supportive. Diuresis should be treated by maintaining fluid and electrolyte balance and CNS symptoms can be controlled by intravenous administration of diazepam.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Aspirin

Mechanisms of action/effect

Salicylates inhibit the activity of the enzyme cyco-oxygenase to decrease the formation of precursors of prostaglandins and thromboxanes from arachidonic acid. Although many of the therapeutic effects may result from inhibition of prostaglandin synthesis (and consequent reduction of prostaglandin activity) in various tissues, other actions may also contribute significantly to the therapeutic effects.

Analgesic

Produces analgesia through a peripheral action by blocking pain impulse generation and via a central action, possibly in the hypothalamus.

Anti-inflammatory (Non-steroidal)

Exact mechanisms have not been determined. Salicylates may act peripherally in inflamed tissue probably by inhibiting the synthesis of prostaglandins and possibly by inhibiting the synthesis and/or actions of other mediators of the inflammatory response.

Antipyretic

May produce antipyresis by acting centrally on the hypothalamic heat-regulating centre to produce peripheral vasolidation resulting in increased cutaneous blood flow, sweating and heat loss.

PARACETAMOL

Mechanism of action/effect

Analgesic – the mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and, to a lesser extent, through a peripheral action by blocking pain-impulse generation.

The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Antipyretic – paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating, and heat loss. The central action probably involved inhibition of prostaglandin synthesis in the hypothalamus.

CAFFEINE

Mechanisms of action/effect

Central nervous system stimulant – caffeine stimulates all levels of the CNS, although its cortical effects are milder and of shorter duration than those of amphetamines.

Analgesia adjunct

Caffeine constricts cerebral vasculature with an accompanying decrease in the cerebral blood flow and in the oxygen tension of the brain. It is believed that caffeine helps to relieve headache by providing more rapid onset of action and/or enhanced pain relief with lower doses of analgesic. Recent studies with ergotamine indicate that the enhancement of effect by the addition of caffeine may also be due to improved gastrointestinal absorption of ergotamine when administered with caffeine.

5.2 Pharmacokinetic Properties

Aspirin

Absorption and fate

Absorption is generally rapid and complete following oral administration. It is largely hydrolysed in the gastrointestinal tract, liver and blood to salicylate, which is further metabolised primarily in the liver.

Paracetamol

Absorption and fate

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

A minor hydroxylated metabolite, which is usually produced in very small amounts by mixed-function oxidases in the liver, and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause liver damage.

Caffeine

Absorption and fate

Caffeine is completely and rapidly absorbed after oral administration with peak concentrations occurring between 5 and 90 minutes after dose in fasted subjects. There is no evidence of presystemic metabolism. Elimination is almost entirely by hepatic metabolism in adults.

In adults, marked individual variability in the rate of elimination occurs. The mean plasma elimination half-life is 4.9 hours with a range of 1.9 - 12.2 hours. Caffeine distributes into all body fluids. The mean plasma protein binding of caffeine is 35%.

Caffeine is metabolised almost completely via oxidation, demethylation, and acetylation, and is excreted in the urine as 1-methyluric acid, 1-methylxanthine, 7-methylxanthine, 1,7-dimethylxanthine (paraxanthine). Minor metabolites include 1-methylacrylic acid and 5-acethylamine-6-formylamine-3-methyluracil (AFMU).

5.3 Preclinical Safety Data

The active ingredients in Anadin Extra / Powerin tablets have a well established safety record. This combination of ingredients has been marketed for a number of years.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize Starch

Microcrystalline Cellulose

Hydrogenated vegetable oil

Hypromellose

Hypromellose 15

Carbowax 3350

Pregelatinised Starch

Polyvinylpyrollidone

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years:

Blister strip: 4, 6, 8, 12, 16, 24, 32 tablets.

2 years:

Paper/Polyethylene strip / laminated strip: 4, 8

HDPE tablet container: 10, 24, 32

Aluminium containers: 16, 32

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Pack A

Cartons containing blister strips.

Pack sizes: 8, 12, 16, 24, 32 tablets.

Pack B

The tablets are packed into tablet containers.

Pack sizes: 10, 16, 24 and 32 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL00165/5013R

9. Date Of First Authorisation/Renewal Of The Authorisation

19 August 1996

10. Date Of Revision Of The Text

September 2010

Targocid 200mg & 400mg

1. Name Of The Medicinal Product

Targocid 200mg

Teicoplanin 200mg Powder for Injection

Targocid 400mg

Teicoplanin 400mg Powder for Injection

2. Qualitative And Quantitative Composition

Teicoplanin 200mg

Teicoplanin 400mg

3. Pharmaceutical Form

Powder for Injection

4. Clinical Particulars

4.1 Therapeutic Indications

Targocid is indicated in potentially serious Gram-positive infections including those which cannot be treated with other antimicrobial drugs, eg. penicillins and cephalosporins.

Targocid is useful in the therapy of serious staphylococcal infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins, or who have infections with staphylococci resistant to other antibiotics.

The effectiveness of teicoplanin has been documented in the following infections:-

Skin and soft tissue infections, urinary tract infections, lower respiratory tract infections, joint and bone infections, septicaemia, endocarditis and peritonitis related to continuous ambulatory peritoneal dialysis.

Targocid may be used for antimicrobial prophylaxis in orthopaedic surgery at risk of Gram-positive infection.

4.2 Posology And Method Of Administration

Administration

The reconstituted Targocid injection may be administered directly either intravenously or intramuscularly. The intravenous injection may be administered either as a bolus or as a 30 minute infusion. Only the infusion method must be used in neonates. Dosage is usually once daily but, in cases of severe infection, a second injection should be administered on the first day in order to reach more rapidly the required serum concentrations.

The administration of teicoplanin by the intraventricular route is not indicated (see sections 4.4 and 4.8)

The majority of patients with infections caused by organisms sensitive to the antibiotic show a therapeutic response within 48-72 hours. The total duration of therapy is determined by the type and severity of the infection and the clinical response of the patient. In endocarditis and osteomyelitis, treatment for three weeks or longer is recommended.

TARGOCID^®must not be administered for more than 4 months.

Determination of teicoplanin serum concentrations may optimise therapy. In severe infections, trough serum concentrations should not be less than 10mg/l. Peak concentrations measured one hour after a 400mg intravenous dose are usually in the range of 20-50mg/l; peak serum concentrations of up to 250mg/l have been reported after intravenous doses of 25mg/kg. A relationship between serum concentration and toxicity has not been established.

Therapeutic dosage:

Adult or elderly patients with normal renal function

Prophylaxis:	400mg intravenously as a single dose at induction of anaesthesia
Moderate infections:	Skin and soft tissue infection, urinary tract infection, lower respiratory tract infection
Loading dose:	One single i.v. or i.m. injection of 400mg on the first day
Maintenance dose:	A single i.v. or i.m. injection of 200mg daily
Severe infections:	Joint and bone infection, septicaemia, endocarditis
Loading dose:	Three 400mg i.v. injections, administered 12 hours apart
Maintenance dose:	A single i.v. or i.m. injection of 400mg daily

1. Standard doses of 200 and 400mg equate respectively to mean doses of 3 and 6mg/kg. In patients weighing more than 85kg it is recommended to adapt the dosage to the weight following the same therapeutic schedule: moderate infection 3mg/kg, severe infection 6mg/kg.

2. In some clinical situations, such as infected, severely burned patients or Staphylococcus aureus endocarditis, unit maintenance doses of up to 12mg/kg have been administered (intravenously). In endocarditis caused by Staphylococcus aureus, satisfactory results have been achieved with teicoplanin in polytherapy. When serum concentrations are controlled in severe infections, the trough levels must be 10 times higher than the MIC or, generally, at least 10 mg/l.

In the treatment of antibiotic-associated diarrhoea caused by Clostridium difficile: one oral dose of 200 mg twice a day.

Children

Teicoplanin can be used to treat Gram-positive infections in children from the age of 2 months. For severe infections and neutropenic patients the recommended dose is 10mg/kg every 12 hours for the first three doses; thereafter a dose of 10mg/kg should be administered by either intravenous or intramuscular injection as a single dose each day.

For moderate infections the recommended dose is 10mg/kg every twelve hours for the first three doses; thereafter a dose of 6mg/kg should be administered by either intravenous or intramuscular injection as a single dose each day.

The recommended dosage regimen for neonates is a loading dose of 16mg/kg followed by a daily dose of 8mg/kg.

The I.V. dose must be infused over 30 minutes.

In continuous ambulatory periotoneal dialysis

After a single loading IV dose of 400mg of the patient is febrile, the recommended dosage is 20mg/l per bag in the first week, 20mg/l in alternate bags in the second week and 20mg/l in the overnight dwell bag only during the third week, feverish patients must also take an I.V. loading dose of 400 mg of teicoplanin.

Teicoplanin remains stable in solutions for peritoneal dialysis (1.36% or 3.86% dextrose). These solutions must not be kept for more than 24 hours.

Combined treatment:

It is recommended that the treatment be combined with an appropriate antibacterial agent when the infection requires a maximum antibacterial activity (e.g. staphylococcal endocarditis) and when it cannot be ruled out that there is a mixed infection with gram-negatives (e.g. empirical treatment of fever in a neutropenic patient).

Prophylaxis of endocarditis caused by gram-positives in dental surgery and in patients with heart valve disease:

To induce anaesthesia, 400 mg (6 mg/kg) of I.V. teicoplanin.

Adults and elderly patients with renal insufficiency

For patients with impaired renal function, reduction of dosage is not required until the fourth day of Targocid treatment. Measurement of the serum concentration of teicoplanin may optimise therapy (see section 'Administration').

From the fourth day of treatment

In mild renal insufficiency

Creatinine clearance between 40 and 60ml/min, Targocid dose should be halved, either by administering the initial unit dose every two days, or by administering half of this dose once a day.

In severe renal insufficiency

Creatinine clearance less than 40ml/min and in haemodialysed patients, Targocid dose should be one third of the normal either by administering the initial unit dose every third day, or by administering one third of this dose once a day. Teicoplanin is not removed by dialysis.

4.3 Contraindications

Teicoplanin is contra-indicated in patients who have exhibited previous hypersensitivity to the drug.

4.4 Special Warnings And Precautions For Use

Warnings:

Targocid should be administered with caution in patients known to be hypersensitive to vancomycin since cross hypersensitivity may occur. However, a history of the “Red Man Syndrome” that can occur with vancomycin is not a contra-indication to Targocid.

Thrombocytopenia has been reported with teicoplanin, especially at higher doses than those usually recommended. It is advisable for periodic haematological studies to be performed during treatment. Liver and renal function tests are advised during treatment.

Serial renal and auditory function tests should be undertaken in the following circumstances:

Prolonged treatment in patients with renal insufficiency.

Concurrent and sequential use of other drugs which may have neurotoxic and/or nephrotoxic properties. These include aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide and etacrynic acid.

However, there is no evidence of synergistic toxicity with combinations with Targocid.

Dosage must be adapted in patients with renal impairment (see 'Dosage').

Precautions:

Superinfection: as with other antibiotics, the use of teicoplanin, especially if prolonged, may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.

In some cases of intraventricular use, seizures have been reported (see sections 4.2 and 4.8)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Targocid should be used with care in conjunction with or sequentially with other drugs with known nephrotoxic or ototoxic potential. These include aminoglycosides, amphotericin B, ciclosporin, and furosemide (see section 4.4). Of particular concern are streptomycin, neomycin, kanamycin, gentamicin, amikacin, tobramycin, cephaloridine, colistin.

In clinical trials teicoplanin has been administered to many patients already receiving various medications including other antibiotics, antihypertensives, anaesthetic agents, cardiac drugs and antidiabetic agents without evidence of adverse interaction.

Animal studies have shown lack of interaction with diazepam, thiopental, morphine, neuromuscular blocking agents or halothane.

4.6 Pregnancy And Lactation

There are no adequate data from the use of teicoplanin in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Teicoplanin should not be used during pregnancy unless clearly necessary.

It is not known whether teicoplanin is excreted in human breast milk. The excretion of teicoplanin in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with teicoplanin should be made taking into account the benefit of breast-feeding to the child and the benefit of teicoplanin therapy to the mother.

4.7 Effects On Ability To Drive And Use Machines

Teicoplanin can cause dizziness and headaches. The ability to drive or use machines may be affected. Patients experiencing these undesirable effects should not drive or use machines.

4.8 Undesirable Effects

Although causal relationships have not been established in every case, the following undesirable effects have been reported with the administration of teicoplanin:

System organ class	Very common (	Common (	Uncommon (	Rare (	Very rare (<1/10,000)	Frequency not known (cannot be estimated from available data)*
Infections and infestations				Abscess		Injection site abscess, superinfection (overgrowth of non-susceptible organisms)
Blood and the lymphatic system disorders			Eosinophilia, thrombocytopenia, leucopenia			Agranulocytosis, neutropenia
Immune system disorders			Anaphylactic reaction (anaphylaxis)			Anaphylactic shock
Nervous system disorders			Dizziness, headache			Seizures with intraventricular use
Ear and labyrinth disorders			Deafness (mild hearing loss), tinnitus, vestibular disorder
Vascular disorders			Phlebitis			Thrombophelebitis
Respiratory, thoracic and mediastinal disorders			Bronchospasm
Gastrointestinal disorders			Nausea, vomiting, diarrhoea
Skin and subcutaneous tissue disorders		Erythema (redness), rash (skin rash), pruritus				Urticaria, angioedema, dermatitis exfoliative (exfoliative dermatitis), toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome
Renal and urinary disorders						Renal failure
General disorders and administration site conditions		Pain, pyrexia (fever),				Chills (rigors)
Investigations			Transaminases abnormal (transient abnormality of transaminases), blood alkaline phosphatase abnormal (transient abnormality of alkaline phosphatase), blood creatinine increased (transient rise of serum creatinine)

* postmarketing experience.

4.9 Overdose

Cases have been reported of accidental administration of excessive doses to paediatric patients. Several overdoses of 100mg/kg/day have been administered in error to two neutropenic patients aged 4 and 8 years. Despite high plasma concentrations of teicoplanin up to 300mg/ml there were no symptoms or laboratory abnormalities. In one case agitation occurred in a 29-day-old newborn who had been administered 400 mg I.V. (95 mg/kg).

Management:

Treatment of overdosage should be symptomatic

Teicoplanin is not removed by haemodialysis and only slowly by peritoneal dialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Teicoplanin is a bactericidial, glycopeptide antibiotic, produced by fermentation of Actinoplanes teichomyceticus. It is active against both aerobic and anaerobic Gram-positive bacteria.

Species usually sensitive (MIC less than or equal to 16mg/l):

Staphylococcus aureus and coagulase negative staphylococci (sensitive or resistant to meticillin), streptococci, enterococci, Listeria monocytogenes, micrococci, Eikenella corrodens, group JK corynebacteria and Gram-positive anaerobes including Clostridium difficile, and peptococci.

Species usually resistant (MIC superior to 16mg/l):

Nocardia asteroides, Lactobacillus spp, Leuconostoc and all Gram-negative bacteria.

Bactericidal synergy has been demonstrated in vitro with aminoglycosides against group D streptococci and staphylococci. In vitro combinations of teicoplanin with rifampicin or fluorinated quinolones show primarily additive effects and sometimes synergy.

One-step resistance to teicoplanin could not be obtained in vitro and multi-step resistance was only reached in vitro after 11-14 passages.

Teicoplanin does not show cross-resistance with other classes of antibiotics.

The use of teicoplanin may result in overgrowth of non-susceptible organisms. If new infections due to bacteria or fungi appear during treatment appropriate measures should be taken.

Susceptibility testing:

Sensidiscs are charged with 30 micrograms of teicoplanin. Strains showing an inhibition zone diameter of 14mm or more are susceptible and those of 10mm or less are resistant.

5.2 Pharmacokinetic Properties

Following injection teicoplanin rapidly penetrates into tissues, including skin, fat and bones and reaches the highest concentrations in the kidney, trachea, lungs and adrenals. Teicoplanin does not readily penetrate into the cerebro-spinal fluid (CSF).

In man the plasma level profile after intravenous administration indicates a biphasic distribution (with a rapid distribution phase having a half-life of about 0.3 hours, followed by a more prolonged distribution phase having a half-life of about 3 hours), followed by slow elimination (with a terminal elimination half-life of about 150 hours). At 6mg/kg administered intravenously at 0, 12, 24 hours and every 24 hours thereafter as a 30 minute infusion, a predicted trough serum concentration of 10mg/l would be reached by Day 4. The steady state volume of distribution after 3 to 6mg/kg intravenously ranges from 0.94 l/kg to 1.4 l/kg. The volume of distribution in children is not substantially different from that in adults.

Approximately 90-95% teicoplanin is bound with weak affinity to plasma proteins. Teicoplanin penetrates readily into blister exudates and into joint fluid; it penetrates neutrophils and enhances their bactericidal activity; it does not penetrate red blood cells.

No metabolites of teicoplanin have been identified; more than 97% of the administered teicoplanin is excreted unchanged. The elimination of teicoplanin from the plasma is prolonged with a terminal half-life of elimination in man of about 150 hours. Teicoplanin is excreted mainly in the urine.

5.3 Preclinical Safety Data

Not Applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride

6.2 Incompatibilities

Solutions of teicoplanin and aminoglycosides are incompatible when mixed directly and should not be mixed before injection.

6.3 Shelf Life

3 years unopened.

24 hours after reconstitution.

6.4 Special Precautions For Storage

Finished Product:

Vials of dry Targocid should not be stored above 25^oC.

Reconstituted Product:

In keeping with good clinical pharmaceutical practise reconstituted vials of Targocid should be used immediately and any unused portion discarded. On the few occasions when changing circumstances make this impractical reconstituted solutions should be kept at 2 - 8^oC and discarded within 24 hours.

Do not store in a syringe.

6.5 Nature And Contents Of Container

Colourless, BP, Type I glass vials, closed with a butyl rubber plug and combination aluminium/plastic “flip-off cap” (200mg colour coded yellow, 400mg colour coded green).

Pack size: 1 vial

6.6 Special Precautions For Disposal And Other Handling

Preparation of Injection

The entire contents of the water ampoule should be slowly added to the vial of Targocid and the vial rolled gently until the powder is completely dissolved, taking care to avoid formation of foam. If the solution does become foamy then allow to stand for about 15 minutes for the foam to subside.

A calculated excess is included in each vial of Targocid so that, when prepared as described above, a full dose of 100mg, 200mg or 400mg (depending on the strength of the vial) will be obtained if all the reconstituted solution is withdrawn from the vial by a syringe. The concentration of teicoplanin in these injections will be 100mg in 1.5ml (from the 100mg and 200mg vials) and 400mg in 3ml (from the 400mg vial).

The reconstituted solution may be injected directly, or alternatively diluted with:

• 0.9% Sodium Chloride Injection

• Compound Sodium Lactate Injection (Ringer-Lactate Solution, Hartmanns Solution)

• 5% Dextrose Injection

• 0.18% Sodium Chloride and 4% Dextrose Injection

• Peritoneal dialysis solution containing 1.36% or 3.86% Dextrose.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

8. Marketing Authorisation Number(S)

200 mg: PL 04425/0088

400 mg: PL 04425/0089

9. Date Of First Authorisation/Renewal Of The Authorisation

2 August 1989/7 March 2001

10. Date Of Revision Of The Text

4^th April 2010

LEGAL CATEGORY

POM

Idéos

Idéos may be available in the countries listed below.

Ingredient matches for Idéos

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Idéos in the following countries:

• France


• Norway

Colecalciferol

Colecalciferol is reported as an ingredient of Idéos in the following countries:

• France


• Norway

International Drug Name Search

Plasma-Lyte 148 and Dextrose

Dosage Form: Injection

Plasma-Lyte 148 and Dextrose Description

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. Each 100 mL contains 5 g Dextrose Hydrous, USP*, 526 mg Sodium Chloride, USP (NaCl); 502 mg Sodium Gluconate (C6H11NaO7); 368 mg Sodium Acetate Trihydrate, USP (C2H3NaO2•3H2O), 37 mg Potassium Chloride, USP (KCl); and 30 mg Magnesium Chloride, USP (MgCl2•6H2O). It contains no antimicrobial agents. The pH is 5.0 (4.0 to 6.5). The pH is adjusted with hydrochloric acid.

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate and 23 mEq gluconate. The osmolarity is 547 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. The caloric content is 190 kcal/L.

The Viaflex® plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146® Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Plasma-Lyte 148 and Dextrose - Clinical Pharmacology

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) has value as a source of water, electrolytes, and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) produces a metabolic alkalinizing effect. Acetate and gluconate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

Indications and Usage for Plasma-Lyte 148 and Dextrose

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is indicated as a source of water, electrolytes, and calories, or as an alkalinizing agent.

Contraindications

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Warnings

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate or gluconate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.

The intravenous administration of Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

In patients with diminished renal function, administration of Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) may result in sodium or potassium retention.

GENERAL PRECAUTIONS

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be used with caution. Excess administration may result in metabolic alkalosis.

Caution must be exercised in the administration of Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) to patients receiving corticosteroids or corticotropin.

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be used with caution in patients with overt or subclinical diabetes mellitus.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP). It is also not known whether Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness of Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in pediatric patients have not been established by adequate and well controlled trials, however, the use of plasmalyte and dextrose solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible hemorrhage.

Carcinogenesis and Mutagenesis and Impairment of Fertility

Studies with Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is administered to a nursing mother.

Geriatric Use

Clinical studies of Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

Do not administer unless solution is clear and seal is intact.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Plasma-Lyte 148 and Dextrose Dosage and Administration

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in Viaflex® plastic containers are intended for intravenous administration using sterile equipment.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

How is Plasma-Lyte 148 and Dextrose Supplied

Plasma-Lyte® 148 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in Viaflex® plastic containers is available as shown below:

Size (mL)	Code	NDC
1000	2B2584	NDC 0338-0149-04
500	2B2583	NDC 0338-0149-03

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

DIRECTIONS FOR USE OF VIAFLEX® PLASTIC CONTAINER

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for Administration

1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning:

Additives may be incompatible.

To add medication before solution administration

1. Prepare medication site.

2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

1. Close clamp on the set.

2. Prepare medication site.

3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

4. Remove container from IV pole and/or turn to an upright position.

5. Evacuate both ports by squeezing them while container is in the upright position.

6. Mix solution and medication thoroughly.

7. Return container to in use position and continue administration.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

©Copyright 1982, 1983, 1989, 1993, Baxter Healthcare Corporation.

All rights reserved.

7-19-22-968

Plasma-Lyte 148 and Dextrose  sodium chloride, potassium chloride, calcium chloride, sodium gluconate, sodium acetate and dextrose  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0338-0149 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Dextrose hydrous (dextrose) Active 5 GRAM  In 100 MILLILITER Sodium Chloride (Sodium Chloride) Active 526 MILLIGRAM  In 100 MILLILITER Potassium Chloride (Potassium Chloride) Active 37 MILLIGRAM  In 100 MILLILITER Magnesium Chloride (Magnesium Chloride) Active 30 MILLIGRAM  In 100 MILLILITER Sodium Gluconate (sodium gluconate) Active 502 MILLIGRAM  In 100 MILLILITER Sodium Acetate (sodium acetate) Active 368 MILLIGRAM  In 100 MILLILITER Water Inactive   Hydrochloric acid Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0149-03 500 mL (MILLILITER) In 1 BAG None 2 0338-0149-04 1000 mL (MILLILITER) In 1 BAG None

Revised: 04/2006Baxter Healthcare Corporation

More Plasma-Lyte 148 and Dextrose resources

• Plasma-Lyte 148 and Dextrose Support Group
• 0 Reviews for Plasma-Lyte48 and Dextrose - Add your own review/rating

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• Fluid Retention

carbetapentane, pseudoephedrine, and pyrilamine

Generic Name: carbetapentane, pseudoephedrine, and pyrilamine (kar BET a PEN tane SOO doe ee FED rin, pir IL a meen)

Brand Names: Corzall Plus, Zotex-D

What is carbetapentane, pseudoephedrine, and pyrilamine?

Carbetapentane is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pyrilamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of carbetapentane, pseudoephedrine, and pyrilamine is used to treat runny nose, sneezing, cough, watery eyes, and itching caused by allergies, the common cold, or flu.

This medication will not treat a cough that is caused by smoking, asthma, or emphysema.

Carbetapentane, pseudoephedrine, and pyrilamine may also be used to treat other conditions not listed in this medication guide.

What is the most important information I should know about carbetapentane, pseudoephedrine, and pyrilamine?

You should not use this medication if you are allergic to carbetapentane, pseudoephedrine, pyrilamine. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Before you take carbetapentane, pseudoephedrine, and pyrilamine, tell your doctor if you have asthma or other breathing disorder, heart disease, high blood pressure, glaucoma, diabetes, liver or kidney disease, urination problems, a seizure disorder, stomach ulcer or intestinal blockage, or an overactive thyroid.

Also tell your doctor about all other medications you use.

This medication can cause side effects that may cause drowsiness, dizziness, or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Avoid drinking alcohol. It can increase some of the side effects of carbetapentane, pseudoephedrine, and pyrilamine.

Talk with your doctor if your symptoms do not improve after 7 days of taking this medication. Call your doctor any time if your symptoms get worse or if you also have a fever, headache, or skin rash.

What should I discuss with my health care provider before taking carbetapentane, pseudoephedrine, and pyrilamine?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough or cold medicine before the MAO inhibitor has cleared from your body. You should not use this medication if you are allergic to carbetapentane, pseudoephedrine, pyrilamine.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• 
  

  asthma, emphysema, or other breathing problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  glaucoma;

  
  


• 
  

  diabetes;

  
  


• 
  

  liver or kidney disease;

  
  


• 
  

  an enlarged prostate or urination problems;

  
  


• 
  

  a seizure disorder;

  
  


• 
  

  stomach ulcer, intestinal blockage; or

  
  


• 
  

  overactive thyroid.

  
  

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking carbetapentane, pseudoephedrine, and pyrilamine, tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

How should I take carbetapentane, pseudoephedrine, and pyrilamine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may take this medication with or without food. Taking it with food or milk may decrease stomach upset.

This medication may cause dry mouth. You may need to suck on ice chips or hard candy to relieve this side effect.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

Talk with your doctor if your symptoms do not improve after 7 days of taking this medication. Call your doctor any time if your symptoms get worse or if you also have a fever, headache, or skin rash.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medication at room temperature away from moisture, heat, and light.

See also: Carbetapentane, pseudoephedrine, and pyrilamine dosage (in more detail)

What happens if I miss a dose?

Since cold or allergy medicine is often taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause restlessness, feeling excited, confusion, hallucinations, extreme drowsiness, fainting, or seizure (convulsions).

What should I avoid while taking carbetapentane, pseudoephedrine, and pyrilamine?

This medication can cause side effects that may cause drowsiness, dizziness, or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase some of the side effects of carbetapentane, pseudoephedrine, and pyrilamine. Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. Decongestants and antihistamines are contained in many combination medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains a decongestant or antihistamine.

Carbetapentane, pseudoephedrine, and pyrilamine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  confusion, hallucinations, tremors;

  
  


• 
  

  seizure (confusion);

  
  


• 
  

  extreme weakness;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  fast, slow, or uneven heart rate; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  drowsiness, dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  dryness in your mouth, nose, or throat;

  
  


• 
  

  nausea; or

  
  


• 
  

  warmth, redness, or tingly feeling under your skin.

  
  

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.

Carbetapentane, pseudoephedrine, and pyrilamine Dosing Information

Usual Adult Dose for Cough and Nasal Congestion:

Carbetapentane/pseudoephedrine/pyrilamine 20 mg-8 mg-7.5 mg/5 mL oral syrup:
carbetapentane/pseudoephedrine/pyrilamine 20 mg-30 mg-7.5 mg/5 mL oral liquid:
5 to 10 mL orally every 4 to 6 hours not to exceed 60 mL daily.

Usual Pediatric Dose for Cough and Nasal Congestion:

Carbetapentane/pseudoephedrine/pyrilamine 20 mg-8 mg-7.5 mg/5 mL oral syrup:
Carbetapentane/pseudoephedrine/pyrilamine 20 mg-30 mg-7.5 mg/5 mL oral liquid:
6 to 11 years: 2.5 to 5 mL orally every 4 to 6 hours not to exceed 30 mL daily.
12 years or older: 5 to 10 mL orally every 4 to 6 hours not to exceed 60 mL daily.

What other drugs will affect carbetapentane, pseudoephedrine, and pyrilamine?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by carbetapentane, pseudoephedrine, and pyrilamine.

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

• 
  

  blood pressure medications;

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  reserpine; or

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

  
  

This list is not complete and there may be other drugs that can interact with carbetapentane, pseudoephedrine, and pyrilamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More carbetapentane, pseudoephedrine, and pyrilamine resources

• Carbetapentane, pseudoephedrine, and pyrilamine Dosage
• Carbetapentane, pseudoephedrine, and pyrilamine Use in Pregnancy & Breastfeeding
• Carbetapentane, pseudoephedrine, and pyrilamine Drug Interactions
• Carbetapentane, pseudoephedrine, and pyrilamine Support Group
• 0 Reviews for Carbetapentane, pseudoephedrine, and pyrilamine - Add your own review/rating

Compare carbetapentane, pseudoephedrine, and pyrilamine with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about carbetapentane, pseudoephedrine, and pyrilamine.

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