Infovir 10 mg (Tablet)

Indications

• Treatment of chronic hepatitis B in adults with evidence of active viral replication

Pharmacology

• Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV)
• Approximate oral bioavailability of adefovir from a 10 mg single dose is 59%
• In vitro binding of adefovir to human plasma or human serum proteins is 4%
• Adefovir is excreted through renal route by a combination of glomerular filtration and active tubular secretion

Dosage & Administration

• Recommended dose of Adefovir in chronic hepatitis B patients with adequate renal function is 10 mg, once daily, taken orally, without regard to food

Interaction

• Unchanged pharmacokinetics when coadministered with certain medications
• Increases in adefovir Cmax (33%), AUC (23%) and urinary recovery observed when co-administered with ibuprofen

Contraindications

• Contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product

Side Effects

• Most common side effects are weakness, headache, stomach pain and nausea
• Severe acute exacerbations of hepatitis reported in patients who have discontinued anti-hepatitis B therapy
• Chronic administration may result in nephrotoxicity
• Lactic acidosis and severe hepatomegaly with steatosis reported with the use of nucleoside analogs alone or in combination with other antiretrovirals

Pregnancy & Lactation

• Pregnancy Category C
• Adefovir dipivoxil should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits
• Not known whether adefovir is excreted in human milk
• Mothers should be instructed not to breast-feed if they are taking adefovir dipivoxil

Precautions & Warnings

• Patients who discontinued Infovir should be monitored at repeated intervals over a period of time for hepatic function
• Patients at risk of or having underlying renal dysfunction should be monitored closely for renal function and may require dose adjustment

Use in Special Populations

• Safety and effectiveness in pediatric patients have not been established
• Caution advised when prescribing to elderly patients due to greater frequency of decreased renal or cardiac function
• Dosing interval of Infovir should be adjusted in patients with baseline creatinine clearance <50 ml/min

Overdose Effects

• Doses of Infovir associated with gastrointestinal side effects
• If overdose occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment applied as necessary

Therapeutic Class

• Hepatic viral infections (Hepatitis B)

Storage Conditions

• Store at cool and dry place
• Protect from light and moisture
• Keep all the medicines out of the reach of children

Related Brands