InfovirTablet

Indications of Infovir

Infovir is used to treat chronic hepatitis B in people who have active viral replication and either persistent increases in serum aminotransferases (ALT or AST) or histologically active disease.

Pharmacology

Adefovir dipivoxil is an adefovir diester prodrug. Adefovir is an acyclic nucleotide analog that inhibits the replication of the human hepatitis B virus (HBV). Cellular kinases phosphorylate adefovir to its active metabolite, adefovir diphosphate. By competing with the natural substrate deoxyadenosine triphosphate and inducing DNA chain termination following incorporation into viral DNA, adefovir diphosphate inhibits HBV DNA polymerase (reverse transcriptase). A single 10 mg dosage of adefovir has an estimated oral bioavailability of 59 percent. Adefovir binds to human plasma or serum proteins in vitro at a rate of 4%. Adefovir is eliminated from the body via the kidneys by a combination of glomerular filtration and active tubular secretion.

Dosage & Administration of Infovir

The recommended dose of Infovir in chronic hepatitis B patients with adequate renal function is 10 mg, once daily, taken orally, without regard to food.

Interaction of Infovir

When adefovir dipivoxil was coadministered with lamivudine, trimethoprim/sulfamethoxazole, and acetaminophen, the pharmacokinetics of adefovir remained unaltered. Increases in adefovir Cmax (33%), AUC (23%), and urine recovery were seen when adefovir dipivoxil was co-administered with ibuprofen (800 mg three times day). This was attributed to increased oral bioavailability of adefovir.

Contraindications

Adefovir dipivoxil is not recommended for individuals who have previously exhibited hypersensitivity to any of the product's components.

Side Effects of Infovir

The most frequent adefovir dipivoxil side effects include weakness, headache, stomach discomfort, and nausea. Severe acute hepatitis exacerbations have been recorded in individuals who have stopped using anti-hepatitis B medications, including adefovir dipivoxil. Chronic administration of adefovir dipivoxil in individuals at risk of or with underlying renal impairment may result in nephrotoxicity. Lactic acidosis and severe hepatomegaly with steatosis have been described with the use of nucleoside analogs alone or in combination with other antiretrovirals, including fatal instances.

Pregnancy & Lactation

Pregnancy Type C. In pregnant women, there are no appropriate and well-controlled trials. Adefovir dipivoxil should be taken during pregnancy only if obviously necessary and after carefully weighing the risks and benefits. Adefovir is not known to be excreted in human milk. If a mother is taking adefovir dipivoxil, she should not breast-feed her child.

Precautions & Warnings

Patients who have stopped using adefovir dipivoxil should have their liver function checked at regular intervals for a length of time. Patients at risk of or with underlying renal dysfunction should be regularly monitored for renal function, which may necessitate dosage modification.

Therapeutic Class

Infections of the liver caused by viruses (Hepatitis B)

Storage Conditions

Keep in a cool, dry place. Keep out of direct sunlight and dampness. Keep any medications out of children's reach.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd

Generic Name of Infovir

Adefovir Dipivoxil

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