Infovir Tablet
Adefovir Dipivoxil
10mg
Incepta Pharmaceuticals Ltd.
| Pack size | 20's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 35.00 AED |
Indications
Infovir Tablet is used for:
Chronic hepatitis B
Adult Dose
Chronic Hepatitis B
Adult:
PO:10 mg, once daily.
Child Dose
Chronic Hepatitis B
Child:
Oral
<12 years old: Not recommended
>12 years old: Administer as in adults, 10 mg PO once daily.
Renal Dose
Renal impairment: Haemodialysis patients: 10 mg every 7 days after dialysis.
CrCl (ml/min)
30-49 10 mg every 48 hr.
10-29 10 mg every 72 hr.
Administration
Taken orally, without regard to food.
Contra Indications
Adefovir Dipivoxil is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.
Precautions
Severe acute exacerbations of hepatitis reported following discontinuation drug; monitoring hepatic function
Chronic use may result in nephrotoxicity in patients with renal impairment or in those at risk of renal dysfunction; dose adjustment may be required
Resistance to HIV NRTIs may emerge in patients with chronic hepatitis B in whom HIV infection is unrecognized or untreated
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogs alone or in combination with other antiretrovirals; obesity and prolonged nucleoside exposure may be risk factors
Discontinuation may result in severe acute exacerbation of hepatitis B
Patients who discontinue treatment: Monitor hepatic function for several months
Patients with renal dysfunction: Risk of nephrotoxicity (monitor and adjust dose accordingly)
Coadministration with drugs that reduce renal function may increase adefovir serum concentration
Do not administer with tenofovir (additive toxicity)
May increase HIV resistance in untreated patients who are HIV+
Risk of lactic acidosis, severe hepatomegaly with steatosis
Monitoring Parameters
Monitor liver function tests every 3 months, and viral markers for hepatitis B every 3–6 months during treatment (continue monitoring for at least 1 year after
discontinuation—recurrent hepatitis may occur on discontinuation).
Monitor renal function before treatment then every 3 months, more frequently in patients receiving nephrotoxic drugs.
Pregnancy-Lactation
Pregnancy
Prospective pregnancy data from APR are not sufficient to adequately assess risk of birth defects, miscarriage or adverse maternal or fetal outcomes; adefovir disoproxil (ADV) use during pregnancy has been evaluated in a limited number of individuals reported to APR and the number of exposures to adefovir is insufficient to make a risk assessment compared to a reference population; estimated background rate for major birth defects is 2.7% in the U.S. reference population of Metropolitan Atlanta Congenital Defects Program (MACDP); estimated rate of miscarriage is not reported in APR; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes
Animal data
In animal reproduction studies with oral ADV, no adverse developmental effects were observed at exposures (Cmax) 23 times higher in rats and 40 times higher in rabbits than those at recommended human dose (RHD)
Lactation
It is not known whether adefovir is present in human breast milk, affects human milk production, or has effects on breastfed infant
The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Interactions
Increased risk of nephrotoxicity with nephrotoxic drugs e.g. aminoglycosides, ciclosporin, NSAIDs, vancomycin, tacrolimus. Ibuprofen increases bioavailability of adefovir.
Contraindicated (0)
Serious - Use Alternative (2)
bacitracin
tenofovir DF
Adverse Effects
Side effects of Adefovir Dipivoxil :
>10%
Hematuria (11% vs 10% in placebo-treated),Asthenia (13% vs. 14% placebo),Hepatitis exacerbation (25%)
1-10%
Nausea (5%),Flatulence (4%),Diarrhea (3%)Dyspepsia (3%),Headache (9%),Rash (1-10%),Pruritus (1-10%),Dyspepsia (5-9%),Cough (6-8%),Rhinitis (5%)
Increased AST/ALT,Abnormal liver function,Renal failure,Renal insufficiency,Increased serum Cr (2-3%),Hypophosphatemia
Potentially Fatal: Lactic acidosis, severe hepatomegaly with steatosis, hepatotoxicity, nephrotoxicity.
Mechanism of Action
Adefovir dipivoxil is an acyclic nucleoside reverse transciptase inhibitor. The diester function is hydrolyzed and subsequently phosphorylated to the active adefovir diphosphate. The active metabolite inhibits HBV DNA polymerase (reverse transcriptase) and hence inhibits viral replication. It can be used in patients with lamivudine-resistant hepatitis B.
Note
Infovir 10mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Adefovir Dipivoxil. Infovir is availble in Bangladesh.
Farmaco BD drug index information on Infovir Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.