Uses of Vironil: - HIV infection - Chronic hepatitis B virus (HBV) infection HIV-1 infection, Chronic hepatitis B Tenofovir is contraindicated in patients with previously demonstrated hypersensitivity to Tenofovir or any component of the product.

Drugs for HIV / Anti-retroviral drugs, Hepatic viral infections (Hepatitis B)

Tenofovir Disoproxil Fumarate, an acyclic nucleotide analogue of adenosine monophosphate, is a pro-drug of Tenofovir. It shows activity against hepatitis B virus polymerase and HIV reverse transcriptase after phosphorylation to the active diphosphate form. Tenofovir diphosphate inhibits viral polymerase (reverse transcriptase) by directly competing with the natural substrate deoxyribonucleotide and by causing DNA chain termination after its incorporation into viral DNA.

How to use Tenofovir Disoproxil Fumarate: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Tenofovir Disoproxil Fumarate is to be taken with food. Administration: May be taken with or without food. Take consistently either always w/ or always w/o food. Adult Dose: Oral Chronic hepatitis B; HIV infection (Indicated in combination with other antiretroviral agents for treatment of HIV-1 infection) Adult: 300 mg once daily. Child Dose: HIV Infection <2 years: Safety and efficacy not established >2 years: 8 mg/kg PO qDay; not to exceed 300 mg/day Hepatitis B Infection <12 years: Safety and efficacy not established >12 years; <35 kg: Safety and efficacy not established >12 years; >35 kg: 300 mg PO qDay Renal Dose: Renal impairment: Haemodialysis patients: 300 mg once every 7 days or after a cumulative total of 12 hr of dialysis. CrCl (ml/min) Dosage Recommendation 10-29 300 mg 72-96 hrly. 30-49 300 mg 48 hrly.

Decreased atazanavir concentration with tenofovir unless also co-administered with ritonavir. Increased serum concentration of tenofovir or co-administered drug if taken with drugs that are eliminated by active tubular secretion. Potentially Fatal: Increased risk of renal impairment with recent or concurrent use of nephrotoxic agents (e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2); monitor renal function wkly if unavoidable. Increased didanosine levels and thereby increasing risk of pancreatitis and peripheral neuropathy, with a high treatment failure rate with concurrent use; avoid concurrent use.

Tenofovir is contraindicated in patients with previously demonstrated hypersensitivity to Tenofovir or any component of the product.

Common - Rash - Weakness - Nausea - Stomach pain - Diarrhea >10% Asthenia (11%),Diarrhea (16%),Nausea (11%),Pain (12%) 1-10% Anorexia,Depression,Myalgia,Peripheral neuropathy,Dyspepsia,Rash,Headache,Vomiting,Flatulence,Abdominal pain,Neutropenia,Increased transaminases

Pregnancy: Pregnancy category B. It should be used during pregnancy only if clearly needed.Lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breast feed if they are taking Tenofovir.

Precaution: Patient w/ hepatomegaly or other risk factors for liver disease. Renal impairment. Pregnancy. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor renal function and serum phosphate concentrations before start of therapy, 4 wkly during the 1st wk, and then 3 mthly; hepatic function for several mth following discontinuation. Determine HIV status in all hepatitis B virus (HBV) infected patients prior to treatment. Lactation: HIV+ women are advised not to breastfeed

There is no experience of Tenofovir overdose reported in patients

Store in a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.

Tenofovir disoproxil fumarate, a diester prodrug of tenofovir, is a nucleotide reverse transcriptase inhibitor. After oral absorption, tenofovir disoproxil fumarate is rapidly converted to tenofovir and then undergo subsequent phosphorylation by cellular enzymes to the active tenofovir diphosphate, which inhibits the activity of HIV-1 reverse transcriptase.