Chronic hepatitis B, HIV infection
Adult: ≥18 yr: 300 mg once daily.
Renal impairment: Haemodialysis patients: 300 mg once every 7 days or 300 mg after a cumulative total of 12 hr of dialysis.
CrCl (ml/min)Dosage Recommendation
30-49300 mg every 48 hr.
10-29300 mg every 72-96 hr
Lactation. Not for treatment for chronic hepatitis B virus infection. Do not co-administer with fixed dose combinations containing tenofovir.
Warnings / Precautions
Renal impairment, hepatomegaly or at risk for liver disease. Elderly and pregnancy. Discontinue therapy if there is a rapid rise in aminotransferase concentrations, progressive hepatomegaly or steatosis, metabolic or lactic acidosis of unknown cause. Monitor creatinine clearance and serum phosphorus routinely in patients at risk of renal impairment. Bone monitoring for patients with history of pathologic bone fracture or at risk of osteopenia. Test for presence of chronic hepatitis B virus (HBV) before initiating therapy. If tenofovir is discontinued in patients co-infected with HIV and HBV, monitor hepatic function for several mth for exacerbation of hepatitis. Monitor child exposed in utero to combination drug for possible mitochondrial dysfunction.
Adverse Reactions
Diarrhoea, nausea, vomiting, abdominal pain, flatulence, dyspepsia, anorexia, skin rash, peripheral neuropathy, headache, dizziness, insomnia, depression, dyspnoea, asthenia, sweating, myalgia, myopathy, body fat redistribution, osteomalacia. Hypophosphataemia, raised amylase and liver enzymes, hepatitis, hypertriglyceridaemia, hyperglycaemia, neutropenia, nephritis, nephrogenic diabetes insipidus, renal impairment, proximal tubulopathy, Fanconi syndrome, immune reconstitution syndrome.
Potentially Fatal: Lactic acidosis with severe hepatomegaly with steatosis; severe acute exacerbations of hepatitis B. Acute renal failure.
Overdose Reactions
Treatment is supportive. Haemodialysis may be beneficial.
Drug Interactions
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.
See Below for More tenofovir disoproxil fumarate Drug Interactions
Mechanism of Actions
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.
Absorption: Rapidly absorbed; converted to tenofovir after oral doses. Oral bioavailability: Approx 25% after fasting, increased when taken with a high fat meal. Peak plasma concentrations reached in 1 hr (fasting) to 2 hr (with food).
Distribution: Widely distributed into most tissues, especially kidneys, liver and intestinal contents. Protein binding: <0.7% to plasma proteins, 7% to serum protein.
Excretion: Excreted renally by glomerular filtration and active tubular secretion. Terminal elimination half life: 12-18 hr.
Storage Conditions
Oral: Store between 15-30 °C (59-86 °F).
Oral: Store between 15-30 °C (59-86 °F).
Available As
  • Tenofovir 300 mg
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