Drug Information
Drug Generic Name | TENOFOVAIR |
Drug Class | NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS. |
Chapter | Infections |
Indications: HIV infection in combination with other antiretroviral drugs chronic hepatitis B infection with either compensated liver disease (with evidence of viral replication, and histologically documented active liver inflammation or fibrosis) ordecompensated liver disease. Cautions: test renal function and serum phosphate before treatment, then every 4 weeks (more frequently if at increased risk of renal impairment) for 1 year and then every 3 months, interrupt treatment if renal function deteriorates or serum phosphate decreases. Contra-indications: Hypersensitivity to tenofovir or any component of the formulation; concurrent use with fixed- dose combination products that contain tenofovir (Truvada, Atripla, Complera, or Stribild); concurrent use with adefovir (Hepsera Renal Impairment: Children: No dosage adjustment provided in manufacturer’s labeling (has not been studied). Adults: Note: Use of powder formulation has not been evaluated in renal impairment. CrCl 30-49 ml/minute: 300 mg every 48 hours CrCl 10-29 ml/minute: 300 mg every 72-96 hours CrCl <10 ml/minute without hemodialysis: No dosage adjustment provided in manufacturer’s labeling, has not been studied. Hemodialysis: 300 mg following dialysis every 7 days or after a total of ~12 hours of dialysis (usually once weekly assuming 3 dialysis sessions lasting about 4 hours each). Hepatic Impairment: No dosage adjustment necessary. Side Effects: Central nervous system: Insomnia, headache pain, dizziness, depression Dermatologic: Skin rash (includes maculopapular, pustular, or vesiculobullous rash; pruritus; or urticaria:, pruritus Endocrine & metabolic: Hypercholesterolemia, increased serum triglycerides Gastrointestinal: Abdominal pain, nausea, diarrhea, vomiting Neuromuscular & skeletal: Decreased bone mineral density (28%; ≥5% at spine or ≥7% at hip), increased creatine phosphokinase, weakness Miscellaneous: Fever Cardiovascular: Chest pain Central nervous system: Fatigue, anxiety, peripheral neuropathy Dermatologic: Diaphoresis Endocrine & metabolic: Weight loss, glycosuria, hyperglycemia, lipodystrophy Gastrointestinal: Increased serum amylase, anorexia, dyspepsia, flatulence Genitourinary: Hematuria, Hematologic & oncologic: Neutropenia Hepatic: Increased serum ALT, increased serum AST, increased serum transaminases increased serum alkaline phosphatase Neuromuscular & skeletal: Back pain, arthralgia, myalgia, Renal: Increased serum creatinine, renal failure. Respiratory: Sinusitis, upper respiratory tract infection, nasopharyngitis, pneumonia Postmarketing and/orcase reports: Angioedema, exacerbation of hepatitis B (following discontinuation), Fanconi’s syndrome, hepatitis, hypersensitivity reaction, hypokalemia, hypophosphatemia, immune reconstitution syndrome, increased gamma-glutamyl transferase, interstitial nephritis, lactic acidosis, myopathy, nephrogenic diabetes insipidus, nephrotoxicity, osteomalacia, pancreatitis, polyuria, proteinuria, proximal tubular nephropathy, renal insufficiency, renal tubular necrosis, rhabdomyolysis, severe hepatomegaly with steatosis. Dose: adult over 18 years, 245 mg once daily. MISSED DOSE : If a dose is more than 12 hours late, the missed dose should not be taken and the next dose should be taken at the normal time. |
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