Tenofo-B

Tenofo-B

tenofovir disoproxil fumarate

Manufacturer:

Getz Pharma

Distributor:

Getz Pharma
Concise Prescribing Info
Contents
Tenofovir disoproxil fumarate
Indications/Uses
In combination w/ at least 2 other antiretroviral agents for the management of HIV infected adults. Treatment of chronic hepatitis B in adults w/ compensated liver disease, w/ evidence of active viral replication, persistent elevated serum ALT level & histological evidence of active inflammation & fibrosis.
Dosage/Direction for Use
Adult HIV or chronic hepatitis B 300 mg once daily. Renal impairment CrCl ≥50 mL/min 300 mg every 24 hr, 30-49 mL/min 300 mg every 48 hr, 10-29 mL/min 300 mg every 72-96 hr. Hemodialysis patient 300 mg every 7 days or after a total of approx 12 hr of dialysis.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Concomitant use w/ other tenofovir-containing combination formulation or adefovir dipivoxil. Not recommended in childn <18 yr.
Special Precautions
Lactic acidosis & severe hepatomegaly w/ steatosis & severe acute exacerbations of hepatitis. Not proven to prevent the risk of transmission of HIV or HBV through sexual contact or blood contamination. Opportunistic infection & other HIV complications may develop. Patients w/ cirrhosis; preexisting liver dysfunction including chronic active hepatitis. Suspend treatment if lactic acidosis & hepatotoxicity develops. Observe for evidence of bone abnormalities; lipodystrophy; inflammatory symptoms; joint aches/pain, joint stiffness or difficulty in movement. Routine monitoring for changes in serum creatinine & P. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Decreased hepatic, renal or cardiac function. Use of effective contraception in women of childbearing potential. Pregnancy. Do not use during lactation. Elderly.
Adverse Reactions
Mild GI effects particularly diarrhea, nausea & anorexia; raised serum-amylase conc, pancreatitis; hypophosphatemia; skin rashes; peripheral neuropathy, headache, dizziness, insomnia, depression, asthenia, sweating, myalgia; raised liver enzymes, hypertriglyceridemia, hyperglycemia, neutropenia; renal impairment, acute renal failure; effects on renal proximal tubules including Fanconi syndrome; lactic acidosis, usually associated w/ severe hepatomegaly & steatosis.
Drug Interactions
Caution when in combination w/ didanosine. Affected pharmacokinetics of atazanavir. High rates of virological failure & emergence of resistance at early stage in HIV patients w/ lamivudine, abacavir & didanosine. Increased serum conc w/ tacrolimus or other drugs affecting renal function. Risk of development of HIV resistance in combination regimen in HIV/HBV con-infected patients.
MIMS Class
Antivirals
ATC Classification
J05AF07 - tenofovir disoproxil ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Tenofo-B FC tab 300 mg
Packing/Price
30's (P1,749/bottle)
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