Tenofovir Disoproxil Fumarate Hetero

Tenofovir Disoproxil Fumarate Hetero

tenofovir disoproxil fumarate

Manufacturer:

Hetero

Distributor:

Hind Wing
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Tenofovir disoproxil fumarate
Indications/Uses
In combination w/ other antiretroviral agents for treatment of HIV-1 infection in adults. Treatment of chronic HBV in adults.
Dosage/Direction for Use
300 mg once daily. Patient w/ CrCl ≥50 mL/min 300 mg every 24 hr; CrCl 30-49 mL/min 300 mg every 48 hr; CrCl 10-29 mL/min 300 mg every 72-96 hr. Hemodialysis patients 300 mg every 7 days or after a total of approx 12 hr of dialysis.
Administration
May be taken with or without food: Take consistently either always w/ or always w/o food.
Special Precautions
Prior to or when initiating treatment, test patients for HBV & HIV-1 infection. Prior to initiation & during treatment, on a clinically appropriate schedule, assess serum creatinine, estimated CrCl, urine glucose & urine protein in all patients. In patients w/ chronic kidney disease, also assess serum P. Severe acute exacerbations of hepatitis B upon discontinuation of anti-HBV therapy. Renal impairment, including cases of acute renal failure & Fanconi syndrome. Closely monitor renal function in all patients w/ CrCl <50 mL/min. Patients co-infected w/ HIV-1 & HBV. Immune reconstitution syndrome. Bone loss & mineralization defects. Lactic acidosis & severe hepatomegaly w/ steatosis. Avoid concurrent or recent use of a nephrotoxic agent. Should not be used in combination w/ other drugs containing tenofovir disoproxil fumarate, tenofovir alafenamide, or adefovir dipivoxil. Lactation. Elderly.
Adverse Reactions
Severe acute exacerbations of hepatitis B; new onset or worsening of renal impairment; immune reconstitution syndrome; bone loss & mineralization defects; lactic acidosis/severe hepatomegaly w/ steatosis.
Drug Interactions
Co-administration w/ drugs that are eliminated by active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides eg, gentamicin, & high-dose or multiple NSAIDs) may increase conc of tenofovir &/or the co-administered drug. Increased conc w/ drugs that decrease renal function; lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir; sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, ledipasvir/sofosbuvir. Increased conc of didanosine. Decreased conc of atazanavir.
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
Tenofovir Disoproxil Fumarate Hetero tab 300 mg
Packing/Price
30's
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