Product Overview
[Drug Name]
Generic Name: Tenofovir Disoproxil Fumarate Tablets
Trade Name: JianGanLing Tenofovir Disoproxil Fumarate Tablets 300mg*30 Tablets/Bottle
Pinyin Full Code: JianGanLing FuMaSuanTiNuoFuWeiErZuoZuoZuoPian 300mg*30 Tablets/Ping
[Main Ingredients]
The main ingredient of this product is tenofovir disoproxil fumarate. Chemical Name: 9-[(R)-2-[Bis[(isopropyloxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1) Molecular Formula:
C19H30N5010P·C4H4O4 Molecular Weight: 635.52
[Properties]
This product is a white, almond-shaped film-coated tablet that appears white after removal of the coating.
[Indications/Main Functions]
Tenofovir disoproxil fumarate is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. When initiating treatment with tenofovir disoproxil fumarate for HIV-1 infection, the following considerations should be considered: Tenofovir disoproxil fumarate should not be used in combination with fixed-dose combinations containing tenofovir, including: efavirenz/emtricitabine/tenofovir disoproxil fumarate, bictegravir/emtricitabine/tenofovir alafenamide, rilpivirine/emtricitabine/tenofovir disoproxil fumarate, and emtricitabine/tenofovir alafenamide. Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in adults and children aged 12 years and older. The following points should be considered when initiating tenofovir disoproxil fumarate for the treatment of chronic hepatitis B infection: This indication in adult patients is based on safety and efficacy data from nucleoside therapy-naive subjects and previously treated subjects with demonstrated lamivudine resistance. Subjects are HBeAg-positive and HBeAg-negative adults with chronic hepatitis B who have compensated liver function. Tenofovir disoproxil fumarate has been evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease. The number of subjects with adefovir-associated mutations at baseline in clinical trials was too small to allow conclusions about efficacy.
[Specifications]
300 mg x 30 tablets/bottle
[Dosage and Administration]
Recommended dose for HIV-1 in adults: 300 mg (one tablet) once daily, orally, regardless of diet. Recommended dose for the treatment of chronic hepatitis B in adults and children aged 12 years and older: 300 mg (one tablet) once daily, orally, regardless of diet. The optimal duration of treatment for chronic hepatitis B has not been established. Safety and efficacy have not been studied in children with chronic hepatitis B weighing less than 35 kg. Dose Adjustment for Adults with Renal Impairment: Tenofovir disoproxil fumarate significantly increases drug exposure in subjects with moderate to severe renal impairment (see [Pharmacokinetics]). For patients with a baseline creatinine clearance <50 mL/min, the dosing interval of tenofovir disoproxil fumarate should be adjusted according to Table 1. The recommended dosing intervals are based on pharmacokinetic modeling data from single doses in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including patients with end-stage renal disease requiring hemodialysis. The safety and efficacy of these recommended dosing interval adjustments have not been clinically evaluated in patients with moderate to severe renal impairment; therefore, clinical response to treatment and renal function should be closely monitored in these patients (see [Precautions]). No dose adjustment is required for patients with mild renal impairment (creatinine clearance 50-80 mL/min). Estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be monitored regularly in these patients (see [Precautions]).
[Adverse Reactions]
See package insert for details.
[Contraindications]
Tenofovir disoproxil fumarate is contraindicated in patients with a prior hypersensitivity to any of the components of this drug.
[Precautions]
See package insert for details.
