Product Overview
[Drug Name]
Generic Name: Tenofovir Disoproxil Fumarate Tablets
Trade Name: Baiyunshan/Qingyuan Tenofovir Disoproxil Fumarate Tablets 0.3g x 30 Tablets
[Main Ingredients]
The main ingredient of this product is tenofovir disoproxil fumarate. Its chemical name is: 9-[(R)-2[[Bis[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]-propyl]adenine fumarate (1:1). Molecular Formula: C19H30N5010P-C4H4O4. Molecular Weight: 635.52
[Properties]
This product is a light blue film-coated tablet that appears white or off-white after removal of the coating.
[Indications/Main Functions]
HIV-1 Infection. Tenofovir disoproxil fumarate is indicated for use in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults. When initiating treatment of HIV-1 infection with tenofovir disoproxil fumarate, the following points should be considered: Tenofovir disoproxil fumarate should not be used in combination with fixed-dose combinations containing tenofovir, including: · Efavirenz/emtricitabine/tenofovir disoproxil fumarate, · Rilpivirine/emtricitabine/tenofovir disoproxil fumarate, · Emtricitabine/tenofovir alafenamide · Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide · Emtricitabine/rilpivirine/tenofovir alafenamide · Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide · Emtricitabine/rilpivirine/tenofovir alafenamide · Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate · Emtricitabine/tenofovir alafenamide · Tenofovir disoproxil fumarate · Emtricitabine/tenofovir alafenamide · Tenofovir disoproxil fumarate When initiating tenofovir disoproxil fumarate for the treatment of HBV infection, the following key points should be considered: · This indication in adult patients is based on safety and efficacy data from both nucleoside-naive subjects and previously treated subjects with demonstrated lamivudine resistance. Subjects are HBeAg-positive and HBeAg-negative adults with compensated chronic hepatitis B. · Tenofovir disoproxil fumarate has been evaluated in a limited number of subjects with decompensated chronic hepatitis B. · The number of subjects with adefovir-associated mutations at baseline in clinical trials is too small to allow conclusions about efficacy.
[Specification]
0.3g*30 tablets
[Dosage and Administration]
Recommended Dosage for Adults with HIV-1: For the treatment of HIV-1 in adults: 300 mg (one tablet) once daily, orally, regardless of diet. Recommended dosage for the treatment of chronic hepatitis B in adults and children 12 years of age or 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 in children with chronic hepatitis B weighing less than 35 kg have not been studied. Dosage Adjustment for Adults with Renal Impairment: Tenofovir disoproxil fumarate exposure is significantly increased when administered to subjects with moderate to severe renal impairment (see Pharmacokinetics). For patients with baseline creatinine clearance <50 mL/min, the dosing interval for tenofovir disoproxil fumarate should be adjusted according to Table 1. The recommended dosing intervals are based on modeled pharmacokinetic 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]). (For other details, see the package insert.)
[Adverse Reactions]
See the package insert for details.
[Contraindications]
Tenofovir disoproxil fumarate is contraindicated in patients with a prior hypersensitivity to any of the ingredients in this drug.
[Precautions]
See the package insert for details.
