Hetero Tenofovir - Tenofovir disoproxil fumarate 300 mg Indications HETERO TENOFOVIR 300 mg is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Dosage The dose of HETERO TENOFOVIR 300 mg (tenofovir disoproxil fumarate) is 300 mg once daily taken orally, with or without food. Dose Adjustment for Renal Impairment: Significantly increased exposure occurred when HETERO TENOFOVIR 300 mg is administered to patients with moderate to severe renal impairment. The pharmacokinetics of HETERO TENOFOVIR 300 mg have not been evaluated in non-haemodialysis patients with creatinine clearance < 10 ml/min; therefore, no dosing recommendation is available for these patients. Where it’s positioned Tenofovir is recommended as part of 1st line treatment by the S.A. HIV Clinicians Society. (1) FDA APPROVED* ✓ WHO APPROVED* ✓ Nucleoside reverse transcriptase inhibitors (NRTIs) References: 1. Meintjes G, Moorhouse MA, Carmona S, et al. Adult antiretroviral therapy guidelines 2017. S Afr J HIV Med 2017; 18(1), a776. https://doi.org/10.4102/sajhivmed.v18i1.776. S4 HETERO TENOFOVIR (tablets). Reg. No. 46/20.2.8/0019. Each film-coated tablet contains 300 mg of tenofovir disoproxil fumarate. Applicant: Hetero Drugs SA, 252 Jean Avenue, Jean Park Chambers, Building 6, Unit 19, Centurion. South Africa, 0157, Tel: +27 12 644 2120. Marketed by: Activo Health (Pty) Ltd. Co. Reg. No.: 2009/009541/07. Block B, Arena Office Park, 272 West Avenue, Centurion, 0157, South Africa. PO Box 11911, Zwartkop, 0051, South Africa. Tel: 0800 (ACTIVO) 228486 | Fax: 086 619 5833 | [email protected] | www.activo.co.za. For full prescribing information refer to the respective package inserts approved by the Medicines Regulatory Authority.

Hetero Tenofovir - Tenofovir disoproxil fumarate 300 mg · 2020. 9. 23. · HETERO TENOFOVIR 300 mg is indicated in combination with other antiretroviral agents for the treatment

Download PDF Report

Upload
others
View
4
Download
0

Embed Size (px)

Citation preview

Hetero Tenofovir - Tenofovir disoproxil fumarate 300 mg

IndicationsHETERO TENOFOVIR 300 mg is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

DosageThe dose of HETERO TENOFOVIR 300 mg (tenofovir disoproxil fumarate) is 300 mg once daily taken orally, with or without food.Dose Adjustment for Renal Impairment: Significantly increased exposure occurred when HETERO TENOFOVIR 300 mg is administered to patients with moderate to severe renal impairment. The pharmacokinetics of HETERO TENOFOVIR 300 mg have not been evaluated in non-haemodialysis patients with creatinine clearance < 10 ml/min; therefore, no dosing recommendation is available for these patients.

Where it’s positioned Tenofovir is recommended as part of 1st line treatment by the S.A. HIV Clinicians Society.(1)

FDA APPROVED* ✓

WHO APPROVED* ✓

Nucleoside reverse transcriptase inhibitors (NRTIs)

References: 1. Meintjes G, Moorhouse MA, Carmona S, et al. Adult antiretroviral therapy guidelines 2017. S Afr J HIV Med 2017; 18(1), a776. https://doi.org/10.4102/sajhivmed.v18i1.776.

S4 HETERO TENOFOVIR (tablets). Reg. No. 46/20.2.8/0019. Each film-coated tablet contains 300 mg of tenofovir disoproxil fumarate. Applicant: Hetero Drugs SA,252 Jean Avenue, Jean Park Chambers, Building 6, Unit 19, Centurion. South Africa, 0157, Tel: +27 12 644 2120.

Marketed by: Activo Health (Pty) Ltd. Co. Reg. No.: 2009/009541/07. Block B, Arena Office Park, 272 West Avenue, Centurion, 0157, South Africa. PO Box 11911, Zwartkop, 0051, South Africa. Tel: 0800 (ACTIVO) 228486 | Fax: 086 619 5833 | [email protected] | www.activo.co.za. For full prescribing information refer to the respective package inserts approved by the Medicines Regulatory Authority.