Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
UNIMED SDN BHD
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
30 Tablets
Aurobindo Pharma Limited (Unit III),
CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) FORSTAVIR-EM Emtricitabine 200 mg dan Tenofovir Disoproxil Fumarate 300 mg Tablets 1 WHAT IS IN THIS LEAFLET 1. What FORSTAVIR-EM is used for 2. How FORSTAVIR-EM works 3. Before you use FORSTAVIR- EM. 4. How to use FORSTAVIR-EM 5. While you are using it 6. Side effects 7. Storage and Disposal of FORSTAVIR-EM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT FORSTAVIR-EM IS USED FOR FORSTAVIR-EM is used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults. FORSTAVIR-EM is used in combination with safe sex practices as pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults. HOW FORSTAVIR-EM WORKS FORSTAVIR-EM contains two active ingredients which are emtricitabine and tenofovir disoproxil fumarate. Both of these active ingredients are antiretrovirals used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. However, both are generally known as NRTIs and they work by interfering with the normal function of an enzyme (reverse transcriptase) that is essential for viruses to reproduce on their own. BEFORE YOU USE FORSTAVIR-EM - When you must not use it Do not take FORSTAVIR- EM If you are : Allergic to Emtricitabine or Tenofovir Disoproxil Fumarate, or any of the other ingredients in FORSTAVIR-EM Tablets. Do not take FORSTAVIR-EM if you are pregnant, planning to become pregnant or may become pregnant. Do not take FORSTAVIR-EM if you are breast-feeding. Consult a doctor or pharmacist before taking any medication. - Before you start to use FORSTAVIR- EM tablet Tell your doctor if you have lactic acidosis (excess lactic acid in the blood) or liver inflammation and fatty liver disease. Tell your doctor if you have a combination of Human Immunodeficiency Virus (HIV) - Hepatitis B Virus (HBV) disease. Discontinuation of the drug tenofovir dis Preberite celoten dokument
COMPOSITION: Each film coated tablet contains Emtricitabine ..... ........... ......... .......... 200 mg Tenofovir disoproxil fumarate ...... ... ... 300 mg equivalent to Tenofovir disoproxil ........ 245 mg DOSAGE FORM Film coated tablet PRODUCT DESCRIPTION - FORSTAVIR-EM should not be coadministered with lamivudine+tenofovir DF+Efavirenz,emtricitabine,tenofovir DF or lamivudine-containing products [seeWARNINGS AND PRECAUTIONS ]. In treatment experienced patients, the use of FORSTAVIR-EM should be guided by laboratory testing and treatment history. PHARMACOLOGY PHARMACODYNAMICS Emtricitabine is an NRTI that is converted intracellularly to its active metabolite, emtricitabine 5'-triphosphate. Tenofovir DF is an ester prodrug of the NRTI, tenofovir. The prodrug is hydrolysed intracellularly to tenofovir, which is then converted to the active metabolite, tenofovir diphosphate. The active metabolites of the drugs compete with deoxycytidine 5'-triphosphate (emtricitabine 5'-triphosphate) or deoxyadenosine 5'- triphosphate (tenofovir diphosphate) for incorporation into HIV DNA, thereby terminating viral DNA chain growth and inhibiting the activity of the viral reverse transcriptase. PHARMACOKINETICS ABSORPTION The median bioavailability of emtricitabine in fasted patients following a single oral dose is 92%. The median bioavailability of tenofovir in fasted patients following a single oral dose is 25%. DISTRIBUTION Protein binding of emtricitabine is less than 4%; and of tenofovir, is less than 0.7% (plasma) and 7.2% (serum). METABOLISM AND ELIMINATION Emtricitabine undergoes limited metabolism and is primarily excreted by the kidneys. The median terminal elimination half-lives of emtricitabine and tenofovir were 15.5 and 17.6 hours. INDICATION TREATMENT OF HIV-1 INFECTION: FORSTAVIR-EM is indicated in combination with other antiretroviral agents (such as non nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults. The following points should be considered wh Preberite celoten dokument