Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TENOFOVIR DISOPROXIL FUMARATE
SYNERRV SDN BHD
TENOFOVIR DISOPROXIL FUMARATE
30 Tablets
Laurus Labs Limited (Unit-2)
TENOLAURUS TABLET TENOFOVIR DISOPROXIL FUMARATE 300MG _Consumer Medication Information Leaflet (RiMUP) _ 1 WHAT IS IN THIS LEAFLET 1. What TENOLAURUS is used for 2. How TENOLAURUS works 3. Before you use TENOLAURUS 4. How to use TENOLAURUS 5. While you are using it 6. Side effects 7. Storage and Disposal of TENOLAURUS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TENOLAURUS IS USED FOR TENOLAURUS is used for the treatment of Human Immunodeficiency Virus (HIV) infection in adults over 12 years of age. TENOLAURUS is also used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults. HOW TENOLAURUS WORKS Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of enzymes (in HIV: reverse transcriptase; in hepatitis B: DNA polymerase) that are essential for the viruses to reproduce themselves. BEFORE YOU USE TENOLAURUS - _When you must not use it _ Do not take TENOLAURUS If you are allergic (hypersensitive) to tenofovir, or any of the other ingredients of TENOLAURUS. If this applies to you, tell your doctor immediately and don’t take TENOLAURUS. - _Before you start use it _ Take special care with TENOLAURUS • Tell your doctor if you have had kidney disease or if tests have shown problems with your kidneys. TENOLAURUS may affect your kidneys. Before starting treatment, your doctor may order blood tests to check your kidney function and may advise you to take the tablets less often. Your doctor may also order blood tests during treatment to monitor your kidneys. TENOLAURUS are not usually taken with other medicines that can damage your kidneys (see _taking other medicines_ ). If this is unavoidable, your doctor will monitor your kidney function once a week. • Talk to your doctor if you are over 65. TENOLAURUS has not been studied in patients over 65 years of age. If you are older than this and are prescribed TENOLAURUS, your doctor will monitor you carefully. Baca dokumen lengkap
1 TENOLAURUS TABLET (TENOFOVIR DISOPROXIL FUMARATE 300 MG) 1. PRODUCT NAME TENOLAURUS TABLET (Tenofovir Disoproxil Fumarate 300 mg) 2. NAME AND STRENGTH OF ACTIVE INGREDIENTS(S) Each film-coated tablet contains: Tenofovir Disoproxil Fumarate 300 mg (equivalent to tenofovir disoproxil 245 mg). This medicinal product contains lactose monohydrate. LIST OF EXCIPIENTS _Tablet core _ Lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, purified water and magnesium stearate _Film-coating _ Hypromellose, lactose monohydrate, titanium dioxide, triacetin, FD&C Blue #2/Indigo Carmine AL and FD&C Blue #2/Indigo Carmine Aluminum Lake. 3. DOSAGE FORM Film-coated tablet. 4. PRODUCT DESCRIPTION Blue coloured, oval shaped, film-coated tablets, with “LA16” debossed on one side and plain on the other side 5. PHARMACODYANAMICS/PHARMACOKINETICS 6. PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF07 Mechanism of action and pharmacodynamic effects Tenofovir disoproxil fumarate is the fumarate salt of the prodrug tenofovir disoproxil. Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate (nucleotide) analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs). Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. Tenofovir diphosphate is a weak inhibitor of cellular polymerases α, β, and γ. 2 6.1 PHARMACOKINETIC PROPERTIES Tenofovir disoproxil fumarate is a water soluble ester prodrug which is rapidly converted _i Baca dokumen lengkap