Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM VALPROATE; VALPROIC ACID
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
SODIUM VALPROATE; VALPROIC ACID
10Tablet Tablets; 30 Tablet Tablets; 100 Tablet Tablets
TORRENT PHARMACEUTICALS LTD.
VALPARIN XR 300 TABLET _ _ Sodium valproate (300mg) _ _ _ _ 1 _ Consumer Medication Information leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET 1. What is Valparin XR used for 2. How Valparin XR works 3. Before you use Valparin XR 4. How to use Valparin XR 5. While you are using it 6. Side effects 7. Storage and disposal of Valparin XR 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT VALPARIN XR IS USED FOR • The treatment of generalised or partial epilepsy, particularly with the following patterns of seizures: − Absence (short period of “blanking out” or staring into space). − Myoclonic (brief shock-like jerks of a muscle). − Atonic (abrupt loss of muscle tone). − Tonic-clonic (loss of consciousness and violent muscle contractions). − Mixed. • Partial epilepsy: simple (not affecting awareness or memory) or complex seizures, secondary generalised seizures (start in one area and spread to both sides of the brain) and specific syndromes (West, Lennox-Gastaut). • The treatment and prevention of mania associated with bipolar disorder (a brain disorder that causes unusual shifts in mood). HOW VALPARIN XR WORKS Valparin XR contains sodium valproate. It belongs to a group of medicines called anti-convulsants or anti-epileptic agents. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. BEFORE YOU USE VALPARIN XR WARNING FOR WOMEN AND GIRLS BEFORE YOU START TO USE IT: This medicine can seriously harm an unborn baby. Always use effective contraception during treatment with sodium valproate. If you are thinking about becoming pregnant, or if you are pregnant, contact your doctor immediately. You must CONTINUE taking sodium valproate unless your doctor tell you to stop. - _When you must not use it _ Do not take Valparin XR if you are: • Allergic (hypersensitive) to sodium valproate or any of the other ingredients. • Having liver problems or you or your family have a history of liver pro Les hele dokumentet
xxxxxxxx-5253 COMPOSITION VALPARIN XR 300 MG TABLET Each film coated controlled release tablet contains: Sodium Valproate 199.8 mg Valproic acid 87 mg (Both together correspond to Sodium Valproate 300mg) DESCRIPTION Valparin XR 300 mg Tablet is a broad spectrum antiepileptic drug containing sodium valproate in a Controlled Release Form. VALPARIN XR 300 mg TABLET: White, round, biconvex film coated tablets. CLINICAL PHARMACOLOGY Valproate exerts its effect primarily on the central nervous system. Its anticonvulsant properties are exerted against a wide variety of epilepsies experimental animal models and humans. Its main mechanism of action seems to be related to reinforcement of the gabaergic pathway. The various pharmacokinetic studies conducted with valproate demonstrate the following points, some of which may have practical consequences on prescription: - The blood bioavailability of valproate following oral administration approaches 100 %. - The volume of distribution is primarily limited to the blood and to rapid-exchange extracellular fluids. Valproate diffuses into the C.S.F. and brain. - Half-life is approximately 8 to 20 hours and is usually shorter in children. - Significant therapeutic results are achieved with serum concentrations between 40 to 100 mg / l, but there is no definite correlation between serum level and therapeutic response. - The steady state plasma concentration is achieved rapidly (3 to 4 days). - Valproate is extensively bound to proteins. Binding is dose-dependent and saturable. - Valproate is primarily excreted in the urine following glucuronic acid conjugation and beta- oxidation. - Valproate molecule is dialyzable, but hemodialysis only affects the free fraction of valproate in the blood (approximately 10 percent). - Valproate does not induce enzymes involved in cytochrome P 450 metabolism: in contrast to most other antiepileptics, it therefore does not accelerate its own degradation or that of other substances such as oral contraceptives and oral anticoagulants. In comparison to Les hele dokumentet