Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GABAPENTIN
Hovid Pharmacy Sdn. Bhd.
GABAPENTIN
100capsule Capsules
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ HP GABAPENTIN CAPSULE 300MG GABAPENTIN (300MG) 1 WHAT IS IN THIS LEAFLET? 1. What HP Gabapentin Capsule 300 mg is used for 2. How HP Gabapentin Capsule 300 mg works 3. Before you HP Gabapentin Capsule 300 mg 4. How to take HP Gabapentin Capsule 300 mg 5. While you are using HP Gabapentin Capsule 300 mg 6. Side effects 7. After using HP Gabapentin Capsule 300 mg 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision WHAT HP GABAPENTIN CAPSULE 300 MG IS USED FOR To • Control epilepsy (a condition where you have repeated seizures) in adults and children aged 3 years and above. • Treat neuropathic pain (pain caused by nerve damage) in adults aged 18 years and above. HOW HP GABAPENTIN CAPSULE 300 MG WORKS This medicine belongs to a group of medicines called anti-convulsants. It is said to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain. BEFORE YOU USE HP GABAPENTIN CAPSULE 300 MG _When you must not take it _ Do not take this medicine if: • you are allergic to gabapentin or any of its excipients • your child has epilepsy and is under 3 years old • your child has neuropathic pain and is younger than 18 years old. _Before you start to take it _ Tell your doctor if: • you have allergies to any other medicines, especially barbiturates or any other anti- convulsant medicines, foods, preservatives or dyes. • you are pregnant or plan to become pregnant • you are breastfeeding or plan to breastfeed. If you have kidney problems, nervous system disorders, respiratory disorders or you are more than 65 years old, your doctor may prescribe a different dosing regimen. _Taking other medicines _ Talk to your doctor or pharmacist if: • you are taking any other medicines in any form including any that you buy or obtained without a prescription. • you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any ot Прочитайте повний документ
HP GABAPENTIN CAPSULE 300 MG VIGABxx-0 544 DESCRIPTION Light yellow opaque / light yellow opaque with ‘GP300’ printed on one end and ‘hovid’ on the other end of the size 1 capsule filled with white to off-white powder. COMPOSITION Each capsule contains: Gabapentin 300 mg PHARMACODYNAMICS The mechanism of action is unknown. Gabapentin does not react with GABA receptors, is not metabolized to a GABA agonist or to GABA, and does not inhibit GABA uptake or degradation. In rats, gabapentin interacts with a novel binding site on cortical neurons that may be associated with the L-system amino acid transporter of brain cell membranes. PHARMACOKINETICS ABSORPTION Rapid. Gabapentin is absorbed in part by the L-amino acid transport system, which is a carrier-mediated, saturable transport system; as the dose increases, bioavailability decreases. Bioavailability ranges from approximately 60% for a 300mg dose to approximately 35% for a 1600mg dose. Absorption is unaffected by food. DISTRIBUTION Volume of distribution (Vol D ) is approximately 50 to 60 L. Gabapentin penetrates the blood-brain barrier, yielding cerebrospinal fluid (CSF) concentrations approximately equal to 20% of corresponding steady-state plasma through concentrations in patients with epilepsy. Brain tissue concentrations in one patient undergoing temporal lobectomy were approximately 80% of corresponding plasma concentrations. PROTEIN BINDING Very low (< 5%) BIOTRANSFORMATION Gabapentin is not metabolized. ELIMINATION Renal – Entire absorbed dose, as unchanged drug. Gabapentin clearance is directly proportional to creatinine clearance. In dialysis – Gabapentin can be removed from plasma by hemodialysis. The elimination half-life of Gabapentin is independent of dose and averages 5 to 7 hours. INDICATIONS • EPILEPSY: Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 3 years and above. Safety and effectiveness for adjunctive therapy in pediatric p Прочитайте повний документ