Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GABAPENTIN
HOVID BERHAD
GABAPENTIN
100Capsule Capsules
HOVID BERHAD
_ _ _ _ _Consumer Medication Information Leaflet (RiMUP) _ NEURAN CAPSULE Gabapentin (300mg) 1 WHAT IS IN THIS LEAFLET 1. What Neuran is used for 2. How Neuran works 3. Before you use Neuran 4. How to use Neuran 5. While you are using Neuran 6. Side effects 7. Storage and disposal of Neuran 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NEURAN IS USED FOR Neuran is used: • as an additional therapy in the treatment of partial seizure (occurs in a limited area of the brain) with or without secondary generalization (affect the whole brain) in adults and children aged 3 years and above. • to treat neuropathic pain (pain caused by nerve damage) which includes diabetic neuropathy (nerve damage from diabetes), post-herpetic neuralgia (nerve pain at the site of a previous attack of shingles) and trigeminal neuralgia (facial pain) in adults age 18 years and above. HOW NEURAN 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 NEURAN _- When you must not use it _ Do not take this medicine if: • you are allergic to Neuran 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 use it _ Tell your doctor if: • you have allergies to any other medicines or any other anti- convulsant medicines, foods, preservatives or dyes. • you have kidney problems • you have absence seizures (a short period of “blanking out” or staring into space). • you are pregnant or plan to become pregnant or you become pregnant while you are taking gabapentin. • you are breastfeeding or plan to breastfeed. Gabapentin is excreted in breast milk. 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. Lire le document complet
852 VINEU15-var4 (MY) NEURAN CAPSULE 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 ACTIONS AND PHARMACOLOGY 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 Lire le document complet