País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GABAPENTIN
AVERROES PHARMACEUTICALS SDN. BHD.
GABAPENTIN
30capsule Capsules
PT NOVELL PHARMACEUTICAL LABORATORIES.
EPIVEN CAPSULE 300MG _Consumer Medication Information Leaflet (RiMUP)_ Gabapentin 300mg 1 EPIVEN® CAPSULE GABAPENTIN 300 MG WHAT IS IN THIS LEAFLET - WHAT EPIVEN IS USED FOR - HOW EPIVEN WORKS - BEFORE YOU USE EPIVEN - HOW TO TAKE EPIVEN - WHILE YOU ARE USING EPIVEN - SIDE EFFECTS - STORAGE AND DISPOSAL OF EPIVEN - PRODUCT DESCRIPTION - MANUFACTURER - PRODUCT REGISTRATION HOLDER - DATE OF REVISION WHAT EPIVEN IS USED FOR Epilepsy: Epiven is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children age 3 years and above. Safety and effectiveness for adjunctive therapy in pediatric patients below the age of 3 years have not been established. Neuropathic pain: Epiven is indicated for the treatment of neuropathic pain which includes diabetic neuropathy, post-herpetic neuralgia and trigeminal neuralgia in adults age 18 years and above. Safety and effectiveness in patients below the age of 18 years have not been established. HOW EPIVEN WORKS Epiven belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). BEFORE YOU USE EPIVEN • When you must not take it: Do not take Epiven: - If you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Epiven • Before you start to take it: Important information about potentially serious reactions A small number of people taking Epiven get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You need to know these symptoms to look out for while you are taking Epiven. Tell your doctor if you are pregnant or intend to become pregnant. Epiven should not be taken during pregnancy, unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential. There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medications used to treat seizure Llegiu el document complet
EPIVEN CAPSULE 300MG GABAPENTIN DESCRIPTION Capsule type: Hard capsule No.1 Capsule color: Cap: Yellow opaque Body: Yellow opaque Capsule content: white granules COMPOSITION Each capsule contains of Gabapentin 300mg. MODE OF ACTION Gabapentin is structurally related to the neurotransmitter GABA; however, gabapentin and its metabolites do not bind to GABA (A) or GABA (B) receptors or influence the degradation or uptake of GABA. The analgesic action of gabapentin has been demonstrated in animal models of analgesia where gabapentin prevented allodynia and hyperalgesia. Pain related responses in neuropathic pain models and in peripheral inflammation models were prevented or decreased by gabapentin. Immediate pain-related behaviors were not altered. The mechanism by which gabapentin exerts its analgesic effects is unknown. It has been suggested the mechanism of action may be by gabapentin preventing thrombospondin from binding to alpha-2 delta-1 (a receptor involved in excitatory synapse formation). The anticonvulsant action of gabapentin has been demonstrated in animal test systems; however, the mechanism by which gabapentin prevents seizure activity is unknown. SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS ABSORPTION Gabapentin bioavailability is not dose-proportional. That is, as the dose is increased, bioavailability decreases. Gabapentin is absorbed from the gastrointestinal tract by means of a saturable mechanism. After multiple dosing peak plasma concentrations usually occur within 2 to 3 hours of a dose and a steady state within 1 to 2 days. Absolute bioavailability of gabapentin capsules is approximately 60%. DISTRIBUTION Gabapentin is distributed into breast milk. It is widely distributed throughout the body but binding to plasma proteins is minimal. It has a volume of distribution equal to 57.7 liters. METABOLISM Gabapentin is excreted unchanged in the urine, and is not appreciably metabolized. EXCRETION The elimination half-life of gabapentin is independent of dose and averages 5 to 7 hours. The renal c Llegiu el document complet