Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
STAT Rx USA LLC
GABAPENTIN
GABAPENTIN 600 mg
ORAL
PRESCRIPTION DRUG
Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults. Gabapentin tablets USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin tablets USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. Gabapentin tablets USP are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. The abuse and dependence potential of gabapentin has not been evaluated in human studies.
Gabapentin Tablets USP, 600 mg are available as white, oval shaped tablets, debossed “4443”, with a partial score on one side and “600” on the other side containing 600 mg gabapentin USP packaged in bottles of 100, 500 and 1000 tablets and unit-dose boxes of 100 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. J 8/2011
Abbreviated New Drug Application
STAT Rx USA LLC ---------- MEDICATION GUIDE GABAPENTIN (GA-ba-PEN'-tin) TABLETS USP Read the Medication Guide before you start taking gabapentin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about gabapentin? Do not stop taking gabapentin without first talking to your healthcare provider. Stopping gabapentin suddenly can cause serious problems. Gabapentin can cause serious side effects including: 1.Like other antiepileptic drugs, gabapentin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop taking gabapentin without first talking to a healthcare provider. • Stopping gabapentin suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. Lire le document complet
GABAPENTIN - GABAPENTIN TABLET STAT RX USA LLC ---------- GABAPENTIN TABLETS USP RX ONLY 4443 4444 DESCRIPTION Gabapentin tablets USP are an anticonvulsant for oral administration. Gabapentin USP is described as 1- (aminomethyl)cyclohexaneacetic acid. Gabapentin USP is a white to off-white crystalline solid with a pK of 3.7 and a pK of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. The structural formula of gabapentin USP is: C H NO M.W. 171.24 Each gabapentin tablet USP, for oral administration, contains 600 mg or 800 mg of gabapentin USP and contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose and polyethylene glycol. CLINICAL PHARMACOLOGY MECHANISM OF ACTION The mechanism by which gabapentin exerts its analgesic action is unknown, but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). In particular, gabapentin prevents pain-related responses in several models of neuropathic pain in rats or mice (e.g., spinal nerve ligation models, streptozocin-induced diabetes model, spinal cord injury model, acute herpes zoster infection model). Gabapentin also decreases pain-related responses after peripheral inflammation (carrageenan footpad test, late phase of formalin test). Gabapentin did not alter immediate pain-related behaviors (rat tail flick test, formalin footpad acute phase, acetic acid abdominal constriction test, footpad heat irradiation test). The relevance of these models to human pain is not known. The mechanism by which gabapentin exerts its anticonvulsant action is unknown, but in animal test systems designed to detect anticonvulsant activity, gabapentin prevents seizures as do other marketed anticonvulsants. Gabapentin exhibits antiseizure activity in mice and rats in both the maximal electroshock and penty Lire le document complet