Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Ranbaxy Pharmaceuticals Inc.
GABAPENTIN
GABAPENTIN 400 mg
ORAL
PRESCRIPTION DRUG
Gabapentin capsules, USP are indicated for the management of postherpetic neuralgia in adults. Gabapentin capsules, 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 capsules, USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Gabapentin is not a scheduled drug. Gabapentin does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1 receptor sites. A small number of postmarketing cases report gabapentin misuse and abuse. These individuals were taking higher than recommended doses of gabapentin for unapproved uses. Most of the individuals described in these reports had a history of poly-substance abuse or used gabapentin to relieve symptoms of withdrawal from other substan
Gabapentin capsules, USP are supplied as follows: 100 mg Capsule ; White colored opaque cap and body, size “4 ” hard gelatin capsules, imprinted with “RX 627” on cap and body in black ink, containing white to off-white crystalline powder. NDC 63304-627-30 Bottles of 30 capsules NDC 63304-627-01 Bottles of 100 capsules NDC 63304-627-05 Bottles of 500 capsules NDC 63304-627-51 Blister pack of 50 capsules 300 mg Capsule ; Ivory colored opaque cap and body, size “0 ” hard gelatin capsules, imprinted “RX 628” on cap and body in black ink, containing white to off-white crystalline powder. NDC 63304-628-30 Bottles of 30 capsules NDC 63304-628-01 Bottles of 100 capsules NDC 63304-628-05 Bottles of 500 capsules NDC 63304-628-51 Blister pack of 50 capsules 400 mg Capsule ; Orange colored opaque cap and body, size “0el ” hard gelatin capsules, imprinted with “RX 629” on cap and body in black ink, containing white to off-white crystalline powder. NDC 63304-629-30 Bottles of 30 capsules NDC 63304-629-01 Bottles of 100 capsules NDC 63304-629-05 Bottles of 500 capsules NDC 63304-629-51 Blister pack of 50 capsules Storage Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ranbaxy Laboratories Limited New Delhi – 110 019, India June 2013 FDA-12 * Maalox is a registered trademark of Aventis Pharmaceuticals.
Abbreviated New Drug Application
Ranbaxy Pharmaceuticals Inc. ---------- MEDICATION GUIDE GABAPENTIN CAPSULES, USP Rx only Read the Medication Guide before you start taking gabapentin capsules, USP 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 capsules, USP? Do not stop taking gabapentin capsules, USP without first talking to your healthcare provider. Stopping gabapentin capsules, USP suddenly can cause serious problems. Gabapentin capsules, USP can cause serious side effects including: 1. Like other antiepileptic drugs, gabapentin capsules, USP 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 capsules, USP without first talking to a healthcare provider. • Stopping gabapentin capsules, USP 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 thing Citiți documentul complet
GABAPENTIN- GABAPENTIN CAPSULE RANBAXY PHARMACEUTICALS INC. ---------- GABAPENTIN CAPSULES, USP RX ONLY DESCRIPTION Gabapentin capsules, USP are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin, USP. The inactive ingredients for the capsules are corn starch, gelatin, magnesium stearate, mannitol, sodium lauryl sulphate, talc, titanium dioxide, black edible ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 300 mg capsule shell contains yellow iron oxide. The 400 mg capsule shell contains red iron oxide and yellow iron oxide. Gabapentin is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C H NO and a molecular weight of 171.24. The structural formula of gabapentin is: Gabapentin, USP is a white to off-white crystalline powder. It is freely soluble in water and in alkaline and acidic solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is −1.25. 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 te Citiți documentul complet