Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
gabapentin (UNII: 6CW7F3G59X) (gabapentin - UNII:6CW7F3G59X)
Allied Pharma Inc
gabapentin
gabapentin 600 mg
ORAL
PRESCRIPTION DRUG
Postherpetic Neuralgia Gabapentin is indicated for the management of postherpetic neuralgia in adults. Epilepsy Gabapentin is 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 is 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. The abuse and dependence potential of gabapentin has not been evaluated in human studies. 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 po
Gabapentin tablets, USP 600 mg are available for oral administration as white to off -White, film-coated, oval-shaped tablets, deep scoring on both the sides and debossed with "NT"and “150” on one side supplied in bottles of 100 (NDC – 76267-150-02). Gabapentin tablets, USP 800 mg are available for oral administration as white to off -White, film-coated, oval-shaped tablets, deep scoring on both the sides and debossed with "NT"and “151” on one side supplied in bottles of 100 (NDC – 76267-151-02) Storage Store at 20° to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Made in India by: Par Formulations Pvt Ltd, 1/58, Pudupakkam, Kelambakkam 603 103 Manufactured for Allied Pharma Inc 20 Corrielle Street Fords, NJ 08863 I08/13
Abbreviated New Drug Application
GABAPENTIN - GABAPENTIN TABLET, FILM COATED GABAPENTIN - GABAPENTIN TABLET, FILM COATED Allied Pharma Inc ---------- SPL MEDGUIDE SECTION GABAPENTIN TABLETS, USP 600 mg and 800 mg Read the Medication Guide before you start taking GABAPENTIN Tablets 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 Tablets? Do not stop taking GABAPENTIN Tablets without first talking to your healthcare provider. Stopping GABAPENTIN Tablets suddenly can cause serious problems. GABAPENTIN Tablets can cause serious side effects including: 1. Like other antiepileptic drugs, GABAPENTIN Tablets 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 Tablets without first talking to a healthcare provider. · Stopping GABAPENTIN Tablets 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 act Aqra d-dokument sħiħ
GABAPENTIN - GABAPENTIN TABLET, FILM COATED GABAPENTIN - GABAPENTIN TABLET, FILM COATED ALLIED PHARMA INC ---------- GABAPENTIN TABLETS, USP 600 MG AND 800 MG ALLIED PHARMA INC DESCRIPTION Gabapentin tablets are supplied as oval-shaped film-coated tablets containing 600 mg and 800 mg of gabapentin USP. The inactive ingredients are copovidone, hydroxyl propyl cellulose, magnesium stearate mannitol, poloxamer, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide 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 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. Gabapentin tablets meets USP dissolution test 1. 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. 9 17 2 a1 a2 The mechanism by which gabapentin exerts its anticonvulsant action is unknown, but in animal test systems designed to detect anticonvulsant Aqra d-dokument sħiħ