País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Aidarex Pharmaceuticals LLC
GABAPENTIN
GABAPENTIN 600 mg
ORAL
PRESCRIPTION DRUG
Gabapentin tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Gabapentin Tablets USP, 600 mg are white, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with ‘D’ and ‘24’ on either side of the break line on one side and plain on other side. Bottles of 10 NDC 33261-051-10 Bottles of 20 NDC 33261-051-20 Bottles of 21 NDC 33261-051-21 Bottles of 30 NDC 33261-051-30 Bottles of 42 NDC 33261-051-42 Bottles of 45 NDC 33261-051-45 Bottles of 60 NDC 33261-051-60 Bottles of 81 NDC 33261-051-81 Bottles of 90 NDC 33261-051-90 Bottles of 100 NDC 33261-051-00 Bottles of 120 NDC 33261-051-02 Bottles of 126 NDC 33261-051-97 Bottles of 180 NDC 33261-051-99 Gabapentin Tablets USP, 800 mg are white, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with ‘D’ and ‘25’ on either side of the break line on one side and plain on other side. Bottles of 10 NDC 33261-116-10 Bottles of 20 NDC 33261-116-20 Bottles of 21 NDC 33261-116-21 Bottles of 30 NDC 33261-116-30 Bottles of 42 NDC 33261-116-42 Bottles of 45 NDC 33261-116-45 Bottles of 60 NDC 33261-116-60 Bottles of 81 NDC 33261-116-81 Bottles of 90 NDC 33261-116-90 Bottles of 100 NDC 33261-116-00 Bottles of 120 NDC 33261-116-02 Bottles of 126 NDC 33261-116-97 Bottles of 180 NDC 33261-116-99 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Maalox® is a registered trademark of Novartis Consumer Health, Inc. Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt) AP-509302, INDIA Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880 Issued: August 2011
Abbreviated New Drug Application
GABAPENTIN- GABAPENTIN TABLET, FILM COATED Aidarex Pharmaceuticals LLC ---------- MEDICATION GUIDE Gabapentin Tablets, USP Rx only 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 actions can be caused by things other Leia o documento completo
GABAPENTIN- GABAPENTIN TABLET, FILM COATED AIDAREX PHARMACEUTICALS LLC ---------- GABAPENTIN TABLETS, USP DESCRIPTION Gabapentin tablets, USP are supplied as film-coated tablets containing 600 mg and 800 mg of gabapentin USP. The inactive ingredients for the tablets are copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc. 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 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. 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 bot Leia o documento completo