United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 400 mg - gabapentin capsules, usp are indicated for: gabapentin capsules, usp are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy category c : there are no adequate and well-controlled studies in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pregnant mice received oral doses of gabapentin (500 mg, 1000 mg, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effect dose for embryo-fetal developmental toxicity in mice was 500 mg/kg/day or approximately ½ of the maximum recommended human dose (mrhd) of 3600 mg/kg on a body surface area (mg/m2 ) basis. in studies in which rats r

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - gabapentin capsules, usp are indicated for: gabapentin capsules, usp are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy category c : there are no adequate and well-controlled studies in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pregnant mice received oral doses of gabapentin (500 mg, 1000 mg, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effect dose for embryo-fetal developmental toxicity in mice was 500 mg/kg/day or approximately ½ of the maximum recommended human dose (mrhd) of 3600 mg/kg on a body surface area (mg/m2 ) basis. in studies in which rats r

Australia - English - Department of Health (Therapeutic Goods Administration)

medtas pty ltd - gabapentin, quantity: 300 mg - capsule, hard - excipient ingredients: purified talc; maize starch; titanium dioxide; purified water; iron oxide yellow; gelatin; sodium lauryl sulfate - gabapentin is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,gabapentin is indicated for the treatment of neuropathic pain.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtas pty ltd - gabapentin, quantity: 100 mg - capsule, hard - excipient ingredients: maize starch; purified talc; titanium dioxide; purified water; gelatin; sodium lauryl sulfate - gabapentin is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,gabapentin is indicated for the treatment of neuropathic pain.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtas pty ltd - gabapentin, quantity: 400 mg - capsule, hard - excipient ingredients: maize starch; purified talc; titanium dioxide; purified water; iron oxide red; iron oxide yellow; gelatin; sodium lauryl sulfate - gabapentin is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,gabapentin is indicated for the treatment of neuropathic pain.

Australia - English - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - gabapentin -

United States - English - NLM (National Library of Medicine)

safecor health, llc - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - postherpetic neuralgia gabapentin capsules, usp are indicated for the management of postherpetic neuralgia in adults. epilepsy 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 capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. controlled substance gabapentin is not a scheduled drug. abuse 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

United States - English - NLM (National Library of Medicine)

cardinal health - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 300 mg - gabapentin is indicated for: gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy category c there are no adequate and well-controlled studies in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effect dose for embryo-fetal developmental toxicity in mice was 500 mg/kg/day or approximately ½ of the maximum recommended human dose (mrhd) of 3600 mg/kg on a body surface area (mg/m2 ) basis. in studies in which rats received oral doses of gabapentin (500

United States - English - NLM (National Library of Medicine)

apotex corp. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - gabapentin is indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http:/www.aedpregnancyregistry.org/ risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and

United States - English - NLM (National Library of Medicine)

major pharmaceuticals - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - gabapentin is indicated for: gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy category c there are no adequate and well-controlled studies in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effect dose for embryo-fetal developmental toxicity in mice was 500 mg/kg/day or approximately ½ of the maximum recommended human dose (mrhd) of 3600 mg/kg on a body surface area (mg/m2 ) basis. in studies in which rats received oral doses of gabapentin (500