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

preferred pharmaceuticals, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 600 mg - gabapentin tablets are indicated for: gabapentin tablets are 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 visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically [see data]. in the u.s. general populat

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

sun pharmaceutical industries, inc. - 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

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

keltman pharmaceuticals inc. - pentazocine hydrochloride (unii: a36bxo4ppx) (pentazocine - unii:rp4a60d26l), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - pentazocine hydrochloride 50 mg - pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. pentazocine and naloxone hydrochlorides tablets are indicated for oral use only. pentazocine and naloxone hydrochlorides tablets should not be administered to patients who are hypersensitive to either pentazocine or naloxone. controlled substance. pentazocine and naloxone hydrochlorides tablets are a schedule iv controlled substance. there have been some reports of dependence and of withdrawal symptoms with orally administered pentazocine. patients with a history of drug dependence should be under close supervision while receiving pentazocine orally. there have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy. there have been instances of psychological and physical dependence on parenteral pentazocine in patients with a history of drug abuse and rarely, in patients without such a history. abrupt discontinuance following the extended use of

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

ranbaxy pharmaceuticals inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 400 mg - 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

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

taro pharmaceuticals u.s.a., inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 250 mg in 5 ml - gabapentin is indicated for the management of postherpetic neuralgia in adults. 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. 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 substances. when prescribing gabapentin carefully ev

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

stat rx usa llc - pentazocine hydrochloride (unii: a36bxo4ppx) (pentazocine - unii:rp4a60d26l), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - pentazocine hydrochloride 50 mg - pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. pentazocine and naloxone hydrochlorides tablets are indicated for oral use only. pentazocine and naloxone hydrochlorides tablets should not be administered to patients who are hypersensitive to either pentazocine or naloxone. controlled substance. pentazocine and naloxone hydrochlorides tablets are a schedule iv controlled substance. there have been some reports of dependence and of withdrawal symptoms with orally administered pentazocine. patients with a history of drug dependence should be under close supervision while receiving pentazocine orally. there have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy. there have been instances of psychological and physical dependence on parenteral pentazocine in patients with a history of drug abuse and rarely, in patients without such a history. abrupt discontinuance following the exten

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

preferred pharmaceuticals, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 800 mg - gabapentin tablets, usp are indicated for: gabapentin tablets, 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 rec

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

arrotex pharmaceuticals pty ltd - gabapentin, quantity: 400 mg - capsule - excipient ingredients: lactose monohydrate; maize starch; purified talc; gelatin; purified water; sodium lauryl sulfate; titanium dioxide; iron oxide red; iron oxide yellow - 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)

apotex pty ltd - gabapentin, quantity: 300 mg - capsule - excipient ingredients: lactose monohydrate; maize starch; purified talc; gelatin; purified water; sodium lauryl sulfate; titanium dioxide; iron oxide yellow - 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)

apotex pty ltd - gabapentin, quantity: 100 mg - capsule - excipient ingredients: lactose monohydrate; maize starch; purified talc; gelatin; purified water; sodium lauryl sulfate; titanium dioxide - 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.