Stati Uniti - Ingliż - NLM (National Library of Medicine)

amneal pharmaceuticals llc - felbamate (unii: x72rbb02n8) (felbamate - unii:x72rbb02n8) - felbamate 600 mg in 5 ml - felbamate oral suspension is not indicated as a first line antiepileptic treatment (see warnings ). felbamate oral suspension is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. if these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate oral suspension can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with lennox-gastaut syndrome in children. felbamate oral suspension is contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. it should not be used in patients with a history of any blood dyscrasia or hepatic dysfunction. abuse: abuse potential was not evaluated in human studies. dependence: rats administered felbamate orally at doses 8.3 times the recommended human dose 6 days each week for 5 consecutive weeks demonstrated no signs of physical dependence as measured by weight loss following drug withdrawal on day 7 of each week.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - felbamate (unii: x72rbb02n8) (felbamate - unii:x72rbb02n8) - felbamate 600 mg in 5 ml - felbamate oral suspension, usp is not indicated as a first line antiepileptic treatment (see warnings ). felbamate oral suspension is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. if these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with lennox-gastaut syndrome in children. felbamate oral suspension, usp is contraindicated in patients with known hypersensitivity to felbamate oral suspension, its ingredients, or known sensitivity to other carbamates. it should not be used in patients

Stati Uniti - Ingliż - NLM (National Library of Medicine)

northstar rx llc - felbamate (unii: x72rbb02n8) (felbamate - unii:x72rbb02n8) - felbamate oral suspension, usp is not indicated as a first line antiepileptic treatment (see warnings ). felbamate oral suspension is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. if these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with lennox-gastaut syndrome in children. felbamate oral suspension, usp is contraindicated in patients with known hypersensitivity to felbamate oral suspension, its ingredients, or known sensitivity to other carbamates. it should not be used in patients

Stati Uniti - Ingliż - NLM (National Library of Medicine)

pharmaceutical associates, inc. - felbamate (unii: x72rbb02n8) (felbamate - unii:x72rbb02n8) - felbamate oral suspension, usp is not indicated as a first line antiepileptic treatment (see warnings ). felbamate oral suspension is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. if these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with lennox-gastaut syndrome in children. felbamate oral suspension, usp is contraindicated in patients with known hypersensitivity to felbamate oral suspension, its ingredients, or known sensitivity to other carbamates. it should not be use

Kanada - Ingliż - Health Canada

novartis pharmaceuticals canada inc - oxcarbazepine - suspension - 60mg - oxcarbazepine 60mg - miscellaneous anticonvulsants

Stati Uniti - Ingliż - NLM (National Library of Medicine)

bionpharma inc. - rufinamide (unii: wfw942pr79) (rufinamide - unii:wfw942pr79) - rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with lennox-gastaut syndrome in pediatric patients 1 year of age and older and in adults. rufinamide is contraindicated in patients with familial short qt syndrome [ see  warnings and precautions  ( 5.3 ) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as rufinamide, during pregnancy. encourage women who are taking rufinamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no adequate data on the developmental risks associated with use of rufinamide in pregnant women. in animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see data] . in the u.s. general population, the estimated b

Stati Uniti - Ingliż - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam oral suspension is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6)] . pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. healthcare providers are encouraged to recommend that pregnant women taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/. risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.8)  and clinical considerations ] . availab

Stati Uniti - Ingliż - NLM (National Library of Medicine)

lannett company, inc. - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6 )] . pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. physicians are advised to recommend that pregnant patients taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org. risk summary there are no adequate and well-controlled studies of clobazam in pregnant women. available data suggest that the class o

Stati Uniti - Ingliż - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam oral suspension is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6)]. pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. healthcare providers are encouraged to recommend that pregnant women taking clobazam oral suspension enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/. risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.8) and clinical consideration

Stati Uniti - Ingliż - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine is indicated in adults for the treatment of: - major depressive disorder (mdd) - obsessive compulsive disorder (ocd) - panic disorder (pd) - social anxiety disorder (sad) - generalized anxiety disorder (gad) - posttraumatic stress disorder (ptsd) paroxetine is contraindicated in patients: - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions ( 7)]. - taking thioridazine because of risk of qt prolongation [see warnings and precautions (5. 3) and drug interactions (7)] - taking pimozide because of risk of qt prolongation [see warnings and precautions (5.3), drug interactions (7)]. - with known hypersensitivity (e.g., anaphylaxis, angioedema, stevens-johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine oral suspension [see adverse reactions (6.1), (6.2)] . risk summary based on data from published observational stu