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

nucare pharmaceuticals, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

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

stat rx usa llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1)]. topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients  2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.2)]. none. pregnancy category d. [see warnings and precautions (5.6)] topiramate can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). when multiple species of pregnant animals received topiramate

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

proficient rx lp - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 100 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy category d. [

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

rebel distributors corp - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome. topiramate tablets are contraindicated in patients with a history of hypersensitivity to any component of this product. the abuse and dependence potential of topiramate has not been evaluated in human studies.

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

apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 100 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

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

proficient rx lp - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome. topiramate tablets are contraindicated in patients with a history of hypersensitivity to any component of this product. the abuse and dependence potential of topiramate has not been evaluated in human studies.

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

medis pharma pty ltd - topiramate, quantity: 25 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; purified water; industrial methylated spirit; ammonia - epilepsy. adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy;. for conversion to monotherapy in patients with epilepsy;as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.. migraine. prophylaxis of migraine headache in adults.

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

medis pharma pty ltd - topiramate, quantity: 100 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate; pregelatinised maize starch; lactose monohydrate; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; purified water; industrial methylated spirit; ammonia - epilepsy. adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy;. for conversion to monotherapy in patients with epilepsy;as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.. migraine. prophylaxis of migraine headache in adults.

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

medis pharma pty ltd - topiramate, quantity: 200 mg - tablet, film coated - excipient ingredients: lactose monohydrate; colloidal anhydrous silica; pregelatinised maize starch; magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; purified water; industrial methylated spirit; ammonia - epilepsy. adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy;. for conversion to monotherapy in patients with epilepsy;as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.. migraine. prophylaxis of migraine headache in adults.

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

medis pharma pty ltd - topiramate, quantity: 50 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; pregelatinised maize starch; sodium starch glycollate; colloidal anhydrous silica; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; purified water; industrial methylated spirit; ammonia - epilepsy. adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy;. for conversion to monotherapy in patients with epilepsy;as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.. migraine. prophylaxis of migraine headache in adults.