lamotrigine tablet extended release
1 INDICATIONS AND USAGE Lamotrigine extended-release tablets are indicated for: Adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1) Conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. (1.2) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. (1.3) 1.1 Adjunctive Therapy Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. 1.2 Monotherapy Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of lamotrigine extended-release have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.3 Limitation of Use Safety and effectiveness of lamotrigine extended-release for use in patients younger than 13 years have not been established.
zydus pharmaceuticals (usa) inc.
OVAL GREY 984
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE Extended-Release Tablets USP , 25 mg are light yellow to yellow, round tablet, debossed with "979" on one side and plain on other side and are supplied as: NDC 68382-979-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-979-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-979-05 in bottle of 500 tablets
LAMOTRIGINE Extended-Release Tablets USP , 50 mg are light green to green, round tablet, debossed with "980" on one side and plain on other side and are supplied as: NDC 68382-980-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-980-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-980-05 in bottle of 500 tablets
LAMOTRIGINE Extended-Release Tablets USP , 100 mg are light orange to orange, round tablet, debossed with "981" on one side and plain on other side and are supplied as: NDC 68382-981-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-981-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-981-05 in bottle of 500 tablets
LAMOTRIGINE Extended-Release Tablets USP , 200 mg are light blue to blue, round tablet, debossed with "982" on one side and plain on other side and are supplied as: NDC 68382-982-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-982-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-982-05 in bottle of 500 tablets
LAMOTRIGINE Extended-Release Tablets USP , 250 mg are light purple to purple, color, oval shaped tablet, debossed with "983" on one side and plain on other side and are supplied as: NDC 68382-983-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-983-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-983-05 in bottle of 500 tablets
LAMOTRIGINE Extended-Release Tablets USP , 300 mg are light gray to gray color, oval shaped tablet, debossed with "984" on one side and plain on other side and are supplied as: NDC 68382-984-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-984-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-984-05 in bottle of 500 tablets Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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