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lamotrigine 100 mg

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 USP 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 USP 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 tablets USP 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 tablets for use in patients younger than 13 years have not been established.

Torrent Pharmaceuticals Limited


4 years ago ROUND ORANGE 341 100 lamotrigine 100 mg

ROUND ORANGE 341 100

16 HOW SUPPLIED/STORAGE AND HANDLING

LAMOTRIGINE extended-release tablets , USP 25 mg, light yellow to yellow colored, round, biconvex, film coated tablets, debossed with '339' on one side and '25' on other side. Bottles of 30 NDC 13668-339-30 50 mg, light green to green colored, round, biconvex, film coated tablets, debossed with '340' on one side and '50' on other side. Bottles of 30 NDC 13668-340-30 100 mg, light orange to orange colored, round, biconvex, film coated tablets, debossed with '341' on one side and '100' on other side. Bottles of 30 NDC 13668-341-30 200 mg, light blue to blue colored, round, biconvex, film coated tablets, debossed with '342' on one side and '200' on other side. Bottles of 30 NDC 13668-342-30 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].


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