24 HR lamotrigine 100 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Lamotrigine extended-release is 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 is 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 is 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 two 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.
Par Pharmaceutical, Inc.
ROUND BROWN Par 563
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16 HOW SUPPLIED Lamotrigine Extended-Release Tablets 25 mg, round, beige, biconvex, film-coated tablet debossed with “561” on one side and “Par” on the other 30 Tablets - (NDC 49884-561-11) 100 Tablets - (NDC 49884-561-01) 500 Tablets - (NDC 49884-561-05) 50 mg, round, white, biconvex, film-coated tablet debossed with “562” on one side and “Par” on the other 30 Tablets - (NDC 49884-562-11) 100 Tablets - (NDC 49884-562-01) 500 Tablets - (NDC 49884-562-05) 100 mg, round, brown, biconvex, film-coated tablet debossed with “563” on one side and “Par” on the other 30 Tablets - (NDC 49884-563-11) 100 Tablets - (NDC 49884-563-01) 500 Tablets - (NDC 49884-563-05) 200 mg, round, yellow, biconvex, film-coated tablet debossed with “564” on one side and “Par” on the other 30 Tablets - (NDC 49884-564-11) 100 Tablets - (NDC 49884-564-01) 500 Tablets - (NDC 49884-564-05) 250 mg, round, white, biconvex, film-coated tablet debossed with “604” on one side and “Par” on the other 30 Tablets – (NDC 49884-604-11) 100 Tablets – (NDC 49884-604-01) 500 Tablets – (NDC 49884-604-05) 300 mg, round, grey, biconvex, film-coated tablet debossed with “605” on one side and “Par” on the other 30 Tablets - (NDC 49884-605-11) 100 Tablets - (NDC 49884-605-01) 500 Tablets - (NDC 49884-605-05) 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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