lamotrigine 50 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 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 Tablets 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.
yiling pharmaceutical, inc.
ROUND GREEN Y32
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16 HOW SUPPLIED/STORAGE AND HANDLING Lamotrigine Extended-Release Tablets, USP 25 mg, yellow, round, biconvex, film-coated tablets printed with 'Y31' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 30 with white caps (NDC 69117-0044-1). 25 mg, yellow, round, biconvex, film-coated tablets printed with 'Y31' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 100 with white caps (NDC 69117-0044-2). 25 mg, yellow, round, biconvex, film-coated tablets printed with 'Y31' on one side in black ink and no mark on the reverse side, supplied in bottles of 500 with white caps (NDC 69117-0044-3). 50 mg, green, round, biconvex, film-coated tablets printed with 'Y32' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 30 with white caps (NDC 69117-0045-1). 50 mg, green, round, biconvex, film-coated tablets printed with 'Y32' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 100 with white caps (NDC 69117-0045-2). 50 mg, green, round, biconvex, film-coated tablets printed with 'Y32' on one side in black ink and no mark on the reverse side, supplied in bottles of 500 with white caps (NDC 69117-0045-3). 100 mg, orange, round, biconvex, film-coated tablets printed with ‘Y33' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 30 with white caps (NDC 69117-0046-1). 100 mg, orange, round, biconvex, film-coated tablets printed with ‘Y33' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 100 with white caps (NDC 69117-0046-2). 100 mg, orange, round, biconvex, film-coated tablets printed with ‘Y33' on one side in black ink and no mark on the reverse side, supplied in bottles of 500 with white caps (NDC 69117-0046-3). 200 mg, blue, round, biconvex, film-coated tablets printed with 'Y34' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 30 with white caps (NDC 69117-0047-1). 200 mg, blue, round, biconvex, film-coated tablets printed with 'Y34' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 100 with white caps (NDC 69117-0047-2). 200 mg, blue, round, biconvex, film-coated tablets printed with 'Y34' on one side in black ink and no mark on the reverse side, supplied in bottles of 500 with white caps (NDC 69117-0047-3). 250 mg, purple, caplet-shaped, biconvex, film-coated tablets printed with ‘Y35' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 30 with white caps (NDC 69117-0048-1). 250 mg, purple, caplet-shaped, biconvex, film-coated tablets printed with ‘Y35' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 100 with white caps (NDC 69117-0048-2). 250 mg, purple, caplet-shaped, biconvex, film-coated tablets printed with ‘Y35' on one side in black ink and no mark on the reverse side, supplied in bottles of 500 with white caps (NDC 69117-0048-3). 300 mg, gray, caplet-shaped, biconvex, film-coated tablets printed with 'Y36' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 30 with white caps (NDC 69117-0049-1). 300 mg, gray, caplet-shaped, biconvex, film-coated tablets printed with 'Y36' on one side in black ink and no mark on the reverse side, unit-of-use bottles of 100 with white caps (NDC 69117-0049-2). 300 mg, gray, caplet-shaped, biconvex, film-coated tablets printed with 'Y36' on one side in black ink and no mark on the reverse side, supplied in bottles of 500 with white caps (NDC 69117-0049-3). 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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