lamotrigine 150 MG Oral Tablet
1 INDICATIONS AND USAGE Lamotrigine is indicated for: Epilepsy — adjunctive therapy in patients aged 2 years and older: Partial-onset seizures. primary generalized tonic-clonic seizures. generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. ( 1.1 ) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. ( 1.2 ) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established. 1.1 Epilepsy Adjunctive Therapy Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic seizures (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.2 Bipolar Disorder Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies ( 14.2 )] . Limitations of Use Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
zydus pharmaceuticals (usa) inc.
ROUND WHITE ZC 81
ZC 81 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE Tablets
LAMOTRIGINE Tablets USP, 25 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "79" and other side is plain and are supplied as follows: NDC 68382-006-11 in bottles of 25 tablets with child-resistant closure NDC 68382-006-16 in bottles of 90 tablets with child-resistant closure NDC 68382-006-01 in bottles of 100 tablets with child-resistant closure NDC 68382-006-05 in bottles of 500 tablets NDC 68382-006-10 in bottles of 1000 tablets
LAMOTRIGINE Tablets USP, 50 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "90" and other side is plain and are supplied as follows: NDC 68382-007-16 in bottles of 90 tablets with child-resistant closure NDC 68382-007-01 in bottles of 100 tablets with child-resistant closure NDC 68382-007-05 in bottles of 500 tablets NDC 68382-007-10 in bottles of 1000 tablets
LAMOTRIGINE Tablets USP, 100 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "80"and other side is plain and are supplied as follows: NDC 68382-008-16 in bottles of 90 tablets with child-resistant closure NDC 68382-008-01 in bottles of 100 tablets with child-resistant closure NDC 68382-008-05 in bottles of 500 tablets NDC 68382-008-10 in bottles of 1000 tablets
LAMOTRIGINE Tablets USP, 150 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "81" and other side is plain and are supplied as follows: NDC 68382-009-14 in bottles of 60 tablets with child-resistant closure NDC 68382-009-16 in bottles of 90 tablets with child-resistant closure NDC 68382-009-05 in bottles of 500 tablets
LAMOTRIGINE Tablets USP, 200 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "82" and other side is plain and are supplied as follows: NDC 68382-010-14 in bottles of 60 tablets with child-resistant closure NDC 68382-010-16 in bottles of 90 tablets with child-resistant closure NDC 68382-010-05 in bottles of 500 tablets
LAMOTRIGINE Tablets USP, 250 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "91"and other side is plain and are supplied as follows: NDC 68382-011-14 in bottles of 60 tablets with child-resistant closure NDC 68382-011-16 in bottles of 90 tablets with child-resistant closure NDC 68382-011-05 in bottles of 500 tablets
LAMOTRIGINE Tablets for Oral Suspension, USP
LAMOTRIGINE Tablets for Oral Suspension, USP, 5 mg are white to off-white, round, flat- faced, radial-edged tablets with bisect on one side and plain on other side; one side of the bisect is debossed with "Z" and other side is debossed with "13" and are supplied as follows: NDC-68382-108-16 in bottle of 90 tablets with child-resistant closure NDC-68382-108-01 in bottle of 100 tablets with child-resistant closure NDC-68382-108-05 in bottle of 500 tablets
LAMOTRIGINE Tablets for Oral Suspension, USP, 25 mg are white to off-white, round, flat- faced, radial-edged tablets debossed with logo of "Z" and "12" on one side and plain on the other side and are supplied as follows: NDC-68382-109-16 in bottle of 90 tablets with child-resistant closure NDC-68382-109-01 in bottle of 100 tablets with child-resistant closure NDC-68382-109-05 in bottle of 500 tablets Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP.
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