24 HR lamotrigine 50 MG Extended Release Oral Tablet
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.
Dr.Reddy's Laboratories Limited
ROUND GREEN R718
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE extended-release tablets USP, 25 mg are yellow colored round, biconvex tablets imprinted in black ink with ‘R717’ on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s and bottles of 500’s. Bottles of 30 NDC 55111-717-30 Bottles of 500 NDC 55111-717-05
LAMOTRIGINE extended-release tablets USP, 50 mg are light green colored round, biconvex tablets imprinted in black ink with ‘R718’ on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s and bottles of 500’s. Bottles of 30 NDC 55111-718-30 Bottles of 500 NDC 55111-718-05
LAMOTRIGINE extended-release tablets USP, 100 mg are orange colored round, biconvex tablets imprinted in black ink with ‘R719’ on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s and bottles of 500’s. Bottles of 30 NDC 55111-719-30 Bottles of 500 NDC 55111-719-05
LAMOTRIGINE extended-release tablets USP, 200 mg are blue colored round, biconvex tablets imprinted in black ink with ‘R720’ on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s and bottles of 500’s. Bottles of 30 NDC 55111-720-30 Bottles of 500 NDC 55111-720-05
LAMOTRIGINE extended-release tablets USP, 250 mg are purple colored, oval shaped, biconvex tablets imprinted with 'R419' on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s, bottles of 90’s and bottles of 500’s. Bottles of 30 NDC 55111-419-30 Bottles of 90 NDC 55111-419-90 Bottles of 500 NDC 55111-419-05
LAMOTRIGINE extended-release tablets USP, 300 mg are grey colored modified capsule shaped, biconvex tablets imprinted with ‘R428’ on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s, bottles of 90’s and bottles of 500’s. Bottles of 30 NDC 55111-428-30 Bottles of 90 NDC 55111-428-90 Bottles of 500 NDC 55111-428-05 Storage: Store at 20°–25° C (68°–77° F); [See USP Controlled Room Temperature].
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