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.
actavis pharma, inc.
ROUND GREY 435 logo
435 logo ROUND GREY
Related Pills
lamotrigine 300 mg
actavis pharma, inc.
lamotrigine 200 mg
actavis pharma, inc.
lamotrigine 50 mg
actavis pharma, inc.
lamotrigine 100 mg
actavis pharma, inc.
lamotrigine 25 mg
actavis pharma, inc.
lamotrigine 250 mg
actavis pharma, inc.
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE extended-release tablets, USP 25 mg - Each white to off-white, round, unscored, film-coated tablet imprinted with on one side and 410 on the other side contains 25 mg of
LAMOTRIGINE, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1410-03). 50 mg - Each gray, round, unscored, film-coated tablet imprinted with on one side and 435 on the other side contains 50 mg of
LAMOTRIGINE, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1435-03). 100 mg - Each gray, round, unscored, film-coated tablet imprinted with on one side and 422 on the other side contains 100 mg of
LAMOTRIGINE, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1422-03). 200 mg - Each white to off-white, round, unscored, film-coated tablet imprinted with on one side and 453 on the other side contains 200 mg of
LAMOTRIGINE, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1453-03). 250 mg - Each yellow, capsule-shaped, unscored, film-coated tablet imprinted with on one side and 638 on the other side contains 250 mg of
LAMOTRIGINE, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1638-03). 300 mg - Each gray, capsule-shaped, unscored, film-coated tablet imprinted with on one side and 580 on the other side contains 300 mg of
LAMOTRIGINE, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1580-03). 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]. Dispense in a tight, light-resistant container as defined in the USP. 1 1 1 1 1 1
More pills like ROUND 435 logo