lamotrigine 25 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 AED. (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 tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine tablets are 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 tablets are 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 (14.1) ]. Limitation 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.
AvKARE, Inc.
ROUND WHITE J 245
J 245 ROUND WHITE
Related Pills
lamotrigine 25 MG Oral Tablet
JUBILANT CADISTA PHARMACEUTICALS 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 Tablets USP, 25 mg round, white to off-white tablets, debossed with ‘J 245’ on one side and scored on the other side. Bottles of 100 tablets, NDC 42291-366-01 Bottles of 1000 tablets, NDC 42291-366-10
LAMOTRIGINE Tablets USP, 100 mg round, white to off-white tablets, debossed with ‘J 246’ on one side and scored on the other side. Bottles of 100 tablets, NDC 42291-367-01 Bottles of 1000 tablets, NDC 42291-367-10
LAMOTRIGINE Tablets USP, 150 mg round, white to off-white tablets, debossed with ‘J 247’ on one side and scored on the other side. Bottles of 60 tablets, NDC 42291-368-60 Bottles of 500 tablets, NDC 42291-368-50
LAMOTRIGINE Tablets USP, 200 mg round, white to off-white tablets, debossed with ‘J 248’ on one side and scored on the other side. Bottles of 60 tablets, NDC 42291-369-60 Bottles of 500 tablets, NDC 42291-369-50 Store at 20 o C to 25 o C (68 o F to 77 o F); excursions permitted to 15 o C to 30 o C (59 o F to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.
More pills like ROUND J 245