Lamotrigine 25 mg
1 INDICATIONS AND USAGE Lamotrigine tablets are 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 tablets 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 tablets 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 (14.2) ] . Limitations of Use Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.
Aurobindo Pharma Limited
PENTAGON WHITE 93 D
93 D PENTAGON WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMOTRIGINE Tablets USP, 25 mg are white to off-white colored, shield shaped uncoated tablets debossed with “D” and “93” on one side and scoreline on other side. Bottles of 60 NDC 65862-227-60 Bottles of 100 NDC 65862-227-01 Bottles of 1,000 NDC 65862-227-99 10 x 10 Unit-dose Tablets NDC 65862-227-78
LAMOTRIGINE Tablets USP, 100 mg are peach colored, mottled, shield shaped uncoated tablets debossed with “D" and "94" on one side and scoreline on other side. Bottles of 60 NDC 65862-228-60 Bottles of 100 NDC 65862-228-01 Bottles of 1,000 NDC 65862-228-99 10 x 10 Unit-dose Tablets NDC 65862-228-78
LAMOTRIGINE Tablets USP, 150 mg are cream colored, mottled, shield shaped uncoated tablets debossed with "D" and "95" on one side and scoreline on other side. Bottles of 60 NDC 65862-229-60 Bottles of 100 NDC 65862-229-01 Bottles of 1,000 NDC 65862-229-99 10 x 10 Unit-dose Tablets NDC 65862-229-78
LAMOTRIGINE Tablets USP, 200 mg are blue colored, mottled, shield shaped uncoated tablets debossed with "D" and "96" on one side and scoreline on other side. Bottles of 60 NDC 65862-230-60 Bottles of 100 NDC 65862-230-01 Bottles of 1,000 NDC 65862-230-99 10 x 10 Unit-dose Tablets NDC 65862-230-78 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]. Keep in a dry place and protect from light. Blister Packs: If the product is dispensed in a blister pack, the patient should be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing.
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