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Tablet
Files
Lamotrigine ER
Strength: 250mg
Count: 30
NDC
42291-447-30
Class
Rx
Brand Name
LaMICtal
Imprint Code
AN988
Color(s)
PURPLE
Shape
CAPSULE
Score
no score
Case Count
NA
Inactive Ingredients
colloidal silicon dioxide, hypromellose, lactose monohydrate, macrogol, magnesium stearate, methacrylic acid copolymer dispersion, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 250 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40.
Indications and Usage
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.
