Lamotrigine ER

50mg

Product Details

Product Name:
Lamotrigine ER
Strength:
50mg
Count:
30
NDC:
42291-444-30
Class:
Rx
Brand Name(s):
LaMICtal
Imprint Code:
A;956
Color(s):
GREEN
Shape:
ROUND
Score:
no score
Case Count:
Inactive Ingredients:
colloidal silicon dioxide, hypromellose, lactose monohydrate, macrogol, magnesium stearate, methacrylic acid copolymer dispersion, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 50 mg tablets also contain FD&C Blue No. 2 and iron oxide yellow.
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.

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