LAMOTRIGINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)

Available from:

NorthStar RxLLC

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LAMOTRIGINE - LAMOTRIGINE TABLET
NORTHSTAR RXLLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS.
LAMOTRIGINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
WARNING: SERIOUS SKIN RASHES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CASES OF LIFE-THREATENING SERIOUS RASHES, INCLUDING STEVENS-JOHNSON
SYNDROME AND TOXIC EPIDERMAL
NECROLYSIS, AND/OR RASH-RELATED DEATH, HAVE BEEN CAUSED BY
LAMOTRIGINE. THE RATE OF SERIOUS RASH IS
GREATER IN PEDIATRIC PATIENTS THAN IN ADULTS. ADDITIONAL FACTORS THAT
MAY INCREASE THE RISK OF RASH INCLUDE:
COADMINISTRATION WITH VALPROATE.
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE TABLETS.
EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMOTRIGINE TABLETS.(5.1)
BENIGN RASHES ARE ALSO CAUSED BY LAMOTRIGINE; HOWEVER, IT IS NOT
POSSIBLE TO PREDICT WHICH RASHES WILL
PROVE TO BE SERIOUS OR LIFE THREATENING. LAMOTRIGINE TABLETS SHOULD BE
DISCONTINUED AT THE FIRST SIGN OF
RASH, UNLESS THE RASH IS CLEARLY NOT DRUG RELATED. (5.1)
RECENT MAJOR CHANGES
Boxed Warning 5/2015
Indications and Usage, Bipolar Disorder (1.2) 5/2015
Warnings and Precautions, Serious Skin Rashes (5.1) 5/2015
Warnings and Precautions, Laboratory Tests (5.13) 3/2015
INDICATIONS AND USAGE
Lamotrigine is indicated for: (1)
Epilepsy - adjunctive therapy in patients aged 2 years and older: (1)
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) (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)
LI