LAMOTRIGINE tablet extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 100 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET, EXTENDED RELEASE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE EXTENDED-RELEASE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE
EXTENDED-RELEASE TABLETS.
LAMOTRIGINE EXTENDED-RELEASE 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 EXTENDED-RELEASE
TABLETS .
• EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE
EXTENDED-RELEASE 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 EXTENDED-RELEASE
TABLETS SHOULD BE DISCONTINUED AT
THE FIRST SIGN OF RASH, UNLESS THE RASH IS CLEARLY NOT DRUG RELATED.
(5.1)
RECENT MAJOR CHANGES
Dosage and Administration ( 2.1, 2.2) 12/2014
Warnings and Precautions, Laboratory Tests ( 5.13) 3/2015
INDICATIONS AND USAGE
Lamotrigine extended-release tablets are indicated for:
Adjunctive therapy for primary generalized tonic-clonic seizures and
partial-onset seizures with or without secondary
generalization in patients aged 13 years and older. (1.1)
Conversion to monotherapy in patients aged 13 years and older with
partial-onset seizures who are receiving treatment
with a single AED. (1.2)
Limitation of use: Safety and effectiveness in patients younger than
13 years have not been established. (1.3)
DOSAGE AND ADMINISTRATION
Do not exceed the recommended initial dosage and subsequent dose
escalation. ( 2.1)
Initiation of adjun