LAMOTRIGINE tablet film coated extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Lamotrigine (UNII: U3H27498KS) (Lamotrigine - UNII:U3H27498KS)

Dostupno od:

Wilshire Pharmaceuticals, Inc.

INN (International ime):

Lamotrigine

Sastav:

Lamotrigine 25 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

LAMOTRIGINE- LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE
WILSHIRE PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE EXTENDED-RELEASE
TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR LAMOTRIGINE EXTENDED-
RELEASE TABLETS, USP.
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
INC LUDE :
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)
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 adjunctive therapy and conversion to monotherapy
requires slow titration dependent on concomitant
AEDs; th