LAMOTRIGINE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (الاسم الدولي):

LAMOTRIGINE

تركيب:

LAMOTRIGINE 25 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Adjunctive Therapy: Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age: - partial seizures - primary generalized tonic-clonic seizures - generalized seizures of Lennox-Gastaut syndrome Monotherapy: Lamotrigine tablets are indicated for conversion to monotherapy in adults (≥ 16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. Lamotrigine tablets are indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (≥ 18

ملخص المنتج:

Lamotrigine tablets are supplied as follows: 25 mg – white to off-white, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “39” on the other side of the tablet. They are available in blisterpacks of 30 and 31. 100 mg – peach, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “463” on the other side of the tablet. They are available in blisterpacks of 30 and 31. 150 mg – cream, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “7247” on the other side of the tablet. They are available in blisterpacks of 30. 200 mg – blue, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “7248” on the other side of the tablet. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place and protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

LAMOTRIGINE- LAMOTRIGINE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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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, 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
(5.1):
COADMINISTRATION WITH VALPROATE
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE TABLETS
EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMOTRIGINE TABLETS
BENIGN RASHES ARE ALSO CAUSED BY LAMOTRIGINE TABLETS; 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
Warnings and Precautions, Multiorgan Hypersensitivity Reactions and
Organ Failure (5.2) August 2011
INDICATIONS AND USAGE
Lamotrigine tablets are an antiepileptic drug (AED) indicated for:
EPILEPSY—ADJUNCTIVE THERAPY IN PATIENTS ≥ 2 YEARS OF AGE: (1.1)
partial seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome.
EPILEPSY—MONOTHERAPY IN PATIENTS ≥ 16 YEARS OF AGE: conversion to
monotherapy in patients with partial seizures
who are receiving treatment with carbamazepine, phenobarbital,
phenytoin, primidone, or valproate as the single AED.
(1.1)
BIPOLAR DISORDER IN PATIENTS ≥18 YEARS OF AGE: 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)
DOSAGE AND ADMINISTRATION
Dos