LAMOTRIGINE tablet, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Wockhardt Limited

INN (Международно Name):

LAMOTRIGINE

Композиция:

LAMOTRIGINE 25 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Lamotrigine extended-release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. Safety and effectiveness of lamotrigine extended-release tablets for use in patients less than 13 years of age have not been established. Lamotrigine extended-release tablet is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning, Warnings and Precautions (5.1, 5.2)]. As with other AEDs, physiological changes during pregnancy may affect lamotrigine concentrations and/or therapeutic effect. There have been reports of decreased lamotrigine concentrations during pregnancy and restoration of pre-partum concentrations after delivery. Dosage adjustments may be necessary to maintain clinical response. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. In animal stud

Каталог на резюме:

Lamotrigine extended-release tablets 25 mg are available as yellow, enteric-coated, circular shaped tablets, debossed with "W" on one side and "271" on the other side. NDC 64679-271-01, bottle of 30 tablets NDC 64679-271-02, bottle of 500 tablets NDC 64679-271-04, unit dose of 100 tablets 50 mg are available as pink, enteric-coated, circular shaped tablets, debossed with "W" on one side and "274" on the other side. NDC 64679-274-01, bottle of 30 tablets NDC 64679-274-02, bottle of 500 tablets NDC 64679-274-03, unit dose of 100 tablets 100 mg are available as light brown, enteric-coated, circular shaped tablets, debossed with "W" on one side and "273" on the other side. NDC 64679-273-01, bottle of 30 tablets NDC 64679-273-02, bottle of 500 tablets NDC 64679-273-04, unit dose of 100 tablets 200 mg are available as pink, enteric-coated, circular shaped tablets, debossed with "W" on one side and "272" on the other side. NDC 64679-272-01, bottle of 30 tablets NDC 64679-272-02, bottle of 500 tablets NDC 64679-272-04, unit dose of 100 tablets 300 mg are available as pink, enteric-coated, circular shaped tablets, debossed with "W" on one side and "275" on the other side. NDC 64679-275-01, bottle of 30 tablets NDC 64679-275-02, bottle of 500 tablets NDC 64679-275-04, unit dose of 100 tablets Storage: Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].

Статус Оторизация:

Abbreviated New Drug Application

Листовка

LAMOTRIGINE- LAMOTRIGINE TABLET, EXTENDED RELEASE
Wockhardt Limited
----------
MEDICATION GUIDE
Lamotrigine Extended-Release Tablets
Read this Medication Guide before you start taking lamotrigine
extended-release tablets and each time
you get a refill. There may be new information. This information does
not take the place of talking with
your healthcare provider about your medical condition or treatment. If
you have questions about
lamotrigine extended-release tablets, ask your healthcare provider or
pharmacist.
What is the most important information I should know about lamotrigine
extended-release tablets?
1. Lamotrigine extended-release tablets may cause a serious skin rash
that may cause you to be
hospitalized or to stop lamotrigine extended-release tablets; it may
rarely cause death.
There is no way to tell if a mild rash will develop into a more
serious reaction. These serious skin
reactions are more likely to happen when you begin taking lamotrigine
extended-release tablets, within
the first 2 to 8 weeks of treatment. But it can happen in people who
have taken lamotrigine extended-
release tablets for any period of time. Children between 2 to 16 years
of age have a higher chance of
getting this serious skin reaction while taking lamotrigine.
Lamotrigine extended-release tablet is not
approved for use in children less than 13 years of age.
The risk of getting a rash is higher if you:
•
take lamotrigine extended-release tablets while taking valproate
[DEPAKENE® (valproic acid) or
DEPAKOTE® (divalproex sodium)].
•
take a higher starting dose of lamotrigine extended-release tablets
than your healthcare provider
prescribed.
•
increase your dose of lamotrigine extended-release tablets faster than
prescribed.
Lamotrigine extended-release tablets can also cause other types of
allergic reactions or serious problems
that may affect organs and other parts of your body like the liver or
blood cells. You may or may not have
a rash with these types of reactions.
Call your healthcare provider right away if you hav

Данни за продукта

LAMOTRIGINE- LAMOTRIGINE TABLET, EXTENDED RELEASE
WOCKHARDT LIMITED
----------
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
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 (5.1):
WARNING
SUICIDALITY AND ANTIDEPRESSANT DRUGS
COADMINISTRATION WITH VALPROATE
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE EXTENDED-RELEASE
TABLETS
EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMOTRIGINE EXTENDED-RELEASE
TABLETS.
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
Warnings and Precautions, Multiorgan
Hypersensitivity and Organ Failure (5.2) August 2011
INDICATIONS AND USAGE
Lamotrigine extended-release tablet is an antiepileptic drug (AED)
indicated for:
adjunctive therapy for partial onset seizures with or without
secondary generalization in patients ≥13 years of age. (1.1)
Limitation of use: Safety and effectiveness in patients less than 13
years of age 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 requires slow titration dependent on
concomitant AEDs; the prescriber must refer to the
appropriate algorithm in Dosage and Administration (2.2)
● Ad