LAMOTRIGINE tablet, chewable

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Taro Pharmaceuticals U.S.A., Inc.

INN (Internationale Bezeichnung):

Lamotrigine

Zusammensetzung:

Lamotrigine 5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Adjunctive Therapy: Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (PGTC) seizures. - generalized seizures of Lennox-Gastaut syndrome. Monotherapy: Lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine 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 is 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 (aged 1

Produktbesonderheiten:

Lamotrigine Tablets (Chewable, Dispersible), 5 mg: White, oval tablets, engraved with "L5" on one side and "T" on the other side. Lamotrigine Tablets (Chewable, Dispersible), 25 mg: White, round tablets, engraved with "L25" on one side and "T" on the other side. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] in a dry place.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

LAMOTRIGINE- lamotrigine tablet, chewable
Taro Pharmaceuticals U.S.A., Inc.
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MEDICATION GUIDE
Lamotrigine
(la moe' tri jeen) Tablets
(Chewable, Dispersible)
Read this Medication Guide before you start taking lamotrigine 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, ask your healthcare provider or
pharmacist.
What is the most important information I should know about lamotrigine
tablets (chewable, dispersible)?
1. Lamotrigine tablets (chewable, dispersible) may cause a serious
skin rash that may cause you to be
hospitalized or even cause death.
There is no way to tell if a mild rash will become more serious. A
serious skin rash can happen at any time
during your treatment with lamotrigine, but is more likely to happen
within the first 2 to 8 weeks of
treatment. Children aged between 2 and 16 years have a higher chance
of getting this serious skin rash while
taking lamotrigine.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine while taking valproate [DEPAKENE® (valproic acid) or
DEPAKOTE® (divalproex
sodium)].
•
take a higher starting dose of lamotrigine than your healthcare
provider prescribed.
•
increase your dose of lamotrigine faster than prescribed.
Call your healthcare provider right away if you have any of the
following:
•
a skin rash
•
blistering or peeling of your skin
•
hives
•
painful sores in your mouth or around your eyes
These symptoms may be the first signs of a serious skin reaction. A
healthcare provider should examine you
to decide if you should continue taking lamotrigine.
2. Other serious reactions, including serious blood problems or liver
problems. Lamotrigine can also cause
other types of allergic reactions or serious problems that may affect
organs and other parts of your body like
your liver or blood cells. You may or may not have a rash with these
types of re

Fachinformation

LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE
TARO PHARMACEUTICALS U.S.A., INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE.
LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE), 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.
EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE. (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
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, 2.4)
12/2014
Warnings and Precautions, Laboratory Tests (5.14)
3/2015
INDICATIONS AND USAGE
Lamotrigine is indicated for:
Epilepsy—adjunctive therapy in patients aged 2 years and older:
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)
Bipolar disorder in patients aged 18 years and older:
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
Dosing is based on conc