LAMOTRIGINE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Hikma Pharmaceuticals USA Inc.

INN (International namn):

LAMOTRIGINE

Sammansättning:

LAMOTRIGINE 25 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Adjunctive Therapy: Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients ≥2 years of age: - partial seizures - primary generalized tonic-clonic (PGTC) seizures - generalized seizures of Lennox-Gastaut syndrome Monotherapy: Lamotrigine is 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 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 (≥18 years of age) treated for acute

Produktsammanfattning:

Lamotrigine Tablets, USP 25 mg, white, scored, round tablets debossed with W67 on one side, bottles of 100 and 1000. 100 mg, peach, scored, round tablets debossed with WW966 on one side, bottles of 100 and 1000. 150 mg, cream, scored, round tablets debossed with WW965 on one side, bottles of 60 and 1000. 200 mg, blue, scored, round tablets debossed with WW964 on one side, bottles of 60 and 1000. Store at 20º - 25°C (68º - 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

LAMOTRIGINE- LAMOTRIGINE TABLET
West-ward Pharmaceutical Corp
----------
MEDICATION GUIDE
Lamotrigine Tablets
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
1. Lamotrigine may cause a serious skin rash that may cause you to be
hospitalized or to stop lamotrigine;
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,
within the first 2 to 8 weeks of
treatment. But it can happen in people who have taken lamotrigine 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.
The risk of getting a 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.
Lamotrigine can also cause other types of allergic reactions or
serious problems which 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 have any of the
following:
•
a skin rash
•
hives
•
fever
•
swollen lymph glands
•
painful sores in the mouth or around your eyes
•
swelling of your lips or tongue
•
yellowing of your skin or eyes
•
unusual bruising or bleeding
•
severe fatigue or weakness
•
severe muscle pain
•
frequent infections
These symptoms may be the first signs of a serious reaction. A
healthcare provider s

Produktens egenskaper

LAMOTRIGINE- LAMOTRIGINE TABLET
WEST-WARD PHARMACEUTICAL CORP
----------
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
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
EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMOTRIGINE
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
Warnings and Precautions, Multiorgan Hypersensitivity July 2011
Reactions and Organ Failure (5.2)
Warnings and Precautions, Aseptic Meningitis (5.6) October 2010
INDICATIONS AND USAGE
Lamotrigine is an antiepileptic drug (AED) indicated for: (1)
EPILEPSY—ADJUNCTIVE THERAPY IN PATIENTS ≥2 YEARS OF AGE: (1.1) (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) (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) (1)
DOSAGE AND ADMINISTRATION
Dosing is