LAMOTRIGINE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Proficient Rx LP

INN (Internationale Bezeichnung):

LAMOTRIGINE

Zusammensetzung:

LAMOTRIGINE 25 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Adjunctive Therapy: Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age: 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 years of age) treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine tablets in the

Produktbesonderheiten:

Lamotrigine Tablets USP, 25 mg White, caplet shaped, biconvex tablets with ‘U’ debossed on either side of break line on one side and ‘111’ debossed on other side. Bottles of 30:          NDC 63187-487-30 Bottles of 60:          NDC 63187-487-60 Bottles of 90:        NDC 63187-487-90 Bottles of 120:        NDC 63187-487-72 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] in a dry place. Dispense in tight, light-resistant container as defined in the USP.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

LAMOTRIGINE- LAMOTRIGINE TABLET
Proficient Rx LP
----------
MEDICATION GUIDE
LAMOTRIGINE TABLETS USP
Rx Only
Read this Medication Guide before you start taking lamotrigine 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 tablets, ask your
healthcare provider or pharmacist.
What is the most important information I should know about Lamotrigine
tablets?
1. Lamotrigine tablets 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 tablets, but is more likely to
happen within the first 2 to 8 weeks of
treatment. Children between 2 to 16 years of age have a higher chance
of getting this serious skin rash while
taking lamotrigine tablets.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine tablets while taking valproate (valproic acid or
divalproex sodium)
•
take a higher starting dose of lamotrigine tablets than your
healthcare provider prescribed
•
increase your dose of lamotrigine tablets 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 tablets.
2. Other serious reactions, including serious blood problems or liver
problems.
Lamotrigine tablets 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 reactions. Call your healthcare provider right away if
you have

Fachinformation

LAMOTRIGINE- LAMOTRIGINE TABLET
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LAMOTRIGINE TABLETS USP.
LAMOTRIGINE TABLETS USP
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 ):
•
•
•
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 REACTIONS AND
ORGAN FAILURE (5.2) JULY 2011
WARNINGS AND PRECAUTIONS, ASEPTIC MENINGITIS (5.6) OCTOBER 2010
INDICATIONS AND USAGE
Lamotrigine tablets is an antiepileptic drug (AED) indicated for:
EPILEPSY—ADJUNCTIVE THERAPY IN PATIENTS ≥2 YEARS OF AGE: ( 1.1 )
•
•
•
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
•
•
•
•
•
EPILEPSY
•
•
BIPOLAR DISORDER: See Tables 5 and 6 ( 2.4 )
DOSAGE FORMS AND STRENGTHS
TABLETS: 25 mg, 100 mg, 150 mg, and 200 mg scored. ( 3.1 , 16 )
CONTRAINDICATIONS
Hypersensitivity to t