LAMICTAL- lamotrigine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adjunctive Therapy: LAMICTAL is 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: LAMICTAL 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 LAMICTAL 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. LAMICTAL 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 mood episodes with

Product summary:

LAMICTAL (lamotrigine) Tablets 25 mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25”, Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] in a dry place. 100 mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100”, 200 mg, blue, scored, shield-shaped tablets debossed with “LAMICTAL” and “200”, Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

Authorization status:

New Drug Application

Patient Information leaflet

LAMICTAL - LAMOTRIGINE TABLET
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
LAMICTAL® (la-MIK-tal)
(lamotrigine)
Tablets and Chewable Dispersible Tablets
LAMICTAL® ODT™
(lamotrigine)
Orally Disintegrating Tablets
Read this Medication Guide before you start taking LAMICTAL 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 LAMICTAL, ask your
healthcare provider or pharmacist.
What is the most important information I should know about LAMICTAL?
1. LAMICTAL 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 LAMICTAL, 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 LAMICTAL.
The risk of getting a serious skin rash is higher if you:
•
take LAMICTAL while taking valproate [DEPAKENE® (valproic acid) or
DEPAKOTE®
(divalproex sodium)]
•
take a higher starting dose of LAMICTAL than your healthcare provider
prescribed
•
increase your dose of LAMICTAL 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 LAMICTAL.
2. Other serious reactions, including serious blood problems or liver
problems. LAMICTAL 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

Summary of Product characteristics

LAMICTAL - LAMOTRIGINE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMICTAL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LAMICTAL.
LAMICTAL (LAMOTRIGINE) TABLETS
LAMICTAL (LAMOTRIGINE) CHEWABLE DISPERSIBLE TABLETS
LAMICTAL ODT (LAMOTRIGINE) ORALLY DISINTEGRATING 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 LAMICTAL.
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 LAMICTAL
EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMICTAL
BENIGN RASHES ARE ALSO CAUSED BY LAMICTAL; HOWEVER, IT IS NOT POSSIBLE
TO PREDICT WHICH RASHES WILL
PROVE TO BE SERIOUS OR LIFE THREATENING. LAMICTAL 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
LAMICTAL 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)
DOSAG