LAMOTRIGINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 mood e

Product summary:

Lamotrigine Tablets USP, 25 mg: Round, white tablets, scored on one side, embossed with "TARO" on one side and on the other side "LMT" above score and "25" below the score. Lamotrigine Tablets USP, 100 mg: Round, light peach, scored tablets, embossed with "TARO" on one side and on the other side "LMT" above score and 100 below the score. Lamotrigine Tablets USP, 150 mg: Round, cream tablets, scored on one side, embossed with "TARO" on one side and on the other side "LMT" above score and 150 below the score. Lamotrigine Tablets USP, 200 mg: Round, light blue tablets, scored on one side, embossed with "TARO" on one side and on the other side "LMT" above score and 200 below the score. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE - LAMOTRIGINE TABLET
State of Florida DOH Central Pharmacy
----------
MEDICATION GUIDE
Lamotrigine Tablets, USP
(la moe' tri jeen)
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 your 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

Summary of Product characteristics

LAMOTRIGINE - LAMOTRIGINE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
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, 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):
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 Reactions and
Organ Failure (5.2)
August 2011
INDICATIONS AND USAGE
Lamotrigine is an antiepileptic drug (AED) indicated for:
EPILEPSY—ADJUNCTIVE THERAPY IN PATIENTS ≥2 YEARS OF AGE: (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)
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
Dosing is based on concomitant medications, indication, and patient
age.