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: Lamotrigine tablets are 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 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

Product summary:

Lamotrigine tablets are supplied as follows: 25 mg – white to off-white, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “39” on the other side of the tablet. They are available in 100 mg – peach, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “463” on the other side of the tablet. They are available in 150 mg – cream, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “7247” on the other side of the tablet. They are available in 200 mg – blue, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “7248” on the other side of the tablet. They are available in Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place and protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE - LAMOTRIGINE TABLET
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
LAMOTRIGINE ( la MOE tri jeen) TABLETS
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 to stop
lamotrigine tablets; 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
tablets, within the first 2 to 8
weeks of treatment. But it can happen in people who have taken
lamotrigine tablets 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 tablets.
The risk of getting a rash is higher if you:
•
take lamotrigine tablets while taking valproate [DEPAKENE® (valproic
acid) or DEPAKOTE®
(divalproex sodium)].
•
take a higher starting dose of lamotrigine tablets than your
healthcare provider prescribed.
•
increase your dose of lamotrigine tablets faster than prescribed.
Lamotrigine tablets 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 mu

Summary of Product characteristics

LAMOTRIGINE - LAMOTRIGINE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS.
LAMOTRIGINE TABLETS 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, 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 TABLETS
EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMOTRIGINE TABLETS
BENIGN RASHES ARE ALSO CAUSED BY LAMOTRIGINE TABLETS; HOWEVER, IT IS
NOT POSSIBLE TO PREDICT WHICH RASHES
WILL PROVE TO BE SERIOUS OR LIFE-THREATENING. LAMOTRIGINE TABLETS
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
August 2011
Organ Failure (5.2)
INDICATIONS AND USAGE
Lamotrigine tablets are 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