LAMOTRIGINE tablet LAMOTRIGINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

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 aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (PGTC) seizures. - generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset 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 patients treated f

Product summary:

Lamotrigine Tablets Lamotrigine Tablets USP, 25 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "79" and other side is plain and are supplied as follows: NDC 0615-7964-39 in blistercards of 30 tablets Lamotrigine Tablets USP, 50 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "90" and other side is plain. Lamotrigine Tablets USP, 100 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "80"and other side is plain and are supplied as follows: NDC 0615-7975-39 in blistercards of 30 tablets Lamotrigine Tablets USP, 150 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "81" and other side is plain and are supplied as follows: NDC 0615-8150-39 in blistercards of 30 tablets Lamotrigine Tablets USP, 200 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "82" and other side is plain and are supplied as follows: NDC 0615-8267-39 in blistercards of 30 tablets Lamotrigine Tablets USP, 250 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "91"and other side is plain. Lamotrigine Tablets (Chewable, Dispersible) Lamotrigine Tablets (Chewable, Dispersible), 5 mg are white to off-white, round, flat-faced, radial-edged tablets with bisect on one side and plain on other side; one side of the bisect is debossed with "Z" and other side is debossed with "13". Lamotrigine Tablets (Chewable, Dispersible), 25 mg are white to off-white, round, flat-faced, radial-edged tablets debossed with logo of "Z" and "12" on one side and plain on the other side. Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE- LAMOTRIGINE TABLET
LAMOTRIGINE- LAMOTRIGINE TABLET
NCS HealthCare of KY, Inc dba Vangard Labs
----------
AND MEDICATION GUIDE.
MEDICATION GUIDE
Lamotrigine
(la-MOE-tri-jeen)
Tablets, USP
Lamotrigine
(la-MOE-tri-jeen)
Tablets
(Chewable, Dispersible)
Phenylketonurics:
Phenylalanine is a component of aspartame. Each lamotrigine tablet
(chewable, dispersible), 5 mg and 25
mg contains 0.7 mg of phenylalanine.
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 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, but is more likely to
happen within the first 2 to 8 weeks of
treatment. Children and teenagers aged between 2 and 17 years have a
higher chance of getting this
serious skin rash while taking lamotrigine.
The risk of getting a serious skin 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.
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.
2. Other serious reactions, including serious blood problems or liver
problems.
Lamotrigine 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 any of these symptoms:
•
fever
•
frequent infections
•
severe mu

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET
LAMOTRIGINE- LAMOTRIGINE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS AND
LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE) SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION
FOR LAMOTRIGINE TABLETS AND LAMOTRIGINE TABLETS (CHEWABLE,
DISPERSIBLE).
LAMOTRIGINE TABLETS, FOR ORAL USE
LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE), 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 AND 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
INC LUDE :
• COADMINISTRATION WITH VALPROATE.
• EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE.
• EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE. (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
Boxed Warning 5/2015
Indications and Usage, Bipolar Disorder (1.2) 5/2015
Warnings and Precautions, Serious Skin Rashes (5.1) 5/2015
Warnings and Precautions, Laboratory Tests (5.13) 3/2015
INDICATIONS AND USAGE
Lamotrigine is indicated for:
EPILEPSY—ADJUNCTIVE THERAPY IN PATIENTS AGED 2 YEARS AND OLDER
Partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome. (1.1)
EPILEPSY—MONOTHERAPY IN PATIENTS AGED 16 YEARS AND OLDER
Conversion to monotherapy in patients with partial-onset seizures who
are receiving treatment with carbamazepine,
phenytoin, phenobarbital, primidone, or valproate as the single AED.
(1.