LAMOTRIGINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TYA Pharmaceuticals

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 100 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 year

Product summary:

NDC:64725-0112-1 in a BOTTLE of 100 TABLETS

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE- LAMOTRIGINE TABLET
TYA Pharmaceuticals
----------
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 aboutLamotrigine
tablets?
1. Lamotrigine tabletsmay 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 hav

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET
TYA PHARMACEUTICALS
----------
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
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 ( ) JULY 2011 5.2
WARNINGS AND PRECAUTIONS, ASEPTIC MENINGITIS ( ) OCTOBER 2010 5.6
INDICATIONS AND USAGE
Lamotrigine tablets is an antiepileptic drug (AED) indicated for:
— ( ) EPILEPSYADJUNCTIVE THERAPY IN PATIENTS ≥2 YEARS OF AGE:1.1
partial seizures
primary generalized tonic-clonic seizures
generalized seizures of Lennox-Gastaut syndrome
≥ conversion to monotherapy in patients with partial seizures who
are receiving treatment with carbamazepine,
phenobarbital, phenytoin, primidone, or valproate as the single AED. (
) EPILEPSY—MONOTHERAPY IN PATIENTS16 YEARS OF
AG E :1.1
≥ 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. ( ) BIPOLAR DISORDER IN
PATIENTS18 YEARS OF AGE:1.2
DOSAGE AND AD