LAMOTRIGINE- lamotrigine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

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 aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (PGTC) seizures. - generalized seizures of Lennox-Gastaut syndrome.       Monotherapy: Lamotrigine tablets are 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 tablets are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, ma

Product summary:

Lamotrigine Tablets USP, 25 mg Round, white to off white tablets, debossed with ‘J’ and ‘245’ on one side and scoreline on the other side. NDC 50268-461-15   10 tablets per card, 5 cards per carton. Lamotrigine Tablets USP, 100 mg Round, white to off white tablets, debossed with ‘J’ and ‘246’ on one side and scoreline on the other side. NDC 50268-462-15   10 tablets per card, 5 cards per carton. Lamotrigine Tablets USP, 150 mg Round, white to off white tablets, debossed with ‘J’ and ‘247’ on one side and scoreline on the other side. NDC 50268-463-15   10 tablets per card, 5 cards per carton. Lamotrigine Tablets USP, 200 mg Round, white to off white tablets, debossed with ‘J’ and ‘248’ on one side and scoreline on the other side. NDC 50268-464-15   10 tablets per card, 5 cards per carton. Dispensed in blister punch material. For Institutional Use Only. Store at 20 o C - 25 o C (68 o F - 77 o F); excursions permitted to 15 o C - 30 o C (59 o F - 86°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
AvPAK
----------
MEDICATION GUIDE
Lamotrigine Tablets, USP
(la-MOE-tri-jeen)
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 about Lamotrigine
Tablets?
1. Lamotrigine Tablets 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 Tablets, but is more
likely to happen within the first 2 to 8
weeks of treatment. Children aged between 2 and 16 years 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 [*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.
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 hea

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET
AVPAK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
LAMOTRIGINE TABLETS, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE.
LAMOTRIGINE TABLETS USP, FOR ORAL USE
RX ONLY
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
Dosage and Administration ( 2.1, 2.2, 2.4) 12/2014
INDICATIONS AND USAGE
LAMOTRIGINE is an antiepileptic drug (AED) 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. ( 1.1)
BIPOLAR DISORDER IN PATIENTS AGED 18 YEARS AND OLDER: 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 p