LAMOTRIGINE - lamotrigine tablet LAMOTRIGINE- lamotrigine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Corporation dba SKY Packaging

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 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 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, hypoman

Product summary:

Product: 63739-516 NDC: 63739-516-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-517 NDC: 63739-517-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE - LAMOTRIGINE TABLET
LAMOTRIGINE- LAMOTRIGINE TABLET
McKesson Corporation dba SKY Packaging
----------
MEDICATION GUIDE
Lamotrigine
(lam-OH-try-jeen)
Tablets USP
Rx only
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 and teenagers aged between 2 and 17 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
healthcare provider right away if you have any of these symptoms:
· fever
· frequent infections
· severe muscle pain
· swelling of your face, eyes, lips, or tongue
· swollen lymph glands
· unusual bruising or bleeding
· weakness, fatigue
· yellowing of your skin or the white

Summary of Product characteristics

LAMOTRIGINE - LAMOTRIGINE TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
----------
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, 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 INCLUDE:
COADMINISTRATION WITH VALPROATE.
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE TABLETS.
EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMOTRIGINE TABLETS.(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 TABLETS 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: (1)
Epilepsy - adjunctive therapy in patients aged 2 years and older: (1)
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) (1)
Bipolar disorder : Maintenance treatment of bipolar I disorder to
delay the time to occurrence of mood episodes in
patients treated for acute mood episodes with standard therap