LAMOTRIGINE tablet, orally disintegrating

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

ScieGen Pharmaceuticals, Inc.

INN:

Lamotrigine

composition:

Lamotrigine 25 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

Lamotrigine Orally Disintegrating Tablets, USP 25 mg, white to off-white, round, flat-faced, radius edge tablets, debossed with SG 319 on one side and plain on the other supplied in bottles of 30 (NDC 50228-319-30) and 100 (NDC 50228-319-01). 50 mg, white to off-white, round, flat-faced, radius edge tablets, debossed with SG 320 on one side and plain on the other supplied in bottles of 30 (NDC 50228-320-30) and 100 (NDC 50228-320-01). 100 mg, white to off-white, round, flat-faced, radius edge tablets, debossed with SG 321 on one side and plain on the other supplied in bottles of 30 (NDC 50228-321-30) and 100 (NDC 50228-321-01). 200 mg, white to off-white, round, flat-faced, radius edge tablets, debossed with SG 322 on one side and plain on the other supplied in bottles of 30 (NDC 50228-322-30) and 100 (NDC 50228-322-01). Store at 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature].

authorization_status:

Abbreviated New Drug Application

PIL

LAMOTRIGINE- LAMOTRIGINE TABLET, ORALLY DISINTEGRATING
ScieGen Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Lamotrigine (la moe' tri jeen) orally disintegrating tablets, USP
What is the most important information I should know about lamotrigine
orally disintegrating tablets?
1. Lamotrigine orally disintegrating 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 orally disintegrating 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 orally
disintegrating tablets.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine orally disintegrating tablets while taking valproate
[DEPAKENE (valproic acid) or
DEPAKOTE (divalproex sodium)].
•
take a higher starting dose of lamotrigine orally disintegrating
tablets than your healthcare provider
prescribed.
•
increase your dose of lamotrigine orally disintegrating 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 orally
disintegrating tablets.
2. Other serious reactions, including serious blood problems or liver
problems. Lamotrigine orally
disintegrating 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

SPC

LAMOTRIGINE- LAMOTRIGINE TABLET, ORALLY DISINTEGRATING
SCIEGEN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LAMOTRIGINE ORALLY DISINTEGRATING TABLETS.
LAMOTRIGINE ORALLY DISINTEGRATING 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 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.
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
Warnings and Precautions, Cardiac Rhythm and Conduction Abnormalities
( 5.4)
3/2021
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 antiepileptic drug. ( 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 therapy. ( 1.2)
Limitations of Use: Tre