LAMOTRIGINE- lamotrigine tablet, chewable

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Teva Pharmaceuticals USA, Inc.

INN (Rahvusvaheline Nimetus):

LAMOTRIGINE

Koostis:

LAMOTRIGINE 5 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Adjunctive Therapy Lamotrigine tablets for oral suspension (chewable dispersible 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 for oral suspension (chewable dispersible 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 for oral suspension (chewable dispersible 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. Lamotrigi

Toote kokkuvõte:

Lamotrigine tablets for oral suspension USP (chewable dispersible tablets) are supplied as follows: 5 mg – white to off-white, round tablets debossed “93” on one side and “688” on the other. They are available in bottles of 100 (NDC 0093-0688-01). 25 mg – white to off-white, oval-shaped tablets debossed “93” on one side and “132” on the other. They are available in bottles of 100 (NDC 0093-0132-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place and protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE
Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
LAMOTRIGINE (la MOE tri jeen) TABLETS FOR ORAL SUSPENSION USP
(CHEWABLE
DISPERSIBLE TABLETS)
What is the most important information I should know about lamotrigine
tablets for oral suspension
(chewable dispersible tablets)?
1.
Lamotrigine tablets for oral suspension (chewable dispersible 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 for oral
suspension (chewable dispersible 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 for
oral suspension (chewable dispersible tablets).
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine tablets for oral suspension (chewable dispersible
tablets) while taking valproate
[DEPAKENE® (valproic acid) or DEPAKOTE® (divalproex sodium)].
•
take a higher starting dose of lamotrigine tablets for oral suspension
(chewable dispersible tablets)
than your healthcare provider prescribed.
•
increase your dose of lamotrigine tablets for oral suspension
(chewable dispersible 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 for
oral suspension (chewable dispersible
tablets).
2. Other serious reactions, including serious blood problems or liver
problems. Lamotrigine tablets for
oral suspension (chewable dispersible tablets) can also cause other
types of all

Toote omadused

LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS FOR ORAL
SUSPENSION (CHEWABLE DISPERSIBLE TABLETS) SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION
FOR LAMOTRIGINE TABLETS FOR ORAL SUSPENSION (CHEWABLE DISPERSIBLE
TABLETS).
LAMOTRIGINE TABLETS FOR ORAL SUSPENSION (CHEWABLE DISPERSIBLE 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
INC LUDE :
● COADMINISTRATION WITH VALPROATE
● EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE TABLETS FOR ORAL
SUSPENSION (CHEWABLE
DISPERSIBLE TABLETS)
● EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE TABLETS FOR
ORAL SUSPENSION (CHEWABLE
DISPERSIBLE TABLETS) (5.1)
BENIGN RASHES ARE ALSO CAUSED BY LAMOTRIGINE TABLETS FOR ORAL
SUSPENSION (CHEWABLE DISPERSIBLE
TABLETS); HOWEVER, IT IS NOT POSSIBLE TO PREDICT WHICH RASHES WILL
PROVE TO BE SERIOUS OR LIFE THREATENING.
LAMOTRIGINE TABLETS FOR ORAL SUSPENSION (CHEWABLE DISPERSIBLE 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 tablets for oral suspension (chewable dispersible
tablets)are 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 synd