LAMOTRIGINE tablet, chewable

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Rising Pharmaceuticals, Inc.

INN (Международно Name):

LAMOTRIGINE

Композиция:

LAMOTRIGINE 5 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Adjunctive Therapy Lamotrigine tablets for oral suspension 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 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 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 for oral suspension are indicated for the maintenance treatment of bipolar I disorder to

Каталог на резюме:

Lamotrigine Tablets for Oral Suspension USP, 5 mg are white to off-white, capsule shaped, flat faced, beveled edge uncoated tablets debossed with “D” on one side and “98” on the other side.                Bottles of 100                                       NDC 64980-400-01 Lamotrigine Tablets for Oral Suspension USP, 25 mg are white to off-white, circular, flat faced, beveled edge uncoated tablets debossed with “D99” on one side and plain another side.                 Bottles of 100                                       NDC 64980-401-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep in a dry place.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

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

Данни за продукта

LAMOTRIGINE - LAMOTRIGINE TABLET, CHEWABLE
RISING PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS FOR ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR LAMOTRIGINE TABLETS FOR ORAL
SUSPENSION.
LAMOTRIGINE TABLETS FOR ORAL SUSPENSION
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
Warnings and Precautions, Cardiac Rhythm and Conduction
Abnormalities (5.4) 10/2020
INDICATIONS AND USAGE
Lamotrigine tablets for oral suspension 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 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: Treatmen