LAMOTRIGINE- lamotrigine tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Preferred Pharmaceuticals, Inc.

INN (Международно Name):

LAMOTRIGINE

Композиция:

LAMOTRIGINE 150 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Adjunctive Therapy Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: 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, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (14.1)]. Limitation of Use

Каталог на резюме:

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. Bottles of 30 tablets with Child Resistant Closure, NDC 68788-9526-3 Bottles of 60 tablets with Child Resistant Closure, NDC 68788-9526-6 Store at 20o C- 25o C (68o F - 77o F); excursions permitted to 15o C - 30o C (59o F- 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

LAMOTRIGINE- LAMOTRIGINE TABLET
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Lamotrigine tablets, USP
(la-MOE-tri-jeen)
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 part of your eyes
3. L

Данни за продукта

LAMOTRIGINE- LAMOTRIGINE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS.
LAMOTRIGINE TABLETS, FOR ORAL USE
RX ONLY
INITIAL U.S. APPROVAL: 1994
WARNING: SERIOUS SKIN RASHES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
Lamotrigine is indicated for:
Epilepsy—adjunctive therapy in patients aged 2 years and older:
•
•
•
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:
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: TREATMENT OF ACUTE MANIC OR MIXED EPISODES IS NOT
RECOMMENDED. EFFECTIVENESS OF
LAMOTRIGINE IN THE ACUTE TREATMENT OF MOOD EPISODES HAS NOT BEEN
ESTABLISHED.
DOSAGE AND ADMINISTRATION
•
•
•
•
•
Epile psy:
•
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)
partial-onset seizures.
primary generalized tonic-clonic seizures.
general