LAMOTRIGINE tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Lake Erie Medical DBA Quality Care Products LLC

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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, hyp

Обзор продуктов:

Lamotrigine Tablets USP, 25 mg White, caplet shaped, biconvex tablets with 'U' debossed on either side of break line on one side and '111' debossed on other side. Lamotrigine Tablets USP, 100 mg White, trigonal shaped, biconvex tablets with 'U' debossed on either side of break line on one side and '112' debossed on other side. 55700-626-30 Lamotrigine Tablets USP, 150 mg White, trigonal shaped, biconvex tablets with 'U' debossed on either side of break line on one side and '113' debossed on other side. Lamotrigine Tablets USP, 200 mg Light blue, trigonal shaped, biconvex tablets with 'U' debossed on either side of break line on one side and '114' debossed on other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in a dry place. Dispense in tight, light-resistant container as defined in the USP.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

LAMOTRIGINE- LAMOTRIGINE TABLET
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Lamotrigine Tablets, USP
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 (valproic acid or
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. Like other antiepileptic drugs, lamotrigi

Характеристики продукта

LAMOTRIGINE- LAMOTRIGINE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LAMOTRIGINE TABLETS USP.
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.
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
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 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 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