LAMOTRIGINE- lamotrigine tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Glenmark Pharmaceuticals Inc., USA

INN (International ime):

LAMOTRIGINE

Sastav:

LAMOTRIGINE 25 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: 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 adults (aged 18 years and older) treated for acute mood episodes with standard therapy [see Clinical Studies (14.1)] . Limitations of Use Treatment of acute manic or mixed episod

Proizvod sažetak:

Lamotrigine Tablets USP, 25 mg White to off-white, circular, flat faced beveled edged, uncoated tablets with score line on one side and “243” debossed on the other side. Bottles of 30 (NDC 68462-243-30) Bottles of 100 (NDC 68462-243-01) Bottles of 1000 (NDC 68462-243-10) 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] in a dry place. Lamotrigine Tablets USP, 100 mg Light peach to peach colored, circular, flat faced beveled edged, uncoated tablets with score line on one side and “244” debossed on the other side. Bottles of 30 (NDC 68462-244-30) Bottles of 100 (NDC 68462-244-01) Bottles of 1000 (NDC 68462-244-10) Lamotrigine Tablets USP, 150 mg Light yellow to yellow colored, circular, flat faced beveled edged, uncoated tablets with score line on one side and “245” debossed on the other side. Bottles of 30 (NDC 68462-245-30) Bottles of 60 (NDC 68462-245-60) Bottles of 1000 (NDC 68462-245-10) Lamotrigine Tablets USP, 200 mg Light blue to blue colored, circular, flat faced beveled edged, uncoated tablets with score line on one side and “246” debossed on the other side. Bottles of 30 (NDC 68462-246-30) Bottles of 60 (NDC 68462-246-60) Bottles of 1000 (NDC 68462-246-10) 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] in a dry place and protect from light.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

LAMOTRIGINE- LAMOTRIGINE TABLET
Glenmark Pharmaceuticals Inc., USA
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MEDICATION GUIDE
Lamotrigine Tablets USP
(la moe' tri jeen)
Read this Medication Guide before you start taking lamotrigine and
each time you get a refill. There may
be new information. This information does not take the place of
talking with your healthcare provider
about your medical condition or treatment. If you have questions about
lamotrigine, ask your healthcare
provider or pharmacist.
What is the most important information I should know about
lamotrigine?
1. Lamotrigine 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, but is more likely to
happen within the first 2 to 8 weeks of
treatment. Children aged between 2 and 16 years have a higher chance
of getting this serious skin rash
while taking lamotrigine.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine while taking valproate [DEPAKENE ® (valproic acid)
or DEPAKOTE ®
(divalproex sodium)].
•
take a higher starting dose of lamotrigine than your healthcare
provider prescribed
•
increase your dose of lamotrigine 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 the 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.
2. Other serious reactions, including serious blood problems or liver
problems. Lamotrigine 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:
•
feve

Svojstava lijeka

LAMOTRIGINE- LAMOTRIGINE TABLET
GLENMARK PHARMACEUTICALS INC., USA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LAMOTRIGINE.
LAMOTRIGINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
WARNING: SERIOUS SKIN RASHES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
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 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-THREATEN