LAMOTRIGINE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Lupin Pharmaceuticals, Inc.

INN (International namn):

LAMOTRIGINE

Sammansättning:

LAMOTRIGINE 25 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Adjunctive Therapy Lamotrigine tablet is 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 tablet 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 tablet 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 tablet is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed

Produktsammanfattning:

Lamotrigine Tablets  25 mg White to off white, round, flat beveled edge tablets debossed with 'L' and 'U' on either side of break line on one side and 'E31' on the other side. Bottles of 100 NDC 68180-250-01 Bottles of 500 NDC 68180-250-02 100 mg Peach coloured, round, flat beveled edge tablets debossed with 'L' and 'U' on either side of break line on one side and 'E32' on the other side. Bottles of 100 NDC 68180-251-01 Bottles of 500 NDC 68180-251-02 150 mg Yellow coloured, round, flat beveled edge tablets debossed with 'L' and 'U' on either side of the break line on one side and 'E33' on the other side. Bottles of 60   NDC 68180-252-07 Bottles of 500 NDC 68180-252-02 200 mg Blue coloured with mottled surface, round, flat beveled edge tablets debossed with 'L' and 'U' on either side of break line on one side and 'E34' on the other side. Bottles of 60   NDC 68180-253-07 Bottles of 500 NDC 68180-253-02 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

LAMOTRIGINE- LAMOTRIGINE TABLET
Lupin Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Lamotrigine Tablets
(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. Like other antie

Produktens egenskaper

LAMOTRIGINE- LAMOTRIGINE TABLET
LUPIN 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
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.
EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE TABLETS (5.1)
BENIGN RASHES ARE ALSO CAUSED BY LAMOTRIGINE TABLETS; HOWEVER, IT IS
NOT POSSIBLE TO PREDICT WHICH
RASHES WILL PROVE TO BE SERIOUS OR LIFE THREATENING. LAMOTRIGINE
TABLETS 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, Hemophagocytic 5/2018
Lymphohistiocytosis (5.2)
INDICATIONS AND USAGE
Lamotrigine tablet is 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 therapy. (1.2)
LIMITATIONS OF USE: TREATMENT OF ACUTE MANIC OR MIXED EPISODES IS NOT
RECOMMENDED. EFFECTIVENESS OF
LAMO