LAMOTRIGINE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Preferred Pharmaceuticals, Inc

INN (International namn):

LAMOTRIGINE

Sammansättning:

LAMOTRIGINE 200 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 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, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (14.1)].          Limit

Produktsammanfattning:

Lamotrigine Tablets, USP 200 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C152" debossed on one side and central breakline on the other side, supplied in; bottles of 30 (NDC 68788-6822-3) bottles of 60 (NDC 68788-6822-6) bottles of 90 (NDC 68788-6822-9) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

LAMOTRIGINE- LAMOTRIGINE TABLET
Preferred Pharmaceuticals, Inc
----------
MEDICATION GUIDE
Lamotrigine Tablets, USP
(la moe'tri jeen)
What is the most important information I should know about lamotrigine
tablets, USP?
1. Lamotrigine tablets, USP 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, USP but is more likely
to happen within the first 2 to 8 weeks
of treatment. Children and teenagers between 2 and 17 years have a
higher chance of getting this serious skin
rash while taking lamotrigine tablets, USP.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine tablets, USP while taking valproate [DEPAKENE ®
(valproic acid) or DEPAKOTE ®
(divalproex sodium)].
•
take a higher starting dose of lamotrigine tablets, USP than your
healthcare provider prescribed
•
increase your dose of lamotrigine tablets, USP 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, USP.
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:
•
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

Produktens egenskaper

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
INITIAL U.S. APPROVAL:1994
WARNING: SERIOUS SKIN RASHES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Hemophagocytic 9/2019
Lymphohistiocytosis (5.2)
INDICATIONS AND USAGE
Lamotrigine tablets, USP are 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
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: 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
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•
•
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•
Epile psy
•
•
CASES OF LIFE-THREATENING SERIOUS RASHES, INCLUDING STEVENS-JOHNSON
SYNDROME, 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 OF 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 RA