LAMOTRIGINE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Clinical Solutions Wholesale, LLC

DCI (Dénomination commune internationale):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Adjunctive Therapy   Lamotrigine tablets, USP is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: Monotherapy   Lamotrigine tablets, USP 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 tablets, USP 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, USP 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 patients treated for acute mood episodes with standard therapy Lamotrigine tablet

Descriptif du produit:

Lamotrigine Tablets, USP 25 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C148" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-148-02), bottles of 100 (NDC 69097-148-07), bottles of 500 (NDC 69097-148-12), bottles of 1000 (NDC 69097-148-15), and blister cards of 30 (NDC 58118-2148-8). 100 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C149" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-149-02), bottles of 100 (NDC 69097-149-07), bottles of 500 (NDC 69097-149-12) and bottles of 1000 (NDC 69097-149-15). 150 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C151" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-151-02), bottles of 60 (NDC 69097-151-03), bottles of 500 (NDC 69097-151-12) and bottles of 1000 (NDC 69097-151-15). 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 69097-152-02), bottles of 60 (NDC 69097-152-03), bottles of 500 (NDC 69097-152-12) and bottles of 1000 (NDC 69097-152-15). 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.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

LAMOTRIGINE- LAMOTRIGINE TABLET
Clinical Solutions Wholesale, LLC
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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

Résumé des caractéristiques du produit

LAMOTRIGINE- LAMOTRIGINE TABLET
CLINICAL SOLUTIONS WHOLESALE, LLC
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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, 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 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) 5/2015
INDICATIONS AND USAGE
Lamotrigine tablets, USP 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 thera