LAMOTRIGINE tablet, chewable

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Lamotrigine (UNII: U3H27498KS) (Lamotrigine - UNII:U3H27498KS)

Disponibil de la:

Jubilant Cadista Pharmaceuticals Inc.

INN (nume internaţional):

Lamotrigine

Compoziție:

Lamotrigine 5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Adjunctive Therapy Lamotrigine tablets (chewable, dispersible) are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. partial-onset seizures. - primary generalized tonic-clonic (PGTC) seizures. primary generalized tonic-clonic (PGTC) seizures. - generalized seizures of Lennox-Gastaut syndrome. generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine tablets (chewable, dispersible) 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 (chewable, dispersible) 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 mono

Rezumat produs:

Lamotrigine Tablets (Chewable, Dispersible) 5 mg, white to off-white, caplet-shaped tablets, debossed “CA3” on one side and scored on the other side, bottles of 100 with child-resistant closure (NDC 59746-311-01).   25 mg, white to off-white, round tablets, debossed “A4” on one side and “C” on the other side, bottles of 100 with child-resistant closure (NDC 59746-312-01).   Store lamotrigine tablets (chewable, dispersible) at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature] in a dry place.

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

Jubilant Cadista Pharmaceuticals Inc.
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MEDICATION GUIDE
Lamotrigine Tablets (Chewable, Dispersible)
(la-MOE-tri-jeen)
Phenylketonurics: Contains phenylalanine 0.224 mg and 1.12 mg per 5 mg
and 25 mg lamotrigine tablets
(chewable, dispersible) respectively.
What is the most important information I should know about lamotrigine
tablets (chewable, dispersible)?
1. Lamotrigine tablets (chewable, dispersible) 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 (chewable,
dispersible), 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 (chewable, dispersible).
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine tablets (chewable, dispersible) while taking
valproate [*DEPAKENE (valproic
acid) or *DEPAKOTE (divalproex sodium)].
•
take a higher starting dose of lamotrigine tablets (chewable,
dispersible) than your healthcare
provider prescribed.
•
increase your dose of lamotrigine tablets (chewable, dispersible)
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 (chewable, dispersible).
2. Other serious reactions, including serious blood problems or liver
problems. Lamotrigine tablets
(chewable, dispersible) 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 r

Caracteristicilor produsului

LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE
JUBILANT CADISTA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS (CHEWABLE,
DISPERSIBLE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR LAMOTRIGINE TABLETS
(CHEWABLE, DISPERSIBLE).
LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE), 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
Warnings and Precautions, Hemophagocytic Lymphohistiocytosis (5.2)
08/2019
INDICATIONS AND USAGE
Lamotrigine tablets (chewable, dispersible) 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
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.