LAMOTRIGINE tablet, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Torrent Pharmaceuticals Limited

INN (Nome Internazionale):

LAMOTRIGINE

Composizione:

LAMOTRIGINE 25 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Lamotrigine extended-release tablets USP are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. Lamotrigine extended-release tablets USP are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of lamotrigine extended-release tablets USP have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established. Lamotrigine extended-release tablets are contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients

Dettagli prodotto:

Lamotrigine extended-release tablets , USP 25 mg, light yellow to yellow colored, round, biconvex, film coated tablets, debossed with '339' on one side and '25' on other side. Bottles of 30                           NDC 13668-339-30 50 mg, light green to green colored, round, biconvex, film coated tablets, debossed with '340' on one side and '50' on other side. Bottles of 30                           NDC 13668-340-30 100 mg, light orange to orange colored, round, biconvex, film coated tablets, debossed with '341' on one side and '100' on other side. Bottles of 30                           NDC 13668-341-30 200 mg, light blue to blue colored, round, biconvex, film coated tablets, debossed with '342' on one side and '200' on other side. Bottles of 30                           NDC 13668-342-30 Storage: 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].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Torrent Pharmaceuticals Limited
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MEDICATION GUIDE
Lamotrigine (la-MOE-tri-jeen) extended-release tablets, USP
What is the most important information I should know about lamotrigine
extended-release
tablets?
1. Lamotrigine extended-release 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
extended-release tablets,
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 extended-release tablets. Lamotrigine extended-release
tablets are not
approved for use in children younger than 13 years.
The risk of getting a serious skin rash is higher if you:
● take lamotrigine extended-release tablets while taking valproate
[DEPAKENE
(valproic acid) or
● DEPAKOTE (divalproex sodium)].
● take a higher starting dose of lamotrigine extended-release
tablets than your
healthcare provider prescribed.
increase your dose of lamotrigine extended-release 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
extended-release
tablets.
2. Other serious reactions, including serious blood problems or liver
problems.
Lamotrigine extended-release 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
● sever

Scheda tecnica

LAMOTRIGINE- LAMOTRIGINE TABLET, EXTENDED RELEASE
TORRENT PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LAMOTRIGINE
EXTENDED-RELEASE TABLETS.
LAMOTRIGINE EXTENDED-RELEASE 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 INCLUDE:
COADMINISTRATION WITH VALPROATE.
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE EXTENDED-RELEASE
TABLETS.
EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE EXTENDED-RELEASE
TABLETS.
( 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
EXTENDED-
RELEASE 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, Cardiac Rhythm and
Conduction Abnormalities ( 5.4) 3/2021
INDICATIONS AND USAGE
Lamotrigine extended-release tablets are indicated for:
adjunctive therapy for primary generalized tonic-clonic seizures and
partial-onset seizures with or
without secondary generalization in patients aged 13 years and older.
( 1.1)
conversion to monotherapy in patients aged 13 years and older with
partial-onset seizures who are
receiving treatment with a single antiepileptic drug. ( 1.2)
Limitation of use: Safety and effectiveness in patients younger than
13 years have not been established. (
1.3)
DOSAGE AND ADMINISTRATION
Do not exceed the recommended initial dosage and subsequent dose
escalation. ( 2.1)
Initiation of adj