LAMOTRIGINE- lamotrigine tablet, film coated, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

REMEDYREPACK INC.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Lamotrigine extended-release tablets 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 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 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 is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning, Warnings and

Descriptif du produit:

Lamotrigine Extended-Release Tablets USP  25 mg - Each white to off-white, round, unscored, film-coated tablet imprinted with  on one side and 410 on the other side contains 25 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1410-03). 50 mg - Each gray, round, unscored, film-coated tablet imprinted with  on one side and 435 on the other side contains 50 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1435-03). 100 mg - Each gray, round, unscored, film-coated tablet imprinted with  on one side and 422 on the other side contains 100 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1422-03). 200 mg - Each white to off-white, round, unscored, film-coated tablet imprinted with on one side and 453 on the other side contains 200 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1453-03). 250 mg - Each yellow, capsule-shaped, unscored, film-coated tablet imprinted with  on one side and 638 on the other side contains 250 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1638-03). 300 mg - Each gray, capsule-shaped, unscored, film-coated tablet imprinted with  on one side and 580 on the other side contains 300 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1580-03). 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]. Dispense in a tight, light-resistant container as defined in the USP.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

LAMOTRIGINE- LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE
REMEDYREPACK INC.
----------
MEDICATION GUIDE
LAMOTRIGINE (la moe' tri jeen)
EXTENDED-RELEASE TABLETS
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 sy

Résumé des caractéristiques du produit

LAMOTRIGINE- LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE
REMEDYREPACK INC.
----------
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
INC LUDE :
COADMINISTRATION WITH VALPROATE.
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE EXTENDED-RELEASE.
EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE
EXTENDED-RELEASE. ( 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
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 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 AED. ( 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 adjunctive therapy and conversion to monotherapy
req