LAMOTRIGINE tablet, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Preferred Pharmaceuticals Inc.

DCI (Dénomination commune internationale):

LAMOTRIGINE

Composition:

LAMOTRIGINE 300 mg

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 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 [see Boxed Warning, Warn

Descriptif du produit:

Lamotrigine extended-release tablets USP, 300 mg are grey colored modified capsule shaped, biconvex tablets imprinted with ‘R428’ on one side and plain on the other side and are supplied in: Bottles of 20                                        NDC 68788-6868-2 Bottles of 30                                        NDC 68788-6868-3 Bottles of 60                                        NDC 68788-6868-6 Bottles of 90                                        NDC 68788-6868-9 Bottles of 100                                        NDC 68788-6868-1 Bottles of 120                                        NDC 68788-6868-8 Storage: Store at 20°–25° C (68°–77° F); [See USP Controlled Room Temperature].

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

LAMOTRIGINE- LAMOTRIGINE TABLET, EXTENDED RELEASE
Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Lamotrigine Extended-Release Tablets, USP
(la-MOE-tri-jeen)
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 sym

Résumé des caractéristiques du produit

LAMOTRIGINE- LAMOTRIGINE TABLET, EXTENDED RELEASE
PREFERRED PHARMACEUTICALS 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 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:
3.
4.
Limitation of use: Safety and effectiveness in patients younger than
13 years have not been established.
(1.3)
DOSAGE AND ADMINISTRATION
7.
8.
9.
10.
11.
12.
DOSAGE FORMS AND STRENGTHS
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)
Do not exceed the recommended initial dosa