LAMOTRIGINE- lamotrigine tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

DCI (Dénomination commune internationale):

Lamotrigine

Composition:

Lamotrigine 25 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Adjunctive Therapy: Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients ≥2 years of age: - partial seizures - primary generalized tonic-clonic seizures - generalized seizures of Lennox-Gastaut syndrome Monotherapy: Lamotrigine is indicated for conversion to monotherapy in adults (≥16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine 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 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 adults (≥18 years of age) treated for acute mood e

Descriptif du produit:

Lamotrigine Tablets USP, 25 mg: Round, white tablets, scored on one side, embossed with "TARO" on one side and on the other side "LMT" above score and "25" below the score. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] in a dry place. Meets USP Dissolution Test 1. Lamotrigine Tablets USP, 100 mg: Round, light peach, scored tablets, embossed with "TARO" on one side and on the other side "LMT" above score and 100 below the score. Lamotrigine Tablets USP, 150 mg: Round, cream tablets, scored on one side, embossed with "TARO" on one side and on the other side "LMT" above score and 150 below the score. Lamotrigine Tablets USP, 200 mg: Round, light blue tablets, scored on one side, embossed with "TARO" on one side and on the other side "LMT" above score and 200 below the score. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] in a dry place and protect from light. Meets USP Dissolution Test 1. Lamotrigine Starter Kit for Patients Taking Valproate 25-mg, round, white tablets, scored on one side, embossed with "TARO" on one side and on the other side "LMT" above score and "25" below the score, 3 blistercards of 7 tablets and 1 blistercard of 14 tablets (NDC 51672-4130-8). Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] in a dry place. Lamotrigine Starter Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate 25-mg, round, white tablets, scored on one side, embossed with "TARO" on one side and on the other side "LMT" above score and "25" below the score and 100-mg , round, light peach, scored tablets embossed with "TARO" on one side and on the other side "LMT" above score and 100 below the score, bottle of 84, 25-mg tablets and 2 blistercards of 7, 100-mg tablets (NDC 51672-4134-5). Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] in a dry place and protect from light. Lamotrigine Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate 25-mg, round, white tablets, scored on one side, embossed with "TARO" on one side and on the other side "LMT" above score and "25" below the score and 100-mg , round, light peach, scored tablets embossed with "TARO" on one side and on the other side "LMT" above score and 100 below the score, bottle of 42, 25-mg tablets and blister card of 7, 100-mg tablets (NDC 51672-4134-2). Store at 20°-25°C (68°-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
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
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MEDICATION GUIDE
Lamotrigine Tablets, USP
Read this Medication Guide before you start taking lamotrigine and
each time you get a refill. There may
be new information. This information does not take the place of
talking with your healthcare provider
about your medical condition or treatment. If you have questions about
lamotrigine, ask your healthcare
provider or pharmacist.
What is the most important information I should know about
Lamotrigine?
1.
Lamotrigine 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, but is more likely to
happen within the first 2 to 8
weeks of treatment. Children between 2 to 16 years of age have a
higher chance of getting this
serious skin rash while taking lamotrigine.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine while taking valproate [DEPAKENE® (valproic acid) or
DEPAKOTE®
(divalproex sodium)]
•
take a higher starting dose of lamotrigine than your healthcare
provider prescribed
•
increase your dose of lamotrigine 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.
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
sympto

Résumé des caractéristiques du produit

LAMOTRIGINE- LAMOTRIGINE TABLET
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LAMOTRIGINE.
LAMOTRIGINE TABLETS, USP
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 INCLUDE
(5.1):
COADMINISTRATION WITH VALPROATE
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE
EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMOTRIGINE
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, Aseptic Meningitis (5.7) October 2010
INDICATIONS AND USAGE
Lamotrigine is an antiepileptic drug (AED) indicated for:
EPILEPSY—ADJUNCTIVE THERAPY IN PATIENTS ≥2 YEARS OF AGE: (1.1)
partial seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome.
EPILEPSY—MONOTHERAPY IN PATIENTS ≥16 YEARS OF AGE: conversion to
monotherapy in patients with partial seizures who
are receiving treatment with carbamazepine, phenobarbital, phenytoin,
primidone, or valproate as the single AED. (1.1)
BIPOLAR DISORDER IN PATIENTS ≥18 YEARS OF AGE: 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. (1.2)
DOSAGE AND ADMINISTRATION
Dosing is based on concomitant medications, indication, and patient
age. (2.2, 2.4