LAMOTRIGINE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Aidarex Pharmaceuticals LLC

INN (Jina la Kimataifa):

LAMOTRIGINE

Tungo:

LAMOTRIGINE 25 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Adjunctive Therapy: Lamotrigine tablets are 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 tablets are 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 tablets are 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 a

Bidhaa muhtasari:

Lamotrigine Tablets USP, 25 mg Round, white to off white tablets, debossed with ‘J’ and ‘245’ on one side and scoreline on the other side.      Bottles of 30    NDC 33261-0647-30       Bottles of 90    NDC 33261-0647-90      Bottles of 120  NDC 33261-0647-02 Lamotrigine Tablets USP, 200 mg Round, white to off white tablets, debossed with ‘J’ and ‘248’ on one side and scoreline on the other side.      Bottles of 60    NDC 33261-0946-60       Storage: Store at 20 - 25°C (68 - 77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.  

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

LAMOTRIGINE- LAMOTRIGINE TABLET
Aidarex Pharmaceuticals LLC
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MEDICATION GUIDE
Lamotrigine Tablets, USP
Rx Only
Read this Medication Guide before you start taking Lamotrigine Tablets
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 Tablets, ask
your healthcare provider or pharmacist.
What is the most important information I should know about Lamotrigine
Tablets?
1. Lamotrigine Tablets may cause a serious skin rash that may cause
you to be hospitalized or to stop
Lamotrigine Tablets; it may rarely cause death.
There is no way to tell if a mild rash will develop into a more
serious reaction. These serious skin
reactions are more likely to happen when you begin taking Lamotrigine
Tablets, within the first 2 to 8
weeks of treatment. But it can happen in people who have taken
Lamotrigine Tablets for any period of
time. Children between 2 to 16 years of age have a higher chance of
getting this serious skin reaction
while taking Lamotrigine Tablets.
The risk of getting a rash is higher if you:
•
take Lamotrigine Tablets while taking valproate [*DEPAKENE (valproic
acid) or *DEPAKOTE
(divalproex sodium)].
•
take a higher starting dose of Lamotrigine Tablets than your
healthcare provider prescribed.
•
increase your dose of Lamotrigine Tablets faster than prescribed.
Lamotrigine Tablets can also cause other types of allergic reactions
or serious problems which may affect
organs and other parts of your body like the 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 the
following:
•
a skin rash
•
hives
•
fever
•
swollen lymph glands
•
painful sores in the mouth or around your eyes
•
swelling of your lips or tongue
•
yellowing or your skin or eyes
•
unusual bruising or bleeding
•
severe fatigue or weakness
•
severe muscle pai

Tabia za bidhaa

LAMOTRIGINE- LAMOTRIGINE TABLET
AIDAREX PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE.
LAMOTRIGINE TABLETS, USP
RX ONLY
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, Multiorgan Hypersensitivity Reactions and
Organ Failure (5.2) August, 2011
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 patien