LAMOTRIGINE EXTENDED RELEASE- lamotrigine extended release tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

REMEDYREPACK INC.

ИНН (Международная Имя):

LAMOTRIGINE

состав:

LAMOTRIGINE 50 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Lamotrigine extended-release is 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 is 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 have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant AEDs. Safety and effectiveness of lamotrigine extended-release 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 Precautions ( 5.1, 5.2)] . As w

Обзор продуктов:

Lamotrigine Extended-Release Tablets 25 mg, round, beige, biconvex, film-coated tablet debossed with “561” on one side and “Par” on the other 30 Tablets - (NDC 49884-561-11) 100 Tablets - (NDC 49884-561-01) 500 Tablets - (NDC 49884-561-05) 50 mg, round, white, biconvex, film-coated tablet debossed with “562” on one side and “Par” on the other 30 Tablets - (NDC 49884-562-11) 100 Tablets - (NDC 49884-562-01) 500 Tablets - (NDC 49884-562-05) 100 mg, round, brown, biconvex, film-coated tablet debossed with “563” on one side and “Par” on the other 30 Tablets - (NDC 49884-563-11) 100 Tablets - (NDC 49884-563-01) 500 Tablets - (NDC 49884-563-05) 200 mg, round, yellow, biconvex, film-coated tablet debossed with “564” on one side and “Par” on the other 30 Tablets - (NDC 49884-564-11) 100 Tablets - (NDC 49884-564-01) 500 Tablets - (NDC 49884-564-05) 250 mg, round, white, biconvex, film-coated tablet debossed with “604” on one side and “Par” on the other 30 Tablets – (NDC 49884-604-11) 100 Tablets – (NDC 49884-604-01) 500 Tablets – (NDC 49884-604-05) 300 mg, round, grey, biconvex, film-coated tablet debossed with “605” on one side and “Par” on the other 30 Tablets - (NDC 49884-605-11) 100 Tablets - (NDC 49884-605-01) 500 Tablets - (NDC 49884-605-05) 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].

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

LAMOTRIGINE EXTENDED RELEASE- LAMOTRIGINE EXTENDED RELEASE TABLET
REMEDYREPACK INC.
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MEDICATION GUIDE
Lamotrigine (la-MO-tri-jen) Extended-Release Tablets
Read this Medication Guide before you start taking lamotrigine
extended-release 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 extended-release tablets, ask your healthcare provider or
pharmacist.
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 is 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 tablet
than your healthcare provider
prescribed.
•
increase your dose of lamotrigine extended-release tablet 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 r

Характеристики продукта

LAMOTRIGINE EXTENDED RELEASE- LAMOTRIGINE EXTENDED RELEASE TABLET
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
include:
coadministration with valproate
exceeding recommended initial dose of lamotrigine extended-release
exceeding recommended dose escalation of 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
Dosage and Administration ( 2.1, 2.2) 12/2014
Warnings and Precautions, Laboratory Tests ( 5.13) 03/2015
INDICATIONS AND USAGE
Lamotrigine extended-release is 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 conversi