LAMOTRIGINE EXTENDED RELEASE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Par Pharmaceutical, Inc.

INN (International Name):

LAMOTRIGINE

구성:

LAMOTRIGINE 25 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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, 5.3)] . Pregna

제품 요약:

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].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

LAMOTRIGINE EXTENDED RELEASE- LAMOTRIGINE EXTENDED RELEASE TABLET
Par Pharmaceutical, Inc.
----------
MEDICATION GUIDE
Lamotrigine (la-MO-tri-jen) 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 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 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

제품 특성 요약

LAMOTRIGINE EXTENDED RELEASE- LAMOTRIGINE EXTENDED RELEASE TABLET
PAR PHARMACEUTICAL, 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
Warnings and Precautions, Cardiac Rhythm and Conduction Abnormalities
(5.4) 03/2021
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 antiepileptic drug. (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