LAMOTRIGINE tablet, for suspension

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Alembic Pharmaceuticals Inc.

INN (الاسم الدولي):

LAMOTRIGINE

تركيب:

LAMOTRIGINE 5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Adjunctive Therapy Lamotrigine tablets for oral suspension are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (PGTC) seizures. -  generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine tablets for oral suspension are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets for oral suspension 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 for oral suspension are indicated for the maintenance treatment of bipolar I

ملخص المنتج:

Lamotrigine tablets for oral suspension USP, 5 mg White to off-white, caplet-shaped tablets debossed with ‘L217’ on one side and plain on other side. They are supplied as follows: NDC 62332-095-30 bottle of 30 tablets NDC 62332-095-31 bottle of 100 tablets NDC 62332-095-91 bottle of 1000 tablets Lamotrigine tablets for oral suspension USP, 25 mg White to off-white, super elliptical-shaped tablets debossed with ‘L’ on one side and ‘218’ on other side. They are supplied as follows: NDC 62332-096-30 bottle of 30 tablets NDC 62332-096-31 bottle of 100 tablets NDC 62332-096-91 bottle of 1000 tablets 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].

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Alembic Pharmaceuticals Inc.
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MEDICATION GUIDE
Lamotrigine (lam-OH-try-jeen)
Tablets for Oral Suspension USP
Rx only
Phenylketonurics: Phenylalanine is a component of aspartame. Each
lamotrigine tablets for oral suspension 5
mg and 25 mg contains 1.4 mg and 0.98 mg of phenylalanine,
respectively.
What is the most important information I should know about lamotrigine
tablets for oral suspension ?
1. Lamotrigine tablets for oral suspension 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 tablets for oral suspension,
but is more likely to happen within the
first 2 to 8 weeks of treatment. Children and teenagers aged between 2
and 17 years have a higher chance of
getting this serious skin rash while taking lamotrigine tablets for
oral suspension.
The risk of getting a serious skin rash is higher if you:
· take lamotrigine tablets for oral suspension while taking valproate
[DEPAKENE (valproic acid) or
DEPAKOTE(divalproex sodium)].
· take a higher starting dose of lamotrigine tablets for oral
suspension than your healthcare provider
prescribed.
· increase your dose of lamotrigine tablets for oral suspension
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 tablets for oral
suspension.
2. Other serious reactions, including serious blood problems or liver
problems. Lamotrigine tablets
for oral suspension 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 react

خصائص المنتج

LAMOTRIGINE - LAMOTRIGINE TABLET, FOR SUSPENSION
ALEMBIC PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS
FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LAMOTRIGINE TABLETS FOR ORAL SUSPENSION.
LAMOTRIGINE TABLETS FOR ORAL SUSPENSION
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.
•EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMOTRIGINE. (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
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 tablet for oral suspension is indicated for: (1)
Epilepsy - adjunctive therapy in patients aged 2 years and older: (1)
· partial-onset seizures. (1)
· primary generalized tonic-clonic seizures. (1)
· generalized seizures of Lennox-Gastaut syndrome. (1.1) (1)
Epilepsy - monotherapy in patients aged 16 years and older: Conversion
to monotherapy in patients with
partial-onset seizures who are receiving treatment with carbamazepine,
phenytoin, phenobarbital,
primidone, or valproate as the single antiepileptic drug. (1.1) (1)
Bipolar disorder: Maintenance treatment of bipolar I disorder to delay
the time to occurrence of mood
episodes in patients treated for acute mood episodes with