LAMOTRIGINE tablet, chewable

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Carilion Materials Management

INN (International Adı):

LAMOTRIGINE

Kompozisyon:

LAMOTRIGINE 5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Adjunctive Therapy Lamotrigine tablets (chewable, dispersible) are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: Monotherapy Lamotrigine tablets (chewable, dispersible) 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 (chewable, dispersible) 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 (chewable, dispersible) 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 patients t

Ürün özeti:

Product: 68151-4249 NDC: 68151-4249-0 1 TABLET, CHEWABLE in a PACKAGE

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE
Carilion Materials Management
----------
MEDICATION GUIDE
LAMOTRIGINE (la MOE tri jeen) TABLETS (CHEWABLE, DISPERSIBLE)
What is the most important information I should know about lamotrigine
tablets (chewable, dispersible)?
1.
Lamotrigine tablets (chewable, dispersible) 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 (chewable,
dispersible), 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 (chewable, dispersible).
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine tablets (chewable, dispersible) while taking
valproate [DEPAKENE® (valproic
acid) or DEPAKOTE® (divalproex sodium)].
•
take a higher starting dose of lamotrigine tablets (chewable,
dispersible) than your healthcare
provider prescribed.
•
increase your dose of lamotrigine tablets (chewable, dispersible)
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
(chewable, dispersible).
2.
Other serious reactions, including serious blood problems or liver
problems. Lamotrigine tablets
(chewable, dispersible) 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
symptoms:
• fever
• fre

Ürün özellikleri

LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE
CARILION MATERIALS MANAGEMENT
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS (CHEWABLE,
DISPERSIBLE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR LAMOTRIGINE TABLETS
(CHEWABLE, DISPERSIBLE).
LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE) FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
WARNING: SERIOUS SKIN RASHES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Boxed Warning
5/2015
Indications and Usage, Bipolar Disorder (1.2)
5/2015
Warnings and Precautions, Serious Skin Rashes (5.1)
5/2015
Warnings and Precautions, Laboratory Tests (5.13)
3/2015
INDICATIONS AND USAGE
Lamotrigine tablets (chewable, dispersible) are indicated for:
Epilepsy—adjunctive therapy in patients aged 2 years and older:
•
•
•
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
AED. (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 standard therapy. (1.2)
LIMITATIONS OF USE: TREATMENT OF ACUTE MANIC OR MIXED EPISODES IS NOT
RECOMMENDED. EFFECTIVENESS OF
LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE) IN THE ACUTE TREATMENT OF
MOOD EPISODES HAS NOT BEEN ESTABLISHED.
DOSAGE AND ADMINISTRATION
•
•
•
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
INC LUDE :
● COADMINISTRATION WITH VALPROATE
● EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE TABLETS
(CHEWABLE, DISPERSIBLE)
● EXCEEDING RECOMMENDED DOSE ESCALATION