LAMOTRIGINE- lamotrigine tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Cardinal Health

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Lamotrigine tablets, USP are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: Lamotrigine tablets 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 has 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 two or more concomitant AEDs. Lamotrigine tablets, USP 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 treated for acute mood episodes with standard therapy Lamotrigine tablets, USP are indicated for the maintenance treatment

Ringkasan produk:

Lamotrigine Tablets, USP are available containing 25 mg, 100 mg, 150 mg or 200 mg of lamotrigine, USP. The 25 mg tablets are white to off-white, round, scored tablets debossed with M on one side of the tablet and L above the score and 51 below the score on the other side. They are available as follows: Available overbagged with 10 tablets per bag, NDC 55154-5387-0. The 100 mg tablets are white to off-white, round, scored tablets debossed with M above the score and L52 below the score on one side of the tablet and blank on the other side. They are available as follows: Available overbagged with 10 tablets per bag, NDC 55154-5396-0. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. PHARMACIST: Dispense a Medication Guide with each prescription.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

LAMOTRIGINE- LAMOTRIGINE TABLET
Cardinal Health
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MEDICATION GUIDE
LAMOTRIGINE TABLETS, USP
(la moe′ tri jeen)
25 mg, 100 mg, 150 mg and 200 mg
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 even
cause death.
2.
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, 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.
3.
The risk of getting a serious skin rash is higher if you:
1.
take lamotrigine tablets while taking valproate [DEPAKENE ®*
(valproic acid) or
DEPAKOTE ®* (divalproex sodium)].
2.
take a higher starting dose of lamotrigine tablets than your
healthcare provider prescribed.
3.
increase your dose of lamotrigine tablets faster than prescribed.
4.
Call your healthcare provider right away if you have any of the
following:
4.
a skin rash
5.
blistering or peeling of your skin
6.
hives
7.
painful sores in your mouth or around your eyes
5.
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.
6.
Other serious reactions, including serious blood problems or liver
problems. Lamotrigine 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 symptoms:
8.
fever
9.
frequent infections
10.
severe muscle pain
11.
swelling of your face, eyes, lips, or tongue
12.
swollen lymph glands
13.
unusual bruising or bleeding
14.
weakness, fatigue
15.
yellowing of your skin or the white part of

Ciri produk

LAMOTRIGINE- LAMOTRIGINE TABLET
CARDINAL HEALTH
----------
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 TABLETS.
LAMOTRIGINE TABLETS USP, 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, USP 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 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 include:
•
•
•
COADMINISTRATION WITH VALPROATE.
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE.
EXCEEDING RECOMMENDED DOSE ESCALATION FOR 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 THREATENI