LAMOTRIGINE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Teva Pharmaceuticals USA, Inc.

INN (इंटरनेशनल नाम):

LAMOTRIGINE

रचना:

LAMOTRIGINE 25 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Adjunctive Therapy Lamotrigine tablets USP 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 USP 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 USP 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 USP are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression

उत्पाद समीक्षा:

Lamotrigine tablets USP are supplied as follows: 25 mg – white to off-white, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “39” on the other side of the tablet. They are available in bottles of 100 and 500. NDC 0093-0039-01 – Bottle of 100 NDC 0093-0039-05 – Bottle of 500 100 mg – peach, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “463” on the other side of the tablet. They are available in bottles of 100 and 500. NDC 0093-0463-01 – Bottle of 100 NDC 0093-0463-05 – Bottle of 500 150 mg – cream, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “7247” on the other side of the tablet. They are available in bottles of 60 and 500. NDC 0093-7247-06 – Bottle of 60 NDC 0093-7247-05 – Bottle of 500 200 mg – blue, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “7248” on the other side of the tablet. They are available in bottles of 60 and 500. NDC 0093-7248-06 – Bottle of 60 NDC 0093-7248-05 – Bottle of 500 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place and protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
LAMOTRIGINE (la MOE tri jeen) TABLETS USP
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.
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.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine tablets while taking valproate [DEPAKENE® (valproic
acid) or DEPAKOTE®
(divalproex sodium)].
•
take a higher starting dose of lamotrigine tablets than your
healthcare provider prescribed.
•
increase your dose of lamotrigine tablets 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.
2. 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:
•
fever
•
frequent infections
•
severe muscle pain
•
swelling of your face, eyes, lips, or tongue
•
swollen lymph glands
•
unusual bruising or bleeding
•
weakness, fatigue
•
yellowing of your skin or the white part of your eyes
3. Like other antiepileptic drugs, lamotrigine tab

उत्पाद विशेषताएं

LAMOTRIGINE- LAMOTRIGINE TABLET
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS
USP.
LAMOTRIGINE TABLETS USP, 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
INC LUDE :
COADMINISTRATION WITH VALPROATE.
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE TABLETS.
EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE TABLETS. (5.1)
BENIGN RASHES ARE ALSO CAUSED BY LAMOTRIGINE TABLETS; HOWEVER, IT IS
NOT POSSIBLE TO PREDICT WHICH
RASHES WILL PROVE TO BE SERIOUS OR LIFE THREATENING. LAMOTRIGINE
TABLETS SHOULD BE DISCONTINUED AT THE
FIRST SIGN OF RASH, UNLESS THE RASH IS CLEARLY NOT DRUG RELATED. (5.1)
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:
Partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome. (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
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 ep