LAMOTRIGINE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wockhardt USA LLC.

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lamotrigine extended-release tablets are 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 tablets are 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 tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established. Lamotrigine extended-release tablet 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 Box

Product summary:

Lamotrigine extended-release tablets 25 mg are available as yellow, enteric-coated, circular shaped tablets, debossed with "W" on one side and "271" on the other side. NDC 64679-271-01, bottle of 30 tablets NDC 64679-271-02, bottle of 500 tablets NDC 64679-271-04, unit dose of 100 tablets 50 mg are available as pink, enteric-coated, circular shaped tablets, debossed with "W" on one side and "274" on the other side. NDC 64679-274-01, bottle of 30 tablets NDC 64679-274-02, bottle of 500 tablets NDC 64679-274-03, unit dose of 100 tablets 100 mg are available as light brown, enteric-coated, circular shaped tablets, debossed with "W" on one side and "273" on the other side. NDC 64679-273-01, bottle of 30 tablets NDC 64679-273-02, bottle of 500 tablets NDC 64679-273-04, unit dose of 100 tablets 200 mg are available as pink, enteric-coated, circular shaped tablets, debossed with "W" on one side and "272" on the other side. NDC 64679-272-01, bottle of 30 tablets NDC 64679-272-02, bottle of 500 tablets NDC 64679-272-04, unit dose of 100 tablets 300 mg are available as pink, enteric-coated, circular shaped tablets, debossed with "W" on one side and "275" on the other side. NDC 64679-275-01, bottle of 30 tablets NDC 64679-275-02, bottle of 500 tablets NDC 64679-275-04, unit dose of 100 tablets Storage Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE- LAMOTRIGINE TABLET, EXTENDED RELEASE
Wockhardt USA LLC.
----------
MEDICATION GUIDE
Lamotrigine (la-MOE-tri-jeen) Extended-Release Tablets
Read this Medication Guide before you start taking lamotrigine
extended-release tablets and each time
you get a refill. There may be new information. This information does
not take the place of talking with
your healthcare provider about your medical condition or treatment. If
you have questions about
lamotrigine extended-release tablets, ask your healthcare provider or
pharmacist.
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
tablet 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 tablets
than your healthcare provider
prescribed.
•
increase your dose of lamotrigine extended-release 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
extended-release tablets.
2. Other serious reactions, in

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET, EXTENDED RELEASE
WOCKHARDT USA LLC.
----------
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
INC LUDE :
COADMINISTRATION WITH VALPROATE.
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE EXTENDED-RELEASE
TABLETS.
EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE EXTENDED-RELEASE
TABLETS. ( 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
TABLETS SHOULD BE DISCONTINUED
AT THE FIRST SIGN OF RASH, UNLESS THE RASH IS CLEARLY NOT DRUG
RELATED. ( 5.1)
RECENT MAJOR CHANGES
Dosage and Administration ( 2.1, 2.2) 12/2014
Warnings and Precautions, Laboratory Tests ( 5.13) 3/2015
INDICATIONS AND USAGE
Lamotrigine extended-release tablet is an antiepileptic drug (AED)
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 AED. ( 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)