LAMOTRIGINE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

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 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 tablets are contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning, Warn

Product summary:

Lamotrigine extended-release tablets, USP  25 mg - Each white to off-white, round, unscored, film-coated tablet imprinted with  on one side and 410 on the other side contains 25 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1410-03). 50 mg - Each gray, round, unscored, film-coated tablet imprinted with  on one side and 435 on the other side contains 50 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1435-03). 100 mg - Each gray, round, unscored, film-coated tablet imprinted with  on one side and 422 on the other side contains 100 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1422-03). 200 mg - Each white to off-white, round, unscored, film-coated tablet imprinted with on one side and 453 on the other side contains 200 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1453-03). 250 mg - Each yellow, capsule-shaped, unscored, film-coated tablet imprinted with  on one side and 638 on the other side contains 250 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1638-03). 300 mg - Each gray, capsule-shaped, unscored, film-coated tablet imprinted with  on one side and 580 on the other side contains 300 mg of lamotrigine, USP. Tablets are supplied in bottles of 30 tablets (NDC 0228-1580-03). Storage 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]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Actavis Pharma, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Lamotrigine (la moe' tri jeen) Extended-Release Tablets
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
tablets are 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
2. Other serious reactions, including serious blood problems or liver
problems. Lamotrigine extended-
release 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, lo

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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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 INCLUDE:
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)
INDICATIONS AND USAGE
Lamotrigine extended-release tablets are 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 antiepileptic drug. (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)
Initiation of adjunctive therapy and conversion to monotherapy
requires slow titration dependent on
concomitant AEDs; the pres