LAMOTRIGINE tablet LAMOTRIGINE tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adjunctive Therapy Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic seizures (PGTC) seizures. - generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine is 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 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 is 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

Product summary:

Lamotrigine Tablets Lamotrigine Tablets USP, 25 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "79" and other side is plain and are supplied as follows: NDC 68382-006-11 in bottles of 25 tablets with child-resistant closure NDC 68382-006-16 in bottles of 90 tablets with child-resistant closure NDC 68382-006-01 in bottles of 100 tablets with child-resistant closure NDC 68382-006-05 in bottles of 500 tablets NDC 68382-006-10 in bottles of 1000 tablets Lamotrigine Tablets USP, 50 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "90" and other side is plain and are supplied as follows: NDC 68382-007-16 in bottles of 90 tablets with child-resistant closure NDC 68382-007-01 in bottles of 100 tablets with child-resistant closure NDC 68382-007-05 in bottles of 500 tablets NDC 68382-007-10 in bottles of 1000 tablets Lamotrigine Tablets USP, 100 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "80"and other side is plain and are supplied as follows: NDC 68382-008-16 in bottles of 90 tablets with child-resistant closure NDC 68382-008-01 in bottles of 100 tablets with child-resistant closure NDC 68382-008-05 in bottles of 500 tablets NDC 68382-008-10 in bottles of 1000 tablets Lamotrigine Tablets USP, 150 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "81" and other side is plain and are supplied as follows: NDC 68382-009-14 in bottles of 60 tablets with child-resistant closure NDC 68382-009-16 in bottles of 90 tablets with child-resistant closure NDC 68382-009-05 in bottles of 500 tablets Lamotrigine Tablets USP, 200 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "82" and other side is plain and are supplied as follows: NDC 68382-010-14 in bottles of 60 tablets with child-resistant closure NDC 68382-010-16 in bottles of 90 tablets with child-resistant closure NDC 68382-010-05 in bottles of 500 tablets Lamotrigine Tablets USP, 250 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "91"and other side is plain and are supplied as follows: NDC 68382-011-14 in bottles of 60 tablets with child-resistant closure NDC 68382-011-16 in bottles of 90 tablets with child-resistant closure NDC 68382-011-05 in bottles of 500 tablets Lamotrigine Tablets for Oral Suspension, USP Lamotrigine Tablets for Oral Suspension, USP, 5 mg are white to off-white, round, flat- faced, radial-edged tablets with bisect on one side and plain on other side; one side of the bisect is debossed with "Z" and other side is debossed with "13" and are supplied as follows: NDC-68382-108-16 in bottle of 90 tablets with child-resistant closure NDC-68382-108-01 in bottle of 100 tablets with child-resistant closure NDC-68382-108-05 in bottle of 500 tablets Lamotrigine Tablets for Oral Suspension, USP, 25 mg are white to off-white, round, flat- faced, radial-edged tablets debossed with logo of "Z" and "12" on one side and plain on the other side and are supplied as follows: NDC-68382-109-16 in bottle of 90 tablets with child-resistant closure NDC-68382-109-01 in bottle of 100 tablets with child-resistant closure NDC-68382-109-05 in bottle of 500 tablets Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE
Zydus Pharmaceuticals USA Inc.
----------
MEDICATION GUIDE
Lamotrigine (la moe′ tri jeen) Tablets, USP
Lamotrigine (la moe′ tri jeen) Tablets for Oral Suspension, USP
Phenylketonurics:
Phenylalanine is a component of aspartame. Each lamotrigine tablet for
oral
suspension, 5 mg and 25 mg contains 0.7 mg of phenylalanine.
What is the most important information I should know about
Lamotrigine?
1. Lamotrigine 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,
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.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine while taking valproate [DEPAKENE® (valproic
acid) or DEPAKOTE® (divalproex sodium)]
•
take a higher starting dose of lamotrigine than your healthcare
provider prescribed.
•
increase your dose of lamotrigine 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.
2. Other serious reactions, including serious blood problems or liver
problems .
Lamotrigine 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

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET
LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE
ZYDUS PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS
AND LAMOTRIGINE TABLETS FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS AND LAMOTRIGINE
TABLETS FOR ORAL
SUSPENSION.
LAMOTRIGINE TABLETS, FOR ORAL USE
LAMOTRIGINE TABLETS FOR ORAL SUSPENSION
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.
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 THREATENING. LAMOTRIGINE
SHOULD BE
DISCONTINUED AT THE FIRST SIGN OF RASH, UNLESS THE RASH IS CLEARLY NOT
DRUG RELATED.
(5.1)
INDICATIONS AND USAGE
Lamotrigine is 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 antiepileptic drug. (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 m