LAMOTRIGINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Lamotrigine (UNII: U3H27498KS) (Lamotrigine - UNII:U3H27498KS)

Available from:

Dr.Reddy's Laboratories Limited

INN (International Name):

Lamotrigine

Composition:

Lamotrigine 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adjunctive Therapy Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial seizures - primary generalized tonic-clonic (PGTC) seizures - generalized seizures of Lennox-Gastaut syndrome  Monotherapy Lamotrigine tablets are indicated for conversion to monotherapy in adults (≥16 years of age) 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 are 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 are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episod

Product summary:

Lamotrigine Tablets USP Lamotrigine tablets USP, 25 mg are light yellow, round, flat, bevel edged, uncoated tablets, debossed “RDY” on one side and “220” on other side with bisect line and are supplied in bottles of 30, 60, 100, 500 and unit-dose package of 100 (10x10).  Bottles of 30                                       NDC 55111-220-30 Bottles of 60                                       NDC 55111-220-60 Bottles of 100                                     NDC 55111-220-01 Bottles of 500                                     NDC 55111-220-05 Unit dose package of 100 (10 x 10)   NDC 55111-220-78  Lamotrigine tablets USP, 100 mg are light yellow, round, flat, bevel edged, uncoated tablets, debossed “RDY” on one side and “221” on other side with bisect line and are supplied in bottles of 30, 60, 100, 500 and unit-dose package of 100 (10x10).  Bottles of 30                                       NDC 55111-221-30 Bottles of 60                                       NDC 55111-221-60 Bottles of 100                                     NDC 55111-221-01 Bottles of 500                                    NDC 55111-221-05 Unit dose package of 100 (10 x 10)   NDC 55111-221-78 Lamotrigine tablets USP, 150 mg are light yellow, round, flat, bevel edged, uncoated tablets, debossed “RDY” on one side and “222” on other side with bisect line and are supplied in bottles of 30, 60, 100, 500 and unit-dose package of 100 (10x10).  Bottles of 30                                       NDC 55111-222-30 Bottles of 60                                       NDC 55111-222-60 Bottles of 100                                    NDC 55111-222-01 Bottles of 500                                    NDC 55111-222-05 Unit dose package of 100 (10 x 10)   NDC 55111-222-78  Lamotrigine tablets USP, 200 mg are light yellow, round, flat, bevel edged, uncoated tablets, debossed “RDY” on one side and “223” on other side with bisect line and are supplied in bottles of 30, 60, 100, 500 and unit-dose package of 100 (10x10). Bottles of 30                                       NDC 55111-223-30 Bottles of 60                                       NDC 55111-223-60 Bottles of 100                                     NDC 55111-223-01 Bottles of 500                                     NDC 55111-223-05 Unit dose package of 100 (10 x 10)   NDC 55111-223-78  Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] in a dry place and protect from light. 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE- LAMOTRIGINE TABLET
Dr.Reddy's Laboratories Limited
----------
MEDICATION GUIDE
MEDICATION GUIDE
Lamotrigine Tablets USP
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.
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 [(valproic acid) or
(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 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 may cause suicidal
thoughts or actions in a very
small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, espe

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET
DR.REDDY'S LABORATORIES LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LAMOTRIGINE.
LAMOTRIGINE 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, HAVEBEEN 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 OF 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)
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 tablet 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.
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