Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)
NCS HealthCare of KY, Inc dba Vangard Labs
LAMOTRIGINE
LAMOTRIGINE 25 mg
ORAL
PRESCRIPTION DRUG
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 (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 treated f
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 0615-7964-39 in blistercards of 30 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. 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 0615-7975-39 in blistercards of 30 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 0615-8150-39 in blistercards of 30 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 0615-8267-39 in blistercards of 30 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. Lamotrigine Tablets (Chewable, Dispersible) Lamotrigine Tablets (Chewable, Dispersible), 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". Lamotrigine Tablets (Chewable, Dispersible), 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. Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
LAMOTRIGINE- LAMOTRIGINE TABLET LAMOTRIGINE- LAMOTRIGINE TABLET NCS HealthCare of KY, Inc dba Vangard Labs ---------- AND MEDICATION GUIDE. MEDICATION GUIDE Lamotrigine (la-MOE-tri-jeen) Tablets, USP Lamotrigine (la-MOE-tri-jeen) Tablets (Chewable, Dispersible) Phenylketonurics: Phenylalanine is a component of aspartame. Each lamotrigine tablet (chewable, dispersible), 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 mu Läs hela dokumentet
LAMOTRIGINE- LAMOTRIGINE TABLET LAMOTRIGINE- LAMOTRIGINE TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LAMOTRIGINE TABLETS AND LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS AND LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE). LAMOTRIGINE TABLETS, FOR ORAL USE LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE), 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. • 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) 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 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 AED. (1. Läs hela dokumentet