Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)
Zydus Pharmaceuticals USA Inc.
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 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
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.
Abbreviated New Drug Application
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 Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument