Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)
Par Pharmaceutical, Inc.
LAMOTRIGINE
LAMOTRIGINE 25 mg
ORAL
PRESCRIPTION DRUG
Lamotrigine extended-release is 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 is 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 have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant AEDs. Safety and effectiveness of lamotrigine extended-release for use in patients younger than 13 years have not been established. Lamotrigine extended-release is 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, Warnings and Precautions (5.1, 5.3)] . Pregna
Lamotrigine Extended-Release Tablets 25 mg, round, beige, biconvex, film-coated tablet debossed with “561” on one side and “Par” on the other 30 Tablets - (NDC 49884-561-11) 100 Tablets - (NDC 49884-561-01) 500 Tablets - (NDC 49884-561-05) 50 mg, round, white, biconvex, film-coated tablet debossed with “562” on one side and “Par” on the other 30 Tablets - (NDC 49884-562-11) 100 Tablets - (NDC 49884-562-01) 500 Tablets - (NDC 49884-562-05) 100 mg, round, brown, biconvex, film-coated tablet debossed with “563” on one side and “Par” on the other 30 Tablets - (NDC 49884-563-11) 100 Tablets - (NDC 49884-563-01) 500 Tablets - (NDC 49884-563-05) 200 mg, round, yellow, biconvex, film-coated tablet debossed with “564” on one side and “Par” on the other 30 Tablets - (NDC 49884-564-11) 100 Tablets - (NDC 49884-564-01) 500 Tablets - (NDC 49884-564-05) 250 mg, round, white, biconvex, film-coated tablet debossed with “604” on one side and “Par” on the other 30 Tablets – (NDC 49884-604-11) 100 Tablets – (NDC 49884-604-01) 500 Tablets – (NDC 49884-604-05) 300 mg, round, grey, biconvex, film-coated tablet debossed with “605” on one side and “Par” on the other 30 Tablets - (NDC 49884-605-11) 100 Tablets - (NDC 49884-605-01) 500 Tablets - (NDC 49884-605-05) 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].
Abbreviated New Drug Application
LAMOTRIGINE EXTENDED RELEASE- LAMOTRIGINE EXTENDED RELEASE TABLET Par Pharmaceutical, Inc. ---------- MEDICATION GUIDE Lamotrigine (la-MO-tri-jen) 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 is 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 tablet than your healthcare provider prescribed. • increase your dose of lamotrigine extended-release tablet 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 extended-release tablets. 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 Прочетете целия документ
LAMOTRIGINE EXTENDED RELEASE- LAMOTRIGINE EXTENDED RELEASE TABLET PAR PHARMACEUTICAL, INC. ---------- 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. exceeding recommended dose escalation of lamotrigine extended-release. (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 should be discontinued at the first sign of rash, unless the rash is clearly not drug-related. (5.1) RECENT MAJOR CHANGES Warnings and Precautions, Cardiac Rhythm and Conduction Abnormalities (5.4) 03/2021 INDICATIONS AND USAGE Lamotrigine extended-release is 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 Прочетете целия документ