Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)
TruPharma, LLC
LAMOTRIGINE
LAMOTRIGINE 25 mg
ORAL
PRESCRIPTION DRUG
Lamotrigine extended-release tablets are 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 tablets are 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 tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established. Lamotrigine extended-release tablets are 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
Lamotrigine Extended-Release Tablets, USP 25 mg, white to off-white, round, film-coated tablets engraved with “H008” on one side and plain on the other side supplied in unit-of-use bottles of 30 tablets (NDC 52817-240-30). 50 mg, peach, round, film-coated tablets engraved with “H009” on one side and plain on the other side supplied in unit-of-use bottles of 30 tablets (NDC 52817-241-30). 100 mg, yellow, round, film-coated tablets engraved with “H012” on one side and plain on the other side supplied in unit-of-use bottles of 30 tablets (NDC 52817-242-30). 200 mg, blue, round, film-coated tablets engraved with “H011” on one side and plain on the other side supplied in unit-of-use bottles of 30 tablets (NDC 52817-243-30). Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LAMOTRIGINE EXTENDED RELEASE- LAMOTRIGINE EXTENDED RELEASE TABLET TruPharma, LLC ---------- MEDICATION GUIDE Lamotrigine (la moe tri jeen) 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 are 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 tablets than your healthcare provider prescribed. • increase your dose of lamotrigine extended-release tablets 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 sy Lire le document complet
LAMOTRIGINE EXTENDED RELEASE- LAMOTRIGINE EXTENDED RELEASE TABLET TRUPHARMA, LLC ---------- 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 INC LUDE : COADMINISTRATION WITH VALPROATE. EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE EXTENDED-RELEASE TABLETS. EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE EXTENDED-RELEASE TABLETS. ( 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 TABLETS 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, Hemophagocytic Lymphohistiocytosis ( 5.2) 09/2019 INDICATIONS AND USAGE Lamotrigine extended-release tablets are 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 t Lire le document complet