Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)
Teva Pharmaceuticals USA, Inc.
LAMOTRIGINE
LAMOTRIGINE 5 mg
ORAL
PRESCRIPTION DRUG
Adjunctive Therapy Lamotrigine tablets for oral suspension (chewable dispersible tablets) are 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 tablets for oral suspension (chewable dispersible tablets) are 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 tablets for oral suspension (chewable dispersible tablets) 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. Lamotrigi
Lamotrigine tablets for oral suspension USP (chewable dispersible tablets) are supplied as follows: 5 mg – white to off-white, round tablets debossed “93” on one side and “688” on the other. They are available in bottles of 100 (NDC 0093-0688-01). 25 mg – white to off-white, oval-shaped tablets debossed “93” on one side and “132” on the other. They are available in bottles of 100 (NDC 0093-0132-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place and protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE Teva Pharmaceuticals USA, Inc. ---------- MEDICATION GUIDE LAMOTRIGINE (la MOE tri jeen) TABLETS FOR ORAL SUSPENSION USP (CHEWABLE DISPERSIBLE TABLETS) What is the most important information I should know about lamotrigine tablets for oral suspension (chewable dispersible tablets)? 1. Lamotrigine tablets for oral suspension (chewable dispersible 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 tablets for oral suspension (chewable dispersible tablets), 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 tablets for oral suspension (chewable dispersible tablets). The risk of getting a serious skin rash is higher if you: • take lamotrigine tablets for oral suspension (chewable dispersible tablets) while taking valproate [DEPAKENE® (valproic acid) or DEPAKOTE® (divalproex sodium)]. • take a higher starting dose of lamotrigine tablets for oral suspension (chewable dispersible tablets) than your healthcare provider prescribed. • increase your dose of lamotrigine tablets for oral suspension (chewable dispersible 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 tablets for oral suspension (chewable dispersible tablets). 2. Other serious reactions, including serious blood problems or liver problems. Lamotrigine tablets for oral suspension (chewable dispersible tablets) can also cause other types of all Soma hati kamili
LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LAMOTRIGINE TABLETS FOR ORAL SUSPENSION (CHEWABLE DISPERSIBLE TABLETS) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS FOR ORAL SUSPENSION (CHEWABLE DISPERSIBLE TABLETS). LAMOTRIGINE TABLETS FOR ORAL SUSPENSION (CHEWABLE DISPERSIBLE 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 TABLETS FOR ORAL SUSPENSION (CHEWABLE DISPERSIBLE TABLETS) ● EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE TABLETS FOR ORAL SUSPENSION (CHEWABLE DISPERSIBLE TABLETS) (5.1) BENIGN RASHES ARE ALSO CAUSED BY LAMOTRIGINE TABLETS FOR ORAL SUSPENSION (CHEWABLE DISPERSIBLE TABLETS); HOWEVER, IT IS NOT POSSIBLE TO PREDICT WHICH RASHES WILL PROVE TO BE SERIOUS OR LIFE THREATENING. LAMOTRIGINE TABLETS FOR ORAL SUSPENSION (CHEWABLE DISPERSIBLE TABLETS) 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 tablets for oral suspension (chewable dispersible tablets)are 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 synd Soma hati kamili