Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)
Rising Pharmaceuticals, Inc.
LAMOTRIGINE
LAMOTRIGINE 5 mg
ORAL
PRESCRIPTION DRUG
Adjunctive Therapy Lamotrigine tablets for oral suspension 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 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 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 tablets for oral suspension are indicated for the maintenance treatment of bipolar I disorder to
Lamotrigine Tablets for Oral Suspension USP, 5 mg are white to off-white, capsule shaped, flat faced, beveled edge uncoated tablets debossed with “D” on one side and “98” on the other side. Bottles of 100 NDC 64980-400-01 Lamotrigine Tablets for Oral Suspension USP, 25 mg are white to off-white, circular, flat faced, beveled edge uncoated tablets debossed with “D99” on one side and plain another side. Bottles of 100 NDC 64980-401-01 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]. Keep in a dry place.
Abbreviated New Drug Application
LAMOTRIGINE - LAMOTRIGINE TABLET, CHEWABLE Rising Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Lamotrigine Tablets for Oral Suspension, USP (la moe' tri jeen) What is the most important information I should know about lamotrigine tablets for oral suspension? 1. Lamotrigine tablets for oral suspension 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, 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. The risk of getting a serious skin rash is higher if you: • take lamotrigine tablets for oral suspension while taking valproate [DEPAKENE (valproic acid) or DEPAKOTE (divalproex sodium)]. • take a higher starting dose of lamotrigine tablets for oral suspension than your healthcare provider prescribed. • increase your dose of lamotrigine tablets for oral suspension 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. 2. Other serious reactions, including serious blood problems or liver problems. Lamotrigine tablets for oral suspension 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 pai Baca dokumen lengkapnya
LAMOTRIGINE - LAMOTRIGINE TABLET, CHEWABLE RISING PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LAMOTRIGINE TABLETS FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS FOR ORAL SUSPENSION. 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 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 Warnings and Precautions, Cardiac Rhythm and Conduction Abnormalities (5.4) 10/2020 INDICATIONS AND USAGE Lamotrigine tablets for oral suspension 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 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: Treatmen Baca dokumen lengkapnya