Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)
PD-Rx Pharmaceuticals, Inc.
LAMOTRIGINE
LAMOTRIGINE 200 mg
ORAL
PRESCRIPTION DRUG
Adjunctive Therapy Lamotrigine tablets, USP 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, USP 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, USP 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, USP are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression,
Lamotrigine Tablets, USP 200-mg White to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1049" on one side and break line on other side. Bottle of 30 NDC-43063-202-30 Bottle of 60 NDC-43063-202-60 Bottle of 90 NDC-43063-202-90 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
PD-Rx Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Lamotrigine (la-MOE-tri-jeen) Tablets, USP 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 tongue ● swollen lymph glands ● unusual bruising or bleeding, looking pale ● weakness, fatigue ● yellowing of your skin or the white part of your eyes • trouble walking or seeing • seizures for the first time or happening more often • pain and/or tenderness in Lesen Sie das vollständige Dokument
LAMOTRIGINE- LAMOTRIGINE TABLET PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LAMOTRIGINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS. LAMOTRIGINE TABLETS USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1994 WARNING: SERIOUS SKIN RASHES _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ CASES OF LIFE-THREATENINGSERIOUS 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 THERISK 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) RECENT MAJOR CHANGES Warnings and Precautions, Cardiac Rhythm and 3/2021 Conduction Abnormalities ( 5.4) INDICATIONS AND USAGE Lamotrigine, USP 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 mixed episodes is not recommended. Effectiveness of lamot Lesen Sie das vollständige Dokument