Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)
Mylan Pharmaceuticals Inc.
LAMOTRIGINE
LAMOTRIGINE 25 mg
ORAL
PRESCRIPTION DRUG
Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: Lamotrigine 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 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 are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (14.1)]. Treatment of acute manic or mixed episodes is not
Lamotrigine Tablets, USP are available containing 25 mg, 100 mg, 150 mg or 200 mg of lamotrigine, USP. The 25 mg tablets are white to off-white, round, scored tablets debossed with M on one side of the tablet and L above the score and 51 below the score on the other side. They are available as follows: NDC 0378-4251-01 bottles of 100 tablets The 100 mg tablets are white to off-white, round, scored tablets debossed with M above the score and L52 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4252-01 bottles of 100 tablets NDC 0378-4252-05 bottles of 500 tablets The 150 mg tablets are white to off-white, round, scored tablets debossed with M above the score and L53 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4253-91 bottles of 60 tablets NDC 0378-4253-05 bottles of 500 tablets The 200 mg tablets are green, round, scored tablets debossed with M above the score and L54 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4254-91 bottles of 60 tablets NDC 0378-4254-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE Lamotrigine Tablets, USP (la moe′ tri jeen) What is the most important information I should know about lamotrigine tablets? 1. Lamotrigine 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, 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. The risk of getting a serious skin rash is higher if you: • take lamotrigine tablets while taking valproate [DEPAKENE ® (valproic acid) or DEPAKOTE ® (divalproex sodium)]. • take a higher starting dose of lamotrigine tablets than your healthcare provider prescribed. • increase your dose of lamotrigine 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. 2. Other serious reactions, including serious blood problems or liver problems. Lamotrigine 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 symptoms: • fever • frequent infections • severe muscle pain • swelling of your face, eyes, lips, or tongue • swollen lymph glands • unusual bruising or bleeding • weakness, fatigue • yellowing of your skin or the white part of your eyes 3. Like other antiepileptic drugs, lamotrigine ta Διαβάστε το πλήρες έγγραφο
LAMOTRIGINE- LAMOTRIGINE TABLET MYLAN 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, FOR ORAL USE INITIAL U.S. APPROVAL: 1994 WARNING: SERIOUS SKIN RASHES _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • RECENT MAJOR CHANGES Warnings and Precautions, Hemophagocytic Lymphohistiocytosis (5.2) 5/2018 INDICATIONS AND USAGE Lamotrigine tablets are indicated for: Epilepsy - adjunctive therapy in patients aged 2 years and older: • • • 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 AED. (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 lamotrigine in the acute treatment of mood episodes has not been established. DOSAGE AND ADMINISTRATION • • • • • Epile psy: • 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 DRU Διαβάστε το πλήρες έγγραφο