LAMOTRIGINE tablet, orally disintegrating

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)

Предлага се от:

Amneal Pharmaceuticals of New York LLC

INN (Международно Name):

LAMOTRIGINE

Композиция:

LAMOTRIGINE 25 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Adjunctive Therapy Lamotrigine orally disintegrating tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures partial-onset seizures - primary generalized tonic-clonic (PGTC) seizures primary generalized tonic-clonic (PGTC) seizures - generalized seizures of Lennox-Gastaut syndrome generalized seizures of Lennox-Gastaut syndrome Monotherapy Lamotrigine orally disintegrating 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 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 orally disintegrating 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)] . 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. Lamotrigine orally disintegrating 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 Warning, Warnings and Precautions (5.1 , 5.2)] . As with other AEDs, physiological changes during pregnancy may affect lamotrigine concentrations and/or therapeutic effect. There have been reports of decreased lamotrigine concentrations during pregnancy and restoration of pre-partum concentrations after delivery. Dosage adjustments may be necessary to maintain clinical response.  Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In animal studies, lamotrigine was developmentally toxic at doses lower than those administered clinically. Lamotrigine orally disintegrating tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When lamotrigine was administered to pregnant mice, rats, or rabbits during the period of organogenesis (oral doses of up to 125, 25, and 30 mg/kg, respectively), reduced fetal body weight and increased incidences of fetal skeletal variations were seen in mice and rats at doses that were also maternally toxic. The no-effect doses for embryofetal developmental toxicity in mice, rats, and rabbits (75, 6.25, and 30 mg/kg, respectively) are similar to (mice and rabbits) or less than (rats) the human dose of 400 mg/day on a body surface area (mg/m2 ) basis. In a study in which pregnant rats were administered lamotrigine (oral doses of 5 or 25 mg/kg) during the period of organogenesis and offspring were evaluated postnatally, behavioral abnormalities were observed in exposed offspring at both doses. The lowest effect dose for developmental neurotoxicity in rats is less than the human dose of 400 mg/day on a mg/m2 basis. Maternal toxicity was observed at the higher dose tested. When pregnant rats were administered lamotrigine (oral doses of 5, 10, or 20 mg/kg) during the latter part of gestation, increased offspring mortality (including stillbirths) was seen at all doses. The lowest effect dose for peri/postnatal developmental toxicity in rats is less than the human dose of 400 mg/day on a mg/m2 basis. Maternal toxicity was observed at the 2 highest doses tested. Lamotrigine decreases fetal folate concentrations in rat, an effect known to be associated with adverse pregnancy outcomes in animals and humans. Pregnancy Registry To provide information regarding the effects of in utero exposure to lamotrigine, physicians are advised to recommend that pregnant patients taking lamotrigine orally disintegrating tablets enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334 and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org. The effect of lamotrigine on labor and delivery in humans is unknown. Lamotrigine is present in milk from lactating women taking lamotrigine. Data from multiple small studies indicate that lamotrigine plasma levels in human milk-fed infants have been reported to be as high as 50% of the maternal serum levels. Neonates and young infants are at risk for high serum levels because maternal serum and milk levels can rise to high levels postpartum if lamotrigine dosage has been increased during pregnancy but not later reduced to the pre-pregnancy dosage. Lamotrigine exposure is further increased due to the immaturity of the infant glucuronidation capacity needed for drug clearance. Events including apnea, drowsiness, and poor sucking have been reported in infants who have been human milk-fed by mothers using lamotrigine; whether or not these events were caused by lamotrigine is unknown. Human milk-fed infants should be closely monitored for adverse events resulting from lamotrigine. Measurement of infant serum levels should be performed to rule out toxicity if concerns arise. Human milk-feeding should be discontinued in infants with lamotrigine toxicity. Caution should be exercised when lamotrigine orally disintegrating tablets are administered to a nursing woman. Epilepsy Lamotrigine orally disintegrating tablets are indicated as adjunctive therapy in patients aged 2 years and older for partial-onset seizures, the generalized seizures of Lennox-Gastaut syndrome, and PGTC seizures. Safety and efficacy of lamotrigine used as adjunctive treatment for partial-onset seizures were not demonstrated in a small, randomized, double-blind, placebo-controlled withdrawal trial in very young pediatric patients (aged 1 to 24 months). Lamotrigine was associated with an increased risk for infectious adverse reactions (lamotrigine 37%, placebo 5%), and respiratory adverse reactions (lamotrigine 26%, placebo 5%). Infectious adverse reactions included bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection. Respiratory adverse reactions included nasal congestion, cough, and apnea. Additional information describing a clinical study in which efficacy was not demonstrated in pediatric patients ages 10 to 17 years is approved for GlaxoSmithKline LLC’s LAMICTAL® (lamotrigine) products. However, due to GlaxoSmithKline LLC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Juvenile Animal Data In a juvenile animal study in which lamotrigine (oral doses of 5, 15, or 30 mg/kg) was administered to young rats (postnatal days 7 to 62), decreased viability and growth were seen at the highest dose tested and long-term behavioral abnormalities (decreased locomotor activity, increased reactivity, and learning deficits in animals tested as adults) were observed at the 2 highest doses. The no-effect dose for adverse effects on neurobehavioral development is less than the human dose of 400 mg/day on a mg/m2 basis. Clinical trials of lamotrigine for epilepsy and bipolar disorder did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients or exhibit a different safety profile than that of younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Experience in patients with hepatic impairment is limited. Based on a clinical pharmacology study in 24 patients with mild, moderate, and severe liver impairment [see Clinical Pharmacology (12.3)] , the following general recommendations can be made. No dosage adjustment is needed in patients with mild liver impairment. Initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and 50% in patients with severe liver impairment with ascites. Escalation and maintenance doses may be adjusted according to clinical response [see Dosage and Administration (2.1)] . Lamotrigine is metabolized mainly by glucuronic acid conjugation, with the majority of the metabolites being recovered in the urine. In a small study comparing a single dose of lamotrigine in subjects with varying degrees of renal impairment with healthy volunteers, the plasma half-life of lamotrigine was approximately twice as long in the subjects with chronic renal failure [see Clinical Pharmacology (12.3)] . Initial doses of lamotrigine orally disintegrating tablets should be based on patients’ AED regimens; reduced maintenance doses may be effective for patients with significant renal impairment. Few patients with severe renal impairment have been evaluated during chronic treatment with lamotrigine. Because there is inadequate experience in this population, lamotrigine orally disintegrating tablets should be used with caution in these patients [see Dosage and Administration (2.1)] .

Каталог на резюме:

Lamotrigine Orally Disintegrating Tablets 25 mg, off-white to white circular tablets debossed with “WPI” on one side and “3721” on the other supplied in blisters of 15 (NDC 0115-1526-68) and in cartons of 30 (NDC 0115-1526-08). 50 mg, off-white to white circular tablets debossed with “WPI” on one side and “3722” on the other supplied in blisters of 15 (NDC 0115-1527-68) and in cartons of 30 (NDC 0115-1527-08). 100 mg, off-white to white circular tablets debossed with “WPI” on one side and “3723” on the other supplied in blisters of 10 (NDC 0115-1528-15) and in cartons of 30 (NDC 0115-1528-08). 200 mg, off-white to white circular tablets debossed with “WPI” on one side and “3724” on the other supplied in blisters of 10 (NDC 0115-1529-15) and in cartons of 30 (NDC 0115-1529-08). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Статус Оторизация:

Abbreviated New Drug Application

Листовка

LAMOTRIGINE- LAMOTRIGINE TABLET, ORALLY DISINTEGRATING
Amneal Pharmaceuticals of New York LLC
----------
MEDICATION GUIDE
LAMOTRIGINE (la-moe’-tri-jeen) Orally Disintegrating Tablets
Phenylketonurics: Contains Phenylalanine 1.40 mg Per 25 mg tablet
Contains Phenylalanine 2.80 mg Per 50 mg tablet
Contains Phenylalanine 5.60 mg Per 100 mg tablet
Contains Phenylalanine 11.20 mg Per 200 mg tablet
What is the most important information I should know about lamotrigine
orally disintegrating tablets?
1. Lamotrigine orally disintegrating 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 orally disintegrating
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 orally disintegrating tablets.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine orally disintegrating tablets while taking while
taking valproate [DEPAKENE®
(valproic acid) or DEPAKOTE® (divalproex sodium)]
•
take a higher starting dose of lamotrigine orally disintegrating
tablets than your healthcare
provider prescribed
•
increase your dose of lamotrigine orally disintegrating 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 the 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 orally
disintegrating tablets.
2. Other serious reactions, including serious blood problems or liver
problems. Lamotrigine orally
disintegrating tablets can also cause other types of allergic
reactions or serious problems that may af

Данни за продукта

LAMOTRIGINE- LAMOTRIGINE TABLET, ORALLY DISINTEGRATING
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION
FOR LAMOTRIGINE ORALLY DISINTEGRATING TABLETS.
LAMOTRIGINE ORALLY DISINTEGRATING 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, 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 INCLUDE (5.1):
COADMINISTRATION WITH VALPROATE
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE ORALLY
DISINTEGRATING TABLETS
EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMOTRIGINE ORALLY
DISINTEGRATING 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
ORALLY
DISINTEGRATING 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 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 AED. (1.1)
Bipolar Disorder: Ma