LAMICTAL XR- lamotrigine tablet, film coated, extended release LAMICTAL XR- lamotrigine kit

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

GlaxoSmithKline LLC

Designación común internacional (DCI):

LAMOTRIGINE

Composición:

LAMOTRIGINE 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

LAMICTAL XR is indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. LAMICTAL XR is indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of LAMICTAL XR have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. Safety and effectiveness of LAMICTAL XR for use in patients younger than 13 years have not been established. LAMICTAL XR is 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, 5.3)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy ou

Resumen del producto:

LAMICTAL XR (lamotrigine) extended-release tablets 25-mg, yellow with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 25”, unit-of-use bottles of 30 with orange caps (NDC 0173-0754-00). 50-mg, green with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 50”, unit-of-use bottles of 30 with orange caps (NDC 0173-0755-00). 100-mg, orange with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 100”, unit-of-use bottles of 30 with orange caps (NDC 0173-0756-00). 200-mg, blue with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 200”, unit-of-use bottles of 30 with orange caps (NDC 0173-0757-00). 250-mg, purple with a white center, caplet-shaped, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 250”, unit-of-use bottles of 30 with orange caps (NDC 0173-0781-00). 300-mg, gray with a white center, caplet-shaped, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 300”, unit-of-use bottles of 30 with orange caps (NDC 0173-0761-00). LAMICTAL XR (lamotrigine) Patient Titration Kit for Patients Taking Valproate (Blue XR Kit) 25-mg, yellow with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 25” and 50 mg, green with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 50”; blister pack of 21/25-mg tablets and 7/50-mg tablets (NDC 0173-0758-00). LAMICTAL XR (lamotrigine) Patient Titration Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, and Not Taking Valproate (Green XR Kit) 50-mg, green with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 50”; 100 mg, orange with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 100”; and 200 mg, blue with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 200”; blister pack of 14/50-mg tablets, 14/100-mg tablets, and 7/200-mg tablets (NDC 0173-0759-00). LAMICTAL XR (lamotrigine) Patient Titration Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange XR Kit) 25-mg, yellow with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 25”; 50 mg, green with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 50”; and 100 mg, orange with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 100”; blister pack of 14/25-mg tablets, 14/50-mg tablets, and 7/100-mg tablets (NDC 0173-0760-00). Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Estado de Autorización:

New Drug Application

Información para el usuario

LAMICTAL XR- LAMOTRIGINE
GlaxoSmithKline LLC
----------
MEDICATION GUIDE
LAMICTAL (la-MIK-tal) XR (lamotrigine) extended-release tablets
What is the most important information I should know about LAMICTAL
XR?
1.
LAMICTAL XR 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 LAMICTAL XR, but is more likely to
happen within the first 2 to 8
weeks of treatment. Children aged between 2 and 16 years have a higher
chance of getting this serious
skin rash while taking LAMICTAL XR. LAMICTAL XR is not approved for
use in children younger
than 13 years.
The risk of getting a serious skin rash is higher if you:
•
take LAMICTAL XR while taking valproate [DEPAKENE (valproic acid) or
DEPAKOTE
(divalproex sodium)].
•
take a higher starting dose of LAMICTAL XR than your healthcare
provider prescribed.
•
increase your dose of LAMICTAL XR 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 LAMICTAL XR.
2.
Other serious reactions, including serious blood problems or liver
problems. LAMICTAL XR 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

Ficha técnica

LAMICTAL XR- LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE
LAMICTAL XR- LAMOTRIGINE
GLAXOSMITHKLINE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMICTAL XR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMICTAL XR.
LAMICTAL XR (LAMOTRIGINE) EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
WARNING: SERIOUS SKIN RASHES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
LAMICTAL XR is indicated for:
•
•
Limitation of use: Safety and effectiveness in patients younger than
13 years have not been established.
(1.3)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
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 INCLUDE:
•
•
•
COADMINISTRATION WITH VALPROATE.
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMICTAL XR.
EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMICTAL XR. (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.
LAMICTAL XR
SHOULD BE DISCONTINUED AT THE FIRST SIGN OF RASH, UNLESS THE RASH IS
CLEARLY NOT DRUG
RELATED. (5.1)
adjunctive therapy for primary generalized tonic-clonic seizures and
partial-onset seizures with or
without secondary generalization in patients aged 13 years and older.
(1.1)
conversion to monotherapy in patients aged 13 years and older with
partial-onset seizures who are
receiving treatment with a single antiepileptic drug. (1.2)
Do not exceed the recommended initial dosage and subsequent dose
escalation. (2.1)
Initiation of adjunctive therapy and conversion to monotherapy
requires slow titration dependent on
concomitant antiepileptic drugs (AEDs); the prescriber must refer to
the appropriate algo