SUBVENITE- lamotrigine tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

REMEDYREPACK INC.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Adjunctive Therapy SUBVENITE is 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 SUBVENITE is 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 SUBVENITE 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. SUBVENITE is 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

Produkto santrauka:

SUBVENITE (lamotrigine) tablets, USP 200 mg White to off white, round shape, flat face beveled edge, uncoated tablets debossed with “20LA” on one side and break line on other side. NDC: 70518-2645-00 NDC: 70518-2645-01 PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH 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] Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

SUBVENITE- lamotrigine tablet
REMEDYREPACK INC.
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MEDICATION GUIDE
SUBVENITE (Sub-VE-nite) lamotrigine tablets, USP
What is the most important information I should know about SUBVENITE?
1. SUBVENITE 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 SUBVENITE, 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 SUBVENITE.
The risk of getting a serious skin rash is higher if you:
•
take SUBVENITE while taking valproate [DEPAKENE(valproic acid) or
DEPAKOTE(divalproex
sodium)].
•
take a higher starting dose of SUBVENITE than your healthcare provider
prescribed.
•
increase your dose of SUBVENITE 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 SUBVENITE.
2. Other serious reactions, including serious blood problems or liver
problems. SUBVENITE 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 tender

Prekės savybės

SUBVENITE- LAMOTRIGINE TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUBVENITE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUBVENITE.
SUBVENITE (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-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 SUBVENITE.
EXCEEDING RECOMMENDED DOSE ESCALATION FOR SUBVENITE. ( 5.1)
BENIGN RASHES ARE ALSO CAUSED BY SUBVENITE; 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
SUBVENITE 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: 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
SUBVENITE in the acute treatment of mood episodes h