LAMOTRIGINE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Bryant Ranch Prepack

INN (Alþjóðlegt nafn):

LAMOTRIGINE

Samsetning:

LAMOTRIGINE 200 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Adjunctive Therapy Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: Monotherapy 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)]. Limitations of Use

Vörulýsing:

NDC: 71335-0044-1: 60 Tablets in a BOTTLE NDC: 71335-0044-2: 30 Tablets in a BOTTLE NDC: 71335-0044-3: 90 Tablets in a BOTTLE NDC: 71335-0044-4: 120 Tablets in a BOTTLE NDC: 71335-0044-5: 180 Tablets in a BOTTLE

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

LAMOTRIGINE- lamotrigine tablet
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Lamotrigine Tablets, USP
(la moe'tri jeen)
What is the most important information I should know about lamotrigine
tablets, USP?
1. Lamotrigine tablets, USP 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, USP but is more likely
to happen within the first 2 to 8 weeks
of treatment. Children and teenagers between 2 and 17 years have a
higher chance of getting this serious skin
rash while taking lamotrigine tablets, USP.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine tablets, USP while taking valproate [DEPAKENE
(valproic acid) or DEPAKOTE
(divalproex sodium)].
•
take a higher starting dose of lamotrigine tablets, USP than your
healthcare provider prescribed
•
increase your dose of lamotrigine tablets, USP 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, USP.
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
•
weakness, fatigue
•
yellowing of your skin or the white part of your eyes
3. Lik

Vara einkenni

LAMOTRIGINE- LAMOTRIGINE TABLET
BRYANT RANCH PREPACK
----------
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_
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:
COADMINISTRATION WITH VALPROATE
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE
EXCEEDING RECOMMENDED DOSE ESCALATION OF 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, Hemophagocytic 9/2019
Lymphohistiocytosis (5.2)
INDICATIONS AND USAGE
Lamotrigine tablets, USP are 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
lamotrigine in the acute tr