LAMOTRIGINE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Unichem Pharmaceuticals (USA), Inc.

INN（国际名称）:

LAMOTRIGINE

组成:

LAMOTRIGINE 25 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Adjunctive Therapy Lamotrigine tablets are 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 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, hyp

產品總結:

Lamotrigine Tablets USP, 25 mg White, caplet shaped, biconvex tablets with 'U' debossed on either side of break line on one side and '111' debossed on other side. Bottles of 100: NDC 29300-111-01 Bottles of 500: NDC 29300-111-05 Bottles of 1000: NDC 29300-111-10 Lamotrigine Tablets USP, 100 mg White, trigonal shaped, biconvex tablets with 'U' debossed on either side of break line on one side and '112' debossed on other side. Bottles of 100: NDC 29300-112-01 Bottles of 500: NDC 29300-112-05 Bottles of 1000: NDC 29300-112-10 Lamotrigine Tablets USP, 150 mg White, trigonal shaped, biconvex tablets with 'U' debossed on either side of break line on one side and '113' debossed on other side. Bottles of 60: NDC 29300-113-16 Bottles of 500: NDC 29300-113-05 Bottles of 1000: NDC 29300-113-10 Lamotrigine Tablets USP, 200 mg Light blue, trigonal shaped, biconvex tablets with 'U' debossed on either side of break line on one side and '114' debossed on other side. Bottles of 60: NDC 29300-114-16 Bottles of 500: NDC 29300-114-05 Bottles of 1000: NDC 29300-114-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in a dry place. Dispense in tight, light-resistant container as defined in the USP.

授权状态:

Abbreviated New Drug Application

资料单张

Unichem Pharmaceuticals (USA), Inc.
----------
MEDICATION GUIDE
Lamotrigine (la-MOE-tri-jeen) Tablets, USP
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, looking pale
•
weakness, fatigue
•
yellowing of your skin or the white part of your eyes
•
trouble walking or seeing

产品特点

LAMOTRIGINE - LAMOTRIGINE TABLET
UNICHEM PHARMACEUTICALS (USA), 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._
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 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 drug related. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiac Rhythm and Conduction 03/2021
Abnormalities (5.4)
INDICATIONS AND USAGE
Lamotrigine tablets 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