LACOSAMIDE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5)

제공처:

Alembic Pharmaceuticals Limited

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as lacosamide, during pregnancy. Encourage women who are taking lacosamide during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women. Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. These effects were observed at doses associated w

제품 요약:

Lacosamide tablets USP, 50 mg are pink, oval, film-coated tablets debossed with “423” on one side and plain on other side. They are supplied as follows: Bottle of 30 tablets with child resistant closure, NDC 46708-171-30 Bottle of 60 tablets with child resistant closure, NDC 46708-171-60 Bottle of 1000 tablets, 46708-171-91 100 (10 X 10) unit-dose tablets, NDC 46708-171-10 Lacosamide tablets USP, 100 mg are dark yellow, oval, film-coated tablets debossed with “L424” on one side and plain on other side. They are supplied as follows: Bottle of 30 tablets with child resistant closure, NDC 46708-172-30 Bottle of 60 tablets with child resistant closure, NDC 46708-172-60 Bottle of 1000 tablets, NDC 46708-172-91 100 (10 X 10) unit-dose tablets, NDC 46708-172-10 Lacosamide tablets USP, 150 mg are salmon, oval, film-coated tablets debossed with “L425” on one side and plain on other side. They are supplied as follows: Bottle of 30 tablets with child resistant closure, NDC 46708-173-30 Bottle of 60 tablets with child resistant closure, NDC 46708-173-60 Bottle of 1000 tablets, NDC 46708-173-91 100 (10 X 10) unit-dose tablets, NDC 46708-173-10 Lacosamide tablets USP, 200 mg are blue, oval, film-coated tablets debossed with “L426” on one side and plain on other side. They are supplied as follows: Bottle of 30 tablets with child resistant closure, NDC 46708-174-30 Bottle of 60 tablets with child resistant closure, NDC 46708-174-60 Bottle of 500 tablets, NDC 46708-174-71 100 (10 X 10) unit-dose tablets, NDC 46708-174-10 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

Alembic Pharmaceuticals Limited
----------
Medication Guide
Lacosamide (la KOE sa mide)
film coated tablet, for oral use, CV
Read this Medication Guide before you start taking lacosamide tablets
and each time you get a refill. There
may be new information. This Medication Guide describes important
safety information about lacosamide
tablets. This information does not take the place of talking to your
healthcare provider about your medical
condition or treatment.
What
is
the
most
important
information
I
should
know
about
lacosamide
tablets?
Do not stop taking lacosamide tablets without first talking to your
healthcare provider. Stopping lacosamide
tablets suddenly can cause serious problems. Stopping seizure medicine
suddenly in a patient who has
epilepsy
can
cause
seizures
that
will
not
stop
(status
epilepticus).
Lacosamide
tablets
can
cause
serious
side
effects,
including:
1.
Like other antiepileptic drugs, lacosamide tablets may cause suicidal
thoughts or actions in a very
small
number
of
people,
about
1
in
500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
• thoughts
about
suicide
or
dying • trouble
sleeping
(insomnia)
• attempt
to
commit
suicide • new
or
worse
irritability
• new
or
worse
depression • acting
aggressive,
being
angry,
or
violent
• new
or
worse
anxiety • acting
on
dangerous
impulses
• feeling agitated or restless • an extreme increase in activity
and talking (mania)
• panic
attacks • other
unusual
changes
in
behavior
or
mood
How
can
I
watch
for
early
symptoms
of
suicidal
thoughts
and
actions?
• Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings.
• Keep
all
follow-up
visits
with
your
healthcare
provider
as
scheduled.
• Call your healthcare provider between visits as needed, especially
if you are worried about symptoms.
• Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal thoughts or
actions,
your
hea

제품 특성 요약

LACOSAMIDE - LACOSAMIDE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LACOSAMIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LACOSAMIDE TABLETS.
LACOSAMIDE TABLETS, FILM COATED FOR ORAL USE, CV
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Indications and Usage (1.1) 10/2021
Dosage and Administration (2.1) 10/2021
Warnings and Precautions (5.2) 11/2020
INDICATIONS AND USAGE
Lacosamide tablets are indicated for: (1)
• Treatment of partial-onset seizures in patients 4 years of age and
older (1.1) (1)
DOSAGE AND ADMINISTRATION
• _Adults (17 years and older):_
o Initial dosage for monotherapy for the treatment of partial-onset
seizures is 100 mg twice daily (2.1)
o Initial dosage for adjunctive therapy for the treatment of
partial-onset seizures is 50 mg twice daily
(2.1)
o Maximum recommended dosage for monotherapy and adjunctive therapy is
200 mg twice daily (2.1)
• _Pediatric Patients 4 years to less than 17 years:_ The
recommended dosage is based on body weight
and is administered orally twice daily (2.1)
• Increase dosage based on clinical response and tolerability, no
more frequently than once per week (2.1)
• Dose adjustment is recommended for severe renal impairment (2.3,
12.3)
• Dose adjustment is recommended for mild or moderate hepatic
impairment; use in patients with severe
hepatic impairment is not recommended (2.4, 12.3) (2)
DOSAGE FORMS AND STRENGTHS
50 mg, 100 mg, 150 mg, 200 mg tablets (3)
CONTRAINDICATIONS
None. (4) (4)
WARNINGS AND PRECAUTIONS
Monitor patients for suicidal behavior and ideation (5.1)
Lacosamide may cause dizziness and ataxia (5.2)
Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before
beginning and after titration to
steady-state maintenance is recommended in patients with underlying
proarrhythmic conditions or on
concomitant medications that affect cardiac conduction; closely
monitor these patients (5.3, 7.2)
La