LACOSAMIDE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Sun Pharmaceutical Industries, Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Lacosamide tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT® (lacosamide) tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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 Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study,

Proizvod sažetak:

Lacosamide tablets, USP Bottles of 60 with Child Resistant Cap                      NDC 47335-918-86 Bottles of 180 with Child Resistant Cap                    NDC 47335-918-82 Bottles of 1000                                                               NDC 47335-918-18 Bottles of 60 with Child Resistant Cap                      NDC 47335-922-86 Bottles of 180 with Child Resistant Cap                    NDC 47335-922-82 Bottles of 1000                                                               NDC 47335-922-18 Bottles of 60 with Child Resistant Cap                      NDC 47335-943-86 Bottles of 180 with Child Resistant Cap                    NDC 47335-943-82 Bottles of 1000                                                               NDC 47335-943-18 Bottles of 60 with Child Resistant Cap                      NDC 47335-980-86 Bottles of 180 with Child Resistant Cap                    NDC 47335-980-82 Bottles of 1000                                                                NDC 47335-980-18 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
MEDICATION GUIDE
Lacosamide (la KOE sa mide) Tablets, USP, for oral use
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
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking
(mania)
•
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 c

Svojstava lijeka

LACOSAMIDE - LACOSAMIDE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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, FOR ORAL USE, CV
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 4/2023
INDICATIONS AND USAGE
Lacosamide is indicated for: (1)
· Treatment of partial-onset seizures in patients 4 years of age and
older (1.1) (1)
· Adjunctive therapy in the treatment of primary generalized
tonic-clonic seizures in patients 4 years of
age and older (1.2) (1)
DOSAGE AND ADMINISTRATION
· _Adults_ (17 years and older): (2)
o Initial dosage for monotherapy for the treatment of partial-onset
seizures is 100 mg twice daily (2.1) (2)
o Initial dosage for adjunctive therapy for the treatment of
partial-onset seizures or primary generalized
tonic-clonic seizures is 50 mg twice daily (2.1) (2)
o Maximum recommended dosage for monotherapy and adjunctive therapy is
200 mg twice daily (2.1) (2)
· _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) (2)
· Increase dosage based on clinical response and tolerability, no
more frequently than once per week (2.1)
(2)
· Dose adjustment is recommended for severe renal impairment (2.4,
12.3) (2)
· Dose adjustment is recommended for mild or moderate hepatic
impairment; use in patients with severe
hepatic impairment is not recommended (2.5, 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) (5)
· Lacosamide may cause dizziness and ataxia (5.2) (5)
· Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before
beginning and after titration to
steady-state maintenance is recommended in patients with underlying
proarrhyth