LACOSAMIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Glenmark Pharmaceuticals Inc. USA

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Lacosamide tablets are indicated for the treatment of partial-onset 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 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, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or other

Product samenvatting:

Lacosamide Tablets, USP 50 mg are light pink, oval, film-coated tablets debossed with "G" on one side and "678" on the other side. They are supplied as follows: Bottles of 30 with child-resistant closures, NDC 68462-678-30 Bottles of 60 with child-resistant closures, NDC 68462-678-60 Bottles of 1000, NDC 68462-678-10 Lacosamide Tablets, USP 100 mg are light yellow, oval, film-coated tablets debossed with "G" on one side and "679" on the other side. They are supplied as follows: Bottles of 30 with child-resistant closures, NDC 68462-679-30 Bottles of 60 with child-resistant closures, NDC 68462-679-60 Bottles of 1000, NDC 68462-679-10 Lacosamide Tablets, USP 150 mg are pink, oval, film-coated tablets debossed with "G" on one side and "680" on the other side. They are supplied as follows: Bottles of 30 with child-resistant closures, NDC 68462-680-30 Bottles of 60 with child-resistant closures, NDC 68462-680-60 Bottles of 1000, NDC 68462-680-10 Lacosamide Tablets, USP 200 mg are blue, oval, film-coated tablets debossed with "G" on one side and "681" on the other side. They are supplied as follows: Bottles of 30 with child-resistant closures, NDC 68462-681-30 Bottles of 60 with child-resistant closures, NDC 68462-681-60 Bottles of 1000, NDC 68462-681-10 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

LACOSAMIDE- LACOSAMIDE TABLET, FILM COATED
Glenmark Pharmaceuticals Inc. USA
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Medication Guide
Lacosamide (la-KOE-sa-mide)
Tablets, for oral use, USP 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

Productkenmerken

LACOSAMIDE- LACOSAMIDE TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC. USA
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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, 2.2) 4/2023
INDICATIONS AND USAGE
Lacosamide tablets are indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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Treatment of partial-onset seizures in patients 4 years of age and
older (1.1)
_Adults (17 years and older):_
Initial dosage for monotherapy for the treatment of partial-onset
seizures is 100 mg twice daily (2.1)
Initial dosage for adjunctive therapy for the treatment of
partial-onset seizures is 50 mg twice daily
(2.1)
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 (2.4, 12.3)
Dose adjustment is recommended for mild or moderate hepatic
impairment; use in patients with
severe hepatic impairment is not recommended (2.5, 12.3)
50 mg (light pink), 100 mg (light yellow), 150 mg (pink), 200 mg
(blue) film-coated tablets (3)
None (4)
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 pati