LACOSAMIDE tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Major Pharmaceuticals

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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) tablet. 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 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. De

Огляд продуктів:

Lacosamide Tablets, USP 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]

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Major Pharmaceuticals
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MEDICATION GUIDE
Lacosamide (la-KOE-sa-mide)
Film Coated Tablets, USP 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 healthcare pro

Характеристики продукта

LACOSAMIDE- LACOSAMIDE TABLET, FILM COATED
MAJOR PHARMACEUTICALS
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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 FILM COATED TABLET, FOR ORAL USE, CV
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Indications and Usage (1.1, 1.2) 10/2021
Dosage and Administration (2.1, 2.5, 2.6) 10/2021
Warnings and Precautions (5.2) 11/2020
INDICATIONS AND USAGE
Lacosamide tablets are indicated for:
• Treatment of partial-onset seizures in patients 4 years of age and
older (1.1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASCEND LABORATORIES,
LLC AT 1-877-ASC-
RX01 (877-272-7901) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
_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)
50 mg, 100 mg, 150 mg, 200 mg tablets (3)
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
beginnin