LACOSAMIDE injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Zydus Pharmaceuticals USA Inc.

Адміністрація маршрут:

INTRAVENOUS

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

Lacosamide Injection, USP 200 mg/20 mL is a clear, colorless sterile solution supplied in 20 mL colorless single-dose glass vials. 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] . Do not freeze lacosamide injection.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Zydus Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Lacosamide (la koe' sa mide) injection, USP for intravenous use, CV
Read this Medication Guide before you start taking lacosamide and each
time you get a
refill. There may be new information. This Medication Guide describes
important safety
information about lacosamide. 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?
Do not stop taking lacosamide without first talking to your healthcare
provider. Stopping
lacosamide 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 can cause serious side effects, including:
1. Like other antiepileptic drugs, lacosamide 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 provider may check
for other
causes.
2. Lacosa

Характеристики продукта

LACOSAMIDE- LACOSAMIDE INJECTION
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LACOSAMIDE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LACOSAMIDE INJECTION.
LACOSAMIDE INJECTION, FOR INTRAVENOUS USE, CV
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Dosage and Administration (2.2)4/2023
INDICATIONS AND USAGE
Lacosamide is indicated for:
Treatment of partial-onset seizures in patients 4 years of age and
older (1.1)
Adjunctive therapy in the treatment of primary generalized
tonic-clonic seizures in patients 4 years of
age and older (1.2)
DOSAGE AND ADMINISTRATION
_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 or primary
generalized tonic-clonic 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)
Injection: for intravenous use only when oral administration is
temporarily not feasible; the
recommended dosage is administered two or three times daily over 15 to
60 minutes; obtaining ECG
before initiation is recommended in certain patients (2.7,5.3)
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 (2.4, 12.3)
DOSAGE FORMS AND STRENGTHS
200 mg/20 mL single-dose vial for intravenous use (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Monitor patients for suicidal behavior and ideation (5.1)
Lacosamide may cause dizziness and ataxia (5.2)
Cardiac R