LACOSAMIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

VistaPharm, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Lacosamide oral solution 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 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 followin

Product summary:

Lacosamide Oral Solution NDC 66689-107-01: 5 mL unit-dose cup NDC 66689-107-10: Case contains 10 unit-dose cups of 5 mL (NDC 66689-107-01), packaged in a tray of 10 unit-dose cups. NDC 66689-108-01: 10 mL unit-dose cup NDC 66689-108-10: Case contains 10 unit-dose cups of 10 mL (NDC 66689-108-01), packaged in a tray of 10 unit-dose cups. NDC 66689-109-01: 15 mL unit-dose cup NDC 66689-109-10: Case contains 10 unit-dose cups of 15 mL (NDC 66689-109-01), packaged in a tray of 10 unit-dose cups. NDC 66689-110-01: 20 mL unit-dose cup NDC 66689-110-10: Case contains 10 unit-dose cups of 20 mL (NDC 66689-110-01), packaged in a tray of 10 unit-dose cups. 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 oral solution. Discard any unused lacosamide oral solution remaining after seven (7) weeks of first opening the package.

Authorization status:

New Drug Application

Patient Information leaflet

VistaPharm, Inc.
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MEDICATION GUIDE
Lacosamide (la-KOE-sa-mide) Oral Solution, CV
Read this Medication Guide before you start taking lacosamide oral
solution and each time you get a refill.
There may be new information. This Medication Guide describes
important safety information about
lacosamide oral solution. 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
oral solution?
Do not stop taking lacosamide oral solution without first talking to
your healthcare provider. Stopping
lacosamide oral solution 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 oral solution can cause serious side effects, including:
1. Like other antiepileptic drugs, lacosamide oral solution 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 can be caused by things other than
medicines. If you have suicidal
thoughts or actions,

Summary of Product characteristics

LACOSAMIDE- LACOSAMIDE SOLUTION
VISTAPHARM, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LACOSAMIDE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LACOSAMIDE ORAL
SOLUTION.
LACOSAMIDE ORAL SOLUTION, 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) 10/2021
Warnings and Precautions (5.2) 11/2020
INDICATIONS AND USAGE
Lacosamide oral solution is indicated for:
Treatment of partial-onset seizures in patients 1 month 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 partialonset
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 1 month 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 based on body weight and is administered two or
three times daily over 15 to
60 minutes; obtaining ECG before initiation is recommended in certain
patients (5.3)
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)
DOSAGE FORMS AND STRENGTHS
10 mg/mL oral solution (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Monitor patients for suicidal behavior a