LACOSAMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Tris Pharma Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lacosamide tablets is 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 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, 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

Product summary:

Lacosamide Tablets, USP • 50 mg are pink colored, oval shaped film-coated tablets debossed with "I73" on one side and plain on other side. They are supplied as follows: Bottles of 60                                    NDC 27808-243-01   • 100 mg are dark yellow colored, oval shaped film-coated tablets debossed with "I74" on one side and plain on other side They are supplied as follows: Bottles of 60                                     NDC 27808-244-01   • 150 mg are peach colored, oval shaped film-coated tablets debossed with "I75" on one side and plain on other side. They are supplied as follows: Bottles of 60                                     NDC 27808-245-01   • 200 mg are blue colored, oval shaped film-coated tablets debossed with "I76" on one side and plain on other side. They are supplied as follows: Bottles of 60                                     NDC 27808-246-01 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LACOSAMIDE- LACOSAMIDE TABLET
Tris Pharma Inc
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MEDICATION GUIDE
Lacosamide (la KOE sa mide) film coated tablet, 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
• 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 act

Summary of Product characteristics

LACOSAMIDE- LACOSAMIDE TABLET
TRIS PHARMA 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, FILM COATED FOR ORAL USE, CV
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.2) 04/2023
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
_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)
DOSAGE FORMS AND STRENGTHS
• 50 mg, 100 mg, 150 mg, 200 mg tablets (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
• Monitor patients for suicidal behavior and ideation (5.1)
• Lacosamide tablets 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 patients (5.3, 7.2)
• Lacosamide tablets may cause syncope (5.4)
• Lacosamide tablets should be gradually withdrawn to minimize the
potential