LACOSAMIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York, LLC

INN (International Name):

LACOSAMIDE

Composition:

LACOSAMIDE 10 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lacosamide oral solution is indicated in patients 17 years and older with partial-onset seizures as adjunctive therapy. None. Pregnancy Category C Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. These effects were observed at doses associated with clinically relevant plasma exposures. Lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential related adverse effects on CNS development cannot be ruled out. There are no adequate and well-controlled studies in pregnant women. Lacosamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Product summary:

Lacosamide oral solution 10 mg/mL is a clear, colorless to yellow or yellow-brown, strawberry-flavored liquid. It is supplied in PET bottles as follows: 465 mL (16 oz) bottles                                                                                    NDC 65162-912-68 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° 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 bottle.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Amneal Pharmaceuticals of New York, LLC
----------
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.
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, your healthcare provider may check
for other
causes.
•
Do not stop lacosamide oral solution without

Summary of Product characteristics

LACOSAMIDE- LACOSAMIDE SOLUTION
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
----------
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) 08/2014
Dosage and Administration (2) 08/2014
Warnings and Precautions (5.3, 5.4) 08/2014
INDICATIONS AND USAGE
Lacosamide oral solutionis indicated as adjunctive therapy in patients
with partial onset seizures (1)
DOSAGE AND ADMINISTRATION
Adjunctive Therapy: initial recommended dose is 50 mg twice daily;
based on individual patient response and
tolerability, increase at weekly intervals by 50 mg twice daily, up to
a recommended maintenance dose of 100 mg to
200 mg twice daily (2.1)
Renal impairment: Dose adjustment is recommended for patients with
severe renal impairment (creatinine clearance ≤
30 mL/min) (2.3, 12.3)
Hepatic impairment: Dose adjustment is recommended for patients with
mild or moderate hepatic impairment; use in
severe hepatic impairment patients 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 and ideation (5.1)
Lacosamide may cause dizziness and ataxia (5.2)
Cardiac Rhythm and Conduction Abnormalities: ECG before beginning
lacosamide, and after lacosamide is titrated to
steady-state maintenance dose is recommended in patients with known
cardiac conduction problems, taking drugs
known to induce PR interval prolongation, or with severe cardiac
disease (5.3)
Lacosamide may cause syncope (5.4)
Lacosamide should be gradually withdrawn to minimize the potential of
increased seizure frequency (5.5)
Multiorgan Hypersensitivity Reactions (5.6)
ADVERSE REACTIONS
Adjunctive therapy: Most common adverse reactions (≥10% and greater
than placebo) are diplopia, headache, dizziness,
na