LACOSAMIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Natco Pharma Limited

INN (International Name):

LACOSAMIDE

Composition:

LACOSAMIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lacosamide 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. Or

Product summary:

Lacosamide tablets 50 mg, are purple, oval, film-coated tablets debossed with "11" on one side and plain on the other side. They are supplied as follows: Bottles of 60 NDC 63850-0053-1 Bottles of 500 NDC 63850-0053-2 Lacosamide tablets 100 mg, are yellow, oval, film-coated tablets debossed with "12" on one side and plain on the other side. They are supplied as follows: Bottles of 60 NDC 63850-0054-1 Bottles of 500 NDC 63850-0054-2 Lacosamide tablets 150 mg, are tan, oval, film-coated tablets debossed with "113" on one side and plain on the other side. They are supplied as follows: Bottles of 60 NDC 63850-0055-1 Bottles of 500 NDC 63850-0055-2 Lacosamide tablets 200 mg, are blue, oval, film-coated tablets debossed with "114" on one side and plain on the other side. They are supplied as follows: Bottles of 60 NDC 63850-0056-1 Bottles of 500 NDC 63850-0056-2 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

Summary of Product characteristics

LACOSAMIDE- LACOSAMIDE TABLET, FILM COATED
NATCO PHARMA LIMITED
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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 TABLETS, FILM COATED FOR ORAL USE, 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 is 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
50 mg (purple), 100 mg (yellow), 150 mg (tan), 200 mg (blue)
film-coated 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: ECG before beginning
lacosamide tablets, and after lacosamide tablets
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 tablets may cause syncope (5.4)
Lacosamide tablets 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 adve