Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5)
Natco Pharma Limited
LACOSAMIDE
LACOSAMIDE 50 mg
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
LACOSAMIDE- LACOSAMIDE TABLET, FILM COATED NATCO PHARMA LIMITED ---------- 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 Lugege kogu dokumenti