Country: United States
Language: English
Source: NLM (National Library of Medicine)
LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5)
Novadoz Pharmaceuticals LLC
INTRAVENOUS
PRESCRIPTION DRUG
Lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. Pediatric use information is approved for UCB, Inc.’s VIMPAT® (lacosamide) Injection. 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, misca
Lacosamide Injection, USP 200 mg/20 mL vial in cartons of 10 vials NDC 72205-220-07 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 injection, USP.
Abbreviated New Drug Application
LACOSAMIDE - LACOSAMIDE INJECTION NOVADOZ PHARMACEUTICALS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LACOSAMIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LACOSAMIDE INJECTION. LACOSAMIDE INJECTION, FOR INTRAVENOUS USE, CV INITIAL U.S. APPROVAL: 2008 INDICATIONS AND USAGE Lacosamide injection is indicated for: Treatment of partial-onset seizures in patients 17 years of age and older (1.1) DOSAGE AND ADMINISTRATION _Adults (17 years and older): _ o Initial dosage for monotherapy for the treatment of partial-onset seizures is 100 mg twice daily (2.1) o Initial dosage for adjunctive therapy for the treatment of partial-onset seizures is 50 mg twice daily (2.1) o Maximum recommended dosage for monotherapy and adjunctive therapy is 200 mg 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 administered two or three times daily over 15 to 60 minutes; obtaining ECG before initiation is recommended in certain patients (2.6, 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 200 mg/20 mL single-dose vial for intravenous use (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: 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 may cause syncope (5.4) Lacosamide should be gradually Read the complete document