Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5)
Fresenius Kabi USA, 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 There are no adequate data on the developmental risks associated with the use of Lacosamide in pregnant women. Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. Develo
Lacosamide Injection, USP 200 mg per 20 mL (10 mg per mL) is a clear, colorless sterile solution supplied in 20 mL colorless single-dose glass vials. 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. The container closure is not made with natural rubber latex. Discard unused portion.
Abbreviated New Drug Application
Fresenius Kabi USA, LLC ---------- Dispense with Medication Guide available at: www.Fresenius-kabi.com/us/documents/Lacosamide_Inj_MedGuide.pdf This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 6/2022 MEDICATION GUIDE Lacosamide (la koe' sa mide) Injection, USP, for intravenous use, CV Read this Medication Guide before you start taking lacosamide and each time you get a refill. There may be new information. This Medication Guide describes important safety information about lacosamide. 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 Injection? Do not stop taking Lacosamide without first talking to your healthcare provider. Stopping Lacosamide 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 can cause serious side effects, including: 1. Like other antiepileptic drugs, Lacosamide 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 Les hele dokumentet
LACOSAMIDE- LACOSAMIDE INJECTION FRESENIUS KABI USA, 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 RECENT MAJOR CHANGES Indications and Usage (1.1) 10/2021 Dosage and Administration (2.1, 2.6) 10/2021 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): 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) 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 per 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 Les hele dokumentet