Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
ASENAPINE (UNII: JKZ19V908O) (ASENAPINE - UNII:JKZ19V908O)
Alembic Pharmaceuticals Inc.
SUBLINGUAL
PRESCRIPTION DRUG
Asenapine is indicated for: • Bipolar I disorder [see Clinical Studies (14.2)] • Acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age • Adjunctive treatment to lithium or valproate in adults Asenapine is contraindicated in patients with: - Severe hepatic impairment (Child-Pugh C) [see Specific Populations (8.7), Clinical Pharmacology (12.3)] . - A history of hypersensitivity reactions to asenapine. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see Warnings and Precautions (5.6), Adverse Reactions (6)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asenapine during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to a
Asenapine sublingual tablets are supplied as: 2.5 mg Tablets: White to off white, round tablets debossed with ‘L’ on one side and ‘70’ on the other side. Cartons of 60 - 6 blister cards of 10 tablets each NDC 62332-544-60 Cartons of 100 - 10 blister cards of 10 tablets each NDC 62332-544-31 5-mg Tablets: White to off white, round tablets debossed with “464” on one side and plain on other side. Cartons of 60 - 6 blister cards of 10 tablets each NDC 62332-198-60 Cartons of 100 - 10 blister cards of 10 tablets each NDC 62332-198-31 10-mg Tablets: White to off white, round tablets debossed with “465” on one side and plain on other side. Cartons of 60 - 6 blister cards of 10 tablets each NDC 62332-199-60 Cartons of 100 - 10 blister cards of 10 tablets each NDC 62332-199-31 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ASENAPINE - ASENAPINE TABLET ALEMBIC PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ASENAPINE SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASENAPINE SUBLINGUAL TABLETS. ASENAPINE SUBLINGUAL TABLETS INITIAL U.S. APPROVAL: 2009 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. ASENAPINE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1, 5.2) INDICATIONS AND USAGE Asenapine is an atypical antipsychotic indicated for (1): (1) Bipolar I disorder o Acute monotherapy treatment of manic or mixed episodes, in pediatric patients 10 to 17 years of age (1) o Adjunctive treatment to lithium or valproate in adults (1) DOSAGE AND ADMINISTRATION Starting Dose Recommended Dose Maximum Dose Bipolar mania – pediatric patients (10 to 17 years): monotherapy (2.3) 2.5 mg sublingually twice daily 2.5 to 10 mg sublingually twice daily 10 mg sublingually twice daily Bipolar mania – adults: as an adjunct to lithium or valproate (2.3) 5 mg sublingually twice daily 5 to 10 mg sublingually twice daily 10 mg sublingually twice daily • Do not swallow tablet. Asenapine sublingual tablets should be placed under the tongue and left to dissolve completely. The tablet will dissolve in saliva within seconds. Eating and drinking should be avoided for 10 minutes after administration. (2.1, 17) (2) DOSAGE FORMS AND STRENGTHS Sublingual tablets: 2.5 mg, 5 mg and 10 mg (3) (3) CONTRAINDICATIONS • Severe hepatic impairment (Child-Pugh C). (8.7, 12.3) • Known hypersensitivity to asenapine, or to any components in the formulation. (4, 5.6, 17) (4) WARNINGS AND PRECAUTIONS _• Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: _Increased incidence of Прочитайте повний документ