Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ASENAPINE MALEATE (UNII: CU9463U2E2) (ASENAPINE - UNII:JKZ19V908O)
MSN LABORATORIES PRIVATE LIMITED
SUBLINGUAL
PRESCRIPTION DRUG
Asenapine sublingual tablets are indicated for: - Schizophrenia in adults [see Clinical Studies (14.1)] - Bipolar I disorder [see Clinical Studies (14.2)] Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults - Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age - Adjunctive treatment to lithium or valproate in adults - Maintenance monotherapy treatment in adults Asenapine sublingual tablets are 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
Asenapine sublingual tablets are supplied as: 5 mg Tablets Round, white, uncoated tablets debossed “B” on one side and “1” on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 69539-058-34 10 mg Tablets Round, white, uncoated tablets debossed “B” on one side and “2” on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 69539-060-34 2.5 mg Tablets, black cherry flavor White colored, round shaped, uncoated tablets debossed with "B" on one side and "5" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 69539-245-34 5 mg Tablets, black cherry flavor Round, white, uncoated tablets debossed “B” on one side and “3” on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 69539-057-34 10 mg Tablets, black cherry flavor Round, white, uncoated tablets debossed “B” on one side and “4” on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 69539-059-34 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ASENAPINE - ASENAPINE MALEATE TABLET MSN LABORATORIES PRIVATE LIMITED ---------- 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 SUBLINGUAL TABLETS ARE NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1, 5.2) INDICATIONS AND USAGE Asenapine sublingual tablets are an atypical antipsychotic indicated for (1): Schizophrenia in adults Bipolar I disorder Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults DOSAGE AND ADMINISTRATION STARTING DOSE RECOMMENDED DOSE MAXIMUM DOSE Schizophrenia – acute treatment in adults (2.2) 5 mg sublingually twice daily 5 mg sublingually twice daily 10 mg sublingually twice daily Schizophrenia – maintenance treatment in adults (2.2) 5 mg sublingually twice daily 5-10 mg sublingually twice daily 10 mg sublingually twice daily Bipolar mania-adults: acute and maintenance monotherapy (2.3) 5-10 mg sublingually twice daily 5-10 mg sublingually twice daily 10 mg sublingually twice daily Bipolar mania – pediatric patients (10 to 17 years): monotherapy (2.3) 2.5 mg sublingually twice daily 2.5-10 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 5-10 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 Prečítajte si celý dokument