ASENAPINE- asenapine maleate tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

ASENAPINE MALEATE (UNII: CU9463U2E2) (ASENAPINE - UNII:JKZ19V908O)

Tilgængelig fra:

MSN LABORATORIES PRIVATE LIMITED

Indgivelsesvej:

SUBLINGUAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

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