ASENAPINE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

ASENAPINE (UNII: JKZ19V908O) (ASENAPINE - UNII:JKZ19V908O)

Inapatikana kutoka:

Sigmapharm Laboratories, LLC

Njia ya uendeshaji:

SUBLINGUAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Asenapine sublingual tablet(s) is indicated for: - Bipolar I disorder  [see Clinical Studies ( 14.2)] Adjunctive treatment to lithium or valproate in adults - 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)]. 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 ra

Bidhaa muhtasari:

Asenapine sublingual tablets are supplied as: 5 mg Tablets, black cherry flavor White, Round, FFBE Tablets, debossed “Σ” on one side and “16” on the other side. Child-resistant packaging    Bottle of 10 tablets       NDC 42794-016-22    Bottle of 30 tablets       NDC 42794-016-08    Bottle of 60 tablets       NDC 42794-016-10 10 mg Tablets, black cherry flavor White, Round, FFBE Tablets, debossed “Σ” on one side and “17” on the other side. Child-resistant packaging    Bottle of 10 tablets    NDC 42794-017-22    Bottle of 30 tablets    NDC 42794-017-08    Bottle of 60 tablets    NDC 42794-017-10 Storage Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).  Store Asenapine sublingual tablet(s) in its original container.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

ASENAPINE- ASENAPINE TABLET
SIGMAPHARM LABORATORIES, LLC
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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, FOR ORAL USE
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)
RECENT MAJOR CHANGES
Indications and Usage ( 1) 01/2017
Dosage and Administration ( 2.3) 01/2017
Contraindications ( 4) 01/2017
Warnings and Precautions 01/2017
( 5.1, 5.2, 5.3, 5.4, 5.5, 5.7, 5.9, 5.10, 5.11, 5.12, 5.13, 5.14,
5.15)
Warnings and Precautions ( 5.8) 02/2017
INDICATIONS AND USAGE
Asenapine is an atypical antipsychotic indicated for ( 1):
Bipolar I disorder
Adjunctive treatment to lithium or valproate in adults
DOSAGE AND ADMINISTRATION
STARTING
DOSE
RECOMMENDED
DOSE
MAXIMUM
DOSE
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 tablet(s) 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)
DOSAGE FORMS AND STRENGTHS
Sublingual tablets, black cherry flavor: 5 mg and 10 mg ( 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)
WARNINGS AND PRECAUTIONS
_Cerebrovascular Adverse Reactions in Elderly Patients with
Dementia-Related Psychosis:_ Increased
incidence of cerebrov