Asenapine

Asenapine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Asenapine FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Asenapine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Asenapine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Asenapine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Asenapine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Asenapine in pediatric patients.

Contraindications

There is limited information regarding Asenapine Contraindications in the drug label.

Warnings

There is limited information regarding Asenapine Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Asenapine Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Asenapine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Asenapine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Asenapine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Asenapine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Asenapine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Asenapine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Asenapine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Asenapine in geriatric settings.

Gender

There is no FDA guidance on the use of Asenapine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Asenapine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Asenapine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Asenapine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Asenapine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Asenapine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Asenapine Administration in the drug label.

Monitoring

There is limited information regarding Asenapine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Asenapine and IV administrations.

Overdosage

There is limited information regarding Asenapine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Asenapine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Asenapine Mechanism of Action in the drug label.

Structure

There is limited information regarding Asenapine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Asenapine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Asenapine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Asenapine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Asenapine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Asenapine How Supplied in the drug label.

Storage

There is limited information regarding Asenapine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Asenapine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Asenapine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Asenapine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Asenapine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Asenapine

File:Asenapine.png
Identifiers
IUPAC name (3aS,12bS)-5-Chloro-2,3,3a,12b-tetrahydro- 2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole
CAS Number	65576-45-6
PubChem CID	163091
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C17H16ClNO
Molar mass	285.77 g/mol

Asenapine is a new 5-HT_2A- and D2-receptor antagonist under development for the treatment of schizophrenia and acute mania associated with bipolar disorder by Schering-Plough after its November 19, 2007 combination with Organon International. Development of the drug, through Phase III trials, began while Organon was still a part of Akzo Nobel. Preliminary data indicate that it has minimal anticholinergic and cardiovascular side effects, as well as minimal weight gain. Over 3000 patients have participated in clinical trials of asenapine, and the FDA accepted the manufacturer's NDA on November 26, 2007 for standard review.

Asenapine belongs to a class of neuroleptics known as "atypical antipsychotics", which have, over the last two decades, become increasingly popular alternatives to "typical antipsychotics", such as haloperidol. The manufacturers of asanapine refer to it as a "new generation" or "second generation" atypical antipsychotic.

Other atypical antipsychotics include aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone.

External links

Commercial

• Organon website

Third-party

• Organon Continues With The Development Of Asenapine For Schizophrenia And Acute Mania Associated With Bipolar I Disorder