Xanomeline and trospium chloride

Xanomeline and trospium chloride
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: Parth Vikram Singh, MBBS[2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Xanomeline and trospium chloride is a muscarinic acetylcholine receptors that is FDA approved for the treatment of COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist, of schizophrenia in adults.. Common adverse reactions include Most common adverse reactions (incidence ≥ 5% and at least twice placebo) were:

• nausea,
• dyspepsia,
• constipation,
• vomiting,
• hypertension,
• abdominal pain,
• diarrhea,
• tachycardia,
• dizziness, and
• gastrointestinal reflux disease..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Assess liver enzymes and bilirubin prior to initiating treatment with COBENFY and as clinically indicated during treatment. • Assess heart rate at baseline and as clinically indicated during treatment with COBENFY. • Recommended starting dosage of COBENFY is 50 mg/20 mg orally twice daily for at least two days, then increase the dosage to 100 mg/20 mg twice daily for at least five days. • Dosage may be increased to 125 mg/30 mg orally twice daily based on patient tolerability and response. • See the full prescribing information for the recommended titration and maximum recommended dosage. • Take at least 1 hour before a meal or at least 2 hours after a meal. Do not open capsules. • Geriatric patients: Recommended starting dosage of COBENFY is 50 mg/20 mg orally twice daily. Consider a slower titration. The maximum recommended dosage is 100 mg/20 mg twice daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Xanomeline and trospium chloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Xanomeline and trospium chloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Xanomeline and trospium chloride 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 Xanomeline and trospium chloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Xanomeline and trospium chloride in pediatric patients.

Contraindications

There is limited information regarding Xanomeline and trospium chloride Contraindications in the drug label.

Warnings

There is limited information regarding Xanomeline and trospium chloride Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Xanomeline and trospium chloride Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Xanomeline and trospium chloride Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Xanomeline and trospium chloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Xanomeline and trospium chloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Xanomeline and trospium chloride in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Xanomeline and trospium chloride in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Xanomeline and trospium chloride in geriatric settings.

Gender

There is no FDA guidance on the use of Xanomeline and trospium chloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Xanomeline and trospium chloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Xanomeline and trospium chloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Xanomeline and trospium chloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Xanomeline and trospium chloride in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Xanomeline and trospium chloride Administration in the drug label.

Monitoring

There is limited information regarding Xanomeline and trospium chloride Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Xanomeline and trospium chloride and IV administrations.

Overdosage

There is limited information regarding Xanomeline and trospium chloride 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 Xanomeline and trospium chloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Xanomeline and trospium chloride Mechanism of Action in the drug label.

Structure

There is limited information regarding Xanomeline and trospium chloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Xanomeline and trospium chloride Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Xanomeline and trospium chloride Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Xanomeline and trospium chloride Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Xanomeline and trospium chloride Clinical Studies in the drug label.

How Supplied

There is limited information regarding Xanomeline and trospium chloride How Supplied in the drug label.

Storage

There is limited information regarding Xanomeline and trospium chloride Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Xanomeline and trospium chloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Xanomeline and trospium chloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Xanomeline and trospium chloride Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Xanomeline and trospium chloride 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 Xanomeline and trospium chloride Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Xanomeline and trospium chloride 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.