Dicycloverine

Dicycloverine
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: Aparna Vuppala, M.B.B.S. [2]

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Overview

Dicycloverine is a cholinergic antagonist and a muscarinic antagonist that is FDA approved for the treatment of functional bowel/irritable bowel syndrome. Common adverse reactions include Dry Mouth,Dizziness and Blurred Vision.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

=====For the treatment of functional bowel/irritable bowel syndrome. =====*

• Dosage

• DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS.

• The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient's response during the first week of therapy, the dose should be increased to 160 mg per day unless side effects limit dosage escalation.

• If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

• The intramuscular dosage form is to be used temporarily when the patient cannot take oral medication. Intramuscular injection is about twice as bioavailable as oral dosage forms; consequently, the recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).

• Oral dicyclomine hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Dicycloverine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Dicycloverine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dicycloverine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Dicycloverine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Dicycloverine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Dicycloverine with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Dicycloverine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Dicycloverine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Dicycloverine in the drug label.

Pharmacology

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

Mechanism of Action

Structure

File:Dicycloverine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dicycloverine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Dicycloverine in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Precautions with Alcohol

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

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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Dicycloverine

File:Dicyclomine-trans.png
Clinical data
ATC code	A03AA07 (WHO)
Pharmacokinetic data
Protein binding	>99%
Identifiers
IUPAC name 2-diethylaminoethyl1- cyclohexylcyclohexane- 1-carboxylate
CAS Number	77-19-0
PubChem CID	3042
DrugBank	APRD00113
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C19H35NO2
Molar mass	309.487 g/mol

Dicyclomine is an anticholinergic that blocks muscarinic receptors. Dicyclomine is known as dicycloverine hydrochloride in the UK.

Clinical uses

Dicyclomine is used to treat intestinal hypermotility, the symptoms of Irritable Bowel Syndrome (IBS) (also known as spastic colon). It relieves muscle spasms in the gastrointestinal tract by blocking the activity of a certain natural substance in the body. It is a smooth muscle relaxer.

In America, it is sold under the trade names: Bentyl, Byclomine, Dibent, Di-Spaz, Dilomine.

It is sold under the trade names Bentylol (Hoechst Marion Roussel), Formulex (ICN), and Lomine (Riva) in Canada.

Sources

• Brenner, G. M. (2000). Pharmacology. Philadelphia, PA: W.B. Saunders Company. ISBN 0-7216-7757-6
• Canadian Pharmacists Association (2000). Compendium of Pharmaceuticals and Specialties (25th ed.). Toronto, ON: Webcom. ISBN 0-919115-76-4

External links

• Dicyclomine on Medicine Net
• Dicyclomine on Medline Plus