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Dicyclomine Drug Information Provided by Lexi-Comp

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Pronunciation

(dye SYE kloe meen)

Generic Available (U.S.)

Yes: Excludes syrup

Index Terms

  • Dicyclomine Hydrochloride
  • Dicycloverine Hydrochloride

Brand Names: U.S.

  • Bentyl®

Brand Names: Canada

  • Bentylol®
  • Formulex®
  • Lomine
  • Riva-Dicyclomine

Pharmacologic Category

  • Anticholinergic Agent

Pharmacologic Category Synonyms

  • Cholinergic Antagonist

Use: Labeled Indications

Treatment of functional bowel/irritable bowel syndrome

Use: Unlabeled

Urinary incontinence

Pregnancy Risk Factor

B

Pregnancy Considerations

Teratogenic effects have not been observed in animal studies.

Lactation

Enters breast milk/contraindicated

Contraindications

Hypersensitivity to dicyclomine or any component of the formulation; obstructive diseases of the GI tract; severe ulcerative colitis; reflux esophagitis; unstable cardiovascular status in acute hemorrhage; obstructive uropathy; narrow-angle glaucoma; myasthenia gravis; breast-feeding; should not be used in infants <6 months of age

Warnings/Precautions

Concerns related to adverse effects:

• CNS effects: May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Diarrhea: May be a sign of incomplete intestinal obstruction, treatment should be discontinued if this occurs.

• Heat prostration: May occur in the presence of increased environmental temperature; use caution in hot weather and/or exercise.

• Psychosis: Has been reported in patients with an extreme sensitivity to anticholinergic effects or at excessive dosages.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with coronary artery disease, tachyarrhythmias, heart failure, or hypertension; evaluate tachycardia prior to administration.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Hiatal hernia: Use with caution in patients with hiatal hernia.

• Hyperthyroidism: Use with caution in patients with hyperthyroidism.

• Neuropathy: Use with caution in patients with autonomic neuropathy.

• Prostatic hyperplasia: Use with caution in patients with prostatic hyperplasia (known or suspected).

• Renal impairment: Use with caution in patients with renal impairment.

• Ulcerative colitis: Use with caution in patients with mild-moderate ulcerative colitis.

Special populations:

• Elderly: Avoid long term use in this age group due to potent anticholinergic effects and uncertain effectiveness (Beers Criteria).

• Pediatrics: Safety and efficacy have not been established in children. Serious respiratory reactions, central nervous symptoms, and deaths have been reported following administration to infants; use in infants <6 months of age is contraindicated).

Other warnings/precautions:

• Appropriate administration: Injectable formulation is for I.M. administration only; inadvertent I.V. administration may cause thrombosis/thrombophlebitis and injection site reactions (eg, pain, edema, skin color change, reflex sympathetic dystrophy).

Adverse Reactions

Adverse reactions are included here that have been reported for pharmacologically similar drugs with anticholinergic/antispasmodic action.

Cardiovascular: Palpitation, syncope, tachycardia

Central nervous system: Dizziness (29%), lightheadedness (11%), drowsiness (9%), tingling, headache, nervousness (6%), numbness, mental confusion and/or excitement, dyskinesia, lethargy, speech disturbance, insomnia

Dermatologic: Rash, urticaria, itching, and other dermal manifestations

Endocrine & metabolic: Suppression of lactation

Gastrointestinal: Xerostomia (33%), nausea (14%), vomiting, constipation, bloated feeling, abdominal pain, taste loss, anorexia

Genitourinary: Urinary hesitancy, urinary retention, impotence

Local: Irritation (injection), focal coagulation necrosis (injection)

Neuromuscular & skeletal: Weakness (7%)

Ocular: Blurred vision (27%), diplopia, mydriasis, cycloplegia, increased ocular tension

Respiratory: Dyspnea, apnea, asphyxia, nasal stuffiness or congestion, sneezing, throat congestion

Miscellaneous: Anaphylaxis, diaphoresis decreased, severe allergic reaction

Metabolism/Transport Effects

None known.

Drug Interactions

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Risk C: Monitor therapy

Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy

Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Levocabastine (Nasal); Paliperidone. Risk C: Monitor therapy

Cannabinoids: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoids. Risk C: Monitor therapy

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Risk C: Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Risk D: Consider therapy modification

Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Risk C: Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Risk D: Consider therapy modification

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may increase CNS depression).

Storage

Protect from light.

Mechanism of Action

Blocks the action of acetylcholine at parasympathetic sites in smooth muscle, secretory glands and the CNS

Pharmacodynamics/Kinetics

Onset of action: 1-2 hours

Duration: ≤4 hours

Absorption: Oral: Well absorbed

Metabolism: Extensive

Half-life elimination: Initial: 1.8 hours; Terminal: 9-10 hours

Excretion: Urine (small amounts as unchanged drug)

Dosage

Adults:

Oral: Initiate with 80 mg/day in 4 equally divided doses, then increase up to 160 mg/day. Duration: Safety data not available for duration >2 weeks.

I.M. (should not be used I.V.): 80 mg/day in 4 divided doses (20 mg/dose)

Administration: Oral

Administer 30-60 minutes before a meal.

Administration: I.M.

Administer solution for injection as I.M. injection only.

Administration: I.V.

Do not administer I.V.

Monitoring Parameters

Pulse, anticholinergic effect, urinary output, GI symptoms

Patient Education

Take before meals. Avoid alcohol. This drug may impair mental alertness or cause constipation. Report excessive and persistent anticholinergic effects (blurred vision, headache, flushing, tachycardia, nervousness, dizziness, insomnia, mental confusion or excitement, dry mouth, altered taste perception, dysphagia, palpitations, bradycardia, urinary hesitancy or retention, impotence, decreased sweating); change in color of urine or stools; or irritation or redness at injection site.

Geriatric Considerations

Long-term use of antispasmodics should be avoided in the elderly. The potential for a toxic reaction is greater than the potential benefit. In addition, the anticholinergic effects of dicyclomine are not well tolerated in the elderly.

This medication is considered to be potentially inappropriate in this patient population (Beers Criteria: Quality of evidence - moderate; Strength of recommendation - strong).

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation)

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause nervousness, excitement, insomnia, confusion, drowsiness, dyskinesia

Mental Health: Effects on Psychiatric Treatment

Concurrent use with psychotropics may produce additive sedation and dry mouth

Nursing: Physical Assessment/Monitoring

Monitor for anticholinergic response.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, oral, as hydrochloride: 10 mg

Bentyl®: 10 mg

Injection, solution, as hydrochloride: 10 mg/mL (2 mL)

Bentyl®: 10 mg/mL (2 mL)

Syrup, oral, as hydrochloride:

Bentyl®: 10 mg/5 mL (480 mL) [contains propylene glycol]

Tablet, oral, as hydrochloride: 20 mg

Bentyl®: 20 mg

Pricing: U.S. (www.drugstore.com)

Capsules (Bentyl)

10 mg (30): $23.75

Capsules (Dicyclomine HCl)

10 mg (30): $13.99

Syrup (Bentyl)

10 mg/5 mL (240): $35.99

Tablets (Bentyl)

20 mg (30): $29.99

Tablets (Dicyclomine HCl)

20 mg (30): $11.99

References

"American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults," J Am Geriatr Soc, 2012 [epub ahead of print].

International Brand Names

  • Babypasmil (AR)
  • Bentyl (BR, MX, TW)
  • Blisscolic (PK)
  • Coligon (IN)
  • Cyclominol (IN)
  • Dicymine (HK, TH)
  • Merbentyl (GB, NZ)
  • Nomcramp (ZA)
  • Notensyl (IL)
  • Spasdon Drops (PH)
  • Spatomin (KP)
  • Swityl (TW)
  • Trigan (RU)
  • Wintyl (TW)

Lexi-Comp.com

Last full review/revision April 2012

Content last modified April 2012

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