Your activity: 6 p.v.

Dicyclomine (dicycloverine): Drug information

Dicyclomine (dicycloverine): Drug information
(For additional information see "Dicyclomine (dicycloverine): Patient drug information" and see "Dicyclomine (dicycloverine): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Bentyl
Brand Names: Canada
  • JAMP-Dicyclomine HCl;
  • Protylol;
  • RIVA-Dicyclomine
Pharmacologic Category
  • Anticholinergic Agent
Dosing: Adult
Irritable bowel syndrome-associated abdominal pain

Irritable bowel syndrome-associated abdominal pain:

Note: American College of Gastroenterology (ACG) guidelines recommend against use of antispasmodics such as dicyclomine for the treatment of global symptoms of IBS (Ref); however, some experts consider as-needed use beneficial for relief of abdominal pain associated with IBS (Ref).

Oral: Initial: 20 mg up to 4 times daily; some experts recommend only administering as needed or in anticipation of a stressor that triggers abdominal pain (Ref); intended for short-term use; scheduled dosing for >2 weeks has not been studied (Ref).

According to the manufacturer's labeling, may titrate dose after 1 week, based on response and tolerability, up to 40 mg 4 times daily; however, some experts do not recommend doses >20 mg due to anticholinergic adverse effects (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.

Dosing: Pediatric

(For additional information see "Dicyclomine (dicycloverine): Pediatric drug information")

Gastrointestinal motility disorders/irritable bowel

Gastrointestinal motility disorders/irritable bowel: Limited data available (Ref):

Infants ≥6 months and Children <2 years: Oral: 5 to 10 mg 3 to 4 times daily administered 15 minutes before feeding

Children ≥2 years Oral: 10 mg 3 to 4 times daily

Adolescents: Oral: 10 to 20 mg 3 to 4 times daily. If efficacy not achieved in 2 weeks, therapy should be discontinued.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.

Dosing: Older Adult

Avoid use (Ref).

Dosage Forms: US

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

Capsule, Oral, as hydrochloride:

Generic: 10 mg

Solution, Intramuscular, as hydrochloride:

Bentyl: 10 mg/mL (2 mL) [pyrogen free]

Generic: 10 mg/mL (2 mL)

Solution, Intramuscular, as hydrochloride [preservative free]:

Generic: 10 mg/mL (2 mL)

Solution, Oral, as hydrochloride:

Generic: 10 mg/5 mL (473 mL)

Tablet, Oral, as hydrochloride:

Generic: 20 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as hydrochloride:

Protylol: 10 mg

Generic: 10 mg

Solution, Intramuscular, as hydrochloride:

Generic: 10 mg/mL ([DSC])

Tablet, Oral:

Generic: 10 mg

Tablet, Oral, as hydrochloride:

Generic: 20 mg

Administration: Adult

Oral: May be taken with or without food.

Injection: There is an injectable formulation for IM administration available intended for short-term use (<2 days) in patients unable to take oral medications; however, pain and necrosis have been reported in a case report following IM administration (Ref), and most experts would avoid use (Ref). Do not administer IV (IV administration may result in thrombosis or thrombophlebitis).

Administration: Pediatric

Oral: Administer 30 minutes before eating. For infants and young children, dilute syrup with an equal volume of water before administration.

Use: Labeled Indications

Irritable bowel syndrome: Treatment of irritable bowel syndrome (IBS)–associated abdominal pain.

Limitations of use: The American College of Gastroenterology guideline on the management of IBS recommends against the use of antispasmodics such as dicyclomine for treatment of global symptoms of IBS (ACG [Lacy 2021]); however, some experts consider as-needed use beneficial for relief of abdominal pain associated with IBS (Wald 2021).

Medication Safety Issues
Sound-alike/look-alike issues:

Dicyclomine may be confused with diphenhydrAMINE, doxycycline, dyclonine

Bentyl may be confused with Aventyl, Benadryl, Bontril, Cantil, Proventil, TRENtal

Older Adult: High-Risk Medication:

Beers Criteria: Dicyclomine is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients ≥65 years (independent of diagnosis or condition) due to its highly anticholinergic properties and uncertain effectiveness as an antispasmodic (Beers Criteria [AGS 2019]).

Pharmacy Quality Alliance (PQA): Dicyclomine is identified as a high-risk medication in patients ≥65 years on the PQA’s, Use of High-Risk Medications in the Elderly (HRM) performance measure, a safety measure used by the Centers for Medicare and Medicaid Services (CMS) for Medicare plans (PQA 2017).

Pediatric patients: High-risk medication:

KIDs List: Dicyclomine, when used in neonates and infants <6 months of age, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be avoided due to risk of apnea (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Adverse Reactions (Significant): Considerations
Anticholinergic effects

Dicyclomine causes anticholinergic effects, such as blurred vision, dizziness, dry mouth (xerostomia), and impaired cognitive function (eg, confusion) (Ref). Other effects include (but are not limited to) drowsiness, constipation, delirium, and hallucination. Anticholinergic effects may require dose reductions or discontinuation (Ref); resolution typically occurs within 12 to 24 hours after discontinuation.

Mechanism: Dose-related; related to the pharmacologic action (ie, antimuscarinic) (Ref).

Onset: Rapid; adverse reactions may occur within 2 hours of administration (Ref).

Risk factors:

• Higher doses (>80 mg/day) (Ref)

• Age >65 years (Ref)

• Concurrent use of other medications with anticholinergic effects

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Nausea (14%), xerostomia (33%) (table 1)

Dicyclomine: Adverse Reaction: Xerostomia

Drug (Dicyclomine)

Placebo

Dose

33%

5%

40 mg four times a day

Nervous system: Dizziness (40%) (table 2)

Dicyclomine: Adverse Reaction: Dizziness

Drug (Dicyclomine)

Placebo

Dose

40%

5%

40 mg four times a day

Ophthalmic: Blurred vision (27%) (table 3)

Dicyclomine: Adverse Reaction: Blurred Vision

Drug (Dicyclomine)

Placebo

Dose

27%

2%

40 mg four times a day

1% to 10%:

Nervous system: Drowsiness (9%) (table 4), nervousness (6%)

Dicyclomine: Adverse Reaction: Drowsiness

Drug (Dicyclomine)

Placebo

Dose

9%

1%

40 mg four times a day

Neuromuscular & skeletal: Asthenia (7%)

Postmarketing:

Cardiovascular: Facial edema, palpitations, syncope, tachyarrhythmia

Dermatologic: Allergic dermatitis, erythema of skin, skin rash

Gastrointestinal: Abdominal distention, abdominal pain, constipation, dyspepsia, gastrointestinal pseudo-obstruction (colonic), vomiting

Genitourinary: Lactation insufficiency

Hypersensitivity: Anaphylactic shock, angioedema

Nervous system: Agitation, amnesia (including transient global amnesia), confusion (Kay 2005), delirium, delusion, dementia (pseudodementia), fatigue, hallucination (including visual hallucination), headache, insomnia, malaise, mania, mood changes

Ophthalmic: Cycloplegia, mydriasis

Respiratory: Dyspnea, nasal congestion

Contraindications

Obstructive diseases of the GI tract; severe ulcerative colitis; reflux esophagitis; unstable cardiovascular status in acute hemorrhage; obstructive uropathy; glaucoma; myasthenia gravis; breastfeeding women; infants <6 months of age

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to dicyclomine or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• 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/delirium: Has been reported in patients with an extreme sensitivity to anticholinergic effects or at excessive dosages, such as the elderly or patients with mental illness.

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.

• 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.

• Salmonella dysentery: Do not use anticholinergic agents in patients with salmonella dysentery; toxic dilatation of intestine and intestinal perforation may occur.

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

Concurrent drug therapy issues:

• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.

Special populations:

• Pediatric: 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 IM administration only; inadvertent IV administration may cause thrombosis/thrombophlebitis and injection site reactions (eg, pain, edema, skin color change, reflex sympathetic dystrophy).

Warnings: Additional Pediatric Considerations

Use with caution in children with Down syndrome, spastic paralysis, or brain damage; increased sensitivity to toxic effects compared to adults has been reported.

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapy

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modification

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Risk X: Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Pregnancy Considerations

In epidemiologic studies, birth defects were not observed following maternal doses up to 40 mg daily throughout the first trimester; information has not been located when used in pregnant women at recommended doses (80 to 160 mg daily). Antispasmodics are generally used to treat irritable bowel syndrome in pregnant patients only when symptoms are severe (Body 2016). Agents other than dicyclomine may be preferred for the treatment of irritable bowel syndrome in pregnant women (Enck 2016).

Breastfeeding Considerations

Dicyclomine is present in breast milk. Use is contraindicated in breastfeeding women.

Due to the potential for serious adverse reactions in the breastfeeding infant, use in breastfeeding women and infants <6 months of age is contraindicated. In addition, anticholinergics may suppress lactation.

Monitoring Parameters

Anticholinergic effects, mental alertness, urinary output, GI symptoms.

Mechanism of Action

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

Pharmacokinetics

Onset of action: 1 to 2 hours

Duration: Up to 4 hours

Absorption: Oral: Rapid and well absorbed

Distribution: Vd: 3.65 L/kg

Metabolism: Extensive

Bioavailability: The IM injection is ~2 times more bioavailable compared to oral administration.

Half-life elimination: Initial phase: ~1.8 hours; Terminal phase: Undetermined, but somewhat longer than the initial phase

Time to peak: Oral: 60 to 90 minutes

Excretion: Urine (80%, small amounts as unchanged drug); feces (8%)

Pricing: US

Capsules (Dicyclomine HCl Oral)

10 mg (per each): $0.26 - $0.68

Solution (Bentyl Intramuscular)

10 mg/mL (per mL): $50.44

Solution (Dicyclomine HCl Intramuscular)

10 mg/mL (per mL): $14.54 - $50.40

Solution (Dicyclomine HCl Oral)

10 mg/5 mL (per mL): $0.30

Tablets (Dicyclomine HCl Oral)

20 mg (per each): $0.36 - $0.78

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Babypasmil (AR);
  • Bentyl (BB, BR, CR, DO, GT, HN, MX, NI, PA, SV, TW);
  • Blisscolic (PK);
  • Coligon (IN, LK);
  • Coochil (TW);
  • Cyclominol (IN);
  • Diclomine (TH);
  • Dicymed (PH);
  • Dicymine (HK, TH);
  • Dilomin (PH);
  • Mabex (VE);
  • Merbentyl (AE);
  • Nomcramp (ZA);
  • Notensyl (IL);
  • Spasdon Drops (PH);
  • Spasmorest (EG);
  • Spatomin (KR);
  • Swityl (TW);
  • Trigan (RU);
  • Vantyl (HK);
  • Wintyl (TW)


For country code abbreviations (show table)
  1. 2019 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2019 updated AGS Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2019;67(4):674-694. doi:10.1111/jgs.15767 [PubMed 30693946]
  2. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  3. Bentyl (dicyclomine hydrochloride) [prescribing information]. Irvine, CA: Allergan USA Inc; June 2018.
  4. Bentyl capsules (dicyclomine) [prescribing information]. Bridgewater, NJ: Aptalis Pharma US, Inc; January 2013.
  5. Bentylol tablets, syrup (dicyclomine) [prescribing information]. Mont-St-Hilaire, Quebec: Aptalis Pharma Canada Inc; July 2012.
  6. Body C, Christie JA. Gastrointestinal diseases in pregnancy: nausea, vomiting, hyperemesis gravidarum, gastroesophageal reflux disease, constipation, and diarrhea. Gastroenterol Clin North Am. 2016;45(2):267‐283. doi:10.1016/j.gtc.2016.02.005 [PubMed 27261898]
  7. Dicyclomine hydrochloride oral solution [prescribing information]. Eatontown, NJ: Hikma Pharmaceuticals USA Inc; October 2018.
  8. Dicyclomine hydrochloride solution [prescribing information]. Atlanta, GA: Mikart Inc; June 2017.
  9. Enck P, Aziz Q, Barbara G, et al. Irritable bowel syndrome. Nat Rev Dis Primers. 2016;2:16014. [PubMed 27159638]
  10. Ford AC, Moayyedi P, Lacy BE, et al; Task Force on the Management of Functional Bowel Disorders. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol. 2014;109(suppl 1):S2-26. doi: 10.1038/ajg.2014.187. [PubMed 25091148]
  11. Greenky D, Dixon R. Adolescent with pain and necrosis following intramuscular injection. JAMA Pediatr. 2017;171(10):1008-1009. doi: 10.1001/jamapediatrics.2017.1881. [PubMed 28783814]
  12. Kay GG, Wesnes KA. Pharmacodynamic effects of darifenacin, a muscarinic M selective receptor antagonist for the treatment of overactive bladder, in healthy volunteers. BJU Int. 2005;96(7):1055-1062. doi:10.1111/j.1464-410X.2005.05745.x [PubMed 16225528]
  13. Lacy BE, Pimentel M, Brenner DM, et al. ACG clinical guideline: management of irritable bowel syndrome. Am J Gastroenterol. 2021;116(1):17-44. doi:10.14309/ajg.0000000000001036 [PubMed 33315591]
  14. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  15. Page JG, Dirnberger GM. Treatment of the irritable bowel syndrome with Bentyl (dicyclomine hydrochloride). J Clin Gastroenterol. 1981;3(2):153-156. doi:10.1097/00004836-198106000-00009 [PubMed 7016973]
  16. Pharmacy Quality Alliance. Use of high-risk medications in the elderly (2017 update) (HRM-2017). https://www.pqaalliance.org/medication-safety. Published 2017. Accessed March 21, 2019.
  17. Refer to manufacturer's labeling.
  18. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  19. Wald A. Treatment of irritable bowel syndrome in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed June 3, 2021.
  20. Weinberg DS, Smalley W, Heidelbaugh JJ, Sultan S; American Gastroenterological Association. American Gastroenterological Association Institute Guideline on the pharmacological management of irritable bowel syndrome. Gastroenterology. 2014;147(5):1146-1148. doi: 10.1053/j.gastro.2014.09.001. [PubMed 25224526]
Topic 9350 Version 425.0