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).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Note: The pharmacokinetics of dicyclomine have not been fully determined; the principal route of excretion is via the urine (80% of the dose [% eliminated unchanged and activity of metabolites (ie, active or inactive) unknown]).
Altered kidney function: Oral: There is insufficient evidence to provide specific dosage adjustment recommendations (has not been studied); however, use with caution and at the lowest effective dose, particularly in patients with more severe impairment (Ref).
Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzable (large Vd): Oral: There is insufficient evidence to provide specific dosage adjustment recommendations (has not been studied); use with caution and at the lowest effective dose (Ref).
Peritoneal dialysis: Oral: Unlikely to be significantly dialyzable (large Vd): Oral: There is insufficient evidence to provide specific dosage adjustment recommendations (has not been studied); use with caution and at the lowest effective dose (Ref).
CRRT: Oral: There is insufficient evidence to provide specific dosage adjustment recommendations (has not been studied); use with caution and at the lowest effective dose (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): Oral: There is insufficient evidence to provide specific dosage adjustment recommendations (has not been studied); use with caution and at the lowest effective dose (Ref).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.
Avoid use (Ref).
(For additional information see "Dicyclomine (dicycloverine): Pediatric drug information")
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.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.
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
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Gastrointestinal: Nausea (14%), xerostomia (33%) (table 1)
Drug (Dicyclomine) |
Placebo |
Dose |
---|---|---|
33% |
5% |
40 mg four times a day |
Nervous system: Dizziness (40%) (table 2)
Drug (Dicyclomine) |
Placebo |
Dose |
---|---|---|
40% |
5% |
40 mg four times a day |
Ophthalmic: Blurred vision (27%) (table 3)
Drug (Dicyclomine) |
Placebo |
Dose |
---|---|---|
27% |
2% |
40 mg four times a day |
1% to 10%:
Nervous system: Drowsiness (9%) (table 4) , nervousness (6%)
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
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
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).
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).
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
Yes
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 - $45.34
Solution (Dicyclomine HCl Oral)
10 mg/5 mL (per mL): $0.30
Tablets (Dicyclomine HCl Oral)
20 mg (per each): $0.36 - $3.60
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral, as hydrochloride:
Protylol: 10 mg [DSC]
Generic: 10 mg
Tablet, Oral:
Generic: 10 mg
Tablet, Oral, as hydrochloride:
Generic: 20 mg
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, severe pain and necrosis have been reported following IM administration (Ref). Do not administer IV (IV administration may result in thrombosis or thrombophlebitis).
Oral: Administer 30 minutes before eating. For infants and young children, dilute syrup with an equal volume of water before administration.
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).
Dicyclomine may be confused with diphenhydrAMINE, doxycycline, dyclonine
Bentyl may be confused with Aventyl, Benadryl, Bontril, Cantil, Proventil, Trental
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 2023]).
Dicyclomine is identified in the Screening Tool of Older Person's Prescriptions (STOPP) criteria as a potentially inappropriate medication in older adults (≥65 years of age). Some disease states of concern include chronic cognitive impairment, delirium, dementia, narrow-angle glaucoma, overactive bladder, urge incontinence, and constipation (O’Mahony 2023).
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]).
None known.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Agents with Clinically Relevant Anticholinergic Effects. Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination
Agents with Clinically Relevant Anticholinergic Effects: May enhance the adverse/toxic effect of other Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy
Amantadine: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy
Benperidol: Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Benperidol. Risk C: Monitor therapy
Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy
Bromperidol: Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Bromperidol. Risk C: Monitor therapy
Cannabinoid-Containing Products: Agents with Clinically Relevant Anticholinergic Effects may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy
Chlorprothixene: Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Chlorprothixene. Risk C: Monitor therapy
Cimetropium: Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination
CloZAPine: Agents with Clinically Relevant Anticholinergic Effects 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
Dimethindene (Systemic): Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Dimethindene (Systemic). Risk C: Monitor therapy
Eluxadoline: Agents with Clinically Relevant Anticholinergic Effects may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination
Gastrointestinal Agents (Prokinetic): Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy
Glucagon: Agents with Clinically Relevant Anticholinergic Effects 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): Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination
Glycopyrronium (Topical): May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination
Ipratropium (Nasal): May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination
Itopride: Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy
Levosulpiride: Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination
Mianserin: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy
Mirabegron: Agents with Clinically Relevant Anticholinergic Effects may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy
Nitroglycerin: Agents with Clinically Relevant Anticholinergic Effects 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: Agents with Clinically Relevant Anticholinergic Effects 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 Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination
Potassium Chloride: Agents with Clinically Relevant Anticholinergic Effects 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: Agents with Clinically Relevant Anticholinergic Effects may enhance the ulcerogenic effect of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid combination
Pramlintide: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. These effects are specific to the GI tract. Risk X: Avoid combination
QuiNIDine: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy
Ramosetron: Agents with Clinically Relevant Anticholinergic Effects may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy
Revefenacin: Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination
Rivastigmine: Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Agents with Clinically Relevant Anticholinergic Effects. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification
Secretin: Agents with Clinically Relevant Anticholinergic Effects 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: Agents with Clinically Relevant Anticholinergic Effects may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Tiotropium: Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination
Topiramate: Agents with Clinically Relevant Anticholinergic Effects may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination
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).
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.
Anticholinergic effects, mental alertness, urinary output, GI symptoms.
Blocks the action of acetylcholine at parasympathetic sites in smooth muscle, secretory glands and the CNS
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%); feces (8%)
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