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Treatment of functional bowel/irritable bowel syndrome
Obstructive diseases of the GI tract; severe ulcerative colitis; reflux esophagitis; unstable cardiovascular status in acute hemorrhage; obstructive uropathy; glaucoma; myasthenia gravis; breast-feeding; infants <6 months of age
Canadian labeling: Additional contraindications (not in U.S. labeling): Hypersensitivity to dicyclomine or any component of the formulation
Gastrointestinal motility disorders/irritable bowel:
Oral: Initial: 20 mg 4 times daily for 7 days; after 1 week, may increase to 40 mg 4 times daily. If efficacy not achieved in 2 weeks or if adverse effects require a dose <80 mg/day, therapy should be discontinued. Safety data are not available for doses >80 mg daily for a duration that exceeds 2 weeks.
IM (should not be used IV): 10-20 mg 4 times daily for 1-2 days; convert to oral therapy as soon as possible
Refer to adult dosing. Use caution; lower dosages may be required.
No dosage adjustment provided in the manufacturer 's labeling (has not been studied); use with caution.
No dosage adjustment provided in the manufacturer 's labeling (has not been studied); use with caution.
Injection solution: Do not administer IV; administer as IM injection only.
Capsule, tablet: Store at room temperature, preferably below 30 ‚ °C (86 ‚ °F). Protect tablet from direct sunlight.
Oral solution: Store at 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F); protect from excessive heat.
Solution for injection: Store at room temperature, preferably below 30 ‚ °C (86 ‚ °F); protect from freezing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral, as hydrochloride:
Bentyl: 10 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]
Generic: 10 mg
Solution, Intramuscular, as hydrochloride:
Bentyl: 10 mg/mL (2 mL) [pyrogen free]
Generic: 10 mg/mL (2 mL)
Solution, Oral, as hydrochloride:
Generic: 10 mg/5 mL (473 mL)
Tablet, Oral, as hydrochloride:
Bentyl: 20 mg
Generic: 20 mg
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. 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. Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Pulse, anticholinergic effect, urinary output, GI symptoms
>10%:
Central nervous system: Dizziness (40%)
Gastrointestinal: Xerostomia (33%), nausea (14%)
Ophthalmic: Blurred vision (27%)
1% to 10%:
Central nervous system: Drowsiness (9%), nervousness (6%)
Neuromuscular & skeletal: Weakness (7%)
Postmarketing and/or case reports (Limited to important or life-threatening): Abdominal distention, abdominal pain, anaphylactic shock, angioedema, confusion, constipation, cycloplegia, decreased lactation, delirium, dermatitis (allergic), dyspepsia, dyspnea, erythema, facial edema, fatigue, hallucination, headache, hypersensitivity, insomnia, malaise, mydriasis, nasal congestion, palpitations, skin rash, syncope, tachyarrhythmia, vomiting
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/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).
B
Adverse events have not been observed in animal reproduction studies. In epidemiologic studies, birth defects were not observed in pregnant women taking doses up to 40 mg daily throughout the first trimester; information has not been located when used in pregnant women at recommended doses (80-160 mg daily). Use for the treatment of irritable bowel syndrome (IBS) is not recommended during pregnancy (Mahadevan, 2006).
Blocks the action of acetylcholine at parasympathetic sites in smooth muscle, secretory glands and the CNS
Oral: Rapid and well absorbed
Vd: 3.65 L/kg
Extensive
Urine (80%, small amounts as unchanged drug); feces (8%)
1 to 2 hours
Oral: 60-90 minutes
Up to 4 hours
Initial phase: ~1.8 hours; Terminal phase: Undetermined, but somewhat longer than the initial phase
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience fatigue, blurred vision, nausea, anxiety, loss of strength and energy, dry mouth, or dry skin. Have patient report immediately to prescriber severe dizziness, passing out, confusion, altered speech, dysphagia, difficulty speaking, change in balance, vision changes, urinary retention, severe diarrhea, severe constipation, bradycardia, tachycardia, arrhythmia, hallucinations, memory impairment, or mood changes (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.