Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available as: Dicyclomine hydrochloride capsules, USP for oral use containing 10 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride 10 mg capsules contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Capsule shells contain FD&C Blue No.1, FD&C Red No.40, gelatin, purified water, and sodium lauryl sulfate. The white monogramming ink contains: ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac, simethicone, and titanium dioxide. Dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C 19 H 35 NO 2 •HCl and the following structural formula: Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. Dicyclomine hydrochloride structural image

Dicyclomine hydrochloride capsules, USP are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride capsules, USP are an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome

Dicyclomine hydrochloride capsules, USP 10 mg: Blue/Blue Capsule Printed; "West-ward 3126" in White Ink Dicyclomine hydrochloride capsules, USP 10 mg

Dosage must be adjusted to individual patient needs. Dosage for dicyclomine hydrochloride capsules must be adjusted to individual patient needs . If a dose is missed, patients should continue the normal dosing schedule . Oral in adults (2.1 ) : Starting dose: 20 mg four times a day. After a week treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation Discontinue dicyclomine hydrochloride if efficacy not achieved or side effects require doses less than 80 mg per day after two weeks of treatment 2.1 Oral Dosage and Administration in Adults The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a 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.

Cardiovascular conditions : worsening of conditions Peripheral and central nervous system : heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness): signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride Myasthenia Gravis : overdose may lead to muscular weakness and paralysis. Dicyclomine hydrochloride should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase Incomplete intestinal obstruction : diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride would be inappropriate and possibly fatal Salmonella dysenteric patients : due to risk of toxic megacolon Ulcerative colitis : dicyclomine hydrochloride should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon Prostatic hypertrophy : dicyclomine hydrochloride should be used with caution in these patients; may lead to urinary retention Hepatic and renal disease : should be used with caution Geriatric : use with caution in elderly who may be more susceptible to dicyclomine hydrochloride’s adverse events (5.10) 5.2 Cardiovascular Conditions Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of dicyclomine hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension

Peripheral and Central Nervous System The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation . In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted. Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system (CNS) signs and symptoms include confusional state, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. Psychosis and delirium have been reported in sensitive individuals (such as elderly patients and/or in patients with mental illness) given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug. Dicyclomine hydrochloride may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking dicyclomine hydrochloride

Myasthenia Gravis With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase

Intestinal Obstruction Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful . Rarely development of Ogilvie’s syndrome (colonic pseudo-obstruction) has been reported. Ogilvie’s syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction

Toxic Dilatation of Intestinemegacolon Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery

Ulcerative Colitis Caution should be taken in patients with ulcerative colitis. Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon . Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis

Prostatic Hypertrophy Dicyclomine hydrochloride should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention

Hepatic and Renal Disease Dicyclomine hydrochloride should be used with caution in patients with known hepatic and renal impairment

Geriatric Population Dicyclomine hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.

Antiglaucoma agents : anticholinergics antagonize antiglaucoma agents and may increase intraoccular pressure Anticholinergic agents : may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs Antacids : interfere with the absorption of anticholinergic agents 7.1 Antiglaucoma Agents Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of dicyclomine hydrochloride in patients with glaucoma is not recommended

Other Drugs with Anticholinergic Activity The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine hydrochloride: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity

Other Gastrointestinal Motility Drugs Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide

Effect of Antacids Because antacids may interfere with the absorption of anticholinergic agents including dicyclomine hydrochloride, simultaneous use of these drugs should be avoided

Effect on Absorption of Other Drugs Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result

Effect on Gastric Acid Secretion The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.