Dicyclomine: uses, appearance and warnings

Dicyclomine hydrochloride tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride tablets are an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome ( 1 )

Dicyclomine hydrochloride, USP 20 mg tablets: Blue, Round, Unscored Tablet; Debossed “WW 27” Dicyclomine hydrochloride tablets, USP 20 mg ( 3 )

Dicyclomine hydrochloride tablets, USP 20 mg are supplied as Blue, Round, Unscored Tablet; Debossed “WW 27” and are available in: Bottles of 100 tablets NDC 0054-0885-25 Bottles of 1000 tablets NDC 0054-0885-31 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light and moisture. To prevent fading, avoid exposure to direct sunlight. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific P opu l a ti on s ( 8.4 )], nursing mothers [see Use in Specific Populations ( 8.3 )] and in patients with: • unstable cardiovascular status in acute hemorrhage • myasthenia gravis [see Warnings and Precautions ( 5.4 )] • glaucoma [see Adverse Reactions ( 6.3 ) and Drug Interactions ( 7.1 )] • obstructive uropathy [see Warnings and Precautions ( 5.8 )] • obstructive disease of the gastrointestinal tract [see Warnings and Precautions ( 5.5 )] • severe ulcerative colitis [see Warnings and Precautions ( 5.7 )] • reflux esophagitis • Infants less than 6 months of age ( 4 ) • Nursing mothers ( 4 ) • Unstable cardiovascular status in acute hemorrhage ( 4 ) • Myasthenia gravis ( 4 ) • Glaucoma ( 4 ) • Obstructive uropathy ( 4 ) • Obstructive disease of the gastrointestinal tract ( 4 ) • Severe ulcerative colitis ( 4 ) • Reflux esophagitis ( 4 )

Cardiovascular conditions: worsening of conditions ( 5.2 ) 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 ( 5.3 ) 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 ( 5.3 ) 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 ( 5.4 ) 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 ( 5.5 ) Salmonella dysenteric patients: due to risk of toxic megacolon ( 5.6 ) 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 ( 5.7 ) Prostatic hypertrophy: dicyclomine hydrochloride should be used with caution in these patients; may lead to urinary retention ( 5.8 ) Hepatic and renal disease: should be used with caution ( 5.9 ) 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 [see Adverse Reactions ( 6.3 )]. 5.3 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 [see Adverse Reactions ( 6 )] . 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. 5.4 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 [see Contraindications ( 4 )]. 5.5 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 [see Contraindications ( 4 )]. 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. 5.6 Toxic Dilatation of Intestinemegacolon Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery. 5.7 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 [see Adverse Reactions ( 6.3 )] . Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis [see Contraindications ( 4 )]. 5.8 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 [see Adverse Reactions ( 6.3 )] . 5.9 Hepatic and Renal Disease Dicyclomine hydrochloride should be used with caution in patients with known hepatic and renal impairment. 5.10 Geriatric Population Dicyclomine hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.

The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology ( 12 )] . They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued. The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see Warnings and Precautions ( 5.2 , 5.3 )]. The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. …

Antiglaucoma agents : anticholinergics antagonize antiglaucoma agents and may increase intraoccular pressure ( 7 ) Anticholinergic agents : may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs ( 7 ) Antacids : interfere with the absorption of anticholinergic agents ( 7 ) 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 [see Contraindications ( 4 )]. …