For intramuscular use
INDICATIONS AND USAGE
Dicyclomine hydrochloride injection is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
IMPORTANT SAFETY INFORMATION
Infants less than 6 months of age; nursing mothers; and in patients with: unstable cardiovascular status in acute hemorrhage, myasthenia gravis, glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, severe ulcerative colitis, reflux esophagitis.
WARNINGS AND PRECAUTIONS
Inadvertent Intravenous Administration: For Intramuscular injection only. Do not administer by any other route. Intravenous injection may result in thrombosis or thrombophlebitis and injection site reactions.
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: 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, 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 confusion, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.
Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness).
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: Overdose may lead to muscular weakness and paralysis. Dicyclomine hydrochloride 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 especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride would be inappropriate and possibly fatal.
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: Dicyclomine hydrochloride should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon. Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis.
Prostatic hypertrophy: Dicyclomine hydrochloride should be used with caution in these patients; 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: Dicyclomine hydrochloride should be used with caution in elderly who may be more susceptible to dicyclomine hydrochloride’s adverse events.
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.
USE IN SPECIFIC POPULATIONS
Pregnancy: use only if clearly needed.
Nursing Mothers: Dicyclomine hydrochloride is contraindicated in women who are breastfeeding. Dicyclomine is excreted in human milk.
Pediatric Use: Safety and effectiveness not established. Contraindicated in infants less than 6 months of age.
Geriatric Use: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Hepatic and Renal Impairment: Caution must be taken with patients with impaired hepatic and renal function.
For additional Safety Information, please see Full Prescribing Information.
You are encouraged to report adverse drug events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.