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American Regent, Inc.
5 Ramsey Road
Shirley, NY 11967
Dicyclomine Hydrochloride Injection, USP
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
For Intramuscular injection only; should not be administered by any other route. Intravenous injection may result in thrombosis or thrombophlebitis and injection site reactions.
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). 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.
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.
Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness).
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.
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.
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.
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.
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.