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

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations ( 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 ) Glaucoma ( 4 ) Nursing mothers ( 4 ) Obstructive uropathy ( 4 ) Unstable cardiovascular status in acute hemorrhage ( 4 ) Obstructive disease of the gastrointestinal tract ( 4 ) Myasthenia gravis ( 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 …

8.1 Pregnancy Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride tablets at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine. Because animal reproduction studies are …