Dicyclomine relieves smooth muscle spasms of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: • a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine (in vitro, guinea pig ileum); and • a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine’s antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum. Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl2)-induced intestinal spasm while atropine was at least 200 times more potent against the effects of ACh than BaCl2. See package insert for complete information.

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

The dosage for BENTYL must be adjusted to individual patient needs (2). If a dose is missed, patients should continue the normal dosing schedule (2). Oral in adults (2.1): • Starting dose: 20 mg four times a day. After a week of treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation. • Discontinue BENTYL if efficacy is not achieved or side effects require doses less than 80 mg per day after two weeks of treatment Intramuscular in adults : • Intramuscular administration is recommended no longer than 1 or 2 days when patients cannot take oral administration • Recommended dose: 10 mg to 20 mg four times a day.

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.

•Infants less than 6 months of age • Nursing mothers • Unstable cardiovascular status in acute hemorrhage • Myasthenia gravis • Glaucoma • Obstructive uropathy • Obstructive disease of the gastrointestinal tract • Severe ulcerative colitis • Reflux esophagitis

• 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); the drug should be discontinued and supportive measures instituted. • Psychosis in patients sensitive to anticholinergic drugs: signs and symptoms resolve within 12 to 24 hours after discontinuation of BENTYL. • Myasthenia Gravis: overdose may lead to muscular weakness and paralysis. BENTYL should be given to patients with myasthenia gravis only to reduce the adverse muscarinic effects of anticholinesterase. • Incomplete intestinal obstruction: diarrhea may be an early symptom See package insert for complete information.