BENTYL  - dicyclomine hydrochloride capsule 
BENTYL  - dicyclomine hydrochloride tablet 
BENTYL  - dicyclomine hydrochloride syrup 
BENTYL  - dicyclomine hydrochloride injection, solution 
Axcan Pharma Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BENTYL safely and effectively. See full prescribing information for BENTYL.
Initial U.S. Approval: 1950
BENTYL (Dicyclomine hydrochloride USP)
INDICATIONS AND USAGE
BENTYL is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (1)
DOSAGE AND ADMINISTRATION
Dosage for BENTYL must be adjusted to individual patients 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 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 not achieved or side effects require doses less than 80 mg per day after two weeks of treatment
Intramuscular in adults (2.2):
Intramuscular administration 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
DOSAGE FORMS AND STRENGTHS
BENTYL capsules 10 mg (3)
BENTYL tablets 20 mg (3)
BENTYL syrup 10 mg/5 mL (3)
BENTYL injection 20 mg/2 mL (10 mg/mL) (3)
CONTRAINDICATIONS
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)
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 (5.1)
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 in patients sensitive to anticholinergic drugs: signs and symptoms resolve within 12 to 24 hours after discontinuation of BENTYL (5.3)
Myasthenia Gravis: overdose may lead to muscular weakness and paralysis. BENTYL 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 ilestomy or colostomy.  Treatment with BENTYL would be inappropriate and possibly fatal (5.5)
Salmonella dysenteric patients: due to risk of toxic megacolon (5.6)
Ulcerative colitis: BENTYL 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: BENTYL 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 BENTYL'