Bentyl (Dicyclomine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

For the treatment of functional bowel/irritable bowel syndrome.

DOSAGE AND ADMINSTRATION

DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS (See CLINICAL PHARMACOLOGY.)

Adults-Oral. The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient’s response during the first week of therapy, the dose should be increased to 160 mg per day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

Adults-Intramuscular Injection. NOT FOR INTRAVENOUS USE.

The intramuscular dosage form is to be used temporarily when the patient cannot take oral medication. Intramuscular injection is about twice as bioavailable as oral dosage forms; consequently, the recommended intramuscular dose is 80 mg daily (in 4 equally divided doses). Oral dicyclomine hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

ASPIRATE THE SYRINGE BEFORE INJECTING TO AVOID INTRAVASUCLAR INJECTION, SINCE THROMBOSIS MAY OCCUR IF THE DRUG IS INADVERTENTLY INJECTED INTRAVASCULARLY. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Elderly: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See PRECAUTIONS Geriatric Use)

HOW SUPPLIED

10 mg blue capsules, imprinted BENTYL 10, NDC 58914-012-10: bottles of 100. Store at room temperature, preferably below 86°F (30°C).

20 mg compressed, light blue, round tablets, debossed BENTYL 20, NDC 58914-013-10: bottles of 100. To prevent fading, avoid exposure to direct sunlight. Store at room temperature, preferably below 86°F (30°C).

10 mg/5 mL pink syrup, NDC 58914-015-16: 16 ounce bottle.

Store at room temperature, preferably below 86°F (30°C). Protect from excessive heat.

20 mg/2 mL (10 mg/mL) injection (for intramuscular use only, NOT FOR INTRAVENOUS USE) NDC 58914-080-52: Boxes of five 20 mg/2 mL ampules (10 mg/mL).

Store at room temperature, preferably below 86°F (30°C). Protect from freezing.

Rx only

Rev. March 2005

Bentyl Capsules, Bentyl Tablets and Bentyl Syrup Manufactured by:

Patheon Pharmaceuticals Inc.

Cincinnati, OH 45215

Bentyl Injection Manufactured by:

Akorn Inc.

Decatur, IL 62522

Manufactured for:

Axcan Scandipharm Inc.

Birmingham, AL 35242

www.axcan.com