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Dicyclomine (Dicyclomine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

For the treatment of functional bowel/irritable bowel syndrome.

DOSAGE AND ADMINISTRATION

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

Adults

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.

HOW SUPPLIED

Dicyclomine Hydrochloride Tablets are provided containing 20 mg of dicyclomine hydrochloride. The 20 mg tablet is a blue, round, flat-faced, beveled edge tablet debossed with M over D6 on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-1620-01
bottles of 100 tablets

NDC 0378-1620-05
bottles of 500 tablets

STORE AT CONTROLLED ROOM TEMPERATURE 15° TO 30°C (59° TO 86°F).

TO PREVENT FADING, AVOID EXPOSURE TO DIRECT SUNLIGHT.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REVISED OCTOBER 1999
DICY:R2

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