Urecholine (Bethanechol Chloride) - Indications and Dosage

INDICATIONS AND USAGE

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

DOSAGE AND ADMINISTRATION

Dosage must be individualized, depending on the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE).

HOW SUPPLIED

Urecholine^® Tablets

5 mg - White, round, scored tablets in bottles of 100.
               Debossed OP 697

10 mg - White, round, scored tablets in bottles of 100.
               Debossed OP 703

25 mg - Yellow, round, scored tablets in bottles of 100.
               Debossed OP 704

50 mg - Yellow, round, scored tablets in bottles of 100.
               Debossed OP 700

Dispense in a tight container as defined in the USP.

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

                                                                                                                                             B08-0697

DURAMED PHARMACEUTICALS, INC.

Subsidiary of Barr Pharmaceuticals, Inc.
Pomona, New York 10970

Revised JUNE 2007