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CARDURA® (XL) (doxazosin mesylate extended release tablets) Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

17.1 Postural Hypotension

Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness or syncope, when beginning therapy or when increasing dosage strength of CARDURA XL. Patients should be cautioned about driving, operating machinery, or performing hazardous tasks during this period, until the drug's effect has been determined.

17.2 Priapism

Inform the patient about the possibility of priapism as a result of treatment with CARDURA XL extended release tablets and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction.

17.3 Tablet Administration

Patients should be informed that CARDURA XL extended release tablets should be swallowed whole. Patients should not chew, divide, cut, or crush tablets.

17.4 Dosing Interval

CARDURA XL should be taken each day with breakfast.

17.5 Tablet Elimination

Patients should not be concerned if they occasionally notice in their stool something that looks like a tablet. In the CARDURA XL extended release tablet, the medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. When this process is completed, the empty tablet is eliminated from the body.

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