LeftHeader

References

  1. CARDURA® XL [Prescribing Information]. New York NY: Pfizer Inc; 2006.

  2. Chung M, Vashi V, Puente J, Sweeney M, Meredith P. Clinical pharmacokinetics of doxazosin in a controlled-release gastrointestinal therapeutic system (GITS) formulation. Br J Clin Pharmacol. 1999;48:678-687.

  3. Kirby RS, Andersen M, Gratzke P, Dahlstrand C, Høye K. A combined analysis of double-blind trials of the efficacy and tolerability of doxazosin-gastrointestinal therapeutic system, doxazosin standard and placebo in patients with benign prostatic hyperplasia. BJU Int. 2001;87:192-200.

  4. Andersen M, Dahlstrand C, Høye K. Double-blind trial of the efficacy and tolerability of doxazosin in the gastrointestinal therapeutic system, doxazosin standard, and placebo in patients with benign prostatic hyperplasia. Eur Urol. 2000;38:400-409.

  5. McConnell JD, Roehrborn CG, Bautista OM, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003;349:2387-2398.

 

 

Important Safety Information


CARDURA XL is contraindicated in patients with a known sensitivity to other quinazolines (eg, prazosin, terazosin), doxazosin, or any of the inert ingredients.

Postural hypotension with or without symptoms (eg, dizziness) may develop within a few hours following administration of CARDURA XL. However, infrequently, symptomatic postural hypotension has also been reported more than a few hours after dosing.

As with other alpha blockers, there is a potential for syncope, especially after the initial dose or after an increase in dosage strength. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur. Prior to commencing therapy with CARDURA XL, carcinoma of the prostate should be ruled out. Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with alpha1 blockers.

Caution should be used when administering CARDURA XL to patients with preexisting severe gastrointestinal tract narrowing, chronic constipation, or evidence of mild or moderate hepatic dysfunction. Use in patients with severe hepatic impairment is not recommended.

The most commonly reported adverse events occurring in >2% of patients were: headache, dizziness, respiratory tract infection, asthenia, and back pain.

This product information is intended only for residents of the United States.

Terms of Use | Privacy Policy

Pfizer© 2006 Pfizer Inc. All rights reserved. CA266876B