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References

  1. CARDURA® XL [Prescribing Information]. New York City, 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, Hye 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.

  6. Proscar® [Prescribing Information]. Whitehouse Station, NJ: Merck & Co., Inc; 2004.

 

 

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 later than a few hours after dosing.

Caution should be used when administering CARDURA XL to patients with preexisting severe gastrointestinal tract narrowing, chronic constipation, or evidence of hepatic dysfunction.

The most commonly reported adverse events were: headache, dizziness, respiratory tract infection, asthenia, and back pain.

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