CARDURA XL (doxazosin mesylate)

The pharmacokinetics of CARDURA XL is different from that of doxazosin IR. CARDURA XL provides a controlled release of doxazosin over a 24-hour period.

AbsorptionPharmacokinetic parameters describing absorption following 4 and 8 mg CARDURA XL daily doses are reported in Table 2 below. The relative bioavailability of CARDURA XL compared with doxazosin IR was 54% at the 4 mg dose and 59% for the 8 mg dose. TABLE 2 Mean (±SD) Plasma Concentration of Doxazosin at Steady State in Healthy Volunteers:...

14.1 Studies in Patients with BPH Two controlled clinical studies were conducted with CARDURA XL in BPH patients, followed by an open-label extension study. Study 1 was a randomized, double-blind, parallel-group, placebo- and active-controlled study that compared the safety and efficacy of CARDURA XL (4 or 8 mg/day) with that of doxazosin IR (1, 2, 4, or 8 mg/day) and placebo over 13 weeks in 795 BPH patients, of whom 317 were randomized to CARDURA XL. Study 2 was a randomized, double-blind, parallel-group, active-controlled study that compared the safety and efficacy of CARDURA XL (4 or 8 mg/...

The most commonly reported adverse reactions from clinical trials are asthenia, headache, hypotension, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of ano...

CARDURA XL is contraindicated in patients with a known hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of the inert ingredients. Allergic reactions to doxazosin and other quinazolines have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see Adverse Reactions (6.2) ] . Patients with known sensitivity to doxazosin, other quinazolin...

Postural hypotension with or without syncope may occur in the first few hours after administration. ( 5.1 ) Intraoperative Floppy Iris Syndrome has been observed during cataract surgery in some patients. Advise patients considering cataract surgery to tell their ophthalmologist that they have taken CARDURA XL tablets. ( 5.2 ) Caution should be used when administering to patients with preexisting severe gastrointestinal narrowing or coronary insufficiency. ( 5.3 , 5.7 ) Advise patients to be scre...

7 DRUG INTERACTIONS Caution should be exercised when concomitantly administering CARDURA XL with a strong cytochrome P450 (CYP) 3A4 inhibitor. ( 7.1 ) Concomitant administration of CARDURA XL with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. ( 7.3 ) 7.1 CYP 3A4 Inhibitors No in vivo drug interaction studies were conduct...