Phosphodiesterase -5 Inhibitors (PDE-5 Inhibitors): Caution is advised when alpha-adrenergic antagonist-containing products, including JALYN, are coadministered with PDE-5 inhibitors. Alpha-adrenergic blockers and PDE-5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these 2 drug classes can potentially cause symptomatic hypotension [see Drug Interactions (7.3), Clinical Pharmacology (12.3)].

Warfarin: Caution should be exercised with concomitant administration of warfarin and tamsulosin-containing products, including JALYN [see Drug Interactions (7.4), Clinical Pharmacology (12.3)].

JALYN Capsules should not be handled by a woman who is pregnant or who may become pregnant. Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a woman who is pregnant or may become pregnant comes in contact with a leaking capsule, the contact area should be washed immediately with soap and water [see Use in Specific Populations (8.1)].

Lower urinary tract symptoms of BPH can be indicative of other urological diseases, including prostate cancer. Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with JALYN and periodically thereafter. Patients with a large residual urinary volume and/or severely diminished urinary flow may not be good candidates for 5α-reductase inhibitor therapy and should be carefully monitored for obstructive uropathy.

Coadministration of dutasteride with tamsulosin resulted in similar changes to total prostate-specific antigen (PSA) as with dutasteride monotherapy.

Dutasteride: Dutasteride reduces total serum PSA concentration by approximately 40% following 3 months of treatment and by approximately 50% following 6, 12, and 24 months of treatment. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. Therefore, for interpretation of serial PSAs in a man taking a dutasteride-containing product, including JALYN, a new baseline PSA concentration should be established after 3 to 6 months of treatment, and this new value should be used to assess potentially cancer-related changes in PSA. To interpret an isolated PSA value in a man treated with a dutasteride-containing product, including JALYN, for 6 months or more, the PSA value should be doubled for comparison with normal values in untreated men. Any confirmed increases in PSA levels from nadir while on dutasteride-containing products, including JALYN, may signal the presence of prostate cancer and should be carefully eva luated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor.

The free-to-total PSA ratio (percent free PSA) remains constant at Month 12, even under the influence of dutasteride. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men receiving JALYN, no adjustment to its value appears necessary.

Tamsulosin: Treatment with tamsulosin for up to 24 months had no significant effect on PSA.

Priapism (persistent painful penile erection unrelated to sexual activity) has been associated (probably less than 1 in 50,000) with the use of alpha-adrenergic antagonists, including tamsulosin,