bo 1.1%).
5 alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5 alpha-reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.
5.5 eva luation for Other Urological Diseases
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.
5.6 Exposure of Women—Risk to Male Fetus
JALYN Capsules should not be handled by a woman who is pregnant or who could become pregnant. Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a woman who is pregnant or could 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)].
5.7 Priapism
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, which is a component of JALYN. Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition.
5.8 Blood Donation
Men being treated with a dutasteride-containing product, including JALYN, should not donate blood until at least 6months have passed following their last dose. The purpose of this deferred period is to prevent administration of dutasteride to a pregnant female transfusion recipient.
5.9 Intraoperative Floppy Iris Syndrome
Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha adrenergic antagonists, including tamsulosin, which is a component of JALYN. Most reports were in patients taking the alpha adrenergic antagonist when IFIS occurred, but in some cases, the alpha adrenergic antagonist had been stopped prior to surgery (2days to 9months). Advise patients considering cataract surgery to tell their ophthalmologist that they take or have taken JALYN Capsules. The patient’s ophthalmologist should be prepared for possible modification to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. The benefit of stopping alpha adrenergic antagonist therapy prior to cataract surgery has not been established.
5.10 Sulfa Allergy
In patients with sulfa allergy, allergic reaction to tamsulosin has been rarely reported. If a patient reports a serious or life-threatening sulfa allergy, caution is warranted when administering tamsulosin-containing products, including JALYN.
5.11 Effect on Semen Characteristics
Dutasteride: The effects of dutasteride 0.5mg/day on semen characteristics were eva luated in normal volunteers aged 18 to 52 (n=27 dutasteride, n=23 placebo) throughout 52weeks of treatment and 24weeks of post-treatment follow-up. At 52weeks, the mean percent reductions from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group. Sperm concentration and sperm morphology were unaffected. After 24weeks of follow-up, the mean percent change in total sperm count in t |
