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JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): PRECAUTIONS

Exposure of Women - Risk to Male Fetus

Jalyn (Dutasteride and Tamsulosin Hydrochloride) 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.

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.

Blood Donation

Men being treated with a dutasteride-containing product, including Jalyn, should not donate blood until at least 6 months have passed following their last dose. The purpose of this deferred period is to prevent administration of dutasteride to a pregnant female transfusion recipient.

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 (Dutasteride and Tamsulosin HCl) capsules. 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 (2 days to 9 months). 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.

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.

Effect on Semen Characteristics

Dutasteride

The effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 (n = 27 dutasteride, n = 23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. At 52 weeks, 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 24 weeks of follow-up, the mean percent change in total sperm count in the dutasteride group remained 23% lower than baseline. While mean values for all semen parameters at all time-points remained within the normal ranges and did not meet predefined criteria for a clinically significant change (30%), 2 subjects in the dutasteride group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial recovery at the 24-week follow-up. The clinical significance of dutasteride's effect on semen characteristics for an individual patient's fertility is not known.

Tamsulosin

The effects of tamsulosin hydrochloride on sperm counts or sperm function have not been evaluated.


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