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ALFUSIN-D (ALFUZOSIN/DUTASTERIDE) TABLETS: PRECAUTIONS

Blood Donation

Men being treated with Alfusin-D tablets should not donate blood until at least 6 months have passed following their last dose, so as to prevent pregnant women from receiving dutasteride through blood transfusion.

Effects on Prostate-specific Antigen (PSA) and the use of PSA in Prostate Cancer Detection

In clinical studies, dutasteride reduced serum prostate-specific antigen (PSA) concentration by approximately 50% within 3-6 months of treatment. This decrease was predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals. Dutasteride may also cause decreases in serum PSA in the presence of prostate cancer. To interpret serial PSAs in men taking dutasteride, a new PSA baseline should be established at least 3 months after starting treatment and the PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on dutasteride may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5 alpha-reductase inhibitor. Non-compliance with dutasteride may also affect PSA test results.

To interpret an isolated PSA value in a man treated with dutasteride for 3 months or more, the PSA value should be doubled for comparison with normal values in untreated men.

The free-to-total PSA ratio (percent-free PSA) remains constant, 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 dutasteride, no adjustment to its value appears necessary.

Effect on Semen Characteristics

The effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 years (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 reduction 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.

Coronary Insufficiency

If symptoms of angina pectoris should newly appear or worsen, Alfusin-D tablets should be discontinued.

Patients with Congenital or Acquired QT Prolongation

Use with caution in patients with acquired or congenital QT prolongation or who are taking medications that prolong the QT interval.

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