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AG-DUTASTERIDE is a brand name for Dutasteride, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions AG-Dutasteride is for use for men only.
Exposure of Women-Risk to Male Fetus:
Dutasteride is absorbed through the skin. Therefore, women who are pregnant or may be pregnant should not handle AG-Dutasteride.
General Increased Risk of High-grade Prostate Cancer:
Prior to treatment with AG-Dutasteride, patients should be assessed thoroughly to rule out other urological diseases including prostate cancer. Dutasteride may be associated with an increase in high grade prostate cancer. 0 ng/mL, taking dutasteride for 4 years, there was an increased incidence of Gleason score 8-10 prostate cancer compared with men taking placebo (see ADVERSE REACTIONS).
At this time it is unknown how therapy with dutateride might influence the progression of prostate cancer or affect high grade prostate cancer. No causal relationship between dutasteride and high grade prostate cancer has been established.
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.
See INDICATION AND CLINICAL USE and ADVERSE REACTIONS. Breast changes including breast enlargement, tenderness and cancer have been reported. Prescribers should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge (see ADVERSE REACTIONS).
Patients with a large residual urinary volume and/or severely diminished urinary flow may not be proper candidates for 5 alpha-reductase inhibitor therapy and should be carefully monitored for obstructive uropathy. No study has been conducted to determine if dutasteride can be used for the control of BPH in asymptomatic patients.
The long-term (> 4 years) beneficial and adverse effects of dutasteride have not been established. AG-Dutasteride – Product Monograph Page 5 of 43 Cardiovascular In two 4-year clinical studies, the incidence of cardiac failure (a composite term of reported events, primarily cardiac failure and congestive cardiac failure) was higher among subjects taking the combination of dutasteride and an alpha-blocker, primarily tamsulosin, than it was among subjects not taking the combination.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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07] compared with tamsulosin monotherapy. In these 2 studies, the incidence of cardiac failure was low ( 1%) and variable between the studies. No imbalance was observed in the incidence of cardiovascular adverse events overall in either study.
While no causal relationship between dutasteride (alone or in combination with an alpha- blocker) and cardiac failure has been established, patients with underlying risk factors for cardiovascular disease, including past or current cardiovascular conditions, advanced age, elevated resting heart rate, should be monitored for signs and symptoms of cardiac failure (see ADVERSE REACTIONS).
5 mg/day (n = 26) resulted in no clinically significant change compared with placebo (n = 23) in sex hormone binding globulin, estradiol, luteinizing hormone, follicle-stimulating hormone, thyroxine (free T4), and dehydroepiandrosterone.
05). 4% for TSH at 52 weeks. After stopping dutasteride for 24 weeks, the mean levels of testosterone and TSH had returned to baseline in the group of subjects with available data at the visit. 5 mg/day for 4 years, the median decrease in serum DHT was 94% at 1 year, 93% at 2 years, and 95% at both 3 and 4 years.
The median increase in serum testosterone was 19% at both 1 and 2 years, 26% at 3 years, and 22% at 4 years, but the mean and median levels remained within the physiologic range. In patients with BPH treated with dutasteride in a large Phase III trial, there was a median percent increase in luteinizing hormone of 12% at 6 months and 19% at both 12 and 24 months.
Hematologic Men treated with dutasteride 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.
Hepatic The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolized and has a half-life of 3 to 5 weeks, caution should be used in the administration of dutasteride to patients with liver disease.
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 reduction from baseline in AG-Dutasteride – Product Monograph Page 6 of 43 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 […]