If contact is made with leaking capsule, wash immediately with soap and water.Do not use if printed safety seal under cap is broken or missing.We comply with the HONcode standard for trustworthy health information - Hypospadias and nipple development were observed at 2.5 mg/kg/day or greater (14 times the MRHD or greater, with a no-effect level at 0.05 mg/kg/day). However neither were prescribed by fertility specialist. However, the effect of Avodart on male fertility is not known.These are not all the possible side effects of Avodart. In this study, the major human metabolites were tested for carcinogenicity at approximately 1 to 3 times the expected clinical exposure.Dutasteride was tested for genotoxicity in a bacterial mutagenesis assay (Ames test), a chromosomal aberration assay in Chinese hamster ovary cells, and a micronucleus assay in rats. In human serum following dosing to steady state, unchanged dutasteride, 3 major metabolites (4′-hydroxydutasteride, 1,2-dihydrodutasteride, and 6-hydroxydutasteride), and 2 minor metabolites (6,4′-dihydroxydutasteride and 15-hydroxydutasteride), as assessed by mass spectrometric response, have been detected.
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These 5 alpha-reductase-deficient males have a small prostate gland throughout life and do not develop BPH. At Month 24 the mean changes from baseline (±SD) in IPSS total symptom scores were -6.2 (±7.14) for combination, -4.9 (±6.81) for Avodart, and -4.3 (±7.01) for tamsulosin, with a mean difference between combination and Avodart of ‑1.3 units (After 4 years of treatment, combination therapy with Avodart and tamsulosin did not provide benefit over monotherapy with Avodart in reducing the incidence of AUR or BPH-related surgery.The mean prostate volume at trial entry was approximately 55 cc. Dutasteride can be absorbed through the skin and could result in unintended fetal exposure and potential risk to a male fetus.
Based on the highest measured semen concentration of dutasteride in treated men (14 ng/mL), these doses in the monkey represent up to 16 times the potential maximum exposure of a 50‑kg human female to 5 mL of semen daily from a dutasteride-treated male, assuming 100% absorption. No cases of breast cancer were reported in any treatment group in the 4-year CombAT trial or the 4-year REDUCE trial.The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown.Over 4,800 male subjects with BPH were randomly assigned to receive 0.5-mg Avodart, 0.4-mg tamsulosin, or combination therapy (0.5-mg Avodart plus 0.4-mg tamsulosin) administered once daily in a 4-year double-blind trial. One was after a couple months of sore throats (had a cold that never left kinda thing), and the other was when wisdom teeth were all removed in month prior to ivf. Do not use Avodart for a condition for which it was not prescribed.
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 5 mg/day of dutasteride or placebo for up to 12 weeks prior to transurethral resection of the prostate, mean DHT concentrations in prostatic tissue were significantly lower in the dutasteride group compared with placebo (784 and 5,793 pg/g, respectively, Adult males with genetically inherited type 2 5 alpha-reductase deficiency also have decreased DHT levels.
At Month 24, the primary time point for this endpoint, the mean percent changes from baseline (±SD) in prostate volume were -26.9% (±22.57) for combination therapy, -28.0% (±24.88) for Avodart, and 0% (±31.14) for tamsulosin, with a mean difference between combination and Avodart of 1.1% (Avodart soft gelatin capsules 0.5 mg are oblong, opaque, dull yellow, gelatin capsules imprinted with “GX CE2” with red edible ink on one side, packaged in bottles of 30 (NDC 0173-0712-15) and 90 (NDC 0173-0712-04) with child-resistant closures.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dutasteride is absorbed through the skin.
No clinically significant changes in adrenal hormone responses to adrenocorticotropic hormone (ACTH) stimulation were observed in a subset population (n = 13) of the 1-year healthy volunteer trial.Following administration of a single 0.5-mg dose of a soft gelatin capsule, time to peak serum concentrations (TPharmacokinetic data following single and repeat oral doses show that dutasteride has a large volume of distribution (300 to 500 L). These results are similar to observations in male infants with genetic 5 alpha‑reductase deficiency.In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.In animal reproduction studies, dutasteride inhibited normal development of external genitalia in male offspring when given to rats or rabbits during organogenesis at less than the maximum recommended human dose (MRHD) of 0.5 mg daily, in the absence of maternal toxicity.
Avodart may affect the way other medicines work, and other medicines may affect how Avodart works.Know the medicines you take.