Générique Avodart 0.5 mg

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These adverse events may persist after treatment discontinuation. The role of dutasteride in this persistence is unknown. Whether the effect of dutasteride to reduce prostate volume, or study related factors, the results of this study has not been established.

01.0 DENOMINAZIONE DEL MEDICINALE

The following has been reported in clinical trials and Générique Avodart 0.5 mg use: Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: In clinical studies, doses of 5 mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.

There is no specific antidote for Avodart, therefore, in suspected overdosage symptomatic and supportive treatment should be given as appropriate, Générique Avodart 0.5 mg. Pharmacological properties Pharmacotherapeutic Générique Avodart 0.5 mg In patients with BPH treated with dutasteride 0. Effect on Prostate Volume: Avodart led to a mean reduction of total prostate volume of The reduction of the prostate volume seen during the first 2 years of double-blind treatment was maintained during an additional 2 years of open-label extension studies.

Indications thérapeutiques

Reduction of the size of the prostate leads to improvement of symptoms and a decreased risk for AUR and BPH-related surgery. Clinical efficacy and safety Avodart 0. The Générique Avodart 0.5 mg then continued with an open-label extension to 4 years with all patients remaining in the study receiving dutasteride at the same 0.

At baseline the average score was approx. After six months, one and two years treatment the placebo group had an average improvement of 2. The differences between the groups were statistically significant.

The improvement in AUA-SI seen during the first 2 years of double-blind treatment was maintained during an additional 2 years of open-label extension studies. After one and two years treatment the flow in the placebo group had improved by 0. The difference between the groups was statistically significant from Générique Avodart 0.5 mg 1 to Month The increase in maximum urinary flow rate seen during the first 2 years of double blind treatment was maintained during an additional 2 years of open-label extension studies.

The incidence of BPH-related surgery after two Générique Avodart 0.5 mg was 4. Hair distribution The effect of dutasteride on hair distribution was not formally studied during the phase III programme, however, 5 alpha-reductase inhibitors could reduce hair loss and may induce hair growth in subjects with male pattern hair loss male androgenetic alopecia.

AVODART 0.5MG CAPSULES

Thyroid function Thyroid function was evaluated in a one year study in healthy men. Free thyroxine levels were stable on dutasteride treatment but TSH levels were mildly increased by 0.

In all the clinical studies, Générique Avodart 0.5 mg has been no evidence that dutasteride adversely affects thyroid function. Breast neoplasia In the 2 year clinical trials, providing patient years of exposure to dutasteride, and at the time of registration in the 2 year open label extension, there were 2 cases of male breast cancer reported in dutasteride-treated patients and 1 case in a patient who received placebo.

Further information

In the 4 year CombAT and REDUCE clinical trials providing patient years exposure to dutasteride and patient years exposure to dutasteride and tamsulosin combination, there were no cases of breast cancer reported in any treatment groups, Générique Avodart 0.5 mg. In the second study, the estimated odds ratio for breast cancer associated with the use of 5-alpha Générique Avodart 0.5 mg inhibitors compared with non-use was 1. A causal relationship between the occurrence of male breast cancer and long term use of dutasteride has not been established.

Effects on male fertility The effects of dutasteride 0. Sperm concentration and sperm morphology were unaffected.

The possibility of reduced male fertility cannot be excluded, Générique Avodart 0.5 mg. Secondary efficacy endpoints at 2 years included maximum urine flow rate Qmax and prostate volume. For Qmax combination achieved significance from Month 6 compared to both Avodart and tamsulosin, Générique Avodart 0.5 mg.

After 4 years of treatment, combination therapy statistically significantly reduced the risk of AUR or BPH-related surgery Secondary efficacy endpoints after 4 years of treatment included time to clinical progression defined as a composite of: Results following 4 years of treatment are presented below:

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