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Rats administered doses up to 43 mg/kg/day in males and 52 mg/kg/day in females had no increases in tumor incidence, with the exception of a modest increase in the frequency of mammary gland fibroadenomas in female rats receiving doses ≥5.4 mg/kg (P,0.015). The highest doses of tamsulosin hydrochloride evaluated in the rat carcinogenicity study produced systemic exposures (AUC) in rats 3 times the exposures in men receiving the maximum therapeutic dose of 0.8 mg/day.. Mice were administered doses up to 127 mg/kg/day in males and 158 mg/kg/day in females. There were no significant tumor findings in male mice. Female mice treated for 2 years with the two highest doses of 45 and 158 mg/kg/day had statistically significant increases in the incidence of mammary gland fibroadenomas (P,0.0001) and adenocarcinomas (P,0.0075). The highest dose levels of tamsulosin hydrochloride evaluated in the mice carcinogenicity study produced systemic exposures (AUC) in mice 8 times the exposures in men receiving ...
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In this study, we examined the changes in bladder function and the effects of silodosin in STZ-induced DM rats. Nine weeks after STZ induction, urinary dysfunction was observed on a CMG. Increases in BC and RV were observed in the DM group, and the BC/BlaW ratio was high. Furthermore, BBF was decreased and both gene and protein expression levels of NF-M and peripherin, which are neuronal markers, were decreased in bladder tissue in the DM group. These results suggest that a decrease in BBF and bladder hyperextension with sensory disorder, i.e., UAB-like symptoms, occurred in the DM group. The alpha1A-AR antagonist silodosin showed inhibitory effects against all of these changes in the DM group. Silodosin shows preventive or curative effects against UAB-like symptoms in DM, and these effects may be caused by the improvement in the sensory disorder by preventing the decrease in BBF.. Autonomic nervous system disorders due to peripheral neuropathy, which is one of the 3 major complications of DM, ...
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. ...
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Dutasteride: Following administration of a single 0.5 mg dose of a soft gelatin capsule, time to peak absolute bioavailability in 5 healthy subjects is approximately 60% (range: 40% to 94%). Tamsulosin: Absorption of tamsulosin is essentially complete (,90%) following oral administration of 0.4 mg tamsulosin hydrochloride capsules under fasting conditions. Tamsulosin exhibits linear kinetics following single and multiple dosing, with achievement of steady-state concentrations by the fifth day of once-daily dosing. Effect of Food Food does not affect the pharmacokinetics of dutasteride following administration of dutasteride and tamsulosin hydrochloride capsules. However, a mean 30% decrease in tamsulosin Cmax was observed when dutasteride and tamsulosin hydrochloride capsules was administered with food, similar to that seen when tamsulosin monotherapy was administered under fed versus fasting conditions. Distribution Dutasteride: Pharmacokinetic data following single and repeat oral doses show ...
This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin.. A recently published, landmark study (MTOPS - Medical Therapy of Prostatic Symptoms), co-sponsored by the National Institute of Health and the National Institute of Diabetes, Digestive and Kidney Diseases (NIH-NIDDK), demonstrated that, in selected patients, combination therapy with Doxazosin and Finasteride provided additive symptomatic improvements, reduced the risk of acute urinary retention (AUR) and surgical intervention, and was a more effective treatment for reduction in the ...
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Astellas Pharma this morning said it has begun legal proceedings against several Spanish generics companies for infringing its patent for Omnic (tamsulosin hydrochloride), which is also available in the country under the brand name Urolosin, manufactured by partner Boehringer Ingelheim. - News - PharmaTimes
This project will determine if tamsulosin is useful in patients with a kidney stone. Tamsulosin is used for patients with an enlarged prostate gland, but it has...
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Chapter 10. Adrenoceptor Blockers. In: Trevor AJ, Katzung BG, Kruidering-Hall MM, Masters SB. Trevor A.J., Katzung B.G., Kruidering-Hall M.M., Masters S.B. Eds. Anthony J. Trevor, et al.eds. Katzung & Trevors Pharmacology: Examination & Board Review, 10e New York, NY: McGraw-Hill; 2013. http://accesspharmacy.mhmedical.com/content.aspx?bookid=514§ionid=41817522. Accessed December 10, 2017 ...
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Tamsulosin is a prescription medicine used to treat the medical condition known as benign prostatic hyperplasia (more commonly referred to as enlarged prostate), which affects males.
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Forray C; Bard JA; Wetzel JM; et al. (1994). „The alpha 1-adrenergic receptor that mediates smooth muscle contraction in human prostate has the pharmacological properties of the cloned human alpha 1c subtype.". Mol. Pharmacol. 45 (4): 703-8. PMID 8183249 ...
Alfuzosin, som er et racemat, er et oralt virkende quinazolinderivat, som selektivt blokerer postsynaptiske α1-receptorer. De kliniske symptomer ved benign prostatahypertrofi er ikke kun relateret til størrelsen af prostata, men også til sympatomimetiske nerveimpulser, da stimulation af de postsynaptiske α-receptorer øger spændingen i den glatte muskulatur i de nedre urinveje. Behandling med alfuzosin virker afslappende på muskulaturen i prostata og urethra og forbedrer dermed urinflowet. ...
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The invention relates to processes for the preparation of alfuzosin or pharmaceutically acceptable salts thereof in high purity. More particularly, it relates to the preparation of pure crystalline a