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14-September-2008 11:27:26 - Dutasteride Dutasteride Systematic IUPAC name 5α, 17β-N-2,5 bistrifluoromethyl phenyl-3-oxo-4-azaandrost-1-ene-17-carboxamide Identifiers CAS number 164656-23-9 ATC code G04CB02 PubChem 152945 DrugBank APRD00385 Chemical data Formula C27H30F6N2O2 Mol. mass 528.53 g/mol Pharmacokinetic data Bioavailability 60% Protein binding 99% Metabolism Hepatic CYP3A4-mediated Half life 5 weeks Excretion Fecal Therapeutic considerations Pregnancy cat. XUS Not to be handled by pregnant women Legal status POMUK ℞-onlyUS Routes Oral Dutasteride marketed as Avodart, Avidart, Avolve, Duagen, Dutas, Dutagen, Duprost is a 5-alpha-reductase inhibitor, a drug which inhibits the conversion of testosterone into dihydrotestosterone DHT. It is used to treat conditions caused by DHT, such as benign prostatic hyperplasia BPH. Avodart is manufactured and marketed by GlaxoSmithKline. Contents 1 Classification and Method of Action 2 Uses 3 Side Effects 3.1 Teratogenic effect 4 See also 5 External links 6 References Classification and Method of Action Dutasteride belongs to a class of drugs called 5-alpha-reductase inhibitors, which block the action of the 5-alpha-reductase enzymes that convert testosterone into dihydrotestosterone DHT. Finasteride also belongs to this group. Dutasteride inhibits both isoforms of 5-alpha reductase, while finasteride inhibits only one. But a clinical study done by GlaxoSmithKline, the EPICS trial, did not find dutasteride to be more effective than finasteride in treating BPH. Uses While dutasteride is officially approved to treat enlargement of the prostate gland, Clinical trials for dutasteride as a hair loss drug were undertaken, but called off in late 2002. The reason the trials were called off is not publicly known. Industry sources speculate that Avodart would have been seen as too similar to Propecia to have proved profitable as a hair loss treatment. However, phase II results indicated that dutasteride 2.5mg generated a superior hair count to finasteride 5mg at 12 and 24 weeks.1 In December 2006, GlaxoSmithKline started a new Phase III, six month study in Korea to test the safety, tolerability and effectiveness of a once-daily dose of dutasteride 0.5mg for the treatment of male pattern baldness in the vertex region of the scalp types IIIv, IV and V on the Hamilton-Norwood scale.2 The future impact that this study will have on the FDA's approval or disapproval of Avodart for the treatment of male pattern baldness in the United States is yet to be determined. Dutasteride is also in development for Prostate cancer risk reduction.3 Side Effects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. The most common adverse reactions reported in subjects receiving AVODART were impotence, decreased libido, breast disorders including gynecomastia, and ejaculation disorders. Study withdrawal due to adverse reactions occurred in 4% of subjects receiving AVODART and 3% of subjects receiving placebo. The most common adverse reaction leading to study withdrawal was impotence 1%.citation needed Teratogenic effect The teratogenic effect from Dutasteride is a very large risk for male children. The effect would be similar to 5-alpha-reductase deficiency, where a developing male child naturally is deficient in 5-alpha reductase type 2, and thus unable to synthesize DHT Type 2. As Dutasteride blocks the same process although type 1 and 2 DHT a developing male would have this deficiency as a result of medication, rather than simply naturally. See also baldness treatments finasteride External links Effectiveness of Dutasteride as a treatment for Male Pattern Baldness, as reported by Science Daily. Official site http://www.hairlosshelp.com/html/Dutasteride_hair_loss_trials.cfm References ^ The importance of dual 5alpha-reductase inhibition...J Am Acad Dermatol. 2006 - PubMed Result ^ ClinicalTrials.gov NCT00441116 ^ Sound bites for NCE Entries into Phase III v d e Urologicals G04 Acidifiers Ammonium chloride, Calcium chloride Urinary antispasmodics primarily antimuscarinics Darifenacin, Emepronium, Fesoterodine, Flavoxate, Imidafenacin, Meladrazine, Oxybutynin, Propiverine, Solifenacin, Terodiline, Tolterodine, Trospium For erectile dysfunction Prostaglandins E Alprostadil PDE5 inhibitors Avanafil - Sildenafil - Tadalafil - Udenafil - Vardenafil Alpha blockers Moxisylyte - Phentolamine - Yohimbine Others Apomorphine - Papaverine Other urologicals Acetohydroxamic acid, Collagen, Dimethyl sulfoxide, Magnesium hydroxide, Pentosan polysulfate, Phenazopyridine, Phenyl salicylate, Succinimide For BPH 5α-reductase inhibitors Dutasteride, Finasteride Alpha blockers α1 Alfuzosin, Doxazosin, Silodosin, Tamsulosin, Terazosin Herbals Pygeum africanum, Serenoa repens Retrieved from http://en..org/wiki/Dutasteride Categories: 5-alpha-reductase inhibitors | Hair loss | GlaxoSmithKlineHidden categories: All articles with statements | Articles with statements since September 2008 Views Article Discussion this page History Personal tools Log in / create account Navigation Main page Contents Featured content Current events Random article Search Go Search Interaction Community portal Recent changes Contact Donate to Help Toolbox What links here Related changes Upload file Special pages Printable version Permanent link Cite this page Languages Deutsch Suomi Italiano Türkçe This page was last modified on 12 September 2008, at 06:27
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