DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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June 28, 2013 –The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.
There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin.
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PEXEVA® (paroxetine mesylate) is an orally administered psychotropic drug with a chemical structure related to paroxetine hydrochloride (Paxil®). It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4′-fluorophenyl)-3S-[(3′,4′-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C19H20FNO3•CH3SO3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is: paroxetine mesylate
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Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water.
Tablets
Each oval, film-coated tablet contains paroxetine mesylate equivalent to paroxetine as follows: 10 mg (white); 20 mg (scored, dark orange); 30 mg (yellow); 40 mg (rose). Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only).
EP1286965B1
New Drug Approvals 
Reblogged this on MariaGairos–DRUGS.
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Reblogged this on MedCheminAustralia.
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In my opinion, the use of a psycho-active drug such as paroxetine,an SSRI anti-depressant, for treatment of symptoms caused by menopausal hormone deficiency is an abuse and mistreatment of women belonging in a medical museum as an example of medical iatrogenesis in women.
Paroxetine, Paxil is medically ineffective for treatment of hot flashes, or any menopausal symptom for that matter, Paroxetine, Paxil is one of the most addictive of the SSRI drugs, with warnings about severe withdrawal effects, loss of libido etc.
Menopause is a hormone deficiency state and the correct treatment is with hormones identical to those in the human body. Prescribing SSRI antidepressants for menopausal symptoms is a medical practice which should be halted immediately.
for more http://wp.me/p3gFbV-vs
jeffrey dach md
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