Propecia

In our previous study, a long-acting injectable (LAI) formulation of finasteride was prepared as a new dosage form of PROPECIA®, and in vivo pharmacokinetics (PKs)-pharmacodynamics (PDs) was evaluated in beagle dogs. The resulting PK-PD profiles of the formulation showed pharmacological effects and achievability for monthly delivery. In this study, a first-in-human (FIH) dose of the LAI formulation loaded with finasteride was predicted. The three approaches were used for estimating a FIH dose of the LAI formulation: (1) No observed adverse effect level (NOAEL)-based approach; (2) Pharmacokinetically-guided approach; (3) Pharmacokinetic/pharmacodynamic model-based approach...

Prior literature has suggested that finasteride may negatively impact men's sexual health. In 2011, the Food and Drug Administration (FDA) provided a warning on finasteride drug labels to incorporate sexual side effects such as reduced libido and erectile dysfunction. We aimed to evaluate global online interest in finasteride sexual side effects, their penetrance and variation, and how they compared overtime. We also aimed to evaluate the influence of the FDA label warnings on web-based searches for finasteride side effects...

BACKGROUND: 5α-reductase inhibitors are commonly prescribed medications with multiple side effects used in the treatment of male pattern hair loss and benign prostatic hyperplasia. These side effects including "post-finasteride syndrome" may result in lawsuits. OBJECTIVES: To characterize lawsuits involving the adverse side effects of 5α-reductase inhibitor to better understand drivers of litigation and outcomes. METHODS: Legal cases were queried from Nexis Uni using the search terms "5-alpha reductase inhibitor" as well as specific agents "finasteride," "dutasteride" in combination with "malpractice," "negligence," "damage," "loss," "side effect," and "complication...

BACKGROUND AND OBJECTIVES: Finasteride 1 mg/day is indicated for androgen-dependent conditions such as male androgenetic alopecia (AGA). METHODS: The literature is comprehensively summarized on the pharmacodynamics, pharmacokinetics, mechanism of action, and metabolism of finasteride. Pairwise and network meta-analyses were performed to assess the efficacy of finasteride reported in clinical trials. The adverse events profile is described along with the post-marketing reports...

A controlled drug release formulation based on the subcutaneous injection of poly (lactic-co-glycolic acid) (PLGA) microspheres loaded with finasteride was prepared and evaluated for monthly delivery. After selection of biodegradable polymer and polymer-to-finasteride ratio, the formulation was characterized. Scanning electron microscopy (SEM) and laser-light particle size analysis were used to examine the morphology, surface structure, and particle size. High‑performance liquid chromatography (HPLC) was used to determine the drug loading, while liquid chromatography with tandem mass spectrometry (LC-MS/MS) was employed to analyze plasma finasteride concentrations...

In this report we address an unusual adverse effect of finasteride (Propecia 1 mg tablets) that was associated with painless hematuria and hematospermia in a 38-year-old healthy male during treatment of androgenic alopecia at a dose of 1 mg/day. It was found that the bleeding was linked to finasteride use as it occurred 2-3 days after use and stopped upon discontinuation of the drug. The patient was subjected to urological examination, laboratory investigations, and radiological imaging to identify the probable cause of bleeding...

There are a significant number of men under 40 who experience erectile dysfunction (ED). In the past, the vast majority of cases were thought to be psychogenic in nature. Studies have identified organic etiologies in 15-72% of men with ED under 40. Organic etiologies include vascular, neurogenic, Peyronie's disease (PD), medication side effects and endocrinologic sources. Vascular causes are commonly due to focal arterial occlusive disease. Young men with multiple sclerosis, epilepsy and trauma in close proximity to the spinal cord are at increased risk of ED...

No abstract text is available yet for this article.

OBJECTIVE: Finasteride, a commonly prescribed medication for male pattern hair loss, has recently been associated with persistent sexual side effects. In addition, depression has recently been added to the product labeling of Propecia (finasteride 1 mg). Finasteride reduces the levels of several neuroactive steroids linked to sexual function and depression. This study assesses depressive symptoms and suicidal thoughts in former users of finasteride who developed persistent sexual side effects despite the discontinuation of finasteride...

Background. We examined the efficacy of a new regimen to treat AGA, with attention to male patients who are atopic. Objective. To assess the efficacy of a four-part regimen for the treatment of AGA in atopic and nonatopic patients. NuH Hair is a novel topical combination of finasteride, dutasteride, and minoxidil, which is blended in a hypoallergenic lotion. The other three components included Rogaine foam, Propecia, and ketoconazole shampoo. Methods. A prospective pilot study was conducted in 15 patients. All patients were assessed for the presence of atopy...

Before now, there has been no study of finasteride use exceeding 1 year in Japanese men with androgenetic alopecia (AGA) except the study subsequently conducted from the development phase. Since the launch of finasteride, no study in a larger population had been reported. Ethnic variation of the onset age, progressive nature and degree of hair loss of androgenetic alopecia are known. The therapeutic effect of oral finasteride (Propecia) was examined on androgenetic alopecia of Japanese men. The efficacy and safety of finasteride (1 mg tablet) was evaluated in Japanese men with AGA in the long term...

INTRODUCTION: Finasteride has been associated with reversible adverse sexual side effects in multiple randomized, controlled trials for the treatment of male pattern hair loss (MPHL). The Medicines and Healthcare Products Regulatory Agency of the United Kingdom and the Swedish Medical Products Agency have both updated their patient information leaflets to include a statement that "persistence of erectile dysfunction after discontinuation of treatment with Propecia has been reported in post-marketing use...

Finasteride at a dose of 1 mg (Propecia®) has been used for the treatment of androgenic alopecia in men. Though finasteride has been successfully used, there is ongoing controversy surrounding its use since the publication of the Prostate Cancer Prevention Trial (PCPT) which includes claims of increased risk for higher grade prostate cancers. This has produced confusion on consulting and treatment of patients interested in starting finasteride for androgenic alopecia. We felt there was a need to clarify further the results of PCPT for our readers and help understanding the real risk of prostate cancer development of patients on finasteride...

Finasteride (1 mg/day) is widely utilized by dermatologists for the treatment of androgenetic alopecia. Although enjoying a relatively good safety profile, several sex-related adverse effects have been reported with this drug. Here we report two cases of gynecomastia, one of them bilateral, caused by Propecia((R)) prescribed for the treatment of androgenetic alopecia. Although relatively rare, physicians should be aware of this side effect and inform their patients when prescribing this medication.

OBJECTIVE: To describe the results of two cases of azoospermia and severe oligospermia in men during and after cessation of finasteride 1 mg. DESIGN: Case report. SETTING: Tertiary-care hospital-based clinic for andrology/male infertility. PATIENT(S): Two patients with azoospermia and severe oligospermia using finasteride 1 mg for hair loss. INTERVENTION(S): Discontinuation of finasteride. MAIN OUTCOME MEASURE(S): Improvement in sperm concentration...

BACKGROUND: Use of 5 mg/day finasteride (Proscar) for benign prostatic hyperplasia is known to affect serum concentrations of prostate-specific antigen (PSA). When men taking this treatment undergo screening for prostate cancer, a compensatory adjustment of the PSA concentration (to multiply the value by two) is recommended. Whether this recommendation should apply to men taking 1 mg/day finasteride (Propecia) for the treatment of androgenic alopecia is unknown. We aimed to assess the effect of 1 mg/day finasteride on serum PSA in men aged 40-60 years with male-pattern hair loss...

No abstract text is available yet for this article.

This conference focused on 'lifestyle' drugs, the kind of medicines treating conditions not considered as diseases, such as erectile dysfunction, male baldness, stress, etc, to improve quality of life and well-being. The lifestyle area is the fastest growing area in pharmaceuticals, driven by drugs such as Viagra (sildenafil; Pfizer Inc), Propecia (finasteride; Merck & Co Inc), Xenical (orlistat; F Hoffmann-La Roche Ltd) and others. The aging population in developed countries has a new perception of health, which is an improvement of wellness...

In men who are genetically predisposed to develop androgenetic alopecia (AGA; male pattern hair loss), endogenous androgens alter scalp hair follicles, resulting in production of vellus-like, miniaturised hair, rather than cosmetically significant terminal hair. This change leads to a progressive decline in visible scalp hair density, readily perceived by the patient as thinning and, eventually, baldness. Dihydrotestosterone (DHT), a metabolite of testosterone produced by the enzyme 5alpha-reductase, has been implicated as the specific androgen in the pathogenesis of AGA...

No abstract text is available yet for this article.