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ROPECIA? (Finasteride) Tablets, 1 mg
9328505
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CONTRAINDICATIONS; PRECAUTIONS, Information for Patients and Pregnancy; and HOW SUPPLIED,
Storage and Handling.)
PRECAUTIONS
General
Caution should be used in the administration of PROPECIA in patients with liver function abnormalities,
as finasteride is metabolized extensively in the liver.
Information for Patients
Women should not handle crushed or broken PROPECIA tablets when they are pregnant or may
potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential
risk to a male fetus. Cheap Propecia tablets are coated and will prevent contact with the active ingredient
during normal handling, provided that the tablets have not been broken or crushed. (See also
CONTRAINDICATIONS; WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS;
PRECAUTIONS, Pregnancy; and HOW SUPPLIED, Storage and Handling.)
Physicians should instruct their patients to promptly report any changes in their breasts such as lumps,
pain or nipple discharge. Breast changes including breast enlargement, tenderness and neoplasm have
been reported (see ADVERSE REACTIONS).
See also Patient Package Insert.
Physicians should instruct their patients to read the patient package insert before starting therapy with
PROPECIA and to read it again each time the prescription is renewed so that they are aware of current
information for patients regarding Cheap Propecia.
Drug/Laboratory Test Interactions
Finasteride had no effect on circulating levels of cortisol, thyroid-stimulating hormone, or thyroxine, nor
did it affect the plasma lipid profile (e.g., total cholesterol, low-density lipoproteins, high-density
lipoproteins and triglycerides) or bone mineral density. In studies with finasteride, no clinically meaningful
changes in luteinizing hormone (LH), follicle-stimulating hormone (FSH) or prolactin were detected. In
healthy volunteers, treatment with finasteride did not alter the response of LH and FSH to gonadotropin-
releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected.
In clinical studies with PROPECIA (finasteride, 1 mg) in men 18-41 years of age, the mean value of
serum prostate-specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at Month 12.
Further, in clinical studies with PROSCAR (finasteride, 5 mg) when used in older men who have benign
prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. These findings should be
taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride.
Drug Interactions
No drug interactions of clinical importance have been identified. Finasteride does not appear to affect
the cytochrome P450-linked drug-metabolizing enzyme system. Compounds that have been tested in man
include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions
were found.
Other concomitant therapy: Although specific interaction studies were not performed, finasteride doses
of 1 mg or more were concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, ?-
blockers, analgesics, angiotensin-converting enzyme (ACE) inhibitors, anticonvulsants, benzodiazepines,
beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H
2
antagonists, HMG-CoA reductase
inhibitors, prostaglandin synthetase inhibitors (also referred to as NSAIDs), and quinolone anti-infectives
without evidence of clinically significant adverse interactions.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of a tumorigenic effect was observed in a 24-month study in Sprague-Dawley rats
receiving doses of finasteride up to 160 mg/kg/day in males and 320 mg/kg/day in females. These doses
produced respective systemic exposure in rats of 888 and 2192 times those observed in man receiving
the recommended human dose of 1 mg/day. All exposure calculations were based on calculated
AUC
(0-24 hr)
for animals and mean AUC
(0-24 hr)
for man (0.05 µg•hr/mL).
In a 19-month carcinogenicity study in CD-1 mice, a statistically significant (p?0.05) increase in the
incidence of testicular Leydig cell adenomas was observed at a dose of 250 mg/kg/day (1824 times the
human exposure). In mice at a dose of 25 mg/kg/day (184 times the human exposure, estimated) and in
rats at a dose of ?40 mg/kg/day (312 times the human exposure) an increase in the incidence of Leydig
cell hyperplasia was observed. A positive correlation between the proliferative changes in the Leydig cells
and an increase in serum LH levels (2-to 3-fold above control) has been demonstrated in both rodent
species treated with high doses of finasteride. No drug-related Leydig cell changes were seen in either
rats or dogs treated with finasteride for 1 year at doses of 20 mg/kg/day and 45 mg/kg/day (240 and 2800

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Finasteride in the treatment of men with frontal male pattern hair loss Background. Finasteride, a specific inhibitor of type 11 5a-reductase, decreases serum and scalp dihydrotestosterorie and has been shown to be effective in men with vertex male pat- tem hair loss. Objective: This study evaluated the efficacy of finasteride 1 mg/day in men with frontal (anterior/mid) scalp hair thinning. Methods: This was a 1-year, double-blind, placebo-controlled study followed by a 1-year open extension. Efficacy was assessed by hair counts (I CM2 circular area), patient and investigator assessments, and global photographic review. Results: There was a significant increase in hair count in the frontal scalp of finasteride- treated patients (P < .00 1), as well as significant improvements in patient, investigator, and global photographic assessments. Efficacy was maintained or improved throughout the second year of the study. Finasteride was generally well tolerated. Conclusion: In men with hair loss in the anterior/mid area of the scalp, finasteride 1 mg/day slowed hair loss and increased hair growth. Male pattern hair loss, or androgenetic alopecia, is a common condition with both genetic and hormonal origins. Typically, there is progressive loss and thinning of hair in an easily recognizable pattem of bitemporal and anterior/mid scalp recession or vertex thinning. Although the rate of hair loss varies in individual men, the cyclical process is slow, such that over several years, terminal hairs are gradually replaced by progressively finer and less pigmented miniaturized hairs. Although the genetic component is still being elucidated, the essential involvement of androgens has been known for more than 50 years. It is now clear that dihydrotestosterone rather than testosterone is the principal androgen responsible for male pattern hair loss. This was confirmed by the observation that men with inherited type 11 5a-reductase deficiency have low levels of dihydrotestosterone and normal to high levels of testosterone, but do not experience male pattern hair loss . Furthermore, it has been shown that baseline dihydrotestosterone levels are higher in balding scalp versus hairy scalp. Finasteride, a specific inhibitor of the human type II 5a-reductase enzyme, has been shown to reduce both serum and scalp skin dihydrotestosterone levels in balding men. Recent data have also demonstrated that finasteride 1mg/day increases scalp hair in men with vertex thinning. Because hair loss in the frontal (anterior/mid) region of the scalp is highly visible, and therefore important to patients, this study was undertaken to assess the efficacy and safety of finasteride in men with frontal (anterior/mid) scalp thinning. PATIENTS AND METHODS Study design This was a multicenter, double-blind, placebo-con- trolled study conducted at 45 investigational sites in the United States. The study was approved by the institu- tional review board at each center, and all men gave written informed consent. After a 2-week, single-blind placebo run-in period, each subject was randomized to receive either oral finasteride 1 mg or placebo once daily for 12 months. All men who elected to enter the open extension received finasteride 1 mg daily during a second year of study. The primary end point, hair count, was assessed in a blinded manner at months 6, 12, and 24. Individual photographs of the anterior/mid scalp were obtained at months 6, 12, and 24, and were reviewed in a blinded manner by a panel of expert dermatologists at the end of the trial. Investigator and patient assessments, obtained with a validated questionnaire, were obtained every 3 months during the first year and every 6 months thereafter. Subjects were instructed to maintain the same hair style, and to refrain from dyeing their hair or using any hair enhancement products or procedures throughout the study. A standard shampoo (Neutrogena T/Gel, Neutrogena Corp, Los Angeles, Calif) was given to all subjects to use throughout the study period. Patient selection Men were eligible for enrollment into the study if they were between 18 and 40 years of age, in good physical and mental health, and had typical male pattem hair loss with modified Norwood/Hamilton grade II, grade II vertex, IIa, III, or III vertex pattern hair loss as well as recent or ongoing mild to moderate thinning of their hair in the frontal area of the scalp. The frontal area of the scalp was defined as those areas anterior to the vertex. Evaluation procedures Hair counts. Hair counts were obtained from com- puter assisted scans of standardized macrophotographs of clipped hair in a defined target area (1 cm2), centered on a tattoo located in the anterior or mid area of the scalp. [Cheap Propecia]Macrophotographs were converted into dot maps of each visible hair by trained technicians, validated for precision, and blinded to patient, treatment, and time. Patient self-assessment. Patient self-assessment of hair growth was determined by means of a validated self-administered questionnaire comprising 6 questions, each of which asked the patient about a specific aspect of their hair compared with the start of the study (appearance of hair, growth of hair, slowing down hair loss, satisfaction with appearance of their hair, satisfac- tion with the frontal hairline, and satisfaction with their hair overall). Investigator assessment. Investigators assessed each patient by means of a 7-point scale to answer the following question: “As the investigator, how would you subjectively rate the patient’s hair at this time point compared to baseline?” The options for the investigator were as follows: don’t know, -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, 1 = slightly increased, 2 = moderately increased, 3 = greatly increased. Global photographic assessment. Standardized global photographs of the anterior/mid area of the scalp were taken, before clipping the patient’s hair for the macrophotographs, by means of a stereotactic device in which the patient’s head was placed to ensure consis- tency of patient positioning and photographic distance. Before the global photographs were taken, the patient’s hair was combed in a consistent manner for each patient so that the balding area could be optimally viewed. At the end of the study, an expert panel of 3 dermatologists evaluated hair growth or loss from baseline by comparing baseline with follow-up photographs of each subject by means of the same scale as the investigator assessment

Hair loss can occur in both men and women for a variety of reasons. Genetics, hormones and some medications can all contribute to this condition. If you are noticing that your hair is thinning, or if you are discovering some bald patches on your scalp, it might be time to consider your options in hair loss treatments. The good news is that there are many choices in this arena, including topical solutions, medications and some surgical procedures. If you would like to pursue a hair loss treatment, the first step that you need to make is into your doctor’s office for an exam and guidance as to which treatment might work best for you.

Topical Hair Loss Treatments

There are a couple of topical hair loss treatments available, and these fall under the commercial names of Rogaine and Drithocreme. Rogaine contains minoxidil in either a two or five percent solution. Minoxidil can be rubbed into the scalp to stop current hair loss, and in some case actually regrow hair. This medication works only as long as it is used, which means that hair loss will resume once you are no longer applying the ointment. Drithocreme is a tarry substance that is most often used to treat psoriasis, but it can also be an effective remedy for controlling this condition in some people.(Cheap Propecia)

Finasteride, which is also known as Propecia is an oral medication that is sometimes used as a treatment for men. This medication works by inhibiting the hormone DHT, which is known to shrink hair follicles and contribute to hair loss. In order for this medication to be effective you must continue to take it, since ceasing the medication will result in the loss of hair resuming. Finasteride has not been approved for women, and has in fact proved to be highly dangerous to the unborn child of pregnant women. Corticosteroids can also be used as a loss of hair treatment, and are most often given by injection for this type of condition.

Surgery for Loss Of Hair Treatment

There are two types of surgery available for this condition, and these include hair transplants and scalp reduction. Sometimes a combination of these two procedures is done for maximum results. Surgery for loss of hair treatment can be a painful process that has risks associated with it, so the decision to have surgery should be weighed very carefully. If you are concerned about thinning hair, talk to your doctor today about the treatments that are available to you.Tags:Cheap Propecia

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