Finasteride

Finasteride is metabolized mainly by the liver, and caution should be used in patients with liver dysfunction. Finasteride may be taken with or without food.

Finasteride is a prescription medicine used to treat male pattern baldness and enlarged prostate in men.

Clinical Trials Experience

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 trials of another drug and may not reflect the rates observed in clinical practice.

In three controlled clinical trials for PROPECIA of 12-month duration, 1.4% of patients taking PROPECIA (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934).

Clinical adverse experiences that were reported as possibly, probably or definitely drug-related in ≥1% of patients treated with PROPECIA or placebo are presented in Table 1.

TABLE 1: Drug-Related Adverse Experiences for PROPECIA (finasteride 1 mg) in Year 1 (%)
MALE PATTERN HAIR LOSS

Integrated analysis of clinical adverse experiences showed that during treatment with PROPECIA, 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04). Resolution occurred in men who discontinued therapy with PROPECIA due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to ≤0.3% by the fifth year of treatment with PROPECIA.

In a study of finasteride 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.3 mL (- 11%) compared with 0.2 mL (-8%) for placebo was observed after 48 weeks of treatment. Two other studies showed that finasteride at 5 times the dosage of PROPECIA (5 mg daily) produced significant median decreases of approximately 0.5 mL (-25%) compared to placebo in ejaculate volume, but this was reversible after discontinuation of treatment.

In the clinical studies with PROPECIA, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular pain in finasteride-treated patients were not different from those in patients treated with placebo.

In the PROSCAR Long-Term Efficacy and Safety Study (PLESS), a 4-year controlled clinical study, 3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years (1524 on PROSCAR 5 mg/day and 1516 on placebo). 3.7% (57 patients) treated with PROSCAR 5 mg and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions.

Table 2 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on PROSCAR was ≥1% and greater than placebo over the 4 years of the study. In years 2-4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

TABLE 2: Drug-Related Adverse Experiences for PROSCAR (finasteride 5 mg)
BENIGN PROSTATIC HYPERPLASIA

The adverse experience profiles in the 1-year, placebo-controlled, Phase III BPH studies and the 5-year open extensions with PROSCAR 5 mg and PLESS were similar.

There is no evidence of increased sexual adverse experiences with increased duration of treatment with PROSCAR 5 mg. New reports of drug-related sexual adverse experiences decreased with duration of therapy.

During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with PROSCAR but no cases in men not treated with PROSCAR. During the 4-year placebo-controlled PLESS study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men, but no cases were reported in men treated with PROSCAR.

During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with PROSCAR, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.

The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 healthy men ≥55 years of age with a normal digital rectal examination and a PSA ≤3.0 ng/mL. Men received either PROSCAR (finasteride 5 mg) or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8-10 prostate cancer was higher in men treated with finasteride (1.8%) than in those treated with placebo (1.1%). In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor [AVODART (dutasteride)], similar results for Gleason score 8-10 prostate cancer were observed (1% dutasteride vs 0.5% placebo). The clinical significance of these findings with respect to use of PROPECIA by men is unknown.

No clinical benefit has been demonstrated in patients with prostate cancer treated with PROSCAR. PROSCAR is not approved to reduce the risk of developing prostate cancer.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of PROPECIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

hypersensitivity reactions such as rash, pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face);

sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain. [See Clinical Trials Experience]

male breast cancer;

breast tenderness and enlargement;

depression

Read the entire FDA prescribing information for Propecia (Finasteride)

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using finasteride.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water.

Finasteride can be taken with or without food. Take the medicine at the same time each day.

Use finasteride regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

It may take up to 3 months or longer before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

While using finasteride, you may need frequent blood tests. Your doctor will also test your prostate specific antigen (PSA) to check for prostate cancer.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you notice any signs of male breast cancer, such as:

• breast lumps;

• breast pain or tenderness;

• nipple discharge; or

• any other breast changes.

Common side effects may include:

• loss of interest in sex;

• impotence;

• trouble having an orgasm; or

• abnormal ejaculation.

The sexual side effects of finasteride may continue after you stop taking this medicine. Talk to your doctor if you have concerns about these side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Benign Prostatic Hypertrophy (BPH)

Treatment of symptomatic BPH to improve symptoms and reduce the risk of acute urinary retention and the need for surgery.1 8 15 16 17 19 Ineffective in patients who do not have evidence of prostatic enlargement.25

Used alone or in combination with an α1-adrenergic blocking agent (e.g., doxazosin).1 20 25 Combination therapy with a 5α-reductase inhibitor and an α1-blocker has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression.1 20 25 Men at risk for BPH progression are most likely to benefit from combination therapy.20 25

Steroid 5α-reductase inhibitors may be a useful alternative to surgery in patients with obstructive manifestations who are awaiting or unwilling to undergo surgical correction of BPH; may aid those who are at increased risk from or are not candidates for prostate surgery.3 14 25 Also may be considered in patients who have symptomatic prostatic enlargement but whose symptoms are not bothersome (i.e., do not interfere with activities of daily living) in order to prevent progression of the disease.25

Although drug therapy usually is not as effective as surgical therapy, it may provide adequate symptomatic relief with fewer and less serious adverse effects compared with surgery.25

Androgenetic Alopecia

Stimulates regrowth of hair in men with mild to moderate androgenetic alopecia (male pattern alopecia, hereditary alopecia, common male baldness).d f

Effective in promoting hair regrowth in young and middle-aged men (18–41 years of age) with mild to moderate androgenetic alopecia and hair loss on the vertex of the scalp and/or anterior mid-scalp area; the effects on bitemporal recession are not established.d

Recommended only for use in men;d not indicated for use in women or children.d Ineffective for treatment of hair loss in postmenopausal women with androgenetic alopecia.d

Withdrawal of the drug leads to reversal of clinical benefit within 1 year.d Therapy must be continued to sustain initial regrowth and subsequent slowing of hair loss.d Maximum improvement in hair count occurs during first 2 years of therapy.d

Absorption

Bioavailability

Mean bioavailability is 63–65%.1 d

Onset

Rapid, with maximum decrease in serum DHT concentrations at 8 hours following oral administration of first dose of 5 mg, and 65% suppression of serum DHT within 24 hours after oral administration of 1 mg.1 d

Duration

DHT suppression maintained throughout 24-hour dosage interval; DHT decreased by about 70% with 5-mg daily dosage for at least 4 years.1

Food

Food does not appear to affect absorption.1 d

Distribution

Extent

Crosses blood-brain barrier, but is not preferentially distributed into CSF.1 d

Distributed into semen in amounts estimated to be 50- to 100-fold less than the dose (5 mcg) that had no effect on circulating DHT concentrations in men.1

Crosses the placenta in rats.1 d

Not known whether distributed into human milk.1 d

Plasma Protein Binding

Approximately 90%. 1 d

Elimination

Metabolism

Extensively metabolized, principally in the liver, via CYP3A4; 2 metabolites identified with ≤20% of activity of finasteride.1 d

Elimination Route

Principally excreted in the feces (57%) and in urine (39%) as metabolites.1 d

Half-life

Males 18–60 years of age: 5–6 hours.1 d

Special Populations

Half-life in males ≥70 years of age: 8 hours; increase not clinically important.1 d

Effect of hepatic impairment on pharmacokinetics not studied; extensively metabolized in the liver.1 d

In patients with chronic renal impairment (Clcr 9–55 mL/minute), pharmacokinetics after single-dose administration appear to be similar to those in healthy individuals except that the proportion excreted in feces versus urine is increased in those with impairment.1

In the U.S.

• Propecia
• Proscar

Available Dosage Forms:

• Tablet

Therapeutic Class: Alopecia Agent

Pharmacologic Class: 5-Alpha Reductase Inhibitor

Finasteride tablets USP may be administered with or without meals.

Monotherapy

The recommended dose of Finasteride tablet USP is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].

Combination with Alpha-Blocker

The recommended dose of Finasteride tablets USP is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].

Clinical Trials Experience

Finasteride tablets USP are generally well tolerated; adverse reactions usually have been mild and transient.

4-Year Placebo-Controlled Study (A Long-Term Efficacy and Safety Study)
In a long-term efficacy and safety study, 1524 patients treated with Finasteride tablets USP and 1516 patients treated with placebo were evaluated for safety over a period of 4 years. The most frequently reported adverse reactions were related to sexual function. 3.7% (57 patients) treated with Finasteride tablets USP and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions.
Table 1 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on Finasteride tablets USP was ≥1% and greater than placebo over the 4 years of the study. In years 2 to 4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

                                                                                               *Combined Years 2 to 4

                                                                                                N = 1524 and 1516, Finasteride vs placebo, respectively

Phase III Studies and 5-Year Open Extensions
The adverse experience profile in the 1-year, placebo-controlled, Phase III studies, the 5-year open extensions, and a long-term efficacy and safety study were similar.

Medical Therapy of Prostatic Symptoms (MTOPS) Study
In the MTOPS study, 3047 men with symptomatic BPH were randomized to receive Finasteride tablets USP, 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of Finasteride tablets USP, 5 mg/day and doxazosin 4 or 8 mg/day (n=786), or placebo (n=737) for 4 to 6 years. [See Clinical Studies (14.2).]
The incidence rates of drug-related adverse experiences reported by ≥2% of patients in any treatment group in the MTOPS Study are listed in Table 2.
The individual adverse effects which occurred more frequently in the combination group compared to either drug alone were: asthenia, postural hypotension, peripheral edema, dizziness, decreased libido, rhinitis, abnormal ejaculation, impotence and abnormal sexual function (see Table 2). Of these, the incidence of abnormal ejaculation in patients receiving combination therapy was comparable to the sum of the incidences of this adverse experience reported for the two monotherapies.

Combination therapy with Finasteride and doxazosin was associated with no new clinical adverse experience.
Four patients in MTOPS reported the adverse experience breast cancer. Three of these patients were on Finasteride only and one was on combination therapy. [See Long Term Data.]

The MTOPS Study was not specifically designed to make statistical comparisons between groups for reported adverse experiences. In addition, direct comparisons of safety data between the MTOPS study and previous studies of the single agents may not be appropriate based upon differences in patient population, dosage or dose regimen, and other procedural and study design elements.
 

 *Doxazosin dose was achieved by weekly titration (1 to 2 to 4 to 8 mg). The final tolerated dose (4 mg or 8 mg) was administered at end-Week 4. Only those patients tolerating at least 4 mg were kept on doxazosin. The majority of patients received the 8-mg dose over the duration of the study.

Long-Term Data
High-Grade Prostate Cancer
The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 men ≥55 years of age with a normal digital rectal examination and a PSA ≤ 3.0 ng/mL. Men received either Finasteride tablets USP, 5 mg or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8 to 10 prostate cancer was higher in men treated with Finasteride (1.8%) than in those treated with placebo (1.1%) [see Indications and Usage (1.3)and Warnings and Precautions (5.2)]. In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, AVODART), similar results for Gleason score 8 to 10 prostate cancer were observed (1% dutasteride vs 0.5% placebo).

No clinical benefit has been demonstrated in patients with prostate cancer treated with Finasteride tablets USP.

Breast Cancer
During the 4- to 6-year placebo- and comparator-controlled MTOPS study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with Finasteride but no cases in men not treated with Finasteride. During the 4-year, placebo-controlled long-term efficacy and safety study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men but no cases in men treated with Finasteride. During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with Finasteride, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of Finasteride and male breast neoplasia is currently unknown.

Sexual Function
There is no evidence of increased sexual adverse experiences with increased duration of treatment with Finasteride tablets USP. New reports of drug-related sexual adverse experiences decreased with duration of therapy.

Postmarketing Experience

The following additional adverse effects have been reported in post-marketing experience with Finasteride tablets USP.  Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- hypersensitivity reactions, such as pruritus, urticaria, and  angioedema (including swelling of the lips, tongue, throat, and face)
- testicular pain
- sexual dysfunction that continued after discontinuation of treatment, including   erectile dysfunction, decreased libido and ejaculation disorders (e.g reduced ejaculate volume). These events were reported rarely in men taking Finasteride tablets USP for the treatment of BPH. Most men were older and were taking concomitant medications and/or had co-morbid conditions. The independent role of Finasteride tablets USP in these events is unknown.
- male infertility and/or poor seminal quality have been reported rarely in men taking Finasteride tablets USP for the treatment of BPH. Normalization or improvement of seminal quality has been reported after discontinuation of Finasteride .The independent role of Finasteride tablets USP in these events is unknown.
- depression
- male breast cancer.

The following additional adverse event related to sexual dysfunction that continued after discontinuation of treatment has been reported in postmarketing experience with Finasteride at lower doses used to treat male pattern baldness. Because the event is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure:

- orgasm disorders 

Pregnancy

Teratogenic Effects:
Pregnancy Category X. [See Contraindications (4).]

Finasteride tablets USP are contraindicated for use in women who are or may become pregnant. Finasteride tablets USP is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. In animal studies, Finasteride caused abnormal development of external genitalia in male fetuses. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus.

Abnormal male genital development is an expected consequence when conversion of testosterone to 5α-dihydrotestosterone (DHT) is inhibited by 5α-reductase inhibitors. These outcomes are similar to those reported in male infants with genetic 5α-reductase deficiency. Women could be exposed to Finasteride through contact with crushed or broken Finasteride tablets USP or semen from a male partner taking Finasteride tablets USP. With regard to Finasteride exposure through the skin, Finasteride tablets USP are coated and will prevent skin contact with Finasteride during normal handling if the tablets have not been crushed or broken. Women who are pregnant or may become pregnant should not handle crushed or broken Finasteride tablets USP because of possible exposure of a male fetus. If a pregnant woman comes in contact with crushed or broken Finasteride tablets USP, the contact area should be washed immediately with soap and water. With regard to potential Finasteride exposure through semen, two studies have been conducted in men receiving Finasteride tablets USP, 5 mg/day that measured Finasteride concentrations in semen [see Clinical Pharmacology (12.3)].

In an embryo-fetal development study, pregnant rats received Finasteride during the period of major organogenesis (gestation days 6 to 17). At maternal doses of oral Finasteride approximately 0.1 to 86 times the maximum recommended human dose (MRHD) of 5 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day) there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring. Exposure multiples were estimated using data from nonpregnant rats. Days 16 to 17 days of gestation is a critical period in male fetal rats for differentiation of the external genitalia. At oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose of 0.03 mg/kg/day), male offspring had decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development. Decreased anogenital distance occurred in male offspring of pregnant rats that received approximately 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day). No abnormalities were observed in female offspring at any maternal dose of Finasteride.

No developmental abnormalities were observed in the offspring of untreated females mated with Finasteride treated male rats that received approximately 61 times the MRHD (based on AUC at animal dose of 80 mg/kg/day). Slightly decreased fertility was observed in male offspring after administration of about 3 times the MRHD (based on AUC at animal dose of 3 mg/kg/day) to female rats during late gestation and lactation. No effects on fertility were seen in female offspring under these conditions.

No evidence of male external genital malformations or other abnormalities were observed in rabbit fetuses exposed to Finasteride during the period of major organogenesis (gestation days 6 to 18) at maternal oral doses up to 100 mg/kg /day, (Finasteride exposure levels were not measured in rabbits). However, this study may not have included the critical period for Finasteride effects on development of male external genitalia in the rabbit.

The fetal effects of maternal Finasteride exposure during the period of embryonic and fetal development were evaluated in the rhesus monkey (gestation days 20 to 100), in a species and development period more predictive of specific effects in humans than the studies in rats and rabbits. Intravenous administration of Finasteride to pregnant monkeys at doses as high as 800 ng/day (estimated maximal blood concentration of 1.86 ng/mL or about 143 times the highest estimated exposure of pregnant women to Finasteride from semen of men taking 5 mg/day) resulted in no abnormalities in male fetuses. In confirmation of the relevance of the rhesus model for human fetal development, oral administration of a dose of Finasteride (2 mg/kg/day or approximately 18,000 times the highest estimated blood levels of Finasteride from semen of men taking 5 mg/day) to pregnant monkeys resulted in external genital abnormalities in male fetuses. No other abnormalities were observed in male fetuses and no Finasteride-related abnormalities were observed in female fetuses at any dose.

Nursing Mothers

Finasteride tablets USP is not indicated for use in women.
It is not known whether Finasteride is excreted in human milk.

Pediatric Use

Finasteride tablets USP is not indicated for use in pediatric patients.
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of the total number of subjects included in a long-term efficacy and safety study, 1480 and 105 subjects were 65 and over and 75 and over, respectively. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment is necessary in the elderly [see Clinical Pharmacology (12.3) and Clinical Studies (14)].

Hepatic Impairment

Caution should be exercised in the administration of Finasteride tablets USP in those patients with liver function abnormalities, as Finasteride is metabolized extensively in the liver [see Clinical Pharmacology (12.3)].

Renal Impairment

No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)].

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Propecia: 1 mg

Proscar: 5 mg [contains fd&c blue #2 aluminum lake]

Generic: 1 mg, 5 mg

• Propecia
• Proscar

Finasteride competitively inhibits type II 5-alpha reductase, resulting in inhibition of the conversion of testosterone to dihydrotestosterone and markedly suppresses serum dihydrotestosterone levels

Distribution

Vdss: 76 L

Metabolism

Hepatic (extensive) via CYP3A4; two active metabolites (<20% activity of finasteride)

Excretion

Feces (57%) and urine (39%; as metabolites)

Time to Peak

Serum: 1 to 2 hours

There are no known significant interactions.

To interpret serial PSAs, establish a new PSA baseline ≥6 months after treatment initiation and monitor PSA periodically thereafter. Objective and subjective signs of relief of benign prostatic hyperplasia, including improvement in urinary flow, reduction in symptoms of urgency, and relief of difficulty in micturition.

Use is contraindicated in women of childbearing potential.

Abnormalities of external male genitalia were reported in animal reproduction studies. Use is not indicated in women. Pregnant women are advised to avoid contact with crushed or broken tablets and the semen from a male partner exposed to finasteride.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience sexual dysfunction, loss of strength and energy, or decreased libido. Have patient report immediately to prescriber enlarged breasts, severe dizziness, passing out, depression, testicle pain, lump in breast, breast soreness or pain, or nipple discharge (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

• Finasteride 5mg tablets (brand name Proscar) are indicated for the treatment of symptomatic (BPH) in men with an enlarged prostate. Finasteride reduces lower urinary tract symptoms such as daytime urinary urgency, frequent nighttime voiding, urinary hesitancy, weak stream, straining, and prolonged voiding). Finasteride lowers the risk of needing to have prostate surgery. May be used in combination with doxazosin in men with symptomatic progression of BPH.
• Finasteride 1mg tablets (brand name Propecia) are used for the treatment of male pattern baldness - also called androgenetic alopecia. Finasteride is indicated for hair loss in MEN only.
• Significant increases in hair count at both 6 and 12 months have been reported in men treated with finasteride 1mg tablets (an average increase of 107 hairs when compared to placebo [pretend pill] after 12 months). After two years this hair count was maintained and slightly increased (by an average of 138 hairs over placebo). Most men experienced a slow decline in hair count following the initial improvement; however, hair count was maintained above baseline throughout the 5 years of the studies. Hair loss continued in those men who were assigned a placebo tablet, such that the difference in hair count was 277-hairs at the end of the 5-year study period.
• Finasteride does not affect body levels of cortisol, thyroid hormones, cholesterol or bone mineral density.
• No dosage adjustment is needed in men with kidney disease; however, finasteride must be used with caution in men with liver disease.
• No clinically significant interactions have been reported.
• Does not cause drowsiness.
• Generic finasteride is available.

Finasteride is not indicated for use in females. Excreted into human milk: Unknown Excreted into animal milk: Data not available