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Indications/Uses
FINASTERIDE (PROSCAR) is indicated for the treatment and control of benign prostatic hyperplasia (BPH) and for the prevention of urologic events to: Reduce the risk of acute urinary retention; Reduce the risk of surgery including transurethral resection of the prostate (TURP) and prostatectomy.
FINASTERIDE (PROSCAR) causes regression of the enlarged prostate, improves urinary flow and improves the symptoms associated with BPH.
Patients with an enlarged prostate are the appropriate candidates for therapy with FINASTERIDE (PROSCAR).
FINASTERIDE (PROSCAR) causes regression of the enlarged prostate, improves urinary flow and improves the symptoms associated with BPH.
Patients with an enlarged prostate are the appropriate candidates for therapy with FINASTERIDE (PROSCAR).
Dosage/Direction for Use
The recommended dosage is one 5-mg tablet daily with or without food.
DOSAGE IN RENAL INSUFFICIENCY: No adjustment in dosage is required in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 mL/min) as pharmacokinetic studies did not indicate any change in the disposition of finasteride.
DOSAGE IN THE ELDERLY: No adjustment in dosage is required although pharmacokinetic studies indicated the elimination of finasteride is somewhat decreased in patients more than 70 years of age.
Mode of Administration: FINASTERIDE (PROSCAR) is available for oral administration as tablet. It may be taken with or without food.
DOSAGE IN RENAL INSUFFICIENCY: No adjustment in dosage is required in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 mL/min) as pharmacokinetic studies did not indicate any change in the disposition of finasteride.
DOSAGE IN THE ELDERLY: No adjustment in dosage is required although pharmacokinetic studies indicated the elimination of finasteride is somewhat decreased in patients more than 70 years of age.
Mode of Administration: FINASTERIDE (PROSCAR) is available for oral administration as tablet. It may be taken with or without food.
Overdosage
Patients have received single doses of FINASTERIDE (PROSCAR) up to 400 mg and multiple doses of FINASTERIDE (PROSCAR) up to 80 mg/day for three months without adverse effects.
No specific treatment of overdosage with FINASTERIDE (PROSCAR) is recommended.
No specific treatment of overdosage with FINASTERIDE (PROSCAR) is recommended.
Administration
May be taken with or without food.
Contraindications
FINASTERIDE (PROSCAR) is not indicated for use in women or children.
FINASTERIDE (PROSCAR) is contraindicated in the following: Hypersensitivity to any component of this product; Pregnancy: Use in women when they are or may potentially be pregnant (See EXPOSURE TO FINASTERIDE: RISK TO MALE FETUS under USE IN PREGNANCY & LACTATION).
FINASTERIDE (PROSCAR) is contraindicated in the following: Hypersensitivity to any component of this product; Pregnancy: Use in women when they are or may potentially be pregnant (See EXPOSURE TO FINASTERIDE: RISK TO MALE FETUS under USE IN PREGNANCY & LACTATION).
Special Precautions
General: Patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy.
Effects on PSA and Prostate Cancer Detection: No clinical benefit has yet been demonstrated in patients with prostate cancer treated with FINASTERIDE (PROSCAR). Patients with BPH and elevated prostate-specific antigen (PSA) were monitored in controlled clinical studies with serial PSAs and prostate biopsies. In these BPH studies, FINASTERIDE (PROSCAR) did not appear to alter the rate of prostate cancer detection and the overall incidence of prostate cancer was not significantly different in patients treated with FINASTERIDE (PROSCAR) or placebo.
Digital rectal examinations as well as other evaluations for prostate cancer are recommended prior to initiating therapy with FINASTERIDE (PROSCAR) and periodically thereafter. Serum PSA is also used for prostate cancer detection. Generally, a baseline PSA >10 ng/mL (Hybritech) prompts further evaluation and consideration of biopsy; for PSA levels between 4 and 10 ng/mL, further evaluation is advisable. There is considerable overlap in PSA levels among men with and without prostate cancer. Therefore, in men with BPH, PSA values within the normal reference range do not rule out prostate cancer, regardless of treatment with FINASTERIDE (PROSCAR). A baseline PSA <4 ng/mL does not exclude prostate cancer.
FINASTERIDE (PROSCAR) causes a decrease in serum PSA concentrations by approximately 50% in patients with BPH, even in the presence of prostate cancer. This decrease in serum PSA levels in patients with BPH treated with FINASTERIDE (PROSCAR) should be considered when evaluating PSA data and does not rule out concomitant prostate cancer. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. Analysis of PSA data from over 3000 patients in the 4-year, double-blind, placebo-controlled PROSCAR Long-Term Efficacy and Safety Study (PLESS) confirmed that in typical patients treated with FINASTERIDE (PROSCAR) for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect prostate cancer.
Any sustained increase in PSA levels of patients treated with finasteride should be carefully evaluated, including consideration of non-compliance to therapy with FINASTERIDE (PROSCAR).
Percent free PSA (free to total PSA ratio) is not significantly decreased by FINASTERIDE (PROSCAR). The ratio of free to total PSA remains constant even under the influence of FINASTERIDE (PROSCAR). When percent free PSA is used as an aid in the detection of prostate cancer, no adjustment to its value is necessary.
Drug/Laboratory Test Interactions: EFFECT ON LEVELS OF PSA: Serum PSA concentration is correlated with patient age and prostatic volume, and prostatic volume is correlated with patient age. When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels decrease in patients treated with FINASTERIDE (PROSCAR). In most patients, a rapid decrease in PSA is seen within the first months of therapy, after which time PSA levels stabilize to a new baseline. The post-treatment baseline approximates half of the pre-treatment value. Therefore, in typical patients treated with FINASTERIDE (PROSCAR) for six months or more, PSA values should be doubled for comparison to normal ranges in untreated men. For clinical interpretation, see EFFECTS ON PSA AND PROSTATE CANCER DETECTION as previously mentioned.
Use in Children: FINASTERIDE (PROSCAR) is not indicated for use in children.
Safety and effectiveness in children have not been established.
Effects on PSA and Prostate Cancer Detection: No clinical benefit has yet been demonstrated in patients with prostate cancer treated with FINASTERIDE (PROSCAR). Patients with BPH and elevated prostate-specific antigen (PSA) were monitored in controlled clinical studies with serial PSAs and prostate biopsies. In these BPH studies, FINASTERIDE (PROSCAR) did not appear to alter the rate of prostate cancer detection and the overall incidence of prostate cancer was not significantly different in patients treated with FINASTERIDE (PROSCAR) or placebo.
Digital rectal examinations as well as other evaluations for prostate cancer are recommended prior to initiating therapy with FINASTERIDE (PROSCAR) and periodically thereafter. Serum PSA is also used for prostate cancer detection. Generally, a baseline PSA >10 ng/mL (Hybritech) prompts further evaluation and consideration of biopsy; for PSA levels between 4 and 10 ng/mL, further evaluation is advisable. There is considerable overlap in PSA levels among men with and without prostate cancer. Therefore, in men with BPH, PSA values within the normal reference range do not rule out prostate cancer, regardless of treatment with FINASTERIDE (PROSCAR). A baseline PSA <4 ng/mL does not exclude prostate cancer.
FINASTERIDE (PROSCAR) causes a decrease in serum PSA concentrations by approximately 50% in patients with BPH, even in the presence of prostate cancer. This decrease in serum PSA levels in patients with BPH treated with FINASTERIDE (PROSCAR) should be considered when evaluating PSA data and does not rule out concomitant prostate cancer. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. Analysis of PSA data from over 3000 patients in the 4-year, double-blind, placebo-controlled PROSCAR Long-Term Efficacy and Safety Study (PLESS) confirmed that in typical patients treated with FINASTERIDE (PROSCAR) for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect prostate cancer.
Any sustained increase in PSA levels of patients treated with finasteride should be carefully evaluated, including consideration of non-compliance to therapy with FINASTERIDE (PROSCAR).
Percent free PSA (free to total PSA ratio) is not significantly decreased by FINASTERIDE (PROSCAR). The ratio of free to total PSA remains constant even under the influence of FINASTERIDE (PROSCAR). When percent free PSA is used as an aid in the detection of prostate cancer, no adjustment to its value is necessary.
Drug/Laboratory Test Interactions: EFFECT ON LEVELS OF PSA: Serum PSA concentration is correlated with patient age and prostatic volume, and prostatic volume is correlated with patient age. When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels decrease in patients treated with FINASTERIDE (PROSCAR). In most patients, a rapid decrease in PSA is seen within the first months of therapy, after which time PSA levels stabilize to a new baseline. The post-treatment baseline approximates half of the pre-treatment value. Therefore, in typical patients treated with FINASTERIDE (PROSCAR) for six months or more, PSA values should be doubled for comparison to normal ranges in untreated men. For clinical interpretation, see EFFECTS ON PSA AND PROSTATE CANCER DETECTION as previously mentioned.
Use in Children: FINASTERIDE (PROSCAR) is not indicated for use in children.
Safety and effectiveness in children have not been established.
Use In Pregnancy & Lactation
FINASTERIDE (PROSCAR) is contraindicated for use in women when they are or may potentially be pregnant (See CONTRAINDICATIONS).
Because of the ability of Type II 5α-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male fetus when administered to a pregnant woman.
Exposure to Finasteride: Risk to Male Fetus: Women should not handle crushed or broken tablets of FINASTERIDE (PROSCAR) when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. FINASTERIDE (PROSCAR) tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
FINASTERIDE (PROSCAR) is not indicated for use in women.
It is not known whether finasteride is excreted in human milk.
Because of the ability of Type II 5α-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male fetus when administered to a pregnant woman.
Exposure to Finasteride: Risk to Male Fetus: Women should not handle crushed or broken tablets of FINASTERIDE (PROSCAR) when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. FINASTERIDE (PROSCAR) tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
FINASTERIDE (PROSCAR) is not indicated for use in women.
It is not known whether finasteride is excreted in human milk.
Adverse Reactions
FINASTERIDE (PROSCAR) is well tolerated.
In PLESS, 1524 patients treated with FINASTERIDE (PROSCAR) 5 mg daily and 1516 patients treated with placebo were evaluated for safety over a period of 4 years. 4.9% (74 patients) were discontinued from treatment due to side effects associated with FINASTERIDE (PROSCAR) compared with 3.3% (50 patients) treated with placebo. 3.7% (57 patients) treated with FINASTERIDE (PROSCAR) and 2.1% (32 patients) treated with placebo discontinued therapy as a result of side effects related to sexual function, which were the most frequently reported side effects.
The only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on FINASTERIDE (PROSCAR) was ≥1% and greater than placebo over the 4 years of the study, were those related to sexual function, breast complaints and rash. In the first year of the study, impotence was reported in 8.1% of patients treated with FINASTERIDE (PROSCAR) vs. 3.7% of those treated with placebo; decreased libido was reported in 6.4 vs. 3.4%, and ejaculation disorder in 0.8 vs. 0.1%, respectively. In years 2-4 of the study, there was no significant difference between treatment groups in the incidences of these three effects. The cumulative incidences in years 2-4 were: impotence [5.1% on FINASTERIDE (PROSCAR), 5.1% on placebo]; decreased libido (2.6%, 2.6%); and ejaculation disorder (0.2%, 0.1%). In year 1, decreased volume of ejaculate was reported in 3.7 and 0.8% of patients on FINASTERIDE (PROSCAR) and placebo, respectively; in years 2-4 the cumulative incidence was 1.5% on FINASTERIDE (PROSCAR) and 0.5% on placebo. In year 1, breast enlargement (0.5%, 0.1%), breast tenderness (0.4%, 0.1%) and rash (0.5%, 0.2%) were also reported. In years 2-4 the cumulative incidences were: breast enlargement, (1.8%, 1.1%); breast tenderness, (0.7%, 0.3%); and rash (0.5%, 0.1%).
The adverse experience profile in the 1-year, placebo-controlled, Phase III studies and the 5-year extensions, including 853 patients treated for 5-6 years, was similar to that reported in years 2-4 in PLESS. There is no evidence of increased adverse experiences with increased duration of treatment with FINASTERIDE (PROSCAR). The incidence of new drug-related sexual adverse experiences decreased with duration of treatment.
Other Long-Term Data: In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, of whom 9060 had prostate needle biopsy data available for analysis, prostate cancer was detected in 803 (18.4%) men receiving FINASTERIDE (PROSCAR) and 1147 (24.4%) men receiving placebo. In the FINASTERIDE (PROSCAR) group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Additional analyses suggest that the increase in the prevalence of high-grade prostate cancer observed in the FINASTERIDE (PROSCAR) group may be explained by a detection bias due to the effect of FINASTERIDE (PROSCAR) on prostate volume. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (clinical stage T1 or T2) at diagnosis. The clinical significance of the Gleason 7-10 data is unknown.
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 PLESS 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. There have been postmarketing reports of male breast cancer with the use of finasteride. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.
Post-marketing Experience: The following additional adverse effects have been reported in post-marketing experience with FINASTERIDE (PROSCAR) and/or finasteride at lower doses. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Immune system disorders: hypersensitivity reactions, such as pruritus, urticaria and angioedema (including swelling of the lips, tongue, throat, and face).
Psychiatric disorders: depression; decreased libido that continued after discontinuation of treatment.
Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment; testicular pain; hematospermia; male infertility and/or poor seminal quality. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride.
Laboratory Test Findings: When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels are decreased in patients treated with FINASTERIDE (PROSCAR) (See PRECAUTIONS).
No other difference in standard laboratory parameters was observed between patients treated with placebo or FINASTERIDE (PROSCAR).
In PLESS, 1524 patients treated with FINASTERIDE (PROSCAR) 5 mg daily and 1516 patients treated with placebo were evaluated for safety over a period of 4 years. 4.9% (74 patients) were discontinued from treatment due to side effects associated with FINASTERIDE (PROSCAR) compared with 3.3% (50 patients) treated with placebo. 3.7% (57 patients) treated with FINASTERIDE (PROSCAR) and 2.1% (32 patients) treated with placebo discontinued therapy as a result of side effects related to sexual function, which were the most frequently reported side effects.
The only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on FINASTERIDE (PROSCAR) was ≥1% and greater than placebo over the 4 years of the study, were those related to sexual function, breast complaints and rash. In the first year of the study, impotence was reported in 8.1% of patients treated with FINASTERIDE (PROSCAR) vs. 3.7% of those treated with placebo; decreased libido was reported in 6.4 vs. 3.4%, and ejaculation disorder in 0.8 vs. 0.1%, respectively. In years 2-4 of the study, there was no significant difference between treatment groups in the incidences of these three effects. The cumulative incidences in years 2-4 were: impotence [5.1% on FINASTERIDE (PROSCAR), 5.1% on placebo]; decreased libido (2.6%, 2.6%); and ejaculation disorder (0.2%, 0.1%). In year 1, decreased volume of ejaculate was reported in 3.7 and 0.8% of patients on FINASTERIDE (PROSCAR) and placebo, respectively; in years 2-4 the cumulative incidence was 1.5% on FINASTERIDE (PROSCAR) and 0.5% on placebo. In year 1, breast enlargement (0.5%, 0.1%), breast tenderness (0.4%, 0.1%) and rash (0.5%, 0.2%) were also reported. In years 2-4 the cumulative incidences were: breast enlargement, (1.8%, 1.1%); breast tenderness, (0.7%, 0.3%); and rash (0.5%, 0.1%).
The adverse experience profile in the 1-year, placebo-controlled, Phase III studies and the 5-year extensions, including 853 patients treated for 5-6 years, was similar to that reported in years 2-4 in PLESS. There is no evidence of increased adverse experiences with increased duration of treatment with FINASTERIDE (PROSCAR). The incidence of new drug-related sexual adverse experiences decreased with duration of treatment.
Other Long-Term Data: In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, of whom 9060 had prostate needle biopsy data available for analysis, prostate cancer was detected in 803 (18.4%) men receiving FINASTERIDE (PROSCAR) and 1147 (24.4%) men receiving placebo. In the FINASTERIDE (PROSCAR) group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Additional analyses suggest that the increase in the prevalence of high-grade prostate cancer observed in the FINASTERIDE (PROSCAR) group may be explained by a detection bias due to the effect of FINASTERIDE (PROSCAR) on prostate volume. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (clinical stage T1 or T2) at diagnosis. The clinical significance of the Gleason 7-10 data is unknown.
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 PLESS 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. There have been postmarketing reports of male breast cancer with the use of finasteride. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.
Post-marketing Experience: The following additional adverse effects have been reported in post-marketing experience with FINASTERIDE (PROSCAR) and/or finasteride at lower doses. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Immune system disorders: hypersensitivity reactions, such as pruritus, urticaria and angioedema (including swelling of the lips, tongue, throat, and face).
Psychiatric disorders: depression; decreased libido that continued after discontinuation of treatment.
Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment; testicular pain; hematospermia; male infertility and/or poor seminal quality. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride.
Laboratory Test Findings: When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels are decreased in patients treated with FINASTERIDE (PROSCAR) (See PRECAUTIONS).
No other difference in standard laboratory parameters was observed between patients treated with placebo or FINASTERIDE (PROSCAR).
Caution For Usage
Women should not handle crushed or broken tablets of FINASTERIDE (PROSCAR) when they are or may potentially be pregnant (see CONTRAINDICATIONS and EXPOSURE TO FINASTERIDE: RISK TO MALE FETUS under USE IN PREGNANCY & LACTATION).
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Action
Pharmacology: Pharmacokinetics: Following an oral dose of 14C-finasteride in man, 39% of the dose was excreted in the urine in the form of metabolites (virtually no unchanged drug was excreted in the urine) and 57% of total dose was excreted in the feces. In this study, two metabolites of finasteride were identified which possess only a small fraction of the 5α-reductase inhibitory activity of finasteride.
Relative to an intravenous reference dose, the oral bioavailability of finasteride is approximately 80%. The bioavailability is not affected by food. Maximum finasteride plasma concentrations are reached approximately two hours after dosing and the absorption is complete after six to eight hours. Finasteride displays a mean plasma elimination half-life of six hours. Protein binding is approximately 93%. Plasma clearance and the volume of distribution of finasteride are approximately 165 mL/min and 76 liters, respectively.
A multiple dose study demonstrated a slow accumulation of small amounts of finasteride over time. After daily dosing of 5 mg/day, steady-state trough plasma concentrations of finasteride are estimated to be 8-10 ng/mL and remained stable over time.
The elimination rate of finasteride is somewhat decreased in the elderly. As subjects advance in age, half-life is prolonged from a mean half-life of approximately 6 hours in men 18-60 years of age to 8 hours in men more than 70 years of age. This finding is of no clinical significance and hence, a reduction in dosage is not warranted.
In patients with chronic renal impairment whose creatinine clearance ranged from 9 to 55 mL/min, the disposition of a single dose of 14C-finasteride was not different from that in healthy volunteers. Protein binding also did not differ in patients with renal impairment. A portion of the metabolites which normally is excreted renally was excreted in the feces. It therefore appears that fecal excretion increases commensurate to the decrease in urinary excretion of metabolites. No adjustment in dosage is necessary in non-dialyzed patients with renal impairment.
Finasteride has been recovered in the cerebrospinal fluid (CSF) of patients treated with a 7-10 day course of finasteride, but the drug does not appear to concentrate preferentially to the CSF. Finasteride has also been recovered in the seminal fluid of subjects receiving 5 mg/day FINASTERIDE (PROSCAR). The amount of finasteride in the seminal fluid was 50- to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in adult males.
Relative to an intravenous reference dose, the oral bioavailability of finasteride is approximately 80%. The bioavailability is not affected by food. Maximum finasteride plasma concentrations are reached approximately two hours after dosing and the absorption is complete after six to eight hours. Finasteride displays a mean plasma elimination half-life of six hours. Protein binding is approximately 93%. Plasma clearance and the volume of distribution of finasteride are approximately 165 mL/min and 76 liters, respectively.
A multiple dose study demonstrated a slow accumulation of small amounts of finasteride over time. After daily dosing of 5 mg/day, steady-state trough plasma concentrations of finasteride are estimated to be 8-10 ng/mL and remained stable over time.
The elimination rate of finasteride is somewhat decreased in the elderly. As subjects advance in age, half-life is prolonged from a mean half-life of approximately 6 hours in men 18-60 years of age to 8 hours in men more than 70 years of age. This finding is of no clinical significance and hence, a reduction in dosage is not warranted.
In patients with chronic renal impairment whose creatinine clearance ranged from 9 to 55 mL/min, the disposition of a single dose of 14C-finasteride was not different from that in healthy volunteers. Protein binding also did not differ in patients with renal impairment. A portion of the metabolites which normally is excreted renally was excreted in the feces. It therefore appears that fecal excretion increases commensurate to the decrease in urinary excretion of metabolites. No adjustment in dosage is necessary in non-dialyzed patients with renal impairment.
Finasteride has been recovered in the cerebrospinal fluid (CSF) of patients treated with a 7-10 day course of finasteride, but the drug does not appear to concentrate preferentially to the CSF. Finasteride has also been recovered in the seminal fluid of subjects receiving 5 mg/day FINASTERIDE (PROSCAR). The amount of finasteride in the seminal fluid was 50- to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in adult males.
MedsGo Class
Drugs for Bladder & Prostate Disorders
Features
Brand
Proscar
Full Details
Dosage Strength
5 mg
Drug Ingredients
- Finasteride
Drug Packaging
Tablet 30's
Generic Name
Finasteride
Dosage Form
Tablet
Registration Number
DR-XY16541
Drug Classification
Prescription Drug (RX)