The development and enlargement of the prostate gland is dependent on the potent androgen, 5a-dihydrotestosterone (DHT). Type II 5α-reductase metabolizes testosterone to DHT in the prostate gland, liver and skin. DHT induces androgenic effects by binding to androgen receptors in the cell nuclei of these organs.
Finasteride is a competitive and specific inhibitor of Type II 5α-reductase with which it slowly forms a stable enzyme complex. Turnover from this complex is extremely slow (t½ ~ 30 days). This has been demonstrated both in vivo and in vitro. Finasteride has no affinity for the androgen receptor. In man, the 5α-reduced steroid metabolites in blood and urine are decreased after administration of finasteride.
In man, a single 5-mg oral dose of PROSCAR produces a rapid reduction in serum DHT concentration, with the maximum effect observed 8 hours after the first dose. The suppression of DHT is maintained throughout the 24-hour dosing interval and with continued treatment. Daily dosing of PROSCAR at 5 mg/day for up to 4 years has been shown to reduce the serum DHT concentration by approximately 70%. The median circulating level of testosterone increased by approximately 10-20% but remained within the physiologic range.
Adult males with genetically inherited Type II5α-reductase deficiency also have decreased levels of DHT. Except for the associated urogenital defects present at birth, no other clinical abnormalities related to Type II 5α-reductase deficiency have been observed in these individuals. These individuals have a small prostate gland throughout life and do not develop BPH.
In patients with BPH treated with finasteride (1-100 mg/day) for 7-10 days prior to prostatectomy, an approximate 80% lower DHT content was measured in prostatic tissue removed at surgery, compared to placebo; testosterone tissue concentration was increased up to 10 times over pretreatment levels, relative to placebo. Intraprostatic content of prostate-specific antigen (PSA) was also decreased.
In healthy male volunteers treated with PROSCAR for 14 days, discontinuation of therapy resulted in a return of DHT levels to pretreatment levels in approximately 2 weeks. In patients treated for three months, prostate volume, which declined by approximately 20%, returned to close to baseline value after approximately three months of discontinuation of therapy.
Pharmacokinetics
Absorption
In a study of 15 healthy young subjects, the mean bioavailability of finasteride 5-mg tablets was 63% (range 34-108%), based on the ratio of area under the curve (AUC) relative to an intravenous (IV) reference dose. Maximum finasteride plasma concentration averaged 37 ng/mL (range, 27-49 ng/mL) and was reached 1-2 hours postdose. Bioavailability of finasteride was not affected by food.
Distribution
Mean steady-state volume of distribution was 76 liters (range, 44-96 liters). Approximately 90% of circulating finasteride is bound to plasma proteins. There is a slow accumulation phase for finasteride after multiple dosing. After dosing with 5 mg/day of finasteride for 17 days, plasma concentrations of finasteride were 47 and 54% higher than after the first dose in men 45-60 years old (n=12) and ≥ 70 years old (n=12), respectively. Mean trough concentrations after 17 days of dosing were 6.2 ng/mL (range, 2.4- 9.8 ng/mL) and 8.1 ng/mL (range, 1.8-19.7 ng/mL), respectively, in the two age groups. Although steady state was not reached in this study, mean trough plasma concentration in another study in patients with BPH (mean age, 65 years) receiving 5 mg/day was 9.4 ng/mL (range, 7.1-13.3 ng/mL; n=22) after over a year of dosing.
Finasteride has been shown to cross the blood brain barrier but does not appear to distribute preferentially to the CSF.
In 2 studies of healthy subjects (n=69) receiving PROSCAR 5 mg/day for 6-24 weeks, finasteride concentrations in semen ranged from undetectable ( < 0.1 ng/mL) to 10.54 ng/mL. In an earlier study using a less sensitive assay, finasteride concentrations in the semen of 16 subjects receiving PROSCAR 5 mg/day ranged from undetectable ( < 1.0 ng/mL) to 21 ng/mL. Thus, based on a 5-mL ejaculate volume, the amount of finasteride in semen was estimated to be 50- to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in men (see also PRECAUTIONS, Pregnancy).
Metabolism
Finasteride is extensively metabolized in the liver, primarily via the cytochrome P450 3A4 enzyme subfamily. Two metabolites, the t-butyl side chain monohydroxylated and monocarboxylic acid metabolites, have been identified that possess no more than 20% of the 5a-reductase inhibitory activity of finasteride.
Excretion
In healthy young subjects (n=15), mean plasma clearance of finasteride was 165 mL/min (range, 70- 279 mL/min) and mean elimination half-life in plasma was 6 hours (range, 3-16 hours). Following an oral dose of 14C-finasteride in man (n=6), a mean of 39% (range, 32-46%) of the dose was excreted in the urine in the form of metabolites; 57% (range, 51-64%) was excreted in the feces.
The mean terminal half-life of finasteride in subjects ≥ 70 years of age was approximately 8 hours (range, 6-15 hours; n=12), compared with 6 hours (range, 4-12 hours; n=12) in subjects 45-60 years of age. As a result, mean AUC(0-24 hr) after 17 days of dosing was 15% higher in subjects ≥ 70 years of age than in subjects 45-60 years of age (p=0.02).
Special Populations
Pediatric: Finasteride pharmacokinetics have not been investigated in patients < 18 years of age.
Gender: Finasteride pharmacokinetics in women are not available.
Geriatric: No dosage adjustment is necessary in the elderly. Although the elimination rate of finasteride is decreased in the elderly, these findings are of no clinical significance. See also Pharmacokinetics, Excretion, PRECAUTIONS, Geriatric Use and DOSAGE AND ADMINISTRATION.
Race: The effect of race on finasteride pharmacokinetics has not been studied.
Renal Insufficiency: No dosage adjustment is necessary in patients with renal insufficiency. In patients with chronic renal impairment, with creatinine clearances ranging from 9.0 to 55 mL/min, AUC, maximum plasma concentration, half-life, and protein binding after a single dose of 14C-finasteride were similar to values obtained in healthy volunteers. Urinary excretion of metabolites was decreased in patients with renal impairment. This decrease was associated with an increase in fecal excretion of metabolites. Plasma concentrations of metabolites were significantly higher in patients with renal impairment (based on a 60% increase in total radioactivity AUC). However, finasteride has been well tolerated in BPH patients with normal renal function receiving up to 80 mg/day for 12 weeks, where exposure of these patients to metabolites would presumably be much greater.
Hepatic Insufficiency: The effect of hepatic insufficiency on finasteride pharmacokinetics has not been studied. Caution should be used in the administration of PROSCAR in those patients with liver function abnormalities, as finasteride is metabolized extensively in the liver.
Drug Interactions
(also see PRECAUTIONS: DRUG INTERACTIONS)
No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug metabolism enzyme system. Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin, and no clinically meaningful interactions were found.
Mean (SD) Pharmacokinetic Parameters in Healthy Young Subjects (n=15)
| | Mean (± SD) |
| Bioavailability | 63% (34-108%)* |
| Clearance (mL/min) | 165 (55) |
| Volume of Distribution (L) | 76 (14) |
| Half-Life (hours) | 6.2 (2.1) |
| *Range |
Mean (SD) Noncompartmental Pharmacokinetic Parameters After Multiple Doses of 5 mg/day in Older Men
| | Mean (± SD) |
| 45-60 years old (n=12) | ≥ 70 years old (n=12) |
| AUC (ng?hr/mL) | 389 (98) | 463 (186) |
| Peak Concentration (ng/mL) | 46.2 (8.7) | 48.4 (14.7) |
| Time to Peak (hours) | 1.8 (0.7) | 1.8 (0.6) |
| Half-Life (hours)* | 6.0 (1.5) | 8.2 (2.5) |
| *First-dose values; all other parameters are last-dose values |
Clinical Studies
PROSCAR 5 mg/day was initially evaluated in patients with symptoms of BPH and enlarged prostates by digital rectal examination in two 1-year, placebo-controlled, randomized, double-blind studies and their 5-year open extensions.
PROSCAR was further evaluated in the PROSCAR Long-Term Efficacy and Safety Study (PLESS), a double-blind, randomized, placebo-controlled, 4-year, multicenter study. 3040 patients between the ages of 45 and 78, with moderate to severe symptoms of BPH and an enlarged prostate upon digital rectal examination, were randomized into the study (1524 to finasteride, 1516 to placebo) and 3016 patients were evaluable for efficacy. 1883 patients completed the 4-year study (1000 in the finasteride group, 883 in the placebo group).
Effect on Symptom Score
Symptoms were quantified using a score similar to the American Urological Association Symptom Score, which evaluated both obstructive symptoms (impairment of size and force of stream, sensation of incomplete bladder emptying, delayed or interrupted urination) and irritative symptoms (nocturia, daytime frequency, need to strain or push the flow of urine) by rating on a 0 to 5 scale for six symptoms and a 0 to 4 scale for one symptom, for a total possible score of 34.
Patients in PLESS had moderate to severe symptoms at baseline (mean of approximately 15 points on a 0-34 point scale). Patients randomized to PROSCAR who remained on therapy for 4 years had a mean (± 1 SD) decrease in symptom score of 3.3 (± 5.8) points compared with 1.3 (± 5.6) points in the placebo group. (See Figure 1.) A statistically significant improvement in symptom score was evident at 1 year in patients treated with PROSCAR vs placebo (-2.3 vs -1.6), and this improvement continued through Year 4.
Figure 1
Symptom Score in PLESS
Results seen in earlier studies were comparable to those seen in PLESS. Although an early improvement in urinary symptoms was seen in some patients, a therapeutic trial of at least 6 months was generally necessary to assess whether a beneficial response in symptom relief had been achieved. The improvement in BPH symptoms was seen during the first year and maintained throughout an additional 5 years of open extension studies.
Effect on Acute Urinary Retention and the Need for Surgery
In PLESS, efficacy was also assessed by evaluating treatment failures. Treatment failure was prospectively defined as BPH-related urological events or clinical deterioration, lack of improvement and/or the need for alternative therapy. BPH-related urological events were defined as urological surgical intervention and acute urinary retention requiring catheterization. Complete event information was available for 92% of the patients. The following table (Table 1) summarizes the results.
Table 1
All Treatment Failures in PLESS
| | Patients (%) * | | | |
| Event | Placebo
N=1503 | Finasteride
N=1513 | Relative
Risk** | 95% CI | P
Value** |
| All Treatment Failures | 37.1 | 26.2 | 0.68 | (0.57 to 0.79) | < 0.001 |
| Surgical Interventions for BPH | 10.1 | 4.6 | 0.45 | (0.32 to 0.63) | < 0.001 |
| Acute Urinary Retention Requiring Catheterization | 6.6 | 2.8 | 0.43 | (0.28 to 0.66) | < 0.001 |
| Two consecutive symptom scores ≥ 20 | 9.2 | 6.7 | |
| Bladder Stone | 0.4 | 0.5 |
| Incontinence | 2.1 | 1.7 |
| Renal Failure | 0.5 | 0.6 |
| UTI | 5.7 | 4.9 |
| Discontinuation due to worsening of BPH, lack of improvement, or to receive other medical treatment | 21.8 | 13.3 |
*patients with multiple events may be counted more than once for each type of event
**Hazard ratio based on log rank test |
Compared with placebo, PROSCAR was associated with a significantly lower risk for acute urinary retention or the need for BPH-related surgery [13.2% for placebo vs 6.6% for PROSCAR; 51% reduction in risk, 95% CI: (34 to 63%)]. Compared with placebo, PROSCAR was associated with a significantly lower risk for surgery [10.1% for placebo vs 4.6% for PROSCAR; 55% reduction in risk, 95% CI: (37 to 68%)] and with a significantly lower risk of acute urinary retention [6.6% for placebo vs 2.8% for PROSCAR; 57% reduction in risk, 95% CI: (34 to 72%)]; see Figures 2 and 3.
Figure 2
Percent of Patients Having Surgery for BPH, Including TURP
| Placebo Group | | | | |
No. of events, cumulative
No. at risk, per year | 37
1503 | 89
1454 | 121
1374 | 152
1314 |
| Finasteride Group | | | | |
No. of events, cumulative
No. at risk, per year | 18
1513 | 40
1483 | 49
1438 | 69
1410 |
Figure 3
Percent of Patients Developing Acute Urinary Retention (Spontaneous and Precipitated)
| Placebo Group | | | | |
No. of events, cumulative
No. at risk, per year | 36
1503 | 61
1454 | 81
1398 | 99
1347 |
| Finasteride Group | | | | |
No. of events, cumulative
No. at risk, per year | 14
1513 | 25
1487 | 32
1449 | 42
1421 |
Effect on Maximum Urinary Flow Rate
In the patients in PLESS who remained on therapy for the duration of the study and had evaluable urinary flow data, PROSCAR increased maximum urinary flow rate by 1.9 mL/sec compared with 0.2 mL/sec in the placebo group.
There was a clear difference between treatment groups in maximum urinary flow rate in favor of PROSCAR by month 4 (1.0 vs 0.3 mL/sec) which was maintained throughout the study. In the earlier 1- year studies, increase in maximum urinary flow rate was comparable to PLESS and was maintained through the first year and throughout an additional 5 years of open extension studies.
Effect on Prostate Volume
In PLESS, prostate volume was assessed yearly by magnetic resonance imaging (MRI) in a subset of patients. In patients treated with PROSCAR who remained on therapy, prostate volume was reduced compared with both baseline and placebo throughout the 4-year study. PROSCAR decreased prostate volume by 17.9% (from 55.9 cc at baseline to 45.8 cc at 4 years) compared with an increase of 14.1% (from 51.3 cc to 58.5 cc) in the placebo group (p < 0.001). (See Figure 4.)
Results seen in earlier studies were comparable to those seen in PLESS. Mean prostate volume at baseline ranged between 40-50 cc. The reduction in prostate volume was seen during the first year and maintained throughout an additional five years of open extension studies.
Figure 4
Prostate Volume in PLESS
| Placebo (?) n = | 155 | 136 | 11 9 | 98 | 85 |
| Finasteride ( ) n = | 157 | 144 | 130 | 11 6 | 102 |
Prostate Volume as a Predictor of Therapeutic Response
A meta-analysis combining 1-year data from seven double-blind, placebo-controlled studies of similar design, including 4491 patients with symptomatic BPH, demonstrated that, in patients treated with PROSCAR, the magnitude of symptom response and degree of improvement in maximum urinary flow rate were greater in patients with an enlarged prostate at baseline.
Medical Therapy of Prostatic Symptoms
The Medical Therapy of Prostatic Symptoms (MTOPS) Trial was a double-blind, randomized, placebo-controlled, multicenter, 4- to 6-year study (average 5 years) in 3047 men with symptomatic BPH, who were randomized to receive PROSCAR 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of PROSCAR 5 mg/day and doxazosin 4 or 8 mg/day (n=786), or placebo (n=737). All participants underwent weekly titration of doxazosin (or its placebo) from 1 to 2 to 4 to 8 mg/day. Only those who tolerated the 4 or 8 mg dose level were kept on doxazosin (or its placebo) in the study. The participant's final tolerated dose (either 4 mg or 8 mg) was administered beginning at end-Week 4. The final doxazosin dose was administered once per day, at bedtime.
The mean patient age at randomization was 62.6 years (±7.3 years). Patients were Caucasian (82%), African American (9%), Hispanic (7%), Asian (1%) or Native American ( < 1%). The mean duration of BPH symptoms was 4.7 years (±4.6 years). Patients had moderate to severe BPH symptoms at baseline with a mean AUA symptom score of approximately 17 out of 35 points. Mean maximum urinary flow rate was 10.5 mL/sec (±2.6 mL/sec). The mean prostate volume as measured by transrectal ultrasound was 36.3 mL (+20.1 mL). Prostate volume was ≤ 20 mL in 16% of patients, ≥ 50 mL in 18% of patients and between 21 and 49 mL in 66% of patients.
The primary endpoint was a composite measure of the first occurrence of any of the following five outcomes: a ≥ 4 point confirmed increase from baseline in symptom score, acute urinary retention, BPH- related renal insufficiency (creatinine rise), recurrent urinary tract infections or urosepsis, or incontinence. Compared to placebo, treatment with PROSCAR, doxazosin, or combination therapy resulted in a reduction in the risk of experiencing one of these five outcome events by 34% (p=0.002), 39% (p < 0.001), and 67% (p < 0.001), respectively. Combination therapy resulted in a significant reduction in the risk of the primary endpoint compared to treatment with PROSCAR alone (49%; p ≤ 0.001) or doxazosin alone (46%; p ≤ 0.001). (See Table 2.)
Table 2
Count and Percent Incidence of Primary Outcome Events by Treatment Group in MTOPS
| Event | Treatment Group |
Placebo
N=737
N (%) | Doxazosin
N=756
N (%) | Finasteride
N=768
N (%) | Combination
N=786
N (%) | Total
N=3047
N (%) |
| AUA 4-point rise | 100 (13.6) | 59 (7.8) | 74 (9.6) | 41 (5.2) | 274 (9.0) |
| Acute urinary retention | 18 (2.4) | 13 (1.7) | 6 (0.8) | 4 (0.5) | 41 (1.3) |
| Incontinence | 8 (1.1) | 11 (1.5) | 9 (1.2) | 3 (0.4) | 31 (1.0) |
| Recurrent UTI/urosepsis | 2 (0.3) | 2 (0.3) | 0 (0.0) | 1 (0.1) | 5 (0.2) |
| Creatinine rise | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Total Events | 128 (17.4) | 85 (11.2) | 89 (11.6) | 49 (6.2) | 351 (11.5) |
The majority of the events (274 out of 351; 78%) was a confirmed ≥ 4 point increase in symptom score, referred to as symptom score progression. The risk of symptom score progression was reduced by 30% (p=0.016), 46% (p < 0.001), and 64% (p < 0.001) in patients treated with PROSCAR, doxazosin, or the combination, respectively, compared to patients treated with placebo (see Figure 5). Combination therapy significantly reduced the risk of symptom score progression compared to the effect of PROSCAR alone (p < 0.001) and compared to doxazosin alone (p=0.037).
Figure 5
Cumulative Incidence of a 4-Point Rise in AUA Symptom Score by Treatment Group
Treatment with PROSCAR, doxazosin or the combination of PROSCAR with doxazosin, reduced the mean symptom score from baseline at year 4. Table 3 provides the mean change from baseline for AUA symptom score by treatment group for patients who remained on therapy for four years.
Table 3
Change From Baseline in AUA Symptom Score by Treatment Group at Year 4 in MTOPS
| | Placebo
N=534 | Doxazosin
N=582 | Finasteride
N=565 | Combination
N=598 |
| Baseline Mean (SD) | 16.8 (6.0) | 17.0 (5.9) | 17.1 (6.0) | 16.8 (5.8) |
| Mean ChangeAUA Symptom Score (SD) | -4.9 (5.8) | -6.6 (6.1) | -5.6 (5.9) | -7.4 (6.3) |
| Comparison to Placebo (95% CI) | | -1.8
(-2.5, -1.1) | -0.7
(-1.4, 0.0) | -2.5
(-3.2, -1.8) |
| Comparison to Doxazosin alone (95% CI) | | | | -0.7
(-1.4, 0.0) |
| Comparison to Finasteride alone (95% CI) | | | | -1.8
(-2.5, -1.1) |
The results of MTOPS are consistent with the findings of the 4-year, placebo-controlled study PLESS (see CLINICAL PHARMACOLOGY, Clinical Studies) in that treatment with PROSCAR reduces the risk of acute urinary retention and the need for BPH-related surgery. In MTOPS, the risk of developing acute urinary retention was reduced by 67% in patients treated with PROSCAR compared to patients treated with placebo (0.8% for PROSCAR and 2.4% for placebo). Also, the risk of requiring BPH-related invasive therapy was reduced by 64% in patients treated with PROSCAR compared to patients treated with placebo (2.0% for PROSCAR and 5.4% for placebo).
Summary of Clinical Studies
The data from these studies, showing improvement in BPH-related symptoms, reduction in treatment failure (BPH-related urological events), increased maximum urinary flow rates, and decreasing prostate volume, suggest that PROSCAR arrests the disease process of BPH in men with an enlarged prostate.
PATIENT INFORMATION
Women should not handle crushed or broken PROSCAR tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to the male fetus (see CONTRAINDICATIONS; WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS; PRECAUTIONS, Pregnancy and HOW SUPPLIED).
Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with PROSCAR. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with PROSCAR (see ADVERSE REACTIONS).
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).
Physicians should instruct their patients to read the patient package insert before starting therapy with PROSCAR and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding PROSCAR.
Consumer
IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.
FINASTERIDE - ORAL
(fin-AST-er-ide)
COMMON BRAND NAME(S): Proscar
USES: Finasteride is used to shrink an enlarged prostate (benign prostatic hyperplasia or BPH) in adult men. It may be used alone or taken in combination with other medications to reduce symptoms of BPH and may also reduce the need for surgery.
Finasteride may improve symptoms of BPH and provide benefits such as decreased urge to urinate, better urine flow with less straining, less of a feeling that the bladder is not completely emptied, and decreased nighttime urination.
This medication works by decreasing the amount of a natural body hormone (DHT) that causes growth of the prostate.
Women and children should not use this medication.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking finasteride and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Take this medication by mouth, with or without food, usually once a day, or as directed by your doctor.
If the tablet is crushed or broken, it should not be handled by a woman who is pregnant or by a woman who may become pregnant (see also Precautions section).
Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Do not stop taking this medication without consulting your doctor.
It may take 6-12 months to notice a benefit.
Inform your doctor if your condition persists or worsens.
Consumer (continued)
SIDE EFFECTS: Decreased sexual ability/desire may occur. In some men, this medication can decrease the amount of semen released during sex. This is harmless. Finasteride may also increase hair growth. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: lump in the breast, nipple discharge, breast enlargement/tenderness/pain, pain in the testicles, inability to urinate.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking finasteride, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, prostate cancer, infections, urinary problems.
Finasteride should not be used in children.
The drug can be absorbed through the skin. If the film coating of the tablet has been broken or the tablet crushed, it should not be handled by a woman who is pregnant or planning to become pregnant. Exposing a developing male infant to finasteride can result in abnormalities of the genitals.
Finasteride is not recommended for use in women and must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately.
Because this drug is not intended for use in women, it is not known if finasteride passes into breast milk. Consult your doctor before breast-feeding.
Consumer (continued)
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.
This medication can affect the results of the blood test used to detect prostate cancer (prostatic-specific antigen or PSA levels). Make sure laboratory personnel and your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.
NOTES: Do not share this medication with others.
Laboratory and/or medical tests (e.g., prostate exams, PSA levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Keep all appointments with your doctor and the laboratory. You should have a complete physical examination. Follow your doctor's instructions for examining your breasts and testicles, and report any lumps immediately.
Although early improvement is often seen, at least 6 to 12 months of therapy may be necessary in some patients to assess whether or not a benefit has occurred. Therefore, it is important to keep regular doctor appointments and get blood tests as scheduled to make sure this medication is working.
Many men are born with the condition this drug mimics (prostate glands that are smaller than usual) and lead normal lives with normal sex drives.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store US product at room temperature below 86 degrees F (30 degrees C) away from light and moisture in a tightly closed container.
Store Canadian product at room temperature between 59 to 86 degrees F (15 to 30 degrees C) away from light and moisture in a tightly closed container.
Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
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