Finasteride 5 mg Tablet, Film Coated
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the 5-alpha Reductase Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Finasteride is used to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland) and male pattern hair loss (gradual thinning of the hair on the scalp, leading to a receding hairline or balding on the top of the head in men). Finasteride is in a class of medications called 5-alpha reductase inhibitors. Finasteride treats BPH by blocking the body's production of a male hormone that causes the prostate to enlarge. Finasteride treats male pattern hair loss by blocking the body's production of a male hormone in the scalp that stops hair growth.
Read the full MedlinePlus article ↗- Finasteride is used for two different conditions in men, and the brand matters. Proscar (the higher-strength tablet) is prescribed for an enlarged prostate (BPH) to ease urinary sy...
- What exactly is finasteride used for — and which brand should I be taking?
- It depends on what you're treating. For hair loss with Propecia, you generally need at least three months of daily use before noticing a difference — and you need to keep taking it...
- How long will it take before I see results?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Finasteride — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.068 | $3.42 / 50 tablet |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2017 | $10.09 / 50 tablet |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Finasteride 5 mg 00093-7355-05 | Teva | 500 tablets | $0.068 | AB | Availability likely | — |
| Finasteride 5 mg 00904-6830-06 | Major | 1 tablet | $0.068 | AB | Availability likely | — |
| Finasteride 5 mg 43598-0303-30 | Dr | 30 tablets | $0.068 | AB | Availability likely | — |
| Finasteride 5 mgthis 50268-0314-15 | AvPAK | 1 tablet | $0.068 | AB | Availability likely | — |
| Finasteride 5 mg 57237-0062-05 | Rising | 500 tablets | $0.068 | AB | Availability likely | — |
| Finasteride 5 mg 60687-0428-01 | American | 1 tablet | $0.068 | AB | Availability likely | — |
| Finasteride 5 mg 65862-0149-01 | Aurobindo | 100 tablets | $0.068 | AB | Availability likely | — |
| Finasteride 5 mg 68645-0541-54 | Legacy | 30 tablets | $0.068 | AB | Availability likely | — |
| Finasteride 5 mg 76282-0412-05 | Exelan | 500 tablets | $0.068 | AB | Availability likely | — |
| Finasteride 5 mg 82009-0061-05 | QUALLENT | 500 tablets | $0.068 | AB | Availability likely | — |
| Finasteride 5 mg 16729-0090-01 | Accord | 100 tablets | $0.069 | AB | Availability likely | +2% |
| Proscar 5 mg 78206-0153-01 | Organon | 30 tablets | $5.707 | AB | Availability likely | +8245% |
| Finasteride 5 mg 00615-8562-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 17856-0090-01 | Atlantic | 1 tablet | — | AB | FDA listed | — |
| Finasteride 5 mg 31722-0525-01 | Camber | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 50090-1936-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 50090-4697-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 50090-6940-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 50090-6941-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 50090-7086-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 50090-7228-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 55111-0172-01 | Dr. | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 55154-2639-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Finasteride 5 mg 55154-8083-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Finasteride 5 mg 63187-0265-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 63629-1585-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 67046-1058-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 67877-0288-01 | Ascend | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 68071-2999-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 68071-3234-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 68071-3354-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 68071-3380-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 68071-3417-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 68071-3785-02 | NuCare | 120 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 68788-8377-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 68788-8433-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 68788-8749-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 70518-1704-02 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Finasteride 5 mg 70518-3182-00 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Finasteride 5 mg 70518-3600-01 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Finasteride 5 mg 70518-3616-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Finasteride 5 mg 71205-0767-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 71335-0433-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 71335-1530-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 71335-1634-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 71335-1898-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 71610-0515-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 71610-0520-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 72189-0542-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Finasteride 5 mg 76420-0154-30 | Asclemed | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50268-0314-15 You're viewing this | 50 BLISTER PACK in 1 BOX (50268-314-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-314-11) | 2019-01-23 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Finasteride tablets USP, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1) : • Improve symptoms • Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets USP administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association(AUA) symptom score) (1.2) .
Limitations of Use: Finasteride tablets USP is not approved for the prevention of prostate cancer (1.3) .
1.1Monotherapy Finasteride tablets USP, are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: -Improve symptoms -Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.2Combination with Alpha-Blocker Finasteride tablets USP administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score).
1.3Limitations of Use Finasteride tablets USP are not approved for the prevention of prostate cancer.
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Finasteride tablets USP may be administered with or without meals. Finasteride tablets USP may be administered with or without meals (2) . Monotherapy: One tablet (5 mg) taken once a day (2.1) . Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin (2.2) .
2.1Monotherapy The recommended dose of finasteride tablet USP is one tablet (5 mg) taken once a day [see Clinical Studies (14.1) ].
2.2Combination 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) ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Finasteride tablets USP, 5 mg are blue color, round film coated tablets, debossed with ‘H’ on one side ‘37’ on other side. 5 mg film-coated tablets (3) .
⛔ Contraindications ▾
4 CONTRAINDICATIONS Finasteride tablets USP are contraindicated in the following: • Hypersensitivity to any component of this medication. • Pregnancy . Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride.
If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. [See also Warnings and Precautions (5.3) , Use in Specific Populations (8.1) , How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2) ]. In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. Hypersensitivity to any components of this product (4) .
Women who are or may potentially be pregnant (4 , 5.4 , 8.1 , 16) .
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Finasteride tablets USP reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on finasteride tablets USP may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor (5.1) . • Finasteride tablets USP may increase the risk of high-grade prostate cancer (5.2 , 6.1) . • Women should not handle crushed or broken finasteride tablets USP when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (5.3 , 8.1 , 16) . • Finasteride tablets USP are not indicated for use in pediatric patients or women (5.4 , 8.1 , 8.3 , 8.4 , 12.3) . • Prior to initiating treatment with finasteride tablets USP for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.6) .
5.1Effects on Prostate Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection In clinical studies, finasteride tablets USP reduced serum PSA concentration by approximately 50% within six months of treatment. This decrease is predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals. For interpretation of serial PSAs in men taking finasteride tablets USP, a new PSA baseline should be established at least six months after starting treatment and PSA monitored periodically thereafter.
Any confirmed increase from the lowest PSA value while on finasteride tablets USP may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5α-reductase inhibitor. Non-compliance with finasteride tablets USP therapy may also affect PSA test results. To interpret an isolated PSA value in patients treated with finasteride tablets USP for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men.
These adjustments preserve the utility of PSA to detect prostate cancer in men treated with finasteride tablets USP. Finasteride tablets USP may also cause decreases in serum PSA in the presence of prostate cancer. The ratio of free to total PSA (percent free PSA) remains constant even under the influence of finasteride tablets USP.
If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing finasteride therapy, no adjustment to its value appears necessary.
5.2Increased Risk of High-Grade Prostate Cancer Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0 ng/mL at baseline taking finasteride 5 mg/day in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8 to 10 prostate cancer (finasteride 1.8% vs placebo 1.1%) [See Indications and Usage (1.3) and Adverse Reactions (6.1) ]. Similar results were observed in a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, AVODART) (1% dutasteride vs 0.5% placebo).
5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5α-reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.
5.3Exposure of Women-Risk to Male Fetus Women should not handle crushed or broken finasteride tablets USP 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. Finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed [See Contraindications (4) , Use in Specific Populations (8.1) , Clinical Pharmacology (12.3) , How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2) ].
5.4 Pediatric Patients and Women Finasteride…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The drug-related adverse reactions, reported in ≥1% in patients treated with finasteride tablets USP and greater than in patients treated with placebo over a 4-year study are: impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness and rash (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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.
Table 1: Drug-Related Adverse Experiences Year 1 (%) Years 2, 3 and 4* (%) Finasteride Placebo Finasteride Placebo Impotence 8.1 3.7 5.1
5.1Decreased Libido 6.4 3.4 2.6
2.6Decreased Volume of Ejaculate 3.7 0.8 1.5
0.5Ejaculate Disorder 0.8 0.1 0.2
0.1Breast Enlargement 0.5 0.1 1.8
1.1Breast Tenderness 0.4 0.1 0.7
0.3Rash 0.5 0.2 0.5 0.1 *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. Table 2: Incidence ≥2% in One or More Treatment Groups Drug-Related Clinical Adverse Experiences in MTOPS Adverse Experience Placebo (N=…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Cytochrome P450-Linked Drug Metabolizing Enzyme System 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 have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found.
7.2Other Concomitant Therapy Although specific interaction studies were not performed, finasteride tablets USP was concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, angiotensin-converting enzyme (ACE) inhibitors, analgesics, anti-convulsants, beta-adrenergic blocking agents, diuretics, calcium channel blockers, cardiac nitrates, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), benzodiazepines, H2 antagonists and quinolone anti-infectives without evidence of clinically significant adverse interactions.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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 e…
🤰 Pregnancy ▾
8.1Pregnancy 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…
🧒 Pediatric Use ▾
8.4Pediatric Use Finasteride tablets USP is not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric 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) ].
🆘 Overdosage ▾
10 OVERDOSAGE Patients have received single doses of finasteride tablets USP up to 400 mg and multiple doses of finasteride tablets USP up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with finasteride tablets USP can be recommended. Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m 2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m 2 (400 mg/kg) and 5900 mg/m 2 (1000 mg/kg), respectively.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The development and enlargement of the prostate gland is dependent on the potent androgen, 5α-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 (t ½ ∼ 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.
12.2Pharmacodynamics In man, a single 5-mg oral dose of finasteride tablets USP 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 finasteride tablets USP 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 to 20% but remained within the physiologic range. In a separate study in healthy men treated with finasteride 1 mg per day (n=82) or placebo (n=69), mean circulating levels of testosterone and estradiol were increased by approximately 15% as compared to baseline, but these remained within the physiologic range. In patients receiving finasteride tablets USP, 5 mg/day, increases of about 10% were observed in luteinizing hormone (LH) and follicle-stimulating hormone (FSH), but levels remained within the normal range.
In healthy volunteers, treatment with finasteride tablets USP did not alter the response of LH and FSH to gonadotropin-releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected. In patients with BPH, finasteride tablets USP has no effect on circulating levels of cortisol, prolactin, thyroid-stimulating hormone, or thyroxine. No clinically meaningful effect was observed on the plasma lipid profile (i.e., total cholesterol, low density lipoproteins, high density lipoproteins and triglycerides) or bone mineral density.
Adult males with genetically inherited Type II 5α-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 to 100 mg/day) for 7 to 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 PSA was also decreased. In healthy male volunteers treated with finasteride tablets USP 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.
12.3Pharmacokinetics Absorption In a study of 15 healthy young subjects, the mean bioavailability of finasteride 5 mg tablets was 63% (range 34 to 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 to 49 ng/mL) and was reached 1 to 2 hours postdose. Bioavailability of finasteride was not affected by food.
Distribution Mean steady-state volume of distribution was 76 li…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The development and enlargement of the prostate gland is dependent on the potent androgen, 5α-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 (t ½ ∼ 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Finasteride tablets USP, 5 mg are blue color, round film coated tablets, debossed with ‘H’ on one side ‘37’ on other sideon other side. They are supplied as follows: NDC 50268-314-15 (10 tablets per card, 5 cards per carton). Storage and Handling Dispensed in Unit Dose Package.
For Institutional Use Only. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and keep container tightly closed.
If dispensed, protect from light and keep in tightly closed container. Women should not handle crushed or broken finasteride tablets USP 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 [see Warnings and Precautions (5.3) , Use in Specific Populations (8.1) and Patient Counseling Information (17.2) ].
📋 Description ▾
11 DESCRIPTION Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The empirical formula of finasteride is C 23 H 36 N 2 O 2 and its molecular weight is 372.55.
Its structural formula is: Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, opadry blue (FD&C blue #2 aluminium lake, hypromellose, talc, titanium dioxide, yellow iron oxide).
The botanical source of the Pregelatinized Starch is Maize structure.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Patient Information)
17.1Increased Risk of High-Grade Prostate Cancer Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, including finasteride tablets USP, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer [ see Indications and Usage (1.3), Warnings and Precautions (5.2) , and Adverse Reactions (6.1) ].
17.2Exposure of Women-Risk to Male Fetus Physicians should inform patients that women who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets USP because of the possibility of absorption of finasteride and the subsequent potential risk to the male fetus. Finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. If a woman who is pregnant or may potentially be pregnant comes in contact with crushed or broken finasteride tablets USP, the contact area should be washed immediately with soap and water [see Contraindications (4), Warnings and Precautions (5.3) , Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16) ].
17.3Additional Instructions Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with finasteride tablets USP. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with finasteride tablets USP [see Adverse Reactions (6.1) ].
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 (6.1) ]. Physicians should instruct their patients to read the patient package insert before starting therapy with finasteride tablets USP and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding finasteride tablets USP.
Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 7/17 AV 01/20 (P) AvPAK