Finasteride 5 mg Tablet, Film Coated, 90-count
Past resolved recalls for this product (1)
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the 5-alpha Reductase Inhibitor class.
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🏭 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?
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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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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 30IQX730WE
Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
9 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 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 | $0.070 | $6.26 / 90 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2823 | $25.41 / 90 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2017 | $18.15 / 90 tablets |
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 | save 2% |
| Finasteride 5 mg 00904-6830-06 | Major | 1 tablet | $0.068 | AB | Availability likely | save 2% |
| Finasteride 5 mg 43598-0303-30 | Dr | 30 tablets | $0.068 | AB | Availability likely | save 2% |
| Finasteride 5 mg 50268-0314-15 | AvPAK | 1 tablet | $0.068 | AB | Availability likely | save 2% |
| Finasteride 5 mg 57237-0062-05 | Rising | 500 tablets | $0.068 | AB | Availability likely | save 2% |
| Finasteride 5 mg 60687-0428-01 | American | 1 tablet | $0.068 | AB | Availability likely | save 2% |
| Finasteride 5 mg 65862-0149-01 | Aurobindo | 100 tablets | $0.068 | AB | Availability likely | save 2% |
| Finasteride 5 mg 68645-0541-54 | Legacy | 30 tablets | $0.068 | AB | Availability likely | save 2% |
| Finasteride 5 mg 76282-0412-05 | Exelan | 500 tablets | $0.068 | AB | Availability likely | save 2% |
| Finasteride 5 mg 82009-0061-05 | QUALLENT | 500 tablets | $0.068 | AB | Availability likely | save 2% |
| Finasteride 5 mgthis 16729-0090-15 | Accord | 90 tablets | $0.069 | AB | Availability likely | — |
| Proscar 5 mg 78206-0153-01 | Organon | 30 tablets | $5.707 | AB | Availability likely | +8118% |
| 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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 16729-0090-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-090-01) | $0.0695 / ea | $6.95 | 2010-08-24 | Active |
| 16729-0090-10 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-090-10) | $0.0695 / ea | $2.08 | 2010-05-28 | Active |
| 16729-0090-15 You're viewing this | 90 TABLET, FILM COATED in 1 BOTTLE (16729-090-15) | $0.0695 / ea | $6.25 | 2010-06-08 | Active |
| 16729-0090-16 | 500 TABLET, FILM COATED in 1 BOTTLE (16729-090-16) | $0.0695 / ea | $34.73 | 2011-11-15 | Active |
| 16729-0090-17 | 1000 TABLET, FILM COATED in 1 BOTTLE (16729-090-17) | — | — | 2017-08-23 | Active |
You're viewing one of 5 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 4 priced pack sizes ($0.0695 NADAC).
This pack accounts for about 25% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 16729-0090-15?
What is the difference between NDC 16729-0090-15 and NDC 16729-0090-10?
What NDC number is used to bill for this package of Finasteride 5 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Finasteride, 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 acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride 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 is not approved for the prevention of prostate cancer ( 1.3 ).
1.1Monotherapy Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: -Improve symptoms -Reduce the risk of acute urinary retention -Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.2Combination with Alpha-Blocker Finasteride tablets 5 mg 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 is not approved for the prevention of prostate cancer.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Finasteride tablets 5 mg may be administered with or without meals. Finasteride 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 tablets 5 mg 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 5 mg 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 AND STRENGTHS 5-mg blue, 7 mm, round, biconvex, film coated tablets, marked 'F5' on one side and plain on other side. 5-mg film-coated tablets ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Finasteride is contraindicated in the following: Hypersensitivity to any component of this medication. Pregnancy. Finasteride use is contraindicated in females 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 female who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant female should be apprised of the potential hazard to the male fetus. [See also Warnings and Precautions (5.3) , Use in Specific Populations (8.1) ,and How Supplied/Storage and Handling (16) ].
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 ). Females who are or may potentially be pregnant ( 4 , 5.3 , 8.1 , 16 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Finasteride reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on Finasteride 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 may increase the risk of high-grade prostate cancer ( 5.2 , 6.1 ).
Females should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus ( 5.3 , 8.1 , 16 ). Finasteride is not indicated for use in pediatric patients or females ( 5.4 , 8.1 , 8.2 , 8.4 , 12.3 ). Prior to initiating treatment with finasteride 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 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, 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 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 therapy may also affect PSA test results. To interpret an isolated PSA value in patients treated with finasteride 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. Finasteride 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.
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 Females — Risk to Male Fetus Finasteride tablets are contraindicated in pregnant females and in females who may potentially be pregnant and not indicated for use in females. Based on animal studies and the mechanism of action, finasteride may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female. Females who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets.
Finasteride tablets 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 pregnant female comes in contact with crushed or broken finasteride tablets, the contact area should be washed immediately with soap and water. [See Contraindications (4) , Use…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The drug-related adverse reactions, reported in ≥1% in patients treated with finasteride 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 Accord Healthcare Inc. at 1866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. 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 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 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 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 Combined Years 2 to 4 (%) Finasteride Placebo Finasteride Placebo N = 1524 and 1516, finasteride vs placebo, respectively 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
0.5Ejaculation 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
0.1Phase 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 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of finasteride 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 o…
🔄 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 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, H 2 antagonists and quinolone anti-infectives without evidence of clinically significant adverse interactions.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Finasteride tablets are contraindicated in pregnant females and not indicated for use in females. Based on animal studies and the mechanism of action, finasteride may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female [See Warnings and Precautions (5.3) and Clinical Pharmacology (12.1) .] In an embryo-fetal development study in rats, there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring of pregnant rats administered oral finasteride during the period of major organogenesis at doses 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).
Decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development were also observed in male offspring at oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose of 0.03 mg/kg/day), along with decreased anogenital distance in male offspring at oral maternal doses approximately 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day). Finasteride 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.
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.
Females could be exposed to finasteride through contact with crushed or broken finasteride tablets 5 mg or semen from a male partner taking finasteride tablets. With regard to finasteride exposure through the skin, finasteride tablets 5 mg are coated and will prevent skin contact with finasteride during normal handling if the tablets have not been crushed or broken. Females who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets 5 mg because of possible exposure of a male fetus.
With regard to potential finasteride exposure through semen, three studies have been conducted that measured finasteride concentrations in semen in men receiving finasteride tablets 5 mg/day. In these studies the highest 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 Data and Clinical Pharmacology (12.3) ] . Data Human Data In 2 studies of healthy subjects (n=69) receiving finasteride tablets 5 mg/day for 6 to 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 semen of 16 subjects receiving finasteride tablets 5 mg/day ranged from undetectable (<1.0 ng/mL) to 21 ng/mL. Using the highest semen level measured and assuming 100% absorption would be up to 105 ng per day, which is 50-to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in men [See Clinical Pharmacology (12.3) ] . Animal Data 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 of gestation is a critical period in male fetal rats for di…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Finasteride tablets are contraindicated in pregnant females and not indicated for use in females. Based on animal studies and the mechanism of action, finasteride may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female [See Warnings and Precautions (5.3) and Clinical Pharmacology (12.1) .] In an embryo-fetal development study in rats, there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring of pregnant rats administered oral finasteride during the period of major organogenesis at doses 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).
Decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development were also observed in male offspring at oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose of 0.03 mg/kg/day), along with decreased anogenital distance in male offspring at oral maternal doses approximately 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day). Finasteride 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.
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.
Females could be exposed to finasteride through contact with crushed or broken finasteride tablets 5 mg or semen from a male partner taking finasteride tablets. With regard to finasteride exposure through the skin, finasteride tablets 5 mg are coated and will prevent skin contact with finasteride during normal handling if the tablets have not been crushed or broken. Females who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets 5 mg because of possible exposure of a male fetus.
With regard to potential finasteride exposure through semen, three studies have been conducted that measured finasteride concentrations in semen in men receiving finasteride tablets 5 mg/day. In these studies the highest 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 Data and Clinical Pharmacology (12.3) ] . Data Human Data In 2 studies of healthy subjects (n=69) receiving finasteride tablets 5 mg/day for 6 to 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 semen of 16 subjects receiving finasteride tablets 5 mg/day ranged from undetectable (<1.0 ng/mL) to 21 ng/mL. Using the highest semen level measured and assuming 100% absorption would be up to 105 ng per day, which is 50-to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in men [See Clinical Pharmacology (12.3) ] . Animal Data 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 of gestation is a critical period in male fetal rats for differentiation of the external…
🧒 Pediatric Use ▾
8.4Pediatric Use Finasteride 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 up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with finasteride 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 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 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 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 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 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 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 liters (range, 44 to 96 liters). Approximately 90% of circulating finasteri…
🧬 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 : blue, 7 mm, round, biconvex, film coated tablets, marked 'F5' on one side and plain on other side. They are supplied as follows: NDC 16729-090-10 Bottles of 30 with child resistant closure NDC 16729-090-15 Bottles of 90 with child resistant closure NDC 16729-090-01 Bottles of 100 with child resistant closure NDC 16729-090-16 Bottles of 500 NDC 16729-090-17 Bottles of 1000 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Protect from light and keep container tightly closed. Females should not handle crushed or broken finasteride tablets, USP 5mg 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) , and Use in Specific Populations (8.1) ] .
📋 Description ▾
11 DESCRIPTION Finasteride, 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,17ß)-. 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 (maize), sodium starch glycolate, hypromellose, titanium dioxide, magnesium stearate, lauryl macrogolglycerides, FD&C Blue # 2 aluminum lake and polyethylene glycol. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the 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, 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 Females – Risk to Male Fetus Physicians should inform patients that females who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets 5 mg because of the possibility of absorption of finasteride and the subsequent potential risk to the male fetus. Finasteride tablets 5 mg 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 female who is pregnant or may potentially be pregnant comes in contact with crushed or broken finasteride tablets 5 mg, 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. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with finasteride [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 and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding finasteride.
Manufactured For: Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA. Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad -380 054, India. 10 0716 2 6021883 Issued March 2024