Finasteride

Propecia 1 mg treats androgenetic alopecia in men. Efficacy for bitemporal recession has not been established. The label does not indicate use in women or children.

Proscar 5 mg treats symptomatic benign prostatic hyperplasia in men with an enlarged prostate to improve symptoms and reduce acute urinary retention and surgery. With doxazosin, it reduces symptomatic BPH progression. It is not approved for prostate-cancer prevention.

FDA states that no topical finasteride product is FDA-approved. Compounded sprays can enter the bloodstream and transfer to others; topical use does not establish absence of systemic risk. Compounded topical, non-U.S. spray, and fixed-combination regimens are outside this oral dose reference.

Neither selected oral label requires renal dose adjustment or an elderly pharmacokinetic dose adjustment. Use caution with hepatic abnormalities: hepatic impairment has not been studied and no validated numerical adjustment is supplied. Propecia efficacy in adults aged 65 or older has not been established.

Use the prescribed intact coated tablet. If a dose is missed, resume the next scheduled dose without adding an extra tablet. Do not improvise a crushed-tablet or topical formulation, especially where pregnant people could be exposed.

Hypersensitivity to the selected product and pregnancy or potential pregnancy are contraindications. Both selected products are indicated for men; pregnant people must not handle crushed or broken tablets because exposure can harm male fetal genital development.

The selected U.S. Propecia and Proscar labels do not contain a boxed warning. Their pregnancy, PSA, high-grade prostate-cancer and adverse-reaction information remains clinically important.

Sexual effects include decreased libido, erectile dysfunction, ejaculation changes and reduced ejaculate volume. Postmarketing reports include sexual dysfunction persisting after discontinuation, infertility or poor semen quality, testicular pain, hematospermia, breast changes or male breast cancer, hypersensitivity including angioedema, and psychiatric symptoms. Frequency and causal attribution of voluntary reports are uncertain; persistent symptoms are not guaranteed to resolve after stopping.

No clinically important interactions were identified in the selected labels. Finasteride does not appear to materially affect the CYP-linked drug-metabolizing system; tested drugs included warfarin, digoxin, propranolol and theophylline. This does not establish that every possible combination has been studied.

The selected 5 mg label supports combination with doxazosin for BPH progression. Apply the alpha-blocker’s own precautions and dosing; finasteride does not remove risks such as orthostatic hypotension from another medicine.

Tell clinicians interpreting PSA about finasteride, dose, duration and missed doses. Review other hair-loss or BPH medicines and compounded products to avoid duplicate finasteride exposure or applying a separate product’s directions to these tablets.

Exposure during pregnancy may disrupt development of male fetal external genitalia. Intact coatings prevent contact during normal handling; crushed or broken tablets must not be handled by people who are or may become pregnant. Wash accidental contact immediately with soap and water and obtain medical advice. Finasteride has been measured in semen at low levels; the labels discuss potential exposure rather than prescribing a universal contraception regimen. Propecia milk excretion is unknown; neither product is indicated for women.

Pediatric safety and effectiveness are not established. BPH studies included older men without an overall age-related efficacy or safety difference; no elderly dose adjustment is required. Propecia studies did not establish efficacy at age 65 or older.

No renal adjustment is required in the selected labels. Hepatic metabolism is extensive, and caution is advised with liver abnormalities because hepatic impairment has not been studied. Decreased ejaculate volume and postmarketing poor semen quality or infertility have been reported; improvement after discontinuation has also been reported, without certainty for every patient.

Finasteride inhibits the enzyme converting testosterone to dihydrotestosterone, predominantly Type II 5α-reductase. Reduced scalp DHT contributes to the hair-loss treatment pathway; reduced prostate DHT supports prostate shrinkage. It does not bind the androgen receptor.

Oral peak concentrations occur in roughly 1–2 hours; food does not alter bioavailability meaningfully for the selected products. Protein binding is about 90%. Metabolism is mainly hepatic through CYP3A4; metabolites are eliminated in urine and feces. Plasma half-life is roughly 5–6 hours in younger adults and about 8 hours in men older than 70, while enzyme and clinical effects last longer.

For Proscar, establish a new PSA baseline at least 6 months after initiation and monitor periodically. After at least 6 months, double an isolated PSA value for comparison with untreated-men reference ranges; percent-free PSA needs no adjustment. Evaluate any confirmed rise from the nadir. Propecia also lowers PSA, but its label does not supply the same universal six-month doubling rule. Assess urinary symptoms, flow, retention and possible alternative diagnoses.

Reassess hair benefit and adherence over months. Discuss sexual function, fertility concerns, breast lumps or nipple discharge, and mood changes. For mood changes during 1 mg hair-loss treatment, follow the cited EMA stop-and-contact advice; obtain urgent help for suicidal thoughts. Seek emergency care for swelling affecting breathing. Do not assume compounded topical products are free of systemic or transfer risks.

Do not use high-dose trial experience as a safe self-dosing limit. The labels identify no specific overdose antidote; obtain prompt poison-control or medical advice after accidental excess or pregnancy exposure. Management depends on circumstances and symptoms.

Appearance

Tan, octagonal, convex, film-coated

Imprint

Stylized P logo · PROPECIA

Example package

NDC 78206-152-01 · bottle of 30 with desiccant

Labeler

Organon LLC

Selected Propecia is a 1 mg coated tablet. Selected Proscar is a blue, modified apple-shaped 5 mg coated tablet marked MSD 72 and PROSCAR. Different manufacturers and combination products may have different identifiers. No topical dose is supplied here.

Propecia: store at 15–30°C, keep the container closed and protect from moisture. Proscar: store below 30°C, protect from light and keep the container tightly closed. Preserve intact coatings; follow the pregnancy handling precautions for broken or crushed tablets.