Gepaluo Finasteride Tablets

1. Indications and Usage
Benign Prostatic Hyperplasia (BPH): Treatment of symptomatic BPH to improve symptoms, reduce the risk of acute urinary retention, and decrease the need for surgical intervention (requires 5 mg dose).
Male Pattern Hair Loss: Treatment of male pattern hair loss (androgenetic alopecia) to promote hair growth and prevent further hair loss (requires 1 mg dose).
2. Dosage and Administration
BPH: The recommended dose is 5 mg once daily.
Male Pattern Hair Loss: The recommended dose is 1 mg once daily.
Administration: Can be taken with or without food. Clinical efficacy for hair loss is typically observed after 3 to 6 months of continuous use.
3. Mechanism of Action
Enzyme Inhibition: Finasteride is a competitive inhibitor of type II 5α-reductase.
Hormonal Effects: It blocks the conversion of testosterone to dihydrotestosterone (DHT), the primary androgen responsible for prostate enlargement and hair follicle miniaturization.
4. Safety and Warnings
Pregnancy and Women: Contraindicated in women and children. Women who are pregnant or may become pregnant must not handle crushed or broken tablets due to the risk of causing abnormalities in the external genitalia of a male fetus.
Prostate-Specific Antigen (PSA): Finasteride reduces serum PSA levels by approximately 50% after 6 months of therapy. When evaluating PSA data, the baseline value for treated patients should be doubled.
Prostate Cancer: Finasteride does not increase the incidence of prostate cancer, but any elevation in PSA during treatment requires clinical evaluation to rule out malignancy.
5. Adverse Reactions and Clinical Research
Sexual Dysfunction: The most common adverse reactions include erectile dysfunction, decreased libido, and ejaculation disorders (e.g., decreased semen volume).
Breast Abnormalities: Gynecomastia and breast tenderness may occur.
Hypersensitivity: Post-marketing reports include allergic reactions such as rash, pruritus, and angioedema.
6. Drug Interactions
Cytochrome P450 Inhibitors: Finasteride does not significantly affect the metabolism of drugs processed by cytochrome P450 enzymes (e.g., theophylline, warfarin, digoxin).
Other Antihypertensives and Lipid-lowering agents: Clinical studies have shown no significant adverse interactions when used with ACE inhibitors, beta-blockers, calcium channel blockers, NSAIDs, or HMG-CoA reductase inhibitors.
7. Pharmaceutical Information
Active Ingredient: Finasteride.
Excipients: Lactose monohydrate, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.
Appearance: White or off-white tablets.
Storage: Store in tight containers at controlled room temperature, protected from moisture.