Finast^® (Tablets) Instructions for Use

Marketing Authorization Holder

Dr. Reddy’s Laboratories Ltd. (India)

Contact Information

Dr. Reddy’s Laboratories Ltd. (India)

ATC Code

G04CB01 (Finasteride)

Active Substance

Finasteride (Rec.INN registered by WHO)

Dosage Form

Finast®

Film-coated tablets, 5 mg: 28 or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets blue, oval, biconvex, with the engraving “FIN” on one side and “5” on the other side; the tablet core is white or almost white in cross-section.

Excipients: lactose monohydrate, microcrystalline cellulose (Avicel pH102), corn starch pregelatinized, sodium starch glycolate (type A), docusate sodium, magnesium stearate.

Film coating composition Opadry blue 03B50899 (hypromellose, titanium dioxide (E171), talc, macrogol, FD&C blue No.2/indigo carmine aluminum lake (E132) (11-14%), FD&C blue No.2 indigo carmine aluminum lake (E132) (30-36%)).

10 pcs. – blisters (3) – carton packs.
14 pcs. – blisters (2) – carton packs.

Clinical-Pharmacological Group

Drug for the treatment of benign prostatic hyperplasia. 5α-reductase inhibitor

Pharmacotherapeutic Group

5-alpha reductase inhibitor

Pharmacological Action

Finasteride is a synthetic 4-azasteroid compound, a competitive and specific inhibitor of steroid 5-α-reductase, an intracellular enzyme that converts testosterone to the more active androgen 5-α-dihydrotestosterone. The growth of prostate tissue and the development of benign hyperplasia are due to the conversion of testosterone to dihydrotestosterone in prostate cells. It inhibits the stimulating effect of testosterone on tumor development.

Under the influence of finasteride, a significant decrease in the concentration of 5-alpha-dihydrotestosterone in blood plasma and prostate tissue occurs within 24 hours after oral administration, which is accompanied by a decrease in prostate volume, an increase in maximum urine flow rate, and a decrease in symptoms of urinary tract obstruction. With continuous use, a statistically significant effect is recorded after 3 months (decrease in gland volume), 4 months (increase in maximum urine flow rate), and 7 months (decrease in total symptoms and symptoms of urinary tract obstruction). Finasteride has no affinity for androgen receptors.

The drug does not affect plasma lipid levels, nor the plasma levels of cortisol, estradiol, prolactin, TSH, and thyroxine.

Pharmacokinetics

Absorption and Distribution

After oral administration, Finasteride is rapidly absorbed from the gastrointestinal tract and penetrates into tissues and biological fluids, and is detected in seminal fluid. Bioavailability is about 80% and does not depend on food intake.

C_max is reached 1-2 hours after oral administration. Plasma protein binding is about 90%.

Long-term (3-7 months) administration at a dose of 5 mg/day reduces the concentration of 5-alpha-dihydrotestosterone in blood serum by 70%.

Metabolism and Excretion

Finasteride is metabolized by the liver and excreted as metabolites in urine (39%) and feces (57%). T_1/2 is 6-8 hours.

Pharmacokinetics in Special Clinical Cases

The T_1/2 of the drug in men 18-60 years old is 6 hours; in patients over 70 years old, it may be prolonged to 8 hours.

Indications

Treatment of benign prostatic hyperplasia for the purpose of

• Reducing the size of the prostate gland;
• Increasing the maximum urine flow rate and reducing symptoms associated with hyperplasia;
• Reducing the risk of acute urinary retention requiring catheterization or surgical intervention, including transurethral resection of the prostate (TURP) and prostatectomy.

ICD codes

Dosage Regimen

Take one 5 mg tablet once daily.

Administer the tablet orally, with or without food.

Swallow the tablet whole; do not crush or break it.

Continue therapy daily for at least 6 months to properly evaluate initial therapeutic response.

Approximately 50% of patients experience symptom resolution after 12 months of continuous treatment.

Maintain the once-daily regimen for long-term management of benign prostatic hyperplasia.

Do not alter the dosage or discontinue use without consulting a physician.

Adverse Reactions

From the reproductive system decreased potency and/or libido, decreased ejaculate volume, ejaculation disorder,

From the endocrine system gynecomastia, breast tenderness, increased plasma concentrations of LH and FSH, decreased concentration of prostate-specific antigen (PSA).

Other allergic reactions.

The frequency of side effects does not exceed 3-4% and decreases during treatment.

Contraindications

• Obstructive uropathy;
• Prostate cancer;
• Childhood;
• Hypersensitivity to finasteride and other components of the drug.

Finasteride is not prescribed to women.

With caution, the drug should be prescribed to patients with impaired liver function (liver failure), since Finasteride is largely metabolized in the liver.

Use in Pregnancy and Lactation

Women of childbearing age and pregnant women should avoid contact with crushed or damaged Finast^® tablets due to the possibility of finasteride penetration into the body of a pregnant woman.

The ability of finasteride, which penetrates into seminal fluid, to inhibit the conversion of testosterone to dihydrotestosterone can cause impaired development of the genital organs in a male fetus.

Special Precautions

In patients with a large volume of residual urine and/or a sharply reduced urine flow, careful monitoring for the possible development of obstructive uropathy should be carried out.

Before starting therapy, it is necessary to exclude diseases that mimic benign prostatic hyperplasia – prostate cancer, urethral stricture, bladder hypotonia, its innervation disorders, and infectious prostatitis.

Taking the drug causes a decrease in prostate-specific antigen after 6 and 12 months of administration by 41% and 48%, respectively. To exclude the development of prostate cancer during therapy with finasteride, it is necessary to examine patients.

Overdose

Currently, no cases of overdose of Finast^® have been reported.

Drug Interactions

No clinically significant interaction with other drugs has been identified.

Storage Conditions

List B. The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.