Finast - instructions for use, doses, side effects, contraindications

Excipients: lactose 86.75 mg, microcrystalline cellulose (Ultra-102) 12 mg, sodium carboxymethyl starch (type A) 6 mg, corn pregelatinized corn starch 12 mg, sodium docusate 2.5 mg, magnesium stearate 0.75 mg;

film sheath: hypromellose (15 cps) 2.4 mg, propylene glycol 0.4 mg, titanium dioxide 0.8 mg, talc 0.4 mg.

Description:Round biconvex tablets coated with a film shell, white or almost white with embossing FIN on one side and a smooth surface on the other side

Pharmacotherapeutic group:5-alpha reductase inhibitor

ATX: & nbsp

G.04.C.B.01 Finasteride

Pharmacodynamics:

Antitumor hormone drug. Finasteride - a synthetic 4-azasteroid compound, a competitive and specific inhibitor of steroid 5-alpha-reductase, an intracellular enzyme that converts testosterone in the more active androgen 5-alpha-dihydrotestosterone. The growth of prostate tissue and the development of benign hyperplasia are due to the conversion of testosterone to dihydrotestosterone in the cells of the prostate gland. Oppressing the stimulating effect of testosterone on tumor development. Under the influence of finasteride, there is a significant reduction in the concentration of 5-alpha-dihydrotestosterone in the blood plasma and in the tissue of the prostate gland within 24 hours after oral administration, which is accompanied by a decrease in the volume of the prostate gland, an increase in the maximum urinary flow rate and a decrease in urinary tract obstruction symptoms.

With constant admission, a statistically significant effect is recorded after 3 months (decrease in the volume of the gland), 4 months (increase in the maximum urinary flow rate) and 7 months (decrease in the general symptoms and symptoms of obstruction of the urinary tract). Finasteride does not have an affinity for androgen receptors.

The drug has no effect on the level of plasma lipids, as well as on the blood plasma levels of cortisol, estradiol, prolactin, TSH and thyroxine.

Pharmacokinetics:

Suction and distribution: after taking the drug inside finasteride rapidly absorbed from the gastrointestinal tract and penetrates into tissues and biological fluids, is found in seminal fluid. Bioavailability is about 80% and does not depend on food intake.

The maximum concentration in plasma (C_mOh) is achieved 1-2 hours after taking the drug inside. Binding to plasma proteins is about 90%.

Metabolism and excretion: finasteride metabolized by the liver and excreted as metabolites with urine (39%) and feces (57%). T1/2 - 6-8 hours.

In special cases: the half-life of the drug in men 18-60 years is 6 hours, in patients older than 70 years can extend up to 8 hours.

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

Indications:

Treatment of benign prostatic hyperplasia in order to:

- reducing the size of the prostate gland;

- increasing the maximum rate of urine outflow and reducing symptoms associated with hyperplasia;

- reducing the risk of acute urinary retention requiring catheterization or surgery, including transurethral resection of the prostate (TURP) and prostatectomy.

Contraindications:

Finast® is contraindicated when:

- the presence of hypersensitivity to finasteride and other components of the drug;

- obstructive uropathy;

- prostate cancer;

- in childhood and in women.

Carefully:

Finasteride is largely metabolized in the liver, so caution should be exercised in patients with impaired liver function (hepatic insufficiency).

Pregnancy and lactation:Women of childbearing age and pregnant women should avoid contact with crushed or lost integrity tablets of Finast® because of the possibility of penetration finasteride in the body of a pregnant woman. The ability of finasteride, penetrating into the seminal fluid, suppress the transformation testosterone in dihydrotestosterone can cause impaired development of the genital organs in the male fetus.

Dosing and Administration:

Finast® is prescribed 5 mg once a day, daily, regardless of food intake.The duration of therapy before evaluating its effectiveness should be at least 6 months.

In approximately 50% of patients, the disappearance of clinical symptoms occurred during treatment for 12 months.

Side effects:

Allergic reactions, lower potency and / or libido, decrease in the volume of ejaculate, ejaculation disorder, gynecomastia, breast tenderness, increased concentrations of luteinizing (LH) and follicle stimulating hormone (FSH), hormones in the blood, reducing the concentration of prostate-specific antigen (PSA). The frequency of side effects does not exceed 3-4% and decreases during treatment.

Overdose:

At present, cases of overdose of Finast® have not been reported.

Interaction:

There was no clinically significant interaction with other drugs.

Special instructions:

In patients with a large volume of residual urine and / or a sharply reduced urine flow, careful monitoring of the possible development of obstructive uropathy is necessary.

Before the beginning of therapy it is necessary to exclude diseases that simulate benign prostatic hyperplasia - prostate cancer, urethral stricture, bladder hypotension,disturbances of its innervation and infectious prostatitis.

Causes a decrease in prostate-specific antigen at 6 and 12 months. reception at 41 and 48% respectively.

To exclude the development of prostate cancer during therapy with finasteride, it is necessary to conduct a patient examination.

Form release / dosage:

Tablets, film-coated, 5 mg.

Packaging:

10 tablets in a strip.

For 3 strips, together with instructions for use packed in a pack of cardboard.

Storage conditions:

In dry, protected ot of light at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014580 / 01

Date of registration:18.09.2008

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

DR. REDDY`S LABORATORIES, LTD. India

Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India

Information update date: & nbsp25.09.2015

Illustrated instructions

Instructions

Finast® (Finast®)