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

Excipients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, glyceride lauromacrogol (Gelucir 44 / 14®), sodium carboxymethyl starch, magnesium stearate.

SHELL:

Hypromellose (Pharmacoat 606®), titanium dioxide, indigo carmine dye (E 132), macrogol 6000.

Description:

Round, biconvex tablets, film-coated, blue with "F5 "on one side.

Pharmacotherapeutic group:5-alpha reductase inhibitor

ATX: & nbsp

G.04.C.B.01 Finasteride

Pharmacodynamics:

Finasteride is a synthetic 4-azosteroid compound, a competitive and specific inhibitor of the 5-alpha reductase type II intracellular enzyme that converts testosterone in the active androgen 5-dihydrotestosterone (DHT). 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. Under the influence of the drug, a significant decrease in the concentration of dihydrotestosterone occurs both in the blood plasma and in the gland tissue. Finasteride does not bind to androgen receptors.

As a result of the use of the drug, the size of the prostate gland decreases, the severity of symptoms associated with prostatic hyperplasia decreases, the maximum urinary flow rate increases.

The drug does not affect the concentration of plasma lipids, as well as the blood plasma levels of cortisol, estradiol, prolactin, thyroid-stimulating hormone, thyroxine.

Pharmacokinetics:

Suction and distribution: after taking the drug inside finasteride quickly absorbed from the gastrointestinal tract.Bioavailability is about 80% and does not depend on food intake.

The maximum concentration in the plasma is achieved 1-2 hours after taking the drug inside. The connection with plasma proteins is about 93%. The volume of distribution is 76 liters. When taking 5 mg per day, plasma concentrations of finasteride are 8-10 ng / ml.

Metabolism and excretion: finasteride metabolized by the liver and excreted as metabolites with urine (39%) and through the intestine (57%).

The half-life of the drug in patients older than 60 years is 6 hours, in patients older than 70 years may be lengthened to 8 hours.

Indications:

Benign prostatic hyperplasia (to reduce the size of the prostate gland, increase the maximum urinary flow rate and reduce the symptoms associated with hyperplasia, reduce the risk of acute urinary retention and the associated probability of surgical intervention, including transurethral resection of the prostate (TURP) and prostatectomy).

Contraindications:

- Hypersensitivity to finasteride and other components of the drug;

- prostate cancer;

- obstruction of the urinary tract;

- childhood;

- women;

- because Finpros contains lactose, patients with rare hereditary disorders: galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome is contraindicated.

Carefully:Violation of the function of the liver.

Pregnancy and lactation:Finasteride is for men. The drug is contraindicated during pregnancy. There is no data on the excretion of finasteride through breast milk.

Women of childbearing age and pregnant women should avoid contact with the lack of integrity of Finpros tablets, since finasteride has teratogenic properties (the ability to suppress the conversion of testosterone to dihydrotestosterone can cause impaired development of the genital organs in the fetus of the male fetus).

Dosing and Administration:

Inside, 5 mg once a day, regardless of food intake.

The duration of therapy before evaluating its effectiveness should be at least 6 months.

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

Side effects:

Allergic reactions: itching, hives, rashes, swelling of the face and lips.

From the side of the urinary tract: gynecomastia, tenderness of the mammary glands, impotence, decreased libido and decreased ejaculate volume, ejaculation disorders, increased concentration of LH (luteinizing hormone) and FSH (follicle-stimulating hormone) in the blood, testicular pain.

Overdose:

In clinical studies, high doses of finasteride to 400 mg and repeated use of the drug for 3 months at a dose of 80 mg per day showed no serious side effects.

Interaction:

There was no clinically significant interaction with other drugs.

The drug has no significant effect on the activity of cytochrome P isoenzymes_450.

In the combined use of finasteride with phenazone, digoxin, glibenclamide, warfarin and theophylline, ACE inhibitors (angiotensin converting enzyme), αadrenoblockers, β-blockers, NSAIDs (nonsteroidal anti-inflammatory drugs), blockers of "slow" calcium channels, nitrates, diuretics, antagonists of H₂-receptors, inhibitors of HMG-CoA reductase, quinolones and benzodiazepines, no clinically significant manifestations of drug interaction were found.

Special instructions:

Before the start of treatment, it is necessary to exclude diseases that can simulate benign prostatic hyperplasia, such as infectious prostatitis, prostate cancer, urethral stricture, bladder hypotension, and a number of changes in the urinary system that occur in certain diseases of the nervous system.

Since the use of finasteride decreases prostate-specific antigen (41% and 48% respectively 6 and 12 months from the start of therapy), periodically during the therapy, it is necessary to conduct a patient examination to exclude prostate cancer from them.

Women of childbearing age and pregnant Avoid contact with powdered tablets finasteride, t. the ability of the drug to inhibit the conversion of testosterone to dihydrotestosterone may cause impaired development of the genital organs in the male fetus. The finasteride tablets are film-coated. Therefore, if they are not ground into powder or their integrity is not violated, contact with the active substance is excluded.

Form release / dosage:Tablets, film-coated, 5 mg.

Packaging:

10 tablets in a blister pack.

For 3 or 9 blisters are placed in a pack of cardboard along with instructions for use.

Storage conditions:

Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002869/08

Date of registration:18.04.2008

Date of cancellation:2016-10-27

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA-RUS, LLC Russia

KRKA, d.d. Slovenia

Representation: & nbspKRKA KRKA Slovenia

Information update date: & nbsp27.10.2016

Illustrated instructions

Instructions

FINPROSE (Finpros)