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

Excipients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, copovidone (Kollidon BA-64), croscarmellose sodium (impellose), silicon dioxide colloid (aerosil), magnesium stearate;

sheath: Opadrai II (series 85): partially hydrolysed polyvinyl alcohol, macrogol-3350, titanium dioxide E 171, talc.

Description:

The tablets covered with a cover of white color, round biconcave.

On the fracture is white or almost white.

Pharmacotherapeutic group:5-alpha reductase inhibitor

ATX: & nbsp

G.04.C.B.01 Finasteride

Pharmacodynamics:

Antitumor hormone drug. Inhibits 5-alpha-reductase II type, transforming testosterone in a more active 5-alpha-dihydrotestosterone, reduces its concentration in the blood and prostate tissue within 24 hours after oral administration.

Oppressing the stimulating effect of testosterone on tumor development. Suppression of the formation of dihydrotestosterone is accompanied by a decrease in the volume of the prostate gland, an increase in the maximum rate of urine flow and a decrease in symptoms of obstruction of the urinary tract. 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).

Pharmacokinetics:

Absorption in the gastrointestinal tract is completed 6-8 hours after ingestion. It is well absorbed and penetrates into the tissues and biofluids, is found in the ejaculate (at a concentration of 5. μg). Bioavailability - 80%, does not depend on food intake.Time to reach the maximum concentration in the blood plasma (TC_mOh) - 2 hours, the maximum concentration in the blood plasma (C_mOh) - 8-10 ng / ml. Relationship with plasma proteins - 93%. Penetrates through the blood-brain barrier (BBB) (after 7-10 days of treatment it is detected in cerebrospinal fluid in small amounts).

Systemic clearance of 165 ml / min, volume of distribution - 76 liters. Slightly cumulates with prolonged admission.

Half-life (T_1/2) in men 18-60 years - 6 hours, in men over 70 years - 8 hours. It is excreted as metabolites by the kidneys (39%) and through the intestine (57%). In chronic renal failure, part of the metabolites (which is normally excreted in the urine) is excreted with feces.

Indications:

Benign prostatic hyperplasia (decrease in the size of the prostate, an increase in the maximum rate of urine outflow, a decrease in the risk of developing an acute urinary retention).

Contraindications:

Hypersensitivity, obstructive uropathy, children under 18 years.

Patients with rare hereditary diseases, such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take the drug (due to the presence of lactose).

Carefully:

Liver failure.

Pregnancy and lactation:

Women of childbearing age and pregnant women should avoid contact with the drug (especially touching crushed or lost integrity tablets), since the drug has teratogenic properties (the ability to suppress the conversion of testosterone to dihydrotestosterone can cause impaired development of the genital organs in the male fetus), penetrates into the seminal fluid .

Dosing and Administration:

Inside, regardless of food intake, 1 tablet (5 mg) once a day, both in monotherapy, and in combination with doxazosin.

The minimum duration of therapy is 6 months.

Side effects:

Allergic reactions (rash, skin itching, urticaria, edema of the lips and face), decreased potency and / or libido, ejaculation, decreased ejaculate volume, breast enlargement and tenderness, tenderness of the mammary glands, increased concentrations of luteinizing hormone and follicle-stimulating hormone in the blood, reduction in the concentration of prostate-specific antigen (PSA).

Overdose:

At present, no cases of drug overdose have been reported.

Interaction:

There were no clinically significant interactions 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 stimulate benign prostatic hyperplasia - prostate cancer, urethral stricture, bladder hypotension, disturbances of its innervation and infectious prostatitis.

It causes a decrease in PSA at 6 and 12 months of admission by 41% and 48%, respectively.

To exclude the development of prostate cancer during therapy with Alfinalom®, patients should be examined.

In case of missing one dose of Alfinal® it is recommended to continue treatment according to the usual scheme. Do not take an extra dose of the drug.

Form release / dosage:

Tablets, film-coated, 5 mg.

Packaging:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

3 contour mesh packages together with instructions for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years and 6 months.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N002468 / 01

Date of registration:06.05.2008

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Information update date: & nbsp25.09.2015

Illustrated instructions

Instructions

Alfinal® (Alfinal®)