Zerlon

General characteristics. Structure:

Active agent: финастерид 5 mg

Excipients: lactoses monohydrate, starch prezhelatinizirovanny, sodium carboxymethylstarch (type A), sodium docusate, cellulose microcrystallic, povidone, magnesium stearate.

Structure of a film cover: hypro rod (hydroxypropyl cellulose), gipromelloza, titanium dioxide (E171), talc, dye indigo carmine (E132).

Pharmacological properties:

Finasterid - synthetic 4-azasteroid connection, competitive specific inhibitor steroid 5 - alpha reductases - a desmoenzyme which turns testosterone into more active androgen - 5 dihydrotestosterone (DGT) stimulating growth of tissue of prostate gland and development of a benign hyperplasia.
Under the influence of drug there is a decrease in concentration of dihydrotestosterone both in a blood plasma, and in gland fabrics, reduction of the sizes of the increased gland and expressiveness of the symptoms connected with prostate adenoma. Finasterid does not contact androgenic receptors, also the level of cortisol, oestradiol, prolactin, TTG, thyroxine does not exert impact on the level of lipids of plasma.
At constant reception statistically significant effect is registered in 3 months (reduction of volume of gland), 4 months (increase in the maximum speed of current of urine) and 7 months (reduction of the general symptoms and symptoms of impassability of urinary tract).

Pharmacokinetics. Absorption. After administration of drug inside финастерид it is quickly absorbed from a GIT, absorption comes to the end in 6-8 h after oral administration. Bioavailability makes about 80% and does not depend on meal. Time of achievement of Cmax in plasma - 2 h, Cmax value - 8-10 ng/ml.

Distribution. It is well soaked up and gets into fabrics and bioliquids, it is found in an ejaculate (in concentration of 5 mkg). Communication with proteins of plasma - more than 90%. Gets through GEB, in 7-10 days of treatment it is found in cerebrospinal fluid in insignificant quantities. System clearance - 165 ml/min., Vd - 76 l. Slightly kumulirut at long reception.

Metabolism and removal. It is metabolized by a liver and allocated in the form of metabolites with kidneys (about 39%) and through intestines (57%). T1/2 at men of 18-60 years makes 6 h, 70 years - 8 h are more senior.

Pharmacokinetics in special clinical cases. At a chronic renal failure a part of metabolites (which is normal removed with urine) is removed with a stake.

Indications to use:

Benign hyperplasia of a prostate on purpose:
— reduction of the sizes of a prostate;
— improvements of the maximum speed of current of urine and reduction of the symptoms connected with a hyperplasia;
— decrease in risk of emergence of the acute ischuria demanding catheterization or surgical intervention including a transurethral prostatectomy and a prostatectomy.

Route of administration and doses:

Pill is taken inside, irrespective of meal, without chewing.
Appoint 5 mg of 1 time/days, both in monotherapy, and in a combination with a blocker of α-adrenoceptors doksazoziny...........
Therapy duration to assessment of its efficiency has to be not less than 6 months. Approximately at 50% of patients disappearance of clinical symptoms happened at treatment within 12 months.

It is not necessary to carry out dose adjustment of drug at patients of advanced age, including and at a renal failure (at decrease in KK to 9 ml/min.) since pharmacokinetic researches did not reveal any changes in distribution of a finasterid at these categories of patients.

Features of use:

At patients with the large volume of a residual urine and/or sharply reduced current of urine it is necessary to exercise careful control of possible development of an obstructive uropathy.
Before therapy it is necessary to exclude the diseases simulating a benign hyperplasia of a prostate - a prostate cancer, an urethra stricture, hypotonia of a bladder, disturbance of its innervation and infectious prostatitis.
Against the background of drug use Zerlon is observed decrease in the DOG in 6 and 12 months of reception for 41% and 48% respectively. For an exception of development of a prostate cancer during therapy finasteridy it is necessary to conduct examination of patients.

Influence on ability to driving of motor transport and to control of mechanisms
Use of drug does not exert impact on ability of the patient to performance of the work requiring special attention and speed of psychomotor reactions.

Side effects:

From a reproductive system: decrease in a potentiality and/or libido, disturbance of an ejaculation, reduction of volume of an ejaculate (frequency of these side effects does not exceed 3-4% and decreases in the course of treatment).
From endocrine system: seldom (to 1-2%) - increase and morbidity of chest glands, increase in concentration of LG and FSG in blood, decrease in concentration of the DOG.
Allergic reactions: rash, skin itch, small tortoiseshell, hypostasis of lips and person.

Interaction with other medicines:

Clinically significant interaction of drug Zerlon with other drugs is not revealed.

Contraindications:

— malignant tumor of a prostate;
— obstruction of urinary tract;
— children's age;
— drug is not intended for use for women;
— hypersensitivity to a finasterid and/or to other components of drug.

With care it is necessary to use drug at an abnormal liver function, an obstructive uropathy.

Use of drug ZERLON at pregnancy and feeding by a breast
Women of childbearing age and pregnant women should avoid contact with the drug tablets crushed or lost integrity Zerlon because of a possibility of penetration of a finasterid into an organism of the pregnant woman as финастерид has teratogenic properties (ability to suppress transformation of testosterone into dihydrotestosterone can cause disturbance of development of generative organs in a male fruit), gets into semen.

Use at abnormal liver functions
With care it is necessary to use drug at an abnormal liver function.

Use for elderly patients
It is not necessary to carry out dose adjustment of drug at patients of advanced age, including and at a renal failure (at decrease in KK to 9 ml/min.) since pharmacokinetic researches did not reveal any changes in distribution of a finasterid at these categories of patients

Use for children
Contraindication: children's age.

Overdose:

About drug overdose cases Zerlon it was not reported.

Storage conditions:

List B. Drug should be stored in the place, dry, unavailable to children, at a temperature not above 30 °C.

Issue conditions:

According to the recipe

Packaging:

Tablets, покр. film cover, 5 mg: 30 pieces.