Pro-camp таб. 0,005 No. 10,30

General characteristics. Structure:

Active ingredient: финастерид; 1 tablet contains a finasterid of 5 mg;
excipients: lactose monohydrate, potato starch or starch corn, povidone 25, sodium of a kroskarmeloz, magnesium stearate, cellulose microcrystallic, a gipromelloza, propylene glycol, titanium E 171 dioxide, the twin 80, talc, a macrogoal 6000, Ponso E 124 dye 4 R.Основные physical and chemical svoystva:tabletka, coated, reddish-pink color, with a biconvex surface. On cross section two layers are visible.

Pharmacological properties:

Pharmacodynamics. Finasterid – synthetic 4-azosteroid connection, specific inhibitor 5 - alpha reductases – the desmoenzyme of a prostate turning testosterone into more active androgen – dihydrotestosterone. Finasterid reduces the content of this hormone in blood and tissue of a prostate gland during 24 h after oral administration. The promoting effect of testosterone on prostate gland tissue growth oppresses. Suppression of formation of dihydrotestosterone is followed by reduction of volume of a prostate, increase in the maximum speed of current of urine and reduction of symptoms of impassability of urinary tract. Finasterid has no affinity to receptors of androgens.

Pharmacokinetics. Men after single oral administration have doses of a finasterid, marked by isotopes of carbon 14C, 39 of % of the accepted dose was removed with urine in the form of metabolites (possibly, with urine also insignificant quantity of an invariable finasterid was removed). 57% of the accepted dose were removed with a stake. By researches it is also established that less expressed oppressing action in relation to 5 - alpha reductases is peculiar to two metabolites of a finasterid.
Bioavailability of a finasterid at oral administration makes about 80%. Meal does not break bioavailability of drug. The maximum concentration of a finasterid in a blood plasma is reached approximately in the 2nd hour after oral administration. Absorption of drug from digestive tract terminates in 6 - 8 hour after its reception. The period of half-life of a finasterid in a blood plasma averages six hours. Linkng with proteins of a blood plasma – 93%. The system clearance makes about 165 ml/min., distribution volume – 76 liters.
Researches of reception of repeated doses of a finasterid showed a possibility of accumulation of drug in small quantities for a long time. At daily oral administration of a finasterid in a dose of 5 mg/days concentration it in plasma reaches 8-10 ng/ml and is kept at this level for a long time.
At advanced age the speed of removal of a finasterid decreases. At men age over 70 years the elimination half-life of a finasterid makes near the 8th hour whereas at persons age from 18 to 60 years – the 6th hour. But it is not the indication for reduction of a dose of drug in elderly people.
In patients with a chronic renal failure (clearance of creatinine from 9 to 55 ml/min.) the difference of speed of removal of a single dose of a finasterid, marked carbon 14C isotopes, rather with healthy volunteers is not revealed. Linkng with proteins of a blood plasma in these groups of patients also did not differ. It is explained that patients with a renal failure have a part of metabolites of a finasterid which is under normal conditions removed with urine, removed with a stake. It is confirmed by increase at these patients of quantity of metabolites of a finasterid in Calais at simultaneous decrease in their concentration in urine. Due to brought, at patients with a renal failure to whom the hemodialysis is not shown dose adjustment of Prostan is not necessary.
Finasterid gets through a gematoentsefalitny barrier into patients who received therapy finasteridy within 7-10 days, but its content in cerebrospinal fluid does not reach powerful concentration. At inclusion of Prostan in a dose of 5 mg a day also noted its permeability in semen. At the same time concentration of a finasterid in semen of adult men was 50-100 times lower than its concentration in a blood plasma.

Indications to use:

Treatment and control of a benign hyperplasia of a prostate and for prevention of urological complications (decrease in risk of an acute ischuria) and an operative measure, including a transuretalny resection of a prostate and a prostatectomy.

Route of administration and doses:

Inside, irrespective of meal, on 1 tablet (5 mg) a day within 6 months and more. Patients with a renal failure do not require correction of a dose.
Dosing at a renal failure
For patients with various stages of a renal failure (at decrease in clearance of creatinine to 9 ml/min.) individual selection of a dose is not required as pharmacokinetic researches did not find any changes in distribution of a finasterid.
Dosing for people of advanced age
There is no need for selection of a dose though pharmacokinetic researches indicate that removal of a finasterid at patients is more senior than 70 years slightly decreases.

Features of use:

It is necessary to exercise strict control over possible development of an obstructive uropathy in patients with the large residual volume of urine and/or sharply reduced outflow of urine.
Influence on prostatospetsifichesky antigen (DOG) and diagnosis of a prostate cancer.
By this time beneficial clinical effect of treatment by Prostan in patients, patients on a prostate cancer is not revealed. Patients with adenoma of a prostate and the increased DOG level were observed in the controlled clinical trials with several definitions of the DOG and capture of a biopsy of a prostate. In these researches treatment by Prostan did not influence the frequency of detection of a prostate cancer. The general frequency of developing of a prostate cancer significantly did not differ in groups of patients who received Prostan or placebo.
Before an initiation of treatment and periodically during treatment by Prostan it is recommended to check patients by a rectal research, and also other methods regarding existence of a prostate cancer. Definition of a serumal DOG is also used for detection of a prostate cancer. Generally, at the DOG initial level over 10 ng/ml of (Hybritech) it is necessary to conduct broad examination of the patient, including, in case of need, carrying out a biopsy. At the DOG level within 4-10 ng/ml further inspection of the patient is recommended. There is a considerable coincidence in the DOGS levels in men who are ill on a prostate cancer and who have no this disease. Thus, at men with prostate adenoma the DOGS normal values do not allow to exclude a prostate cancer, irrespective of treatment by Prostan. The DOG initial level below 4 ng/ml does not exclude existence of a prostate cancer.
The pro-camp causes reduction of keeping of a serumal DOG approximately for 50% in patients with prostate adenoma, even in the presence of a prostate cancer. This decrease in level of a serumal DOG in patients with prostate adenoma who receive treatment by Prostan needs to be taken in attention at DOG level assessment as this decrease does not exclude the accompanying prostate cancer. This decrease is provided in all range of values of the DOG level though can deviate at some patients. The analysis of data on the DOG confirmed that in standard patients who receive drug within 6 months and more DOGS values have to be doubled compared with normal values in persons who do not accept treatment. Such correction allows to keep sensitivity and specificity of definition of the DOG and maintains his ability to find a prostate cancer.
At any long increase in the DOG level in the patient who receives treatment finasteridy careful inspection is necessary for clarification of the reasons, including non-compliance with the mode of inclusion of Prostan.
The pro-camp significantly does not reduce percent of a free DOG (the attitude of a free DOG towards the general). The relation of a free and general DOG remains to constants even under the influence of Prostan. When determining percent of a free DOG which is applied to diagnosis of a prostate cancer correction of its values is not obligatory.
Influence of drug on datas of laboratory
Influence on the DOG level
The DOG level in blood serum changes the patient and prostate volume with age, at the same time the volume of a prostate changes the patient with age. At assessment of laboratory indicators of the DOG it is necessary to consider the fact that the DOG level decreases in the course of treatment by Prostan. At most of patients bystry decrease in the DOG within the first months of treatment then the DOG level is stabilized at the new level which makes about a half from initial size is observed. In this regard standard patients who receive Prostan within 6 months and more have to have doubled compared with normal values at persons who do not accept treatment DOGS values.
Ability to influence speed of response at control of motor transport and work with other mechanisms. The pro-camp does not influence ability to driving of the car and work with the equipment.

Side effects:

Drug is well transferred. Side reactions arise seldom (to 3% of patients) and are shown in the form of disorders of sexual function and volume of an ejaculate, impotence, increase and morbidity of chest glands, hypersensitivity reaction, including hypostasis of lips, a skin rash, an itch. Frequency of disorders of sexual function decreases during treatment.

Interaction with other medicines:

Clinically significant interactions with other drugs are not found. Probably, Prostan does not exert noticeable impact on the fermental system metabolizing the drugs connected with P450 cytochrome. The connections checked in public include propranolol, digoxin, Glyburidum, warfarin, theophylline and antipyrine; at the same time clinically significant interactions were not revealed.
Other accompanying therapy
Though special researches of interaction were not conducted, at combined use of Prostan with inhibitors of an angiotensin-converting enzyme, acetaminophen, acetylsalicylic acid, alpha blockers, beta-blockers, antagonists of calcium, nitrates, diuretics, antagonists of H2 of receptors, reductase HMG-CoA inhibitors, nonsteroid protivospalitelny drugs, hinolona and benzodiazepines clinically significant undesirable interactions were not revealed.

Contraindications:

Allergy to drug components, obstructive uropathy, prostate cancer. Drug is not shown to women and children.

Overdose:

At one-time administration of drug in doses up to 400 mg and multiple dose in doses to 80 mg/days within 3 months side effects were not observed.
Specific methods of treatment at overdose of Prostan are not developed.
Use during pregnancy or feeding by a breast.
Women who can potentially become pregnant or pregnant women, have to avoid contact with the crushed tablets of Prostan or a subject which lost integrity. Through ability of inhibitors 5 - alpha reductases like ІІ to slow down transformation of testosterone to dihydrotestosterone, these drugs, including финастерид, can cause disturbances in development of external genitals in a fruit of a men's fruit. Tablets of Prostan are covered with a cover and it prevents contact with active ingredient provided that the tablets which are not crushed and did not lose integrity.
Children. The pro-camp is not shown to children.

Storage conditions:

In the dry, protected from light place at a temperature not above 30 °C.
To store drug in the place, unavailable to children!

Period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in the blister. The 1 or 3 blisters place in a pack from a cardboard.