Financial nuclear heating plant

General characteristics. Structure:

Active agent:  финастерид 5 mg
excipients: lactose — 86,75 mg; MKTs (Ultra-102) — 12 mg; sodium carboxymethylstarch (type A) — 6 mg; starch corn prezhelatinizirovanny — 12 mg; sodium docusate — 2,5 mg; magnesium stearate — 0,75 mg  
the cover is film: a gipromelloza (15 cps) — 2,4 mg; propylene glycol — 0,4 mg; titanium dioxide — 0,8 mg; talc — 0,4 mg.

Pharmacological properties:

Pharmacodynamics. Finasterid – 4-azasteroid connection, selectively and competitively inhibiting 5α-редуктазу. This nicotinamide adenine dinucleotide phosphate (NADF) - dependent enzyme turns testosterone into dihydrotestosterone. Drug specifically inhibits type isoenzyme 5α-редуктазы 2 that leads to considerable decrease in level of dihydrotestosterone in a prostate (> 90%) and in the blood circulatory system (from 60% to 80%).

Finasterid increases prostate testosterone level (approximately for 85%) at patients with DGPZh, it does not influence growth and morphology of a prostate. Drug has no the expressed affinity to androgen receptors. Finasterid considerably reduces the plasma DOG level by 41% - patients have 71% with DGPZh symptoms. Nevertheless, untied and the DOG general level drug does not influence a ratio of values.
The size of a prostate decreases under the influence of a finasterid owing to an atrophy and apoptosis. The histologic changes caused by effect of drug were observed 6 months later from an initiation of treatment. Ferruterous elements of tissues of prostate gland are most sensitive to a finasterid. Drug reduces a detruzor tone at patients with the ischuria caused by DGPZh.

Pharmacokinetics. Finasterid is well soaked up in digestive tract, food slows down absorption speed, but does not influence absorption volume. Average bioavailability of a finasterid makes 63% (within 34 – 71%), is based on the area relation under a curve to an intravenous control dose. The maximum value of concentration of a finasterid in plasma of 37 ng/ml (27 – 49%) is also reached within 1 – 2 hours after introduction. Drug collects in an organism at repeated repeated introductions. Establishment of equilibrium concentration happens after 17 days, the exact time is not known.
About 90% of a finasterid circulate in the state connected with proteins of plasma. The volume of distribution of a finasterid high (76 l in a stable state); drug gets through a blood-brain barrier and a small amount it is revealed in sperm. Drug can be soaked up through skin at contact with the crushed tablets.
Finasterid is metabolized preferential by a liver with formation of inactive metabolites. Plasma clearance of a finasterid of 165 ml/min. (70 - 279ml/mines) and an elimination half-life of 6 hours. About 39% (32 – 46%) of the accepted dose are removed with urine in the form of metabolites and 57 (51 - 64%) through intestines.
The drug pharmacokinetics in general does not change at increase in term of a renal failure. The drug pharmacokinetics in the conditions of insufficiency of function of a liver is not studied.

Indications to use:

Treatment of a benign hyperplasia of a prostate on purpose:
reduction of the sizes of the increased prostate,
increases in the maximum speed of outflow of urine and reduction of the symptoms connected with a hyperplasia
decrease in risk of emergence of an acute ischuria and the probability of surgical intervention connected with it.

Route of administration and doses:

The recommended dose of 5 mg inside once a day.

Features of use:

Use at patients of advanced age
Elderly patients do not need to regulate a dose.

Use in pediatrics
Use of a finasterid for children is not shown.

Use at patients with an abnormal liver function
Action on patients with the broken function of a liver is not studied. To use with care at patients with anomalies of function of a liver since финастерид it is metabolized preferential by a liver.

Use at patients with a renal failure
There is no need of individual selection of a dose to patients with a renal failure

Use at pregnancy and a lactation
Finasterid is not shown to pregnant women and the feeding women.

Influence on driving and other equipment is not studied.

Special preventions and precautionary measures
Before beginning treatment finasteridy it is necessary to conduct the corresponding examination to exclude other diseases similar on clinic to DGPZh, for example infections, a prostate cancer, strictures, a hypertensive bladder or some neurogenic disturbances. Patients with the large residual volume of urine and/or decrease in current of urine have to be under constant observation regarding a possible obstructive uropathy when purpose of a finasterid is not shown.
Women of childbearing age and pregnant women have to avoid contact with the crushed or damaged tablets of a finasterid because of a possibility of accumulation of a finasteid in an organism with the subsequent possible risk of defeat of a fruit.
Laboratory analyses
It is known that финастерид the DOG level (prostate specific antigen) of plasma approximately at 50% of patients with DGPZh even in the presence of a prostate cancer reduces. Bystry decrease in the DOG is observed at most of patients within the first month of treatment then
it is stabilized at the new level making about a half of the level recorded prior to treatment. Therefore when comparing these patients with healthy it is necessary to double the DOG indicator. This adjustment allows to consider sensitivity and specificity of the analysis of the DOG and to diagnose a prostate cancer.

Side effects:

Side effects were noted at 1% or more patients during 4 years, among them there is impotence, decrease in a libido, reduction of volume of an ejaculate and increase in a breast. Other side effects include pain in the field of testicles, reactions of hypersensitivity in the form of skin rash, a small tortoiseshell, hypostasis of lips and the person.

Interaction with other medicines:

With other drugs
Clinically significant interaction of a finasterid with other drugs is not revealed.
Finasterid has no effect on tsitokhy P450 – the fermental system providing metabolism of drugs.

With foodstuff
The concomitant use of food reduces the speed of absorption of a finasterid, nevertheless, food does not influence the general bioavailability.

Contraindications:

Finasterid is contraindicated to patients with the established hypersensitivity to drug and its components
Finasterid is contraindicated to pregnant women.
Finasterid is contraindicated to children.

Overdose:

Specific treatment at overdose of a finasterid is not developed.

Storage conditions:

Period of validity: 24 months of date of production. At a temperature below 25ºС.

Issue conditions:

According to the recipe

Packaging:

10 tablets in a strip from aluminum foil, 3 strips, are packed into a cardboard box with the application instruction.