Proskar

Proskar – drug with anti-androgenic action.

Form of release and structure

Proskar release in the form of tablets, film coated: in the form of apple, blue, on one party an engraving of "PROSCAR", on another – "MSD 72" (on 14 pieces in blisters, on 1 or 2 blisters in a cardboard pack).

Is a part of 1 tablet:

• Active agent: финастерид – 5 mg;
• Additional components: monohydrate of lactose, corn prezhelatinizirovanny starch, sodium salt of carboxymethyl ether of starch, yellow iron oxide, sodium docusate, microcrystallic cellulose, magnesium stearate;
• Film cover: methylhydroxypropyl cellulose, talc, indigo carmine aluminum varnish, hydroxypropyl cellulose, titanium dioxide.

Indications to use

Proskar appoint at treatment of the benign hyperplasia of a prostate (BHP) for the prevention of development of urological complications (decrease in risk of an acute ischuria), decrease in need for performing surgery, improvement of current of urine, reduction of the sizes of the increased prostate and expressiveness of the symptoms connected with a disease.

Drug is shown to patients with the increased prostate.

Contraindications

Contraindication to Proskar's use is existence of hypersensitivity to its components.

Care is demanded by purpose of drug at the large volume of a residual urine and/or significantly the lowered urine current (carrying out careful observation regarding an obstructive uropathy is required).

To women and children Proskar do not appoint.

Because of probability of penetration of a finasterid into an organism women of childbearing age and pregnant women need to avoid contact with the tablets which lost integrity or crushed (there is a risk of impact on a male fruit with development of pathology of pre-natal formation of external genitals).

Route of administration and dosage

Proskar accept inside, irrespective of meal as monotherapy or along with doksazoziny.

Daily dose – 1 tablet (5 mg) in 1 reception.

At a renal failure of varying severity (clearance of creatinine from 9 ml/min.), and also elderly patients should not select doses individually.

Side effects

In the first year of treatment at the patients accepting Proskar in comparison with the patients accepting placebo such disturbances as impotence, decrease in a libido and disturbance of an ejaculation met more often. As a rule, at further administration of drug (for 2-4 year) the frequency of development of above-mentioned side reactions in the patients accepting Proskar did not differ from that at patients who accepted placebo.

Possible side effects:

• Endocrine system: morbidity and increase in chest glands;
• Reproductive system: reduction of volume of an ejaculate, decrease libido, impotence, morbidity of testicles, disturbances of an ejaculation;
• Allergic reactions: rash, urticaria, skin itch, Quincke's disease of the person and lips.

Therapy duration does not render on the frequency of development and expressiveness of disturbances of influence, and the quantity of cases of disturbances of sexual function which are connected with Proskar's reception, at long reception decreases.

The profile of portability and Proskar's safety at its simultaneous use from 4 or 8 mg of a doksazozin a day is comparable with profiles of safety of these drugs separately.

As a result of carrying out seven-year placebo - a controlled research the prostate cancer by results of a biopsy was revealed at 18,4% receiving Proskar and 24,4% of the receiving placebos of patients at the same time estimated at 7-10 points on Gleason's scale – at 6,4% and 5,1% of men respectively.

Therapy can influence laboratory indicators, reducing the level of prostates specific antigens.

Special instructions

The positive clinical effect from Proskar's use for patients with cancer of a prostate was not noted so far.

Before purpose of a medical course and in the course of therapy it is necessary to conduct rectal researches, and also researches by other methods on existence of a prostate cancer. As a rule, at the initial level of prostatspetsifichesky antigen (DOG) higher than 10 ng/ml are shown carrying out broader inspection including, if necessary, a biopsy. If the DOG level is in limits of 4-10 ng/ml further inspection of the patient is recommended. At patients with a prostate cancer and patients who do not have this disease considerable coincidence of the DOGS levels is observed. In this regard at DGPZh, irrespective of treatment by Proskar, normal values of prostatspetsifichesky antigen do not allow to exclude a prostate cancer. Also it is impossible to exclude it at the DOG initial level below 4 ng/ml.

In controlled clinical tests at patients with DGPZh and the increased level of prostatspetsifichesky antigen (with several definitions of the DOG and carrying out a biopsy of a prostate) drug did not render on the frequency of detection of a prostate cancer of influence.

Even in the presence of a prostate cancer when performing therapy significant reduction of serum-born prostatspetsifichesky antigen (about 50%) is observed.

At any long increase in the DOG level at the patients receiving treatment finasteridy it is necessary to conduct careful examination for clarification of the reason (perhaps, it consists in non-compliance with the mode of use of Proskar).

Proskar does not lead to essential decrease in percent of a free DOG (a ratio of a free DOG to the general). This indicator remains invariable even under the influence of a finasterid. In cases when for diagnosis of a prostate cancer use percent of a free DOG, it is optional to carry out correction of values of this indicator.

Concentration of prostatspetsifichesky antigen in blood serum depends on age of the patient and volume of a prostate, and prostate volume, in turn, is depending on age of the patient. When determining the DOG level it is necessary to consider that this indicator decreases at the patients accepting Proskar. In most cases bystry reduction of the DOG level is observed in the first months of treatment then this indicator is stabilized at the new level which, as a rule, makes a half from the value measured prior to therapy. Therefore Proskar taking a long course of therapy (of 6 months) patients need to double value of the DOG level for comparison it with normal indicators at men who do not accept drug.

Medicinal interaction

Clinically significant interaction of Proskar with other drugs / substances it was revealed not.

Terms and storage conditions

To store in protected from light, the place, unavailable to children, at a temperature up to 30 °C.

Period of validity – 3 years.