Alfinal

General characteristics. Structure:

Active agent: финастерид 5 mg

Excipients: lactoses monohydrate; MKTs; starch prezhelatinizirovanny; коповидон (коллидон BA64); croscarmellose sodium (primelloza); silicon dioxide colloid (aerosil); magnesium stearate  
 
The cover is film: Opadry II (series 85) (the polyvinyl alcohol which is partially hydrolyzed, a macrogoal 3350, titanium dioxide (E171), talc).

Pharmacological properties:

Pharmacodynamics. Antineoplastic hormonal drug. Inhibits 5 - the type alpha reductase II turning testosterone into more active 5 - alpha dihydrotestosterone, reduces its concentration in blood and tissue of a prostate gland during 24 h after oral administration.
The promoting effect of testosterone on development of a tumor 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. 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 in a GIT comes to the end in 6–8 h after reception. It is well soaked up and gets into fabrics and bioliquids, it is found in an ejaculate (in concentration of 5 mkg). Bioavailability — 80%, does not depend on meal. Tmax in a blood plasma is 2 h, Cmax in a blood plasma — 8–10 ng/ml. Communication with proteins of plasma — 93%. 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.
T1/2 men of 18-60 years have 6 h, at men 70 years — 8 h are more senior. It is removed in the form of metabolites by kidneys (39%) and through intestines (57%). 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 (reduction of the sizes of a prostate, increase in the maximum speed of outflow of urine, decrease in risk of development of an acute ischuria).

Route of administration and doses:

Inside, irrespective of meal, according to 1 tab. (5 mg) once a day, both in monotherapy, and in combination with doksazoziny.
The minimum duration of a course of therapy — 6 months.

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 stimulating a benign hyperplasia of a prostate — a prostate cancer, an urethra stricture, hypotonia of a bladder, disturbance of its innervation and infectious prostatitis.

Women of childbearing age and pregnant women should avoid contact with drug (especially a touch to the tablets crushed or lost integrity) since drug 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.

Causes 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 by the drug Alfinal® it is necessary to conduct examination of patients.

In case of the admission of one dose of the drug Alfinal® it is recommended to continue treatment according to the usual scheme. It is not necessary to accept an excess dose of drug.

Side effects:

Allergic reactions (rash, a skin itch, a small tortoiseshell, hypostasis of lips and the person), decrease in a potentiality and/or libido, disturbance of an ejaculation, reduction of volume of an ejaculate, increase and morbidity of chest glands, increase in concentration of LG and FSG in blood, decrease in concentration of prostatspetsifichesky antigen (DOG).

Interaction with other medicines:

Clinically significant interactions with other drugs are not revealed.

Contraindications:

- hypersensitivity;
- obstructive uropathy;
- rare hereditary diseases, such as a lactose intolerance, deficit of lactase or glyukozo-galaktozny malabsorption (in connection with existence in composition of lactose);
- age up to 18 years.

With care: liver failure.

Overdose:

Now about cases of overdose of drug it was not reported.

Storage conditions:

In the dry, protected from light place, at a temperature not above 25 °C.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, 5 mg. In a blister strip packaging from the film of PVC and printing aluminum foil varnished on 10 pieces 3 packagings in a pack from a cardboard.