Adenosterid-Zdorovye, the tab. on 5 mg No. 10х3
Producer: LLC Pharmaceutical Company Zdorovye Ukraine
Code of automatic telephone exchange: G04CB01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
International and chemical name: finasteride; N-(1,1-dimethyl) -3-оксо-4-аза-5a-андрост-1эне-17b-карбоксамид;основные physical and chemical properties: tablets, coated, blue color with an insignificant nacreous shade; structure: 1 tablet contains a finasterid (in terms of 100% substance) - 5 mg; excipients: lactoses monohydrate, cellulose microcrystallic, starch corn, aerosil, magnesium stearate, titanium dioxide, gipromelloz (gidroksipropilmetiltsellyuloz), кандурин (silver gloss), Sepispers Dry Blue _ dye.
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. Treatment by drug allows to reduce total quantity of the urological symptoms caused by a prostate hyperplasia by 51%, to reach steady regression of volume of a prostate and increase in the maximum speed of current of urine, improvement of clinical symptoms. At constant reception statistically significant effect is registered in 3 months. The greatest effect renders drug at the volume of gland more than 55 cm3.
Pharmacokinetics. Drug is well soaked up and gets into fabrics and biological liquids, it is found in an ejaculate. Bioavailability makes about 80%. In plasma for 90% contacts proteins. It is removed in the form of metabolites by kidneys (39%) and through intestines (57%).
Indications to use:
Treatment of a benign hyperplasia of a prostate.
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 (at decrease in clearance of creatinine to 9 ml/min.) do not require correction of a dose.
Features of use:
Women of childbearing age and pregnant women have to avoid contact with the tablets crushed or lost integrity in connection with possible potential risk for a male fruit (disturbance in development of generative organs).
At the large volume of a residual urine and/or at sharply reduced outflow of urine it is necessary to exercise strict control of a condition of the patient as development of an obstructive uropathy is possible. Efficiency of drug at a prostate cancer therefore before and periodically during treatment it is necessary to conduct the researches allowing to exclude existence of a prostate cancer is not established.
Finasterid approximately reduces concentration of prostatospetsifichesky antigen (DOG) at patients with a benign hyperplasia of a prostate by 50%, and also with a prostate cancer. Therefore at treatment by drug during
6 months and more indicators of the DOG should be doubled since the DOGS normal values in this case do not exclude existence of a prostate cancer.
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. Frequency of disorders of sexual function decreases during treatment.
Interaction with other medicines:
Clinically significant interaction with other drugs is not revealed.
Contraindications:
Hypersensitivity, obstructive uropathy, cancer predstatel-
ache glands, pregnancy. Drug is not shown to women and children.
Overdose:
At one-time administration of drug in doses to 400 mg and multiple dose in doses to 80 mg/days within 3 months side effects were not observed. Specific methods of treatment of overdose of a finasterid are not developed.
Storage conditions:
In the dry, protected from light place at a temperature not above 30 °C. To store in the place, unavailable to children.
Period of validity – 2 years.
Issue conditions:
According to the recipe
Packaging:
Tablets No. 10, No. 10х3 in a blister strip packaging.