Alfinal tab n / 5mg film about 30 pc

Description

Composition
Active substance:
1 tablet contains: Finasteride – 0.005 g (5 mg) ;.
Excipients:
Lactose monohydrate, microcrystalline cellulose, pregelatinized starch, Copovidone (Kollidon VA-64), croscarmellose sodium (primelloza), colloidal silica (Aerosil), magnesium stearate; shell; Opadry II (85 Series) partially hydrolyzed polyvinyl alcohol, macrogol 3350, titanium dioxide E 171, talc.
Description:
Tablets, coated white, round, biconvex. At the turn white or nearly white.
Product form:
Tablets, film-coated, 5 mg.
10 tablets in blisters of PVC film and aluminum foil printed patent. 3 blisters together with instructions for use placed in a pile of cardboard.
Contraindications
Hypersensitivity, obstructive uropathy, children up to 18 years.
Patients with a rare hereditary diseases such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take the drug (due to the presence of lactose).
Carefully.
Liver failure.
Indications
Benign prostatic hyperplasia (prostate size reduction, increasing the maximum urine flow rate, decrease the risk of acute urinary retention).
Interaction with other drugs
No clinically important drug interactions.
Overdose
Currently, the cases of overdose have been reported.
pharmachologic effect
Pharmacological group:
5-alpha reductase inhibitor.
Pharmacodynamics:
Antitumor hormonal drug. Inhibit 5-alpha-reductase type II, which converts testosterone into the more active 5-alpha-dihydrotestosterone, reduces its concentration in the blood and tissue of the prostate for 24 hours after oral administration.
Inhibits the stimulatory effect of testosterone on the development of tumors. Inhibition of the formation of dihydrotestosterone is accompanied by a decrease in prostate volume, increase in the maximum urine flow rate and decrease in urinary obstruction symptoms. At constant reception statistically significant effects recorded after 3 months (decrease prostate volume), 4 months (maximum increase in urine flow rate) and 7 months (decrease of common symptoms and obstruction of the urinary tract symptoms).
Pharmacokinetics:
Absorption in the gastro-intestinal tract is complete after 6-8 h after administration. And well absorbed into the tissue and biological fluid is detected in the ejaculate (at a concentration of 5 ug). Bioavailability – 80%, regardless of the meal. The time to reach maximum plasma concentration (TSmah) – 2 hours, the maximum plasma concentration (Cmax) – 8-10 ng / ml. Communication with plasma proteins – 93%. It penetrates the blood-brain barrier (BBB). (After 7-10 days of treatment is found in the cerebrospinal fluid in minor amounts).
Systemic clearance of 165 ml / min, the volume of – 76 L. Slightly accumulates during chronic administration.
The half-life (T1 / 2) in males 18-60 years – 6 hours in men older than 70 years -8 hours is derived as metabolites kidneys (39%) and in the intestine (57%) .. In chronic renal failure part metabolites. (which is normally excreted in the urine) excreted in the feces.
Conditions of supply of pharmacies
On prescription.
side effects
Allergic reactions (rash, pruritus, urticaria, swelling of the lips and face), lower potency and / or libido, abnormal ejaculation, reduction ejaculate volume, increasing and soreness of breasts, painful breast, increasing luteinizing hormone concentrations and FSH in the blood, reduction in the concentration of prostate-specific antigen (PSA).
special instructions
Patients with large residual urine volume and / or severely reduced urinary shock should be carefully monitored for the possible development of obstructive uropathy.
Before therapy is necessary to eliminate the disease, stimulating benign prostatic hyperplasia – a cancer of the prostate, urethral stricture, bladder hypotonia, infringement of its innervation and infectious prostatitis.
Women of childbearing age, and pregnant should avoid contact with the drug (particularly touching crushed or lost integrity of the tablets), as the drug has teratogenic properties (ability to inhibit the conversion of testosterone to dihydrotestosterone can cause impaired development of genital organs of male fetus) penetrates into the seminal fluid .
It causes a decrease in PSA after 6 and 12 months, receiving 41% and 48%, respectively. prostate during treatment Alfinalom® need to conduct a survey of patients to exclude cancer.
Treatment should be continued in the case of missing a single dose of Alfinala®. the usual way. Do not take an extra dose.
Storage conditions
In dry protected from light at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Inside, regardless of the meal, and 1 tablet (5 mg), 1 time per day as a monotherapy and in combination with doxazosin.
The minimum duration of a course of therapy – 6 months.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist