2010/09/20

Alfinal

Composition, structure and packing

Tablets, coated white, round, biconvex, on the break - white.

1 tab. Finasteride 5 mg.

Excipients: lactose, potato starch, Tween-80, calcium stearate, gidroksipropiltsellyuloza (or methyl cellulose), titanium dioxide.

Clinico-pharmacological group: Drug for treatment of benign prostatic hyperplasia.

Pharmacological action

The drug for the treatment of benign prostatic hyperplasia. The action of the drug is to reduce the enlarged prostate gland. Finasteride is a specific inhibitor of 5-α-reductase, which transforms testosterone into more active 5-α-dihydrotestosterone. The suppression of dihydrotestosterone formation is accompanied by a decrease in prostate size, increase in maximum urine flow rate and a decrease in symptoms of urinary tract obstruction.

With continued application of a statistically significant effect is recorded after 3 months (a decrease of cancer). After 4 months there is an increase of maximum flow rate of urine. After 7 months, a decrease in overall symptoms and symptoms of urinary tract obstruction. In 50% of patients with clinical symptoms disappear within 12 months.

Pharmacokinetics

Absorption

Finasteride is rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability - 80%, independent of food intake. Cmax plasma levels achieved after 1-2 hours

Distribution

Binding to plasma proteins - 90%. Finasteride penetrates the tissue and body fluids - is found in the ejaculate.

Withdrawal

Outputs in the form of metabolites in the urine (39%) and feces (57%). T1 / 2 is 6-8 hours long (3-7 months) to use the drug in a dose of 5 mg / day reduces the concentration of 5-alpha-dihydrotestosterone in the serum of 70%.

Statement
benign prostatic hyperplasia (reduction in the size of the prostate gland, increase the maximum speed of the outflow of urine, reducing the risk of acute urinary retention requiring catheterization or surgical intervention).

Dosage regimen

Alfinal taken orally for 1 tab. (5 mg) daily. The minimum duration of therapy is 6 months. Alfinal can reduce the severity of symptoms and severity of the disease only during prolonged use.

In the case of missing one dose Alfinala encouraged to continue treatment in the usual way. Do not take an extra dose.

Side effect

On the part of the reproductive system: reduction of potency, decreased libido, reduced ejaculation volume, gynecomastia, breast tenderness, increased levels of LH and FSH in blood plasma.

Allergic reactions: skin rash, swelling of the lips. In some cases, the above side effects disappear, even if the patient continues to take medication. If unwanted side effects during treatment Alfinalom persist after discontinuation of the drug, they usually pass.

Contraindications
obstructive uropathy;
prostate cancer;
Hypersensitivity to the drug's components.

Precautions should use the drug in patients with hepatic insufficiency.

Pregnancy and lactation

Women of childbearing age and pregnant women should avoid contact with the drug (especially touching shredded or lost the integrity of the tablets Alfinala) because the drug has teratogenic effects (the ability to inhibit the conversion of testosterone into DHT can cause a violation of sex organs in male fetus).

Application for violations of liver function

Precautions should use the drug in patients with hepatic insufficiency.

Cautions

Patients with large amounts of residual urine and / or sharply reduced current urine must be closely monitored for possible development of obstructive uropathy. Before starting therapy it is necessary to exclude diseases that contribute to the progression of benign prostatic hyperplasia: prostate cancer, stricture urethra, hypotension bladder, innervation of the bladder, prostate infection.

For early detection of prostate cancer during therapy Alfinalom should undertake regular screening of patients, because applying Alfinala may reduce prostate-specific antigen (by 41% and 48%, respectively, at 6 and 12 th month of admission).

Overdose

Data on drug overdose Alfinal not granted.

Drug Interactions

Data on drug interactions drug Alfinal not granted.

Terms and Conditions of storage

The drug should be stored out of reach of children, dry, dark place at temperatures not above 25 ° C. Shelf life - 2 years 6 months.