Finasteride-OBL - instructions for use, doses, side effects, contraindications

Active substance:
Finasteride	5.0 mg
Excipients:
lactose monohydrate	79.0 mg
calcium hydrogen phosphate dihydrate	21.0 mg
sodium croscarmellose	0.7 mg
sodium dodecyl sulfate	1.2 mg
microcrystalline cellulose	20.0 mg
giprolose (hydroxypropylcellulose)	1.8 mg
magnesium stearate	1.3 mg
Average tablet weight	130 mg
Excipients for the shell:
copovidone	1.6 mg
giprolose (hydroxypropylcellulose)	1.6 mg
talc	0.6 mg
titanium dioxide	1.198 mg
dye azorubin	0.002 mg
Average weight of coated tablet	135 mg

Description:The tablets covered with a film cover from light pink to pink color, round, biconcave form. On the cross-section, two layers are visible, the inner layer is white or almost white.

Pharmacotherapeutic group:5-alpha reductase inhibitor

ATX: & nbsp

G.04.C.B.01 Finasteride

Pharmacodynamics:

Finasteride is a synthetic 4-azasteroid compound, a competitive and specific inhibitor of steroid 5-alpha-reductase II, an intracellular enzyme that converts testosterone in the active androgen 5-dihydrotestosterone, reduces its concentration in the blood and prostate tissue. Finasteride does not bind to androgen receptors.

Suppression of the formation of dihydrotestosterone is accompanied by a decrease in the volume of the prostate gland, an increase in the maximum rate of urine flow and a decrease in the severity of symptoms associated with prostatic hyperplasia.

The drug does not affect the concentration of plasma lipids, as well as the blood plasma levels of cortisol, estradiol, prolactin, thyroid-stimulating hormone, thyroxine.

Pharmacokinetics:

Suction

Absorption of the drug from the gastrointestinal tract ends 6-8 hours after admission. When administered, the bioavailability is about 80% and is not dependent on food intake. The maximum concentration of finasteride in plasma, blood is reached after 2 hours after taking the drug.

Distribution

Binding to plasma proteins is 93%. Penetrates into the seminal fluid, while The concentration of finasteride in the seminal fluid of adult men is 50-100 times lower than its concentration in the blood plasma. Finasteride penetrates the blood-brain barrier, after 7-10 days of treatment is detected in the cerebrospinal fluid, but not reaches significant concentrations.

Slightly cumulates with prolonged admission;

Metabolism and excretion

Metabolised by the liver. Systemic clearance is about 165 ml / min. The half-life is 6 hours.

In elderly patients The rate of excretion of finasteride is somewhat reduced. Men over 70 years of age the half-life of finasteride is about 8 hours, but this is not an indication for reducing the dose of the drug.

It is excreted in the form of metabolites with urine (39%) and feces (57%).

In patients with renal insufficiency the proportion of finasteride metabolites, excreted in urine under normal conditions, is excreted with feces, the amount of finasteride metabolites in the feces is increased, while their concentration in urine decreases. In connection with the above, in patients with renal failure who do not have hemodialysis, correction of the dose of finasteride is not required.

Indications:

Treatment of benign prostatic hyperplasia in order to:

- prevention of urological complications (reducing the risk of acute urinary retention) and reducing the need for surgical operations (including transurethral resection of the prostate and prostatectomy);

- reducing the size of the enlarged prostate gland, improving urine flow and reduce the severity of symptoms associated with benign prostatic hyperplasia.

Contraindications:

Hypersensitivity to finasteride and other components of the drug, prostate cancer, obstructive uropathy, pregnancy, the period of breastfeeding, age to 18 years.

Finasteride is contraindicated in women of childbearing age, lactose intolerance, lactase deficiency, glucose-galactose malabsorption (due to the presence of lactose in the composition).

Carefully:

Patients with impaired liver function.

Patients with a large volume of residual urine and / or significantly reduced urine flow (careful monitoring for obstructive uropathy is necessary).

Pregnancy and lactation:

The drug is not intended for women of childbearing age.

Dosing and Administration:

Inside, regardless of food intake.

The recommended dose is 5 mg (1 tablet) once a day. The minimum duration of treatment is 6 months.

In elderly patients and in patients with impaired renal function dosage adjustment is not required.

Side effects:

From the skin and subcutaneous tissues: allergic reactions, skin rash, itching, urticaria, angioedema, edema of the lips and face.

From the gastrointestinal tract: abdominal pain, diarrhea, increased level of hepatic transaminases.

Co, the side of the reproductive system: soreness of testicles, impotence, decreased libido, ejaculatory disorders, decrease in ejaculate volume.

From the endocrine system: increase and soreness of the mammary glands, gynecomastia.

From the nervous system: headache, dizziness, drowsiness.

From the cardiovascular system: palpitation.

From the laboratory indicators: decrease in the level of prostate-specific antigen.

With prolonged use of finasteride, there is no increase in the frequency and severity of side effects, and the number of cases of violation of sexual functions associated with taking the drug with prolonged therapy is reduced.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: are not described, no cases of drug overdose have been reported.

Treatment: recommendations for specific treatment of overdose with finasteridethere.

Interaction:

He found a clinically significant interaction of finasteride with other drugs.

Finasteride can be used as a monotherapy or in combination with doxazosin.

Special instructions:

It is necessary to carefully monitor the possible development of obstructive uropathy in patients with a large residual volume of urine and / or a sharply reduced urine flow.

Before the start of treatment, it is necessary to exclude diseases that stimulate benign prostatic hyperplasia (infectious prostatitis, prostate cancer, urethral stricture, bladder hypertension, etc.).

Before the start of treatment with finasteride and periodically during the treatment should be carried out rectal examination, as well as research by other methods for the presence of prostate cancer.

It is important to notify the doctor immediately if the following symptoms occur: swelling in the chest, pain, gynecomastia or discharge from the nipple.

Women of childbearing age and pregnant women should avoid contact with crushed or lost integrity tablets of the drug because of the possibility of penetration of finasteride into the body of a pregnant woman and the subsequent risk for the development of a male fetus. Finasteride can cause a pathology of intrauterine formation of external genital organs in a male fetus.

Effect on the ability to drive transp. cf. and fur:

It causes dizziness and drowsiness, and therefore it is necessary to refrain from driving or moving vehicles.

Form release / dosage:

Tablets, film-coated, 5 mg.

Packaging:

By 7, 10, 14, 15, 20 or 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 1, 2, 3 or 4 contour squares, together with the instructions for use, are placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-002040

Date of registration:10.10.2011

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia

Information update date: & nbsp24.09.2015

Illustrated instructions

Instructions

Finasteride-OBL (Finasteride-OBL)