PROSTERID
Active material: Finasteride
When ATH: G04CB01
CCF: Drug for the treatment of benign prostatic hyperplasia. Ингибитор 5a-редуктазы
ICD-10 codes (testimony): N40
When CSF: 28.01.01.01
Manufacturer: GEDEON RICHTER Ltd. (Hungary)
Pharmaceutical form, composition and packaging
Pills, Film-coated white or nearly white, in the form of a rounded triangle, slightly biconcave, almost odorless, Engraved “RG” on one side.
| 1 tab. | |
| finasteride | 5 mg |
Excipients: sodium carboxymethyl starch (Type A), pre-gelatinized starch, lactose monohydrate, magnesium stearate, talc, microcrystalline cellulose.
The composition of the shell: giproloza (hydroksypropyltsellyuloza), gipromelloza, lactose monohydrate, macrogol 6000, Titanium dioxide.
14 PC. – blisters (1) – packs cardboard.
14 PC. – blisters (2) – packs cardboard.
Pharmacological action
antiandrogen, 4-synthetic compound azasteroid. It is a competitive and specific inhibitor of 5-alpha-reductase – intracellular enzyme, which converts testosterone to 5-active androgen DHT (DGT). The growth of prostate tissue and development of benign prostatic hyperplasia due to the conversion of testosterone to dihydrotestosterone in the prostate cells. Under the influence of the drug is a significant reduction in DHT concentrations in plasma, and in prostate tissue. Finasteride does not bind to androgen receptors.
The drug inhibits the stimulatory effect of dihydrotestosterone on the development of benign prostatic hyperplasia, as a result decreases the severity of symptoms, associated with BPH.
The drug has no effect on plasma lipid levels and cortisol levels, Estradiol, prolactin, TSH, tiroksina.
Pharmacokinetics
Absorption
After taking the drug inside finasteride is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 80% and independent of food intake. Cmax plasma achieved through 1-2 h after a single oral administration.
Distribution
Plasma protein binding – about 90%.
Metabolism and excretion
Finasteride is metabolized in the liver and excreted by the kidneys as metabolites (about 40%) and through the intestine (about 60%).
T1/2 Finasteride is about 6 no.
Pharmacokinetics in special clinical situations
Patients older 70 T years1/2 may increase to 8 no.
Testimony
treatment of benign prostatic hyperplasia of the prostate with a view:
- reducing the size of the prostate;
- increasing the maximum velocity of the outflow of urine and reduce symptoms, associated with hyperplasia;
- reduce the risk of acute urinary retention and the associated probability of surgery.
Dosage regimen
The drug is prescribed for 5 mg 1 time / day, regardless of the meal.
Duration of therapy to assess its effectiveness must not be less than 6 months. Approximately 50% patients with disappearance of clinical symptoms only occur during the treatment 12 months.
Side effect
On the part of the endocrine system: 3-4% – gynecomastia, impotence, decreased libido, decrease in the volume of ejaculate (It decreases the frequency of these effects in the treatment of); in some cases – raising LH, FSH and testosterone by approximately 10%, however, these parameters remained within normal limits.
Allergic reactions: Lip possible angioneurotic edema, skin rash.
Contraindications
- Prostate cancer;
- Obstruction of the urinary tract;
- Children's age;
- Hypersensitivity to finasteride or other ingredients.
The drug should not be administered to women.
Pregnancy and lactation
Pregnant women should avoid contact with ground or null integrity finasteride tablets, tk. ability of the drug to inhibit the conversion of testosterone to dihydrotestosterone can cause impaired development of the fetus genitals.
Cautions
Before initiation of therapy is necessary to eliminate the disease with symptoms similar to the symptoms of benign prostatic hyperplasia, such as prostate cancer, infectious prostatitis, urethral stricture, hypotonic bladder, and a number of changes in the urinary system, occur in some diseases of the nervous system.
With care prescribe a drug to patients with impaired hepatic function.
Since the use of finasteride, a decrease in prostate-specific antigen, periodically during therapy should be performed to exclude patients examination have prostate cancer.
Overdose
Data on drug overdose Prosterid® not provided.
Drug Interactions
Clinically significant drug interaction Prosterid® with other drugs have not been found.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children, protected from light, at a temperature from 15 ° to 30 ° C.. Shelf life – 3 year.
