Instructions for Avodart (Dutasteride) 500 mg
English product name
Avodart
Release form
caps. 500 ug: 30 or 90 pcs
Description Avodart:
The capsules are soft gelatine, yellow, oblong, opaque, marked with the code "GX CE2".
1 cap.
dutasteride 500μg
Auxiliary substances: mono-di-glycerides caprilic/caprinic acid (MPC) - 349.5 mg, butyl hydroxytoluene - 0.035 mg.
Capsule shell composition: gelatin - 144.8 mg, glycerol (glycerine) - 70.8 mg, titanium dioxide - 1.78 mg, iron oxide yellow - 0.127 mg; technological additives: triglycerides, medium-chain (SBC) - q.s., lecithin - q.s.
10 pcs - blister packs (3) - cardboard packs.
10 pcs - blister packs (9) - cardboard packs.
ATC codes
G04CB02 Dutasteride
Clinical-pharmacological groups / Group affiliation
Preparation for treating benign prostatic hyperplasia. 5α-reductase inhibitor
Active substance
dutasteride
Pharmacotherapy group
Double inhibitor of five-alpha-reductase
Storage Conditions
The drug should be stored in a place inaccessible to children at a temperature not higher than 30 ° C.
Best before date
The shelf life is four years. Do not apply after expiry date.
Pharmacological effect Avodart
Mechanism of action
Dutasteride is a 5α-reductase double inhibitor. It inhibits the activity of 5α-reductase isoenzymes of the first and types that are responsible for the conversion of testosterone to dihydrotestosterone (DHT). Dihydrotestosterone is the primary androgen responsible for hyperplasia of the glandular tissue of the prostate.
Pharmacodynamic properties Avodart:
The maximum effect of daily dutasteride doses on the reduction of DHT is dose-dependent and observed within one two weeks. After one and two weeks of taking dutasteride at a dose of 500 μg/day, average serum DHT concentrations decreased by 85% and 90%, respectively.
In patients with benign prostatic hyperplasia (BPH) treated with dutasteride at a dose of 500 μg/day, the average reduction in DHT concentration was 94% after 1 year and 93% after two years, the average increase in serum testosterone concentration was 19% after both one year and two years. This is an expected consequence of 5α reductase inhibition and does not result in any known adverse event.
Testimony Avodart:
- as a monotherapy for the treatment and prevention of the progression of benign prostatic hyperplasia by reducing its size,
- relieving symptoms,
- improving urination,
- reducing the risk of acute urinary retention and the need for prompt intervention;
- as a combination therapy with alpha1-adrenoblocators for the treatment and prevention of the progression of benign
- prostatic hyperplasia by reducing its size,
- relieving symptoms,
- improving urination,
- reducing the risk of acute urinary delay and the need for prompt intervention.
- The combination of dutasteride and tamsulosin alpha1-adrenolocator was mainly studied.
Method of use, course and dosage Avodart:
The drug can be taken independently of the ingestion. The capsules should be swallowed whole, not chewed or opened, as the contents of the capsule can cause irritation of the mucous membrane of the mouth.
Benign prostatic hyperplasia (BPH)
In adult males (including older adults), the recommended dose of Avodart® is 1 kaps. (500 ug) once per day.
Although improvement against the background of the use of the drug comes quite quickly, treatment should continue for at least six months in order to objectively assess the therapeutic effect.
Avodart may be prescribed as a monotherapy or in combination with alpha1-adrenolocators for the treatment of BPH.
Special patient groups
At 500 ug/day, less than 0.1% of the dose is given through the kidneys, so there is no need to reduce the dose in patients with kidney disorders.
Currently, there is no data on the use of Avodart® in patients with liver disorders. Since dutasteride is intensively metabolized and its T1/2 is three to five weeks, care must be taken when treating patients with liver
Application for kidney disorders
In cases of kidney disorders, a reduction in the dose of the drug is not required.
Use in liver disorders
With caution, prescribe the drug in liver failure.
Terms of Sale
The drug is prescription.
Use in children
Avodart is to children.
- Nosology (ICD codes)
- N40
- Prostate hyperplasia