Treatment of moderate and severe symptoms of benign prostatic hyperplasia. Reducing the risk of acute urinary retention and the need for surgery in patients with moderate to severe symptoms of benign prostatic hyperplasia.
active ingredients: dutasteride, tamsulosin hydrochloride;
1 capsule contains dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg;
Duodart excipients: caprylic acid monodiglycerides, butylhydroxytoluene (E 321), gelatin, glycerin, titanium dioxide (E 171), yellow iron oxide (E172), medium chain triglycerides and lecithin; microcrystalline cellulose, methacrylate copolymer dispersion, talc, triethyl citrate;
hard capsule shell: carrageenan (E 407), potassium chloride, titanium dioxide (E 171), FD & C Yellow 6 (E 110), hypromellose, carnauba wax, corn starch, red iron oxide (E172), SW-9008 Black Ink (shellac, propylene glycol, black iron oxide (E172), potassium hydroxide).
Duodart Dosage form
The capsules are hard.
Basic physical and chemical properties: a hard capsule of an elongated shape with a brown body and an orange cap with GS marking in black ink.
Drugs used in benign prostatic hyperplasia. Antagonist of α1-adrenergic receptors. ATX code G04C A52.
Duodart is a combination of two drugs: dutasteride, a dual 5α-reductase inhibitor (5 ARI), and tamsulosin hydrochloride, an antagonist of α1a and α1d adrenergic receptors. These drugs have a complementary mechanism of action, due to which there is a rapid weakening of urination, the risk of acute urinary retention (AUR) is reduced and the likelihood of the need for surgery for benign prostatic hyperplasia decreases.
It is not expected that the pharmacodynamic effects of a fixed dose combination of dutasteride and tamsulosin differ from those obtained with the simultaneous use of dutasteride and tamsulosin as separate components.
Dutasteride inhibits the activity of both type 1 and type 2 isoenzymes of 5-alpha reductase, which are responsible for the conversion of testosterone to dihydrotestosterone (DHT). DHT is an androgen primarily responsible for the growth of the prostate gland and the development of benign prostatic hyperplasia. Tamsulosin inhibits the activity of α1a and α1d adrenergic receptors in the stromal smooth muscles of the prostate gland and the bladder neck. Approximately 75% of the α1 receptors in the prostate are α1a receptors.
Tamsulosin increases the maximum urine flow rate by reducing the tone of the smooth muscles of the urethra and prostate gland, eliminates obstruction. The drug also reduces the severity of symptoms of irritation and obstruction, in the development of which urinary incontinence and the contraction of smooth muscles of the lower urinary tract play a significant role. This effect is achieved with prolonged therapy. The need for surgery or catheterization is greatly reduced.
Α1-adrenergic receptor antagonists can reduce blood pressure by decreasing total peripheral resistance. During the study of the effect of tamsulosin, there was no clinically significant reduction in blood pressure.
Bioequivalence has been demonstrated between the administration of the dutasteride-tamsulosin combination and the simultaneous administration of doses of dutasteride and tamsulosin capsules separately.
A single dose bioequivalence study was carried out both on an empty stomach and after a meal. Compared with the fasting state, in the case of application after a meal, there was a 30% decrease in the Cmax (maximum concentration) of tamsulosin in the dutasteride-tamsulosin combination. Food did not affect the AUC (area under the pharmacokinetic curve) of tamsulosin.
After oral administration of a single dose of 0.5 mg of dutasteride, the time to reach its maximum serum concentration was 1 to 3 hours. Bioavailability was about 60%. Food intake does not affect the bioavailability of dutasteride.
Tamsulosin is absorbed from the intestine and is almost completely bioavailable. Both the rate and extent of absorption of tamsulosin are reduced if taken within 30 minutes after a meal. The uniformity of absorption is ensured by taking Duodart at the same time of day after taking the same type of food. The concentration of tamsulosin in blood plasma is proportional to the dose.
After a single dose of tamsulosin after a meal, the peak plasma concentration is reached after 6 hours. Equilibrium concentration is reached on the 5th day of repeated administration. The mean equilibrium concentration (Cmax) in patients is approximately two-thirds higher than the concentration after a single administration of tamsulosin. Although this phenomenon has been observed in older patients, the same result can be expected in younger patients.
Treatment of moderate to severe symptoms of benign prostatic hyperplasia.
Reducing the risk of acute urinary retention and the need for surgery in patients with moderate to severe symptoms of benign prostatic hyperplasia.
Duodart is not used to treat women and children (see section “Use during pregnancy or lactation”).
Duodart is contraindicated in patients with hypersensitivity to dutasteride, other 5a-reductase inhibitors, tamsulosin (including tamsulosin induction angioedema), other components of the drug, or to soy and peanuts.
Duodart is contraindicated in patients with a history of orthostatic arterial hypotension.
Duodart is contraindicated in patients with severe hepatic impairment.