Duodart capsules 0.5 mg + 0.4 mg №90

Release form

Capsules

Packaging

In the package 90 pcs.

Mechanism of action

Drug for the treatment of benign prostatic hyperplasia. Alpha-blockers.

After taking a single dose of dutasteride, the maximum concentration of the drug in serum is reached within 1-3 hours.
Absolute bioavailability is about 60% relative to a 2-hour intravenous infusion. Bioavailability of dutasteride does not depend on food intake.
Tamsulosin hydrochloride is well absorbed in the intestine and has almost 100% bioavailability. Tamsulosin hydrochloride is characterized by linear kinetics, both in single and multiple dosage regimens. With a single dosing regimen, the equilibrium concentration of tamsulosin hydrochloride is reached by the 5th day. The absorption of tamsulosin hydrochloride slows down after a meal. The same level of absorption can be achieved if the patient takes tamsulosin hydrochloride daily, 30 minutes after the same meal.

Indications

- treatment and prevention of progression of benign prostatic hyperplasia (reducing its size, reducing symptoms of the disease, improving urination, reducing the risk of acute urinary retention and the need for surgical treatment)

Contraindications

- known hypersensitivity to tamsulosin hydrochloride, dutasteride, other 5-alpha reductase inhibitors or to any other ingredient of the drug
- women
- children and teenagers under 18 years old
- severe liver failure
- attacks of orthostatic hypotension in the anamnesis
- scheduled cataract surgery

Use during pregnancy and lactation

Douodart drug is contraindicated for use in women.
No data on the allocation of dutasteride or tamsulosin with breast milk.
The use of dutasteride has not been studied in women, since clinical data suggest that the suppression of DHT levels in the circulation may interfere with the formation of the external genitalia in male fetuses if the mother received dutasteride during pregnancy.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery
No studies have been conducted that studied the effect on driving a car and working with machinery.
Patients should be informed about the possibility of symptoms associated with orthostatic hypotension, such as dizziness. Care must be taken when driving vehicles or potentially dangerous machinery.

Special notes

Dutasteride is absorbed through the skin, so women and children should avoid contact with damaged capsules. In case of contact with damaged capsules, it is necessary to immediately wash the corresponding skin area with soap and water.
Effect on the detection of prostate-specific antigen (PSA) and cancer
prostate gland

In patients with BPH, a digital rectal examination and other methods of examining the prostate gland should be carried out before starting treatment with Douodart and periodically repeat these studies during treatment to rule out the development of prostate cancer.

The determination of serum PSA concentrations is an important component of the screening process aimed at detecting prostate cancer.

After 6 months of therapy, dutasteride reduces serum PSA levels in patients with benign prostatic hyperplasia by about 50%.
Patients taking the drug Duodart, should be determined new baseline PSA after 6 months of therapy.
Any sustained increase in PSA levels at the lowest level when treated with Duodart may indicate development of prostate cancer (in particular, prostate cancer with a high degree of differentiation on the Gleason scale) or failure to comply with Duodart therapy and should be carefully evaluated, even if these levels are PSA remain within normal values ​​in patients not taking 5α-reductase inhibitors.
The level of total PSA returns to its original value within 6 months after discontinuation of dutasteride.
The ratio of free PSA to total remains constant even during therapy with dutasteride. When expressing this ratio in fractions to detect prostate cancer in men receiving dutasteride,correction of this value is not required.

Composition

Dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg are contained in one capsule.

Dosage and administration

Adult men (including the elderly)
1 capsule (0.5 mg / 0.4 mg) by mouth, once a day, 30 minutes after the same meal, with water. Capsules should be taken whole, without opening and not chewing, since the contact of the contents of the capsule with the mucous membrane of the mouth can cause inflammation from the mucous membrane.
Patients with impaired renal function
Currently, there is no data on the use of the drug Duodart in patients with impaired renal function.
Patients with impaired liver function
Currently, there is no data on the use of the drug Duodart in patients with impaired liver function. Since dutasteride is subjected to intensive metabolism, and its half-life is 3 to 5 weeks, care must be taken when treating patients with impaired liver function with Duodart.

Side effects

Adverse events caused by the use of tamsulosin hydrochloride in combination with dutasteride:
Very rarely (Rarely (≥1 / 10 000 and Infrequently (≥1 / 1 000 and Frequently (≥1 / 100 and Undesirable effects caused by the use of tamsulosin hydrochloride as monotherapy)
Very rarely (Rarely (≥1 / 10 000 and Infrequently (≥1 / 1 000 and Often (≥1 / 100 and

Drug interaction

There were no studies on the interaction between the interactions for the combination of dutasteride with tamsulosin hydrochloride. The data below reflects information available on individual components.
Dutasteride
Dutasteride is metabolized by the CYP3A4 isoenzyme of the cytochrome P-450 enzyme system. In the presence of CYP3A4 inhibitors, the concentration of dutasteride in the blood may increase.
With the simultaneous use of dutasteride with CYP3A4 inhibitors Verapamil and diltiazem, a decrease in the clearance of dutasteride is noted. However, Amlodipine, another Calcium channel blocker, does not reduce the clearance of dutasteride.
The decrease in clearance of dutasteride and the subsequent increase in its concentration in the blood while using this drug and inhibitors of CYP3A4 is not significant due to the wide range of safety limits of this drug, so there is no need to reduce its dose.
In vitro, dutasteride is not metabolized by the following isoenzymes of the human cytochrome P-450 system: CYP1A2, CYP2C9, CYP2C19, and CYP2D6.
Dutasteride does not inhibit the in vitro enzymes of the human cytochrome P-450 system involved in drug metabolism.
Dutasteride does not displace Warfarin, diazepam and phenytoin from the sites of their binding to plasma proteins, and these drugs, in turn, do not displace dutasteride.
When using dutasteride simultaneously with lipid-lowering drugs, ACE inhibitors, beta-blockers, calcium channel blockers, corticosteroids, diuretics, nonsteroidal anti-inflammatory drugs, phosphodiesterase inhibitors of type V and quinolone antibiotics, no significant drug interactions are noted.The use of dutasteride for 2 weeks at the same time as tamsulosin or terazosin did not reveal any pharmacokinetic or pharmacodynamic interactions. The simultaneous use of dutasteride and tamsulosin for 9 months demonstrated good tolerability of this combination of drugs. Also, warfarin, Digoxin and cholestyramine did not demonstrate clinically significant interactions with dutasteride.

Overdosage

Dutasteride
Symptoms: When using dutasteride at a dose of up to 40 mg / day (80 times higher than the therapeutic dose), no adverse events were observed within 7 days. In clinical studies with the appointment of 5 mg per day for 6 months, no adverse reactions other than those listed for the therapeutic dose (0.5 mg per day) were noted.
Treatment: there is no specific antidote for dutasteride; therefore, if overdose is suspected, it is sufficient to carry out symptomatic and supportive treatment.

Tamsulosin hydrochloride
Symptoms: an overdose of tamsulosin hydrochloride may develop acute hypotension,
Treatment: symptomatic therapy. Blood pressure can recover when a person assumes a horizontal position. In the absence of effect, it is possible to apply agents that increase the volume of circulating blood and, if necessary, vasoconstrictor agents. It is necessary to monitor the function of the kidneys. It is unlikely that dialysis will be effective, since tamsulosin hydrochloride is 94–99% bound to plasma proteins.

Storage conditions

At a temperature not higher than 30 ° C.
Keep out of the reach of children!

Shelf life

2 years.

Pharmacy sales terms

Prescription doctor