Duodart, 0.5 mg+0.4 mg 90 pcs

The drug for the treatment of benign prostatic hyperplasia. Alpha-adrenoblockers.

After a single dose of dutasteride maximum concentration of the drug in the serum is reached within 1-3 hours.
Absolute bioavailability is about 60% with respect to a 2-hour intravenous infusion. The bioavailability of dutasteride is not dependent on food intake.

Tamsulosin hydrochloride is well absorbed in the intestine and has almost 100% bioavailability. Tamsulosin hydrochloride is characterized by linear kinetics with both single and multiple dosing regimens.

In a single dosing regimen, the equilibrium concentration of tamsulosin hydrochloride is reached by day 5. Absorption of tamsulosin hydrochloride slows down after meals.

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)

Pharmacological effect

A drug for the treatment of benign prostatic hyperplasia. Alpha blockers.

After taking one dose of dutasteride, the maximum concentration of the drug in serum is achieved within 1-3 hours.
Absolute bioavailability is approximately 60% relative to a 2-hour intravenous infusion. The bioavailability of dutasteride is independent of food intake.

Tamsulosin hydrochloride is well absorbed from the intestine and has almost 100% bioavailability. Tamsulosin hydrochloride is characterized by linear kinetics, both with single and multiple dosing regimens.

With a single dosing regimen, the equilibrium concentration of tamsulosin hydrochloride is achieved by the 5th day. Absorption of tamsulosin hydrochloride slows down after meals.

The same level of absorption can be achieved if the patient takes tamsulosin hydrochloride daily, 30 minutes after the same meal.

Special instructions

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

In patients with BPH, it is necessary to conduct a digital rectal examination and other methods of examining the prostate gland before starting treatment with Duodart and periodically repeat these studies during treatment to exclude the development of prostate cancer.

Determination of serum PSA concentrations is an important component of the screening process for prostate cancer.

After 6 months of therapy, dutasteride reduces serum PSA levels in patients with benign prostatic hyperplasia by approximately 50%.

Patients taking Duodart should have a new baseline PSA level determined after 6 months of therapy.

Any sustained increase in PSA levels relative to nadir during treatment with Duodart may indicate the development of prostate cancer (particularly high-grade Gleason prostate cancer) or non-adherence to Duodart therapy and should be carefully assessed, even if these PSA levels remain within the normal range in patients not taking 5α-reductase inhibitors.

The total PSA level returns to its original value within 6 months after discontinuation of dutasteride.

The ratio of free PSA to total remains constant even during dutasteride therapy. When this ratio is expressed in proportions to detect prostate cancer in men receiving dutasteride, no correction of this value is required.

Active ingredient

Dutasteride, Tamsulosin

Composition

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

Contraindications

– known hypersensitivity to tamsulosin hydrochloride, dutasteride, other 5-alpha reductase inhibitors or any other ingredient of the drug
– women
– children and adolescents under 18 years of age
– severe liver failure
– history of attacks of orthostatic hypotension
– planned cataract surgery

Side Effects

Adverse events caused by the use of tamsulosin hydrochloride in combination with dutasteride:

Very rare (Rare (≥1/10,000 and Uncommon (≥1/1,000 and Often (≥1/100 and Adverse events associated with the use of tamsulosin hydrochloride as monotherapy)

Very rare (Rare (≥1/10,000 and Uncommon (≥1/1,000 and Often (≥1/100 and

Interaction

No drug-drug interaction studies have been conducted for the combination of dutasteride with tamsulosin hydrochloride. The data below reflects the information available on the individual components.

Dutasteride
Dutasteride is metabolized by the CYP3A4 isoenzyme of the cytochrome P-450 enzyme system. In the presence of CYP3A4 inhibitors, dutasteride blood concentrations may increase.

When dutasteride is used concomitantly with the CYP3A4 inhibitors verapamil and diltiazem, a decrease in the clearance of dutasteride is observed. 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 with simultaneous use of this drug and CYP3A4 inhibitors is not significant due to the wide range of safety margins 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 in vitro enzymes of the human cytochrome P-450 system involved in drug metabolism.
Dutasteride does not displace warfarin, diazepam and phenytoin from their binding sites with plasma proteins, and these drugs, in turn, do not displace dutasteride.

When dutasteride is used simultaneously with lipid-lowering drugs, ACE inhibitors, beta blockers, calcium channel blockers, corticosteroids, diuretics, non-steroidal anti-inflammatory drugs, phosphodiesterase type V inhibitors and quinolone antibiotics, no significant drug interactions are observed.

The use of dutasteride concomitantly with tamsulosin or terazosin for 2 weeks 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, the drugs warfarin, digoxin and cholestyramine did not demonstrate clinically significant interactions with dutasteride.

Overdose

Dutasteride

Symptoms: when using dutasteride at a dose of up to 40 mg/day (80 times higher than the therapeutic dose) for 7 days, no adverse events were observed. In clinical studies, when prescribing 5 mg per day for 6 months, no adverse reactions other than those listed for the therapeutic dose (0.5 mg per day) were observed.

Treatment: there is no specific antidote for dutasteride, so if an overdose is suspected, it is sufficient to carry out symptomatic and supportive treatment.

Tamsulosin hydrochloride

Symptoms: with an overdose of tamsulosin hydrochloride, acute hypotension may develop,

Treatment: symptomatic therapy. Blood pressure can be restored when a person takes a horizontal position. If there is no effect, you can use drugs that increase the volume of circulating blood and, if necessary, vasoconstrictors. It is necessary to monitor kidney function. It is unlikely that dialysis will be effective since tamsulosin hydrochloride is 94–99% bound to plasma proteins.

Storage conditions

At a temperature not exceeding 30 °C.

Shelf life

2 years.

Manufacturer

Catalent Germani Schorndorf GmbH, Germany