Duodart capsules with modified release 0.5mg + 0.4mg, 90pcs

Composition

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

Pharmacological 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 the serum is reached within 1-3 hours. Absolute bioavailability is about 60% compared to a 2-hour intravenous infusion. The bioavailability of dutasteride is independent of food intake.

Tamsulosin hydrochloride is well absorbed in the intestine and has almost 100% bioavailability. Tamsulosin hydrochloride is characterized by linear kinetics, both with a single and multiple dosage regimen.

With a single dosage regimen, the equilibrium concentration of tamsulosin hydrochloride is reached by day 5. 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 (reduction of its size, reduction of symptoms of the disease, improvement of urination, reduction of 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 any other ingredient of the drug-women-children and adolescents under 18 years of age-severe liver failure-history of orthostatic hypotension attacks – planned cataract surgery

Side effects

Adverse events due to the use of tamsulosin hydrochloride in combination with dutasteride:

 Very rare (Rare (≥1/10 000 and Infrequent (≥1/1 000 and Common (≥1/100 and Adverse events due to the use of tamsulosin hydrochloride as monotherapy

Very rare (Rare (≥1/10 000 and Infrequent (≥1/1 000 and infrequent (≥1/100 and

Interaction

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

Dutasteride Dutasteride is metabolized by the CYP3A4 isoenzyme of the Cytochromar-450 enzyme system. In the presence of CYP3A4 inhibitors, blood concentrations of dutasteride may increase. When dutasteride is co-administered with CYP3A4 inhibitors verapamil and diltiazem, there is a decrease in dutasteride clearance. However, amlodipine, another calcium channel blocker, does not reduce dutasteride clearance.

A decrease in the clearance of dutasteride and a 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 limits of this drug, so there is no need to reduce its dose.

In vitro, dutasteride is not metabolized by the following human cytochrome P-450 isoenzymes: CYP1A2, CYP2C9, CYP2C19, and CYP2D6. Dutasteride does not inhibit in vitro human cytochromar-450 enzymes involved in drug metabolism. Dutasteride does not displace warfarin, diazepam, and phenytoin from their plasma protein binding sites, 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 type V inhibitors and quinolone antibiotics, no significant drug interactions were observed.

The use of dutasteride for 2 weeks simultaneously with tamsulosin or terazosin did not reveal any pharmacokinetic or pharmacodynamic interactions. Concomitant use of dutasteride and tamsulosin for 9 months demonstrated good tolerability of this combination of drugs. As well as the drugs warfarin, digoxin and cholestyramine, there were no clinically significant interactions with dutasteride.

How to take, course of use and dosage

Adult males (including the elderly)

1 capsule (0.5 mg/0.4 mg) orally, once a day,30 minutes after the same meal, washed down with water. Capsules should be taken whole, without opening or chewing, as contact of the capsule contents with the oral mucosa can cause mucosal inflammation.

Patients with impaired renal function Currently, there are no data on the use of Duodart in patients with impaired renal function.

Patients with impaired liver function Currently, there are no data on the use of Duodart in patients with impaired liver function. Since dutasteride undergoes intensive metabolism, and its half-life is 3 to 5 weeks, caution should be exercised when treating patients with impaired liver function with Duodart.

Overdose

Dutasteride

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

Treatment: There is no specific antidote for dutasteride, so if an overdose is suspected, it is sufficient to conduct symptomatic and supportive treatment. Tamsulosin Hydrochloride

Symptoms: an overdose of tamsulosin hydrochloride may cause acute hypotension,

Treatment: symptomatic therapy. Blood pressure can be restored when a person takes a horizontal position. In the absence of an effect, you can use drugs that increase the volume of circulating blood and, if necessary, vasoconstrictors. Kidney function should be monitored. It is unlikely that dialysis will be effective, since tamsulosin hydrochloride is bound to plasma proteins by 94-99%.

Description

Capsules.

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, it is necessary to immediately wash the corresponding area of the skin with soap and water. Impact on detection of prostate-specific antigen (PSA) and prostate cancer In patients with BPH, it is necessary to perform digital rectal examination and other methods of prostate examination 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 aimed at detecting 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 stable increase in PSA levels relative to the lowest value during treatment with Duodart may indicate the development of prostate cancer (in particular, prostate cancer with a high degree of differentiation on the Gleason scale) or non-compliance with the Duodart therapy regimen and should be carefully evaluated, even if these PSA levels remain within normal values in patients not taking 5α-reductase inhibitors.

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

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

Storage conditions

At a temperature not exceeding 30 °C. Keep out of reach of children! 

Shelf

life is 2 years.

Active ingredient

Tamsulosin, Dutasteride

Conditions of release from pharmacies

By prescription

Dosage form

long-acting capsules

Description

For adults as directed by your doctor

Indications

Prostatitis, Prostatic Hyperplasia