Duodart capsules with modif. exp. 0.5 mg + 0.4 mg 90 pcs (tamsulosin, dutasteride)

Release form

Capsules.

Packing

Per pack 90 pcs.

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 serum is achieved within 1-3 hours.

Absolute bioavailability is about 60% relative to a 2-hour intravenous infusion. The bioavailability of dutasteride is independent of food intake.

Tamsulosin hydrochloride is well absorbed in the intestines and has almost 100% bioavailability. Tamsulosin hydrochloride is characterized by linear kinetics, both in single and multiple dosing regimen.

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 the 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 any other ingredient of the

preparation - women

- children and adolescents under 18

- severe liver failure

- history of orthostatic hypotension

history - planned cataract surgery

Use in pregnancy and lactation

The drug Duodart is contraindicated for use in women.

There is no evidence of isolation of dutasteride or tamsulosin with breast milk.

The use of dutasteride has not been studied in women, because preclinical data suggest that suppressing the level of DHT in the circulation can disrupt the formation of external genitalia in male fetuses, if the mother received dutasteride during pregnancy.

Peculiarities of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery

No studies have been conducted that examine the effect on car driving and working with machinery.

Patients should be informed of the possibility of symptoms associated with orthostatic hypotension, such as dizziness. Care must be taken when driving vehicles or potentially dangerous machinery.

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 corresponding skin area with soap and water.

Effect on the detection of prostate-specific antigen (PSA) and prostate cancer



In patients with BPH, a digital rectal examination and other methods of examining the prostate should be performed before treatment with Duodart and periodically repeat these studies during treatment to exclude the development of prostate cancer glands.

Determining serum PSA concentrations is an important component of the screening process to detect prostate cancer.

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

Patients taking Duodart should be given a new baseline PSA level after 6 months of therapy.

Any stable increase in PSA level relative to the lowest value with Duodart treatment may indicate the development of prostate cancer (in particular, Gleason's high-grade prostate cancer) or non-compliance with the Duodart therapy regimen and should be carefully evaluated. even if these PSA levels remain within normal limits in patients not taking 5ОІ-reductase inhibitors.

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

The ratio of free PSA to total remains constant even with dutasteride therapy. When expressing this ratio in shares for the detection of prostate cancer in men receiving dutasteride, correction of this value is not required.

Composition

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

Dosage and administration of

Adult men (including the elderly)

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

Patients with impaired renal function

There is currently no data on the use of the drug Duodart in patients with impaired renal function.

Patients with impaired liver function

There is currently no data on the use of the drug Duodart in patients with impaired liver function. Since dutasteride undergoes intensive metabolism, and its half-life is 3 to 5 weeks, caution must be exercised when treating patients with impaired liver function with Duodart.

Side effects

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

Very rare (Rarely (? 1/10 000 and Infrequently (? 1/1 000 and Frequently (? 1/100 and Adverse events due to the use of tamsulosin hydro as a monotherapy

Very rarely (Rarely (? 1/10 000 and Infrequently (? 1/1 000 and Frequently (? 1/100 and

Drug Interactions

No studies have been conducted on the drug-drug interaction 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 concentrations 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 dutasteride clearance.

A decrease in the clearance of dutasteride and a subsequent increase in its concentration in the blood with the 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 isoenzymes of the human P-450 cytochrome system: CYP1A2, CYP2C9, CYP2C19 and CYP2D6.

Dutasteride does not inhibit in vitro enzymes of the human cytochrome P-450 system, involved in the metabolism of drugs.

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, non-steroidal anti-inflammatory drugs, type V phosphodiesterase inhibitors and quinolone antibiotics, no significant drug interactions are noted. The use of dutasteride for 2 weeks simultaneously with tamsulosin or terazosin did not reveal any pharmacokinetic or pharmacodynamic interactions.

The concomitant use of dutasteride and tamsulosin for 9 months demonstrated the good tolerance of this combination of drugs. Also, warfarin, digoxin and cholestyramine did not show clinically significant interactions with dutasteride.

Overdose

Dutasteride

Symptoms: When using dutasteride at a dose of up to 40mg / day (80 times the therapeutic dose) for 7 days, no undesirable effects were observed. In clinical trials, administration of 5 mg per day for 6 months of adverse reactions in addition to those listed for therapeutic dose (0.5 mg per day) was not observed.

Treatment: There is no specific antidote to dutasteride, so it is sufficient to carry out symptomatic and supportive treatment in case of overdose.

Tamsulosin hydrochloride

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

Treatment: symptomatic therapy. Blood pressure can be restored when a person adopts a horizontal position. In the absence of the effect, you can apply agents that increase the volume of circulating blood and, if necessary, vasoconstrictor agents. Kidney function must be monitored. Dialysis is unlikely to be effective since tamsulosin hydrochloride is bound to plasma proteins by 94-99%.

Storage conditions

At a temperature not exceeding 30 ° C.

Keep out of the reach and sight of children!

Shelf life

2 years.

Deystvuyushtee substance Dutasteride

Dosage Form

extended-release capsules

Possible product names

Duodart capsules with mod. exp. 0.5 mg + 0.4 mg 90 pcs

Katalent Germani Schorndorf GmbH, Germany



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