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

Composition

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

How to take, the dosage

Adult men (including elderly)

1 capsule (0.5 mg/0.4 mg) orally, once daily, 30 minutes after the same meal, with water. The capsules should be taken whole without opening or chewing because contact of capsule contents with the oral mucosa may cause mucosal inflammation.

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

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

Interaction

There have been no studies on interdrug interactions for the combination of dutasteride with tamsulosin hydrochloride. The following data reflect the information available on the individual components.

Dutasteride
Dutasteride is metabolized by the CYP3A4 isoenzyme of the cytochromeP-450 enzyme system. Blood concentrations of dutasteride may increase in the presence of CYP3A4 inhibitors.

In concomitant use of dutasteride with CYP3A4 inhibitors verapamil and diltiazem there is a decrease in clearance of dutasteride. At the same time, amlodipine, another calcium channel blocker, does not decrease the clearance of dutasteride.

The decrease in clearance of dutasteride and subsequent increase in its blood concentrations with concomitant 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 cytochrome P-450 system: CYP1A2, CYP2C9, CYP2C19 and CYP2D6.
Dutasteride does not inhibit in vitro human cytochrome P-450 system enzymes 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 using dutasteride concomitantly with hypolipidemic agents, ACE inhibitors, beta-blockers, calcium channel blockers, corticosteroids, diuretics, nonsteroidal anti-inflammatory drugs, type V phosphodiesterase inhibitors and quinolone antibiotics no significant drug interactions have been noted.

The use of dutasteride concomitantly with tamsulosin or terazosin for 2 weeks showed no pharmacokinetic or pharmacodynamic interactions. Simultaneous use of dutasteride and tamsulosin for 9 months showed good tolerability of this drug combination. Also the drugs warfarin, digoxin and cholestyramine showed no clinically significant interactions with dutasteride.

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 wash the corresponding skin area immediately with soap and water.
Effect on the detection of prostate-specific antigen (PSA) and prostate cancer

Patients with BPH should have a finger rectal examination and other prostate examinations before starting treatment with Duodart and periodically repeat these examinations during treatment to rule out 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 sustained elevation of PSA levels relative to the lowest value during Duodart treatment may indicate the development of prostate cancer (in particular, high Gleason grade prostate cancer) or non-compliance with Duodart therapy and should be carefully evaluated even if these PSA levels remain within normal limits in patients not taking 5α-reductase inhibitors.

Total PSA levels return to baseline within 6 months of dutasteride withdrawal.

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

Synopsis

Capsules.

Contraindications

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

Side effects

Unwanted phenomena due to the use of tamsulosinahydrochloride in combination with dutasteride:

Very rare (Rare (≥1/10,000 and Infrequent (≥1/1,000 and Frequent (≥1/100 and Unwanted events due to use of tamsulosin hydrochloride as monotherapy

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

Overdose

Dutasteride

Symptoms: No adverse events were noted when dutasteride was administered at doses up to 40mg/day (80 times the therapeutic dose) for 7 days. In clinical studies there were no adverse reactions other than those listed for the therapeutic dose (0.5 mg/day) when administered 5 mg/day for 6 months.

Treatment:There is no specific antidote for dutasteride, so if overdose is suspected, symptomatic and supportive treatment is sufficient.

Tamsulosin hydrochloride

Symptoms: Tamsulosin hydrochloride overdose may result in acute hypotension,

Treatment: symptomatic therapy. Blood pressure can be restored when the person takes a horizontal position. If there is no effect, agents that increase circulating blood volume and, if necessary, vasoconstrictors may be used. Renal function should be monitored. Dialysis is unlikely to be effective because tamsulosinahydrochloride is 94% to 99% bound to plasma proteins.