Description
Trade name:
Duodart
Compound:
Each modified release capsule contains:
Dutasteride 500 mcg
Tamsulosin hydrochloride 400 mcg.
Properties:
The drug Duodart is a combination of two components with complementary mechanisms of action that help eliminate symptoms in patients with benign prostatic hyperplasia (BPH): a dual 5α-reductase inhibitor – dutasteride and an α1a-adrenergic receptor blocker – tamsulosin hydrochloride.
Dutasteride inhibits the activity of 5α-reductase isoenzymes types 1 and 2, which convert testosterone into 5α-dihydrotestosterone (DHT), the main androgen responsible for hyperplasia of the glandular tissue of the prostate gland.
Tamsulosin inhibits α1a-adrenergic receptors in the smooth muscle of the prostate gland and bladder neck. Approximately 75% of α1-adrenergic receptors in the prostate gland are of the α1a subtype.
Indications:
Treatment and prevention of progression of BPH by reducing its size, eliminating symptoms, increasing the flow rate of urination, reducing the risk of acute urinary retention and the need for surgical intervention.
Method of administration and dosage:
The drug is taken orally. The capsules should be taken whole, without chewing or opening, with water. Contact of the contents of the soft gelatin capsule containing dutasteride, which is contained inside the hard capsule, with the oral mucosa may cause inflammatory phenomena from the mucous membrane.
For adult men (including elderly patients), the recommended dose of Duodart is 1 capsule once a day, approximately 30 minutes after the same meal.
Contraindications:
- Hypersensitivity to dutasteride, other 5α-reductase inhibitors, tamsulosin or any other component of the drug;
- Orthostatic hypotension (including history);
- Severe liver failure;
- Age up to 18 years;
- The use of the drug is contraindicated for women and children.
With caution: chronic renal failure (CC below 10 ml/min), arterial hypotension, planned cataract surgery, when used in combination with strong or moderately active inhibitors of the CYP3A4 isoenzyme (ketoconazole, voriconazole, and others).
Precautions:
Dutasteride is absorbed through the skin, so women and children should avoid contact with damaged capsules. In case of contact with damaged capsules, the affected area should be washed immediately with soap and water.
Concomitant use of tamsulosin with strong inhibitors of the CYP3A4 isoenzyme (eg, ketoconazole) or, to a lesser extent, with strong inhibitors of the CYP2D6 isoenzyme (eg, paroxetine) may increase the exposure of tamsulosin. Therefore, tamsulosin is not recommended for use in patients taking strong inhibitors of the CYP3A4 isoenzyme. The drug should be prescribed with caution to patients taking strong inhibitors of the CYP2D6 isoenzyme (eg, paroxetine).
Tamsulosin should be administered with caution to patients taking moderate CYP3A4 inhibitors (eg, erythromycin) in combination with either strong (eg, paroxetine) or moderate (eg, terbinafine) CYP2D6 inhibitors, or to patients with known decreased CYP2D6 activity.
Since dutasteride is extensively metabolized in the liver and its T1/2 ranges from 3 to 5 weeks, the combination of dutasteride + tamsulosin should be administered with caution to patients with impaired liver function.
Detection of prostate-specific antigen (PSA) and prostate cancer (PCa). Patients should undergo digital rectal examination and other methods of PCa diagnostics before starting treatment with dutasteride + tamsulosin and periodically repeat them during treatment to exclude the development of PCa. Determination of serum PSA level is an important component of screening aimed at detecting PCa. After 6 months of therapy with dutasteride, serum PSA level decreases by approximately 50%.
Patients taking dutasteride/tamsulosin should have a new baseline PSA level determined after 6 months of therapy. Any confirmed increase in PSA from the nadir of dutasteride/tamsulosin may indicate either non-compliance or the development of PCa (particularly high-grade Gleason PCa) and should be carefully evaluated, even if the PSA level remains within the normal range for men not taking PDE5 inhibitors.
The use of the combination dutasteride + tamsulosin does not affect the diagnostic value of the PSA level as a marker of prostate cancer.
Total PSA levels return to baseline within 6 months after discontinuation of dutasteride.
The ratio of free to total PSA remains constant during dutasteride therapy. If free PSA is additionally used to detect prostate cancer in men receiving dutasteride, no adjustment of this value is required.
Orthostatic hypotension. As with all alpha1-adrenergic blocking agents, orthostatic hypotension may occur with tamsulosin, rarely resulting in syncope. Patients starting treatment with dutasteride/tamsulosin should be advised to sit or lie down at the first sign of orthostatic hypotension (dizziness and loss of balance) until the dizziness resolves.
Caution is recommended when using alpha1-adrenoblockers, including tamsulosin, together with PDE-5 inhibitors. Alpha1-adrenoblockers and PDE-5 inhibitors are vasodilators, and their combined use may lead to a decrease in blood pressure. The simultaneous use of drugs of these two classes may potentially lead to symptomatic arterial hypotension.
Intraoperative floppy iris syndrome. Has been observed during cataract surgery in some patients receiving alpha1-adrenergic blockers, including tamsulosin. Floppy iris syndrome may lead to increased complications during surgery.
It is considered appropriate to discontinue tamsulosin 1–2 weeks before cataract surgery, but the benefit and the exact time period for discontinuing therapy before cataract surgery have not yet been determined.
Effect on ability to drive vehicles, operate machinery. There have been no studies examining the effect of the dutasteride + tamsulosin combination on the ability to perform actions requiring quick decision-making, special motor and cognitive skills.
Patients should be advised of the possibility of symptoms associated with orthostatic hypotension, such as dizziness, when using dutasteride + tamsulosin.
Orthostatic hypotension
As with other alpha-blockers, when using tamsulosin-containing drugs, including dutasteride + tamsulosin, patients may experience orthostatic hypotension (postural hypotension, dizziness, and vertigo), which may lead to syncope. Before starting treatment with dutasteride + tamsulosin, patients should be warned to avoid situations where syncope could lead to injury.
Side effects:
From the immune system: very rare – allergic reactions (including rash, itching, urticaria, localized and angioedema).
Psychiatric disorders: very rare – depressive state.
From the skin and subcutaneous tissues: rarely – alopecia (primarily loss of body hair), hypertrichosis.
From the genitals and mammary gland: very rare – testicular pain, testicular edema.
From the heart: uncommon – increased heart rate.
From the gastrointestinal tract: uncommon – constipation, diarrhea, vomiting.
General disorders: uncommon – asthenia.
From the nervous system: often – dizziness; rarely – fainting.
From the genitals and mammary gland: often – ejaculation disorder; very rarely – priapism.
From the respiratory system, chest organs and mediastinum: uncommon – rhinitis.
From the immune system: uncommon – rash, itching, urticaria; rare – angioedema; very rare – Stevens-Johnson syndrome.
From the vascular side: uncommon – postural hypotension.
Storage method:
The drug should be stored out of reach of children at a temperature not exceeding 25 degrees.
Package:
The cardboard box contains a bottle with 30 capsules and paper instructions.
