Composition, release form
Duodart is available in hard capsules made of hypromellose; they are oblong in shape and brown in color. Edible gelatin, which covers the tablets, quickly dissolves upon contact with liquid. They are soft, tasteless, 30 or 90 pieces in polyethylene bottles. A cardboard pack contains 1 bottle. 1 capsule contains carrageenan - 0.1 mg, potassium chloride - 0.8 mg, titanium dioxide - 1 mg and a number of excipients. The active element is dutasteride, in the amount of 0.5 mg per 1 tablet. The average cost in pharmacies is 1,535 rubles, 625 hryvnia. The price depends on the region and place of purchase. Dispensed by prescription. The product is produced by a German pharmaceutical company.
Indications for use
“Duodart” 90 tablets (the price, as well as the instructions, must be studied by the patient before purchasing the drug) are recommended by urologists to prevent, as well as treat, the progression of benign prostatic hyperplasia, when the patient is bothered by mild to moderate symptoms.
Urologists recommend using the described medicine to achieve the following therapeutic effect:
- Reduction in prostate size.
- Normalization of urination.
- Reducing the likelihood of acute urinary retention.
Regular use of the drug "Duodart" also helps to avoid the need for urgent surgical intervention.
Mechanism of action of the drug
The components of Duodart have a complex effect, namely:
- decreased dihydrotestosterone levels;
- reduction in the size of the prostate gland;
- eliminating discomfort when going to the toilet;
- urine is not retained, the rate of urination increases;
- decreased smooth muscle tone in the prostate gland and in the urethra, which improves the outflow of urine;
- decreased obstruction;
- elimination of irritation symptoms.
Dutasteride prevents the conversion of testosterone into the main androgen, which often causes the development of hyperplasia. The effect of tamsulosin is aimed at inhibiting adrenergic receptors in the cervix of the bladder and prostate gland. The above results are felt on average 2 weeks from the start of taking the medication.
Duodart
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.
Concomitant use of tamsulosin with strong CYP3A4 inhibitors (eg, ketoconazole) or, to a lesser extent, with strong CYP2D6 inhibitors (eg, paroxetine) may increase tamsulosin exposure. Therefore, tamsulosin is not recommended for use in patients taking a strong CYP3A4 inhibitor and should be used with caution in patients taking a moderate CYP3A4 inhibitor (eg, erythromycin), a strong or moderate CYP2D6 inhibitor, a combination of CYP3A4 and CYP2D6 inhibitors, or patients with known to be poorly metabolized by CYP2D6.
The effect of liver dysfunction on the pharmacokinetics of dutasteride has not been studied. Because dutasteride is extensively metabolized in the liver and has a half-life of 3 to 5 weeks, the drug should be administered with caution to patients with impaired liver function.
Heart failure with combined use of dutasteride and tamsulosin
In two 4-year clinical studies, the incidence of heart failure (a composite term of events observed, mainly heart failure and congestive heart failure) was higher in patients receiving the combination of dutasteride and an alpha1-blocker, mainly tamsulosin, than in patients not receiving the combination. treatment. In these two clinical studies, the incidence of heart failure remained low (
Impact on the detection of prostate-specific antigen (PSA) and prostate cancer (PCa)
In patients with prostatic hyperplasia, it is necessary to conduct a digital rectal examination and other methods for diagnosing prostate cancer before starting treatment with the drug and periodically repeat them during treatment.
Serum PSA level determination is an important component of screening for PCa. After 6 months of dutasteride therapy, the mean serum PSA level decreases by approximately 50%.
Patients taking the drug should have a new baseline PSA level determined after 6 months of therapy. After this, regular monitoring of PSA levels is recommended. Any confirmed increase in PSA level relative to its nadir during drug treatment may indicate either non-adherence to drug therapy or the development of prostate cancer (particularly high-grade Gleason prostate cancer) and should be carefully assessed, even if these levels PSA remains within the normal range for men not taking 5a-reductase inhibitors. When interpreting PSA results in patients taking Duodart, previous PSA results should be used for comparison.
The use of the drug does not affect the diagnostic value of the PSA level as a marker of prostate cancer after a new baseline PSA level has been established. Total PSA levels return to baseline within 6 months after discontinuation of dutasteride.
The ratio of free PSA to total PSA levels remains constant during dutasteride therapy. If the determination of the percentage of free PSA fraction is additionally used to detect prostate cancer in men receiving dutasteride, no correction of this value is required.
Orthostatic hypotension
As with any alpha1-blocker, orthostatic hypotension may occur when using tamsulosin, which in rare cases can lead to fainting. Patients starting treatment with Duodart should be warned to sit or lie down at the first sign of orthostatic hypotension (dizziness and loss of balance) until symptoms resolve. Caution is recommended when using alpha1-blockers, including tamsulosin, in combination with phosphodiesterase type 5 inhibitors. Alpha1-blockers and phosphodiesterase type 5 inhibitors are vasodilators and can lead to a decrease in blood pressure. Concomitant use of these two classes of drugs may potentially lead to symptomatic hypotension.
Intraoperative atonic iris syndrome
Intraoperative atonic iris syndrome (ISAR, a type of small pupil syndrome) has been observed during cataract surgery in some patients receiving alpha1-blockers, including tamsulosin. ISAR may lead to an increased risk of complications during and after ophthalmic surgery. During the preoperative evaluation, the ophthalmic surgeon should confirm with the patient scheduled for cataract surgery whether he is taking or has previously taken the combination of dutasteride with tamsulosin to ensure adequate management if ISAR develops during surgery. It is considered legitimate to discontinue tamsulosin 1-2 weeks before cataract surgery, but the benefit, as well as the exact period of time for discontinuation of therapy before cataract surgery, have not been established.
PCa and high-grade tumors
A cause-and-effect relationship between taking dutasteride and the development of high-grade prostate cancer has not been established. The clinical significance of numerical imbalance is unknown. Men taking dutasteride should undergo regular screening to assess their risk of developing prostate cancer, including PSA levels.
Breast cancer in men
During clinical trials and in the post-registration period, the development of breast cancer in men taking dutasteride was reported. Providers should instruct patients to immediately report any changes in their breasts, such as breast lumps or nipple discharge. It is not clear whether there is a cause-and-effect relationship between the occurrence of breast cancer in men and long-term use of dutasteride.
There have been no studies examining the effect of the drug on the ability to perform actions requiring quick decision making, special motor and cognitive skills. Patients should be informed about the possibility of symptoms associated with orthostatic hypotension, such as dizziness, while using the drug.
Contraindications
There are a number of restrictions on taking Duodart. Absolute contraindications include:
- severe renal or hepatic dysfunction;
- orthostatic hypotension;
- age under 18 years;
- allergy to the composition of the product.
Among the relative restrictions, the following conditions are distinguished:
- chronic renal or hepatic dysfunction;
- planned cataract surgery;
- arterial hypotension;
- combined use with potent or moderately active inhibitors of the CYP3A4 isoenzyme.
Duodart should be taken for prostatitis only after consulting a urologist.
Instructions for use, dosage
"Duodart" is recommended to take 1 capsule 1 time per day. The medicine is taken orally after 35-40 minutes. after eating. To increase the therapeutic effect, it is recommended to take the drug at the same time of day.
The medicine must be swallowed whole, since if the tablet is chewed, irritation of the mucous membrane of the mouth and pharynx is possible. A package of 90 tablets is designed for 3 months. You can buy Duodart at an affordable price in an online pharmacy.
The described drug is allowed to be used to replace combination therapy with tamsulosin and dutasteride in order to facilitate the therapeutic course. The duration of treatment should be determined by the urologist.
Side effects
Side effects when taking Duodart occur extremely rarely. They usually appear when the drug is taken uncontrolled and the instructions are ignored. Among the negative effects are the following conditions:
- redness on the skin, urticarial rash, itching;
- dizziness, headaches;
- stomach cramps, diarrhea, constipation;
- hypertrichosis, alopecia;
- asthenia, rhinitis;
- decreased sexual desire, impotence, premature ejaculation.
In severe cases, shortness of breath and rapid or slow heartbeat are possible. Even during therapy, blood pressure may decrease or increase. Negative symptoms sometimes remain for a week after discontinuation of the drug.
Overdose
In medical practice, there have not yet been any cases of overdose with Duodart. But in practice, such a situation is quite possible.
If a large dose of the drug is used, the patient may experience the following symptoms:
- Acute arterial hypotension.
- Dizziness, migraine.
- Vomit.
- Diarrhea.
- Tachycardia.
If there are signs of overdose, effective symptomatic treatment should be carried out. The patient is advised to drink plenty of fluids, since the body needs fluid to remove toxins and other breakdown products of damaged tissues.
To improve your health, you can take medicine to improve blood circulation. In a hospital setting, constant monitoring of the patient’s condition and maintaining stable kidney function are necessary. The effectiveness of hemodialysis is unlikely.
