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dutas

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Clinico-pharmacological group
Drug for the treatment of benign prostatic hyperplasia. An inhibitor of 5α-reductase
Composition, structure and packing
Soft gelatin capsules, yellow, oblong, opaque, marked with the code * “GX CE2”.
1 caps. 500 mg dutas
Excipients: mono- and diglycerides of caprylic / capric acid – 349.5 mg BHT – 35 micrograms.
The composition of the capsule shell: gelatin – 144.8 mg, glycerol – 70.8 mg of titanium dioxide – 1.78 mg iron oxide yellow – 127 g, medium-chain triglycerides – qs, lecithin – qs, red ink for printing ** – qs
10 pieces. – Blisters (3) – packs cardboard.
10 pieces. – Blisters (9) – packs cardboard.
* Application code “GX CE2” in red ink used for printing in the manufacture of the finished dosage form production site Catalent France Beinheim SA (France); application code “GX CE2” gray with cold UV laser is used in the manufacture of the finished dosage form production site GlaxoSmithKline SA Rharmaceuticals (Poland).
** Red ink for printing used in the manufacture of the finished dosage form production site Catalent France Beinheim SA (France) and are not used in the manufacture of the finished dosage form production site GlaxoSmithKline SA Rharmaceuticals (Poland). The amount of ink in each capsule is less than 0.28 mg; materials remaining on the capsule are polyvinyl acetate phthalate, polyethylene glycol, propylene glycol, iron oxide red (E172, CI77491).

Pharmachologic effect
Drug for the treatment of benign prostatic hyperplasia. dutas – dual inhibitor of 5α-reductase. Inhibits the activity of 5α-reductase isozymes 1 and type 2, which is responsible for the conversion of testosterone to 5α-dihydrotestosterone (DHT). DHT is the primary androgen responsible for hyperplasia of glandular tissue of the prostate gland.
The maximum impact of dutas to reduce the concentration of DHT is dose dependent and is observed within 1-2 weeks after starting treatment. After 1 and 2 weeks dutas dose of 500 mg / day average dihydrotestosterone concentration in serum is reduced by 85% and 90%.

Pharmacokinetics
Suction
After a single dose of the drug in a dose of 500 mg of dutas serum Cmax is reached within 1-3 hours. The absolute bioavailability is about 60% relative to a 2-hour / infusion. The bioavailability of dutas is not dependent on food intake.
Distribution
Pharmacokinetic data obtained after single and multiple dutas, Vd indicates a large (300 to 500 liters). dutas has a high degree of binding to plasma proteins (> 99.5%).
When taken daily dutas concentration in serum reaches 65% of the steady-state level after 1 month and approximately 90% of that level in 3 months. Stationary dutas concentration in serum (Css), equal to about 40 ng / ml, achieved after 6 months of daily administration of 500 micrograms of the drug. Sperm as serum, dutas stationary concentrations also reached after 6 months. After 52 weeks of treatment, dutas concentrations in semen averaged 3.4 ng / ml (range 0.4 to 14 ng / ml). From the serum in the sperm gets approximately 11.5% of dutas.
Metabolism
In vitro dutas is metabolized by CYP3A2 isoenzyme to form two small monogidroksilirovannyh metabolites; however, it does not apply isoenzymes CYP2C9, CYP1A2, CYP2A6, CYP2E1, CYP2C8, CYP2B6, CYP2C19 and CYP2D6. After reaching Css dutas, serum using mass spectrometric method exhibit unchanged dutas, 3 major metabolite (4′-gidroksidutasterid, 1,2-digidrodutasterid gidroksidutasterid and 6) and two small metabolite.
Withdrawal
In humans, dutas is extensively metabolized. After oral administration in a daily dose of dutas 500 mg to achieve Css from 1% to 15.4% (average 5.4%) of the dose is excreted through the intestines unchanged. The remaining part is excreted in the form of four major metabolites, constituting 39%, 21%, 7% and 7%, respectively, and 6 small metabolites (the share of each of which is less than 5%).
After a person has kidney excreted trace amounts of unchanged dutas (less than 0.1% of the dose).
When receiving therapeutic doses of dutas its final T1 / 2 of 3-5 weeks.
dutas is detected in serum (at concentrations greater than 0.1 ng / ml) up to 4-6 months after discontinuation.
Linearity / non-linearity
Pharmacokinetics dutas can be described as a process of first order absorption and elimination of the two parallel processes, a saturated (m. E. Depending on concentration) and one saturable (m. E. Does not depend on the concentration). At low concentrations in serum (less than 3 ng / ml) dutas rapidly excreted via elimination of two processes. After receiving a single dose of 5 mg or less, dutas is rapidly eliminated from the body and has a short half-life equal to 3-9 days.
At concentrations in serum above 3 ng / ml is slower clearance of dutas (0.35-0.58 l / h), primarily through the unsaturated linear process of elimination with the final T1 / 2 of 3-5 weeks. At therapeutic concentrations, against a background of daily intake of 500 micrograms prevails slower clearance of dutas; total clearance is linear and concentration-dependent character.
Older men
Pharmacokinetics and pharmacodynamics of dutas were studied in 36 healthy men aged 24 to 87 years after a single dose (5 mg) of the drug. Between the different age groups was not statistically significant differences in pharmacokinetic parameters such as AUC and Cmax. There were no statistically significant differences in the values of T1 / 2 of dutas men between the age groups 50-69 years and above 70 years, which includes the majority of men with benign prostatic hyperplasia.
Between different age groups had no significant differences in the degree of reducing the levels of DHT. These results demonstrate the absence of the need to reduce the dose of dutas in elderly patients.

Dosage
The drug can be taken regardless of meals.
The capsules should be swallowed whole, do not chew and do not open, because the contents of the capsule may cause irritation of the mucous membrane of the oropharynx.
Benign prostatic hyperplasia (BPH)
Adult males (including the elderly) The recommended dose of Avodart drug – 1 capsule (500 mg) 1 time / day. The capsules should be taken as a whole.
While improved during treatment with the drug comes pretty quickly, treatment should continue for at least 6 months in order to objectively evaluate the therapeutic effect.
For the treatment of BPH drug Avodart may be appointed as a monotherapy or in combination with alpha 1-blockers.
Special groups of patients
When receiving 500 mg / day via the kidneys excrete less than 0.1% of the dose, so there is no need to reduce the dose in patients with impaired renal function.
There is currently no data on the use of the drug Avodart in patients with impaired hepatic function. Because dutas is extensively metabolized and its half-life of 3-5 weeks, caution should be exercised in treating patients with drug Avodart impaired liver function.

Overdose
When assigning dutas to 40 mg / day once (up to 80 times higher than the therapeutic dose) for 7 days, significant side effects were noted. In clinical studies, patients within 6 months dutas received 5 mg daily, with no additional side-effects to those observed in patients receiving 500 mg of dutas, have been discovered.
dutas no specific antidote, so if you suspect an overdose quite symptomatic and supportive care.

Drug Interactions
In vitro dutas is metabolized by CYP3A4 isoenzyme cytochrome P450 enzyme system. In the presence of inhibitors of CYP3A4 dutas concentration in the blood can increase.
With simultaneous use of dutas with CYP3A4 inhibitors verapamil and diltiazem there is a decrease in clearance of dutas. However, amlodipine, another calcium channel blocker, does not reduce the ground clearance of dutas. The reduction in clearance of dutas and the subsequent increase in its concentration in the blood, while the use of this drug and CYP3A4 inhibitors is not significant due to the wide range of security boundaries dutas, so there is no need to reduce the dose.
In vitro dutas is not metabolized following cytochrome P450 isozymes person: CYP1A2, CYP2A6, CYP2E1, CYP2C8, CYP2C9, CYP2C19 and CYP2D6.
dutas does not inhibit the enzyme in vitro system of human cytochrome P450 involved in the metabolism of drugs.
In vitro dutas does not displace warfarin, acenocoumarol, phenprocoumon, diazepam and phenytoin from their binding sites to plasma proteins, and these drugs are, in turn, do not displace dutas.
When conducting studies of the interaction of dutas with tamsulosin, terazosin, warfarin, digoxin and kolestiraminom a person of any clinically significant pharmacokinetic or pharmacodynamic interactions were observed.
In the application of dutas in conjunction with lipid-lowering drugs, ACE inhibitors, beta-blockers, calcium channel blockers, corticosteroids, diuretics, NSAIDs, inhibitors of phosphodiesterase type 5 and quinolone antibiotics any significant drug interactions were observed.

Pregnancy and lactation
Effects on fertility
Effect of dutas in a daily dose of 500 micrograms of sperm characteristics was studied in healthy volunteers aged 18-52 years. By 52 weeks of treatment the mean percent reduction in total sperm count, semen volume and sperm motor activity were 23%, 26% and 18% respectively compared to baseline. The concentration of spermatozoa and their morphological characteristics do not change.
After 24 weeks of observation of the average value of the percentage change in total sperm count in the group of dutas remained 23% lower compared to the baseline. The average value for all semen parameters at all time points remained within the normal range and did not meet the criteria for a clinically significant change (30%) at the 52 th week of treatment in two volunteers in a group of dutas total sperm count was reduced by more than 90% of Compared with baseline, with partial recovery at the 24 week follow-up.
Therefore, the clinical significance of the effect of dutas on the performance of individual sperm and fertility of the patient is unknown.
Pregnancy
dutas is contraindicated in women. dutas was not studied in women because Preclinical data suggest that inhibition of DHT levels can cause inhibition of the development of the external genitalia of the fetus.
Lactation
No data on the penetration of dutas passes into breast milk.

Side effects
Adverse events reported below are listed according to the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is defined as follows: very common (≥1 / 10), commonly (≥1 / 100 and <1/10), uncommon (≥1 / 1000 and <1/100), rarely (≥ 1/10 000 and < 1/1000), very rare (<1/10 000, including isolated cases). Frequency categories were formed on the basis of clinical studies and post-marketing drug surveillance.
The incidence of adverse events, formed the basis of post-marketing surveillance at
On the part of the immune system
Very rarely allergic reactions (including rash, pruritus, urticaria, localized edema) and angioedema
Skin and subcutaneous fat
Rarely, alopecia (hair loss mainly on the body), or hypertrichosis
Mental Disorders
Very rarely, depression
Reproductive system
Very rarely testicular pain, testicular swelling
The incidence of adverse events, formed on the basis of clinical trial data (adverse events related to the use of dutas monotherapy)
In the third phase, placebo-controlled trials with dutas compared with placebo, the researchers evaluated adverse events associated with taking dutas:
Adverse events of adverse events in the 1st year of application of adverse events in the 2nd year of application
Placebo
(n = 2158) dutas
(n = 2167) Placebo
(n = 1736) dutas
(n = 1744)
Erectile disfunktsiya2 3% 6% 1% 2%
Reduced libido2 2% 4% <1% <1%
Violation eyakulyatsii2 <1% 2% <1% <1%
Violations by zhelez1 infants <1% 1% <1% 1%
1 – including pain and breast enlargement.
2 – adverse effects from the reproductive system and mammary glands associated with the use of dutas (as monotherapy or in combination with tamsulosin). These adverse effects may persist after cessation of treatment and the effect of dutas on data retention adverse events is unknown.
Adverse events associated with the use of dutas in combination with tamsulosin
The following adverse events were reported in the study CombAT (comparison of dutas and tamsulosin 500 mg 400 mg 1 time / day as monotherapy or in combination for four years) and evaluated by researchers from the cumulative effect of ≥1%).
Adverse events of adverse events during the period of application of tamsulosin in combination with dutas
1st year 2nd year 3rd year 4th year
Kombinatsiya1 (n) (n = 1610) (n = 1428) (n = 1283) (n = 1200)
dutas (n = 1623) (n = 1464) (n = 1325) (n = 1200)
Tamsulosin (n = 1611) (n = 1468) (n = 1281) (n = 1112)
Erectile disfunktsiya3
A combination of 6% 2% <1% <1%
dutas 5% 2% <1% <1%
Tamsulosin 3% 1% <1% <1%
Reduced libido3
The combination of 5% <1% <1% 0%
dutas 4% 1% <1% 0%
Tamsulosin 2% <1% <1% <1%
Violation eyakulyatsii3
The combination of 9% 1% <1% <1%
dutas 1% <1% <1% <1%
Tamsulosin 3% <1% <1% <1%
Violations of the thoracic zhelez2
The combination of 2% <1% <1% <1%
dutas 2% 1% <1% <1%
Tamsulosin <1% <1% <1% 0%
Dizziness
The combination of 1% <1% <1% <1%
dutas <1% <1% <1% <1%
Tamsulosin 1% <1% <1% 0%
1 – = combination of dutas 500 mg 1 time / day + tamsulosin 400 mg 1 time / day;
2 – including pain and breast enlargement;
3 – adverse effects from the reproductive system and mammary glands associated with the use of dutas (as monotherapy or in combination with tamsulosin). These adverse effects may persist after cessation of treatment. Effect of dutas on data retention adverse events is unknown.

Conditions and terms
The drug should be stored out of reach of children at or above 30 ° C. Shelf life – 4 years.
Indications
– As monotherapy for the treatment and prevention of the progression of benign prostatic hyperplasia by reducing its size, relief of symptoms, improved urination, reduce the risk of acute urinary retention and the need for surgical intervention;
– As a combination therapy with alpha 1-blockers for the treatment and prevention of the progression of benign prostatic hyperplasia by reducing its size, alleviation of symptoms, improvement of urination, decrease the risk of acute urinary retention and the need for surgical intervention. Mainly I studied the combination of dutas and tamsulosin alpha1-blocker.
Contraindications
– Hypersensitivity to dutas, and other ingredients;
– Hypersensitivity to other inhibitors of 5α-reductase.
Avodart is contraindicated in women and children.
Precautions should be prescribed the drug for liver failure.

Special instructions
dutas is absorbed through the skin, so women and children should avoid contact with damaged capsules. In case of contact with damaged capsules should immediately rinse the appropriate site with soap and water.
Abnormal liver function
There is currently no data on the use of the drug Avodart in patients with impaired hepatic function. Because dutas is extensively metabolized and its half-life of 3-5 weeks, caution should be exercised in treating patients with drug Avodart impaired liver function.
Heart failure is the combined use of dutas and tamsulosin
The two 4-year clinical trials, the incidence of heart failure was higher in patients treated with the combination of dutas and alpha1-adrenergic blocker, primarily tamsulosin, than patients who had not received the combined treatment. In these two studies, the incidence of heart failure has remained low (≤ 1%) with some variability in between. But overall performance discrepancies frequency side effects of the cardiovascular system were noted. A causal relationship between treatment with dutas (alone or in combination with alpha1-blocker) and the development of heart failure has been established.
The impact on the identification of prostate-specific antigen (PSA) and prostate cancer (PCa)
Patients need to carry out a digital rectal examination, as well as use other methods of investigation of the prostate prior to treatment with dutas and repeat them periodically during treatment to rule out prostate cancer development.
Determination of the concentration of PSA in serum is an important component of screening aimed at identifying prostate cancer. After 6 months of therapy with dutas average serum PSA level is reduced by about 50%. Patients taking dutas should be defined a new basic PSA levels after 6 months of therapy. In the future, it is recommended to regularly monitor PSA levels.
The use of dutas did not affect the diagnostic value of PSA as a marker of prostate cancer. Any confirmed increase in PSA with respect to the least of its value in the treatment of dutas may indicate the development of prostate cancer (particularly prostate cancer with a high degree of differentiation by Gleason score) or nonadherence dutas should be carefully evaluated, even if the PSA levels remain within the normal range for this age group of patients not taking inhibitors of 5α-reductase.
Total PSA level returns to its original value within 6 months after discontinuation of dutas.
The ratio of free to total PSA remains constant even during therapy with dutas. If the determination of the percentage of free PSA fraction is further used to detect prostate cancer in men receiving dutas, correction of this magnitude is not required.
Effect of long-term use of dutas on the development of breast cancer in men
There were no long-term effect of dutas on the development of breast cancer in men.
Prostate cancer and high-grade tumors graduation
In the 4-year study (REDUCE) compared the use of placebo and dutas have 8231 volunteers aged 50 years to 75 years, with a negative biopsy in the presence of prostate cancer and a PSA level of 2.5 ng / ml to 10 ng / ml at the initial examination .
In the study, 6706 patients underwent a needle biopsy of the prostate gland and on the basis of the results determined by the degree of malignancy of prostate cancer Gleason. 1517 patients in the study were diagnosed with prostate cancer. In most cases, as in the dutas group and in the placebo group were diagnosed with well-differentiated prostate cancer (score Gleason 5-6). Differences in the number of prostate cancer cases with the assessment of 7-10 points Gleason in the dutas group and the placebo group were absent (p = 0.81).
4, it was observed more cases of breast cancer with the evaluation 8-10 Gleason dutas group (n = 29; 0.9%) compared with the placebo group (n = 19; 0.6%) (p = 0.15). When evaluating biopsy 1-2, the number of patients diagnosed with prostate cancer with an estimate 8-10 Gleason was comparable in groups dutas (n = 17; 0.5%) or placebo (n = 18; 0.5%). In assessing biopsy for 3-4 years it was diagnosed more cases of prostate cancer with the assessment of 8-10 points Gleason in the dutas group (n = 12; 0.5%) compared with the placebo group (n = 1, <0.1%) (p = 0.0035). The percentage of patients diagnosed with prostate cancer with an estimate 8-10 Gleason was stable during all time slots (the period of 1-2 years, and 3-4) in the group of dutas (0.5% in each period), while in placebo percentage of patients diagnosed with prostate cancer with 8-10 evaluation was lower for 3-4 years, 1-2 years than (<0.1% compared to 0.5% respectively).
In the 4-year study (CombAT) patients with BPH, in which prostate biopsy to all participants has not been determined protocol, and all diagnoses of prostate cancer based on a biopsy if indicated, with evaluation 8-10 prostate cancer Gleason was diagnosed in 8 patients (<0.5%) at dutas, 11 patients (<0.7%) with tamsulosin and 5 patients (<0.3%) in the combination therapy with tamsulosin and dutas.
A causal relationship between dutas and the development of prostate cancer a high degree of gradation is not established.
Men taking dutas should undergo regular examinations for assessing the risk of developing prostate cancer, including a PSA.
Effects on ability to drive vehicles and management mechanisms
dutas does not affect driving or using machinery.
If the kidney function
If the kidney function dose reduction is required (because while taking the drug at a dose of 500 mg / day with urine allocated less than 0.1% of the dose).
If abnormal liver function
It should be used with caution on patients with impaired liver function since dutas undergoes extensive metabolism in the liver, and its T1 / 2 of 3-5 weeks.
Precautions should be prescribed the drug for liver failure.
The use in the elderly
No dose adjustment is required.
Application in childhood
Avodart is contraindicated in children.
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