Avodart is the solution to fight prostate issues. These capsules contain dutasteride as an active ingredient and belong to the group of drugs known as anti-androgens (these will block the action of testosterone). As you know, the prostate is a gland located around the urethra and several issues come when an enlarged prostate causes pressure on the urethra and bladder. All this makes the process of urinating complicated. These urinary symptoms tend to appear: Dribbling of urine after urination, intense need to urinate all the time, bladder control problems, Incontinence and an interrupted urinary stream. Avodart will reduce the prostate gland, taking out the pressure from the urethra. All of the urinary symptoms mentioned above will be reduced or even eliminated.
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An online doctor consultation means filling out a medical questionnaire. A registered EU doctor assesses your medical questionnaire and analize whether Avodart (dutasteride) is suitable and safe for you to buy. After approval, a prescription is issued and send to the registered EU pharmacy. You will receive your discretely shipped Avodart pills within 3 business days.
Pharmacodynamics. Dutasteride, an inhibitor of 5-α-reductase, inhibits both type 1 and type 2 isoenzymes of 5-α-reductase, which are responsible for the conversion of testosterone to 5-α-dihydrotestosterone. Dihydrotestosterone is an androgen, primarily responsible for prostatic tissue hyperplasia. The maximum decrease in dihydrotestosterone while taking Avodart is dose-dependent and is observed in the first 1-2 weeks. After the 1st and 2nd week of treatment with Avodart in a daily dose of 0.5 mg, the average concentration of dihydrotestosterone decreases by 85 and 90%, respectively.
In patients with benign prostatic hyperplasia who received 0.5 mg of dutasteride per day, the average decrease in the level of dihydrotestosterone was 94% after 1 year and 93% after 2 years of treatment, the average level of testosterone increased by 19% after 1 and 2 years. This is an expected consequence of the inhibition of 5-α-reductase, and it does not lead to the manifestation of various known side effects.
According to multicenter, placebo-controlled, double-blind clinical trials involving 4325 men with prostatic hyperplasia (> 30 cm3), the use of Avodart at a dose of 0.5 mg / day led to the prevention of disease progression by reducing the risk of acute urinary retention and the need for surgical intervention, and statistically significant improvement in the state of the lower urinary tract, an increase in the rate of urination and a decrease in the volume of the prostate gland compared with placebo. All of the above changes were noted over 24 months.
Pharmacokinetics. Dutasteride is administered orally in the form of a solution in soft gelatin capsules. After taking a single dose of 0.5 mg Cmax of the drug in the blood plasma, it is observed after 1-3 hours. The absolute bioavailability is 60% and does not depend on food intake.
Dutasteride after single or multiple uses has a large volume of distribution (300-500 l). Plasma protein binding -> 99.5%. When applied in a daily dose of 60%, a constant equilibrium concentration of dutasteride in blood plasma is reached after 1 month of treatment and about 90% after 3 months. A constant equilibrium concentration of dutasteride of approximately 40 ng/ml in blood plasma is achieved after 6 months of administration in a daily dose of 0.5 mg. Similarly, with blood plasma, a constant equilibrium concentration of dutasteride in seminal fluid is reached after 6 months. After 52 weeks of treatment, the average concentration of dutasteride in seminal fluid is 3.4 ng/ml (in the range of 0.4-14 ng/ml). The distribution ratio of dutasteride from blood plasma to seminal fluid is about 11.5%.
In vitro, dutasteride is metabolized by the CYP 450 3A4 cytochrome P450 human enzymes to two mono hydroxyl metabolites.
According to spectrometric analysis, unchanged dutasteride, 3 major metabolites (4-hydroxidutasteride, 1,2-dihydrodutasteride and 6-hydroxidutasteride) and 2 small metabolites (6,4-dihydroxidutasteride and 1,5-hydroxidutasteride) are detected in blood plasma.
Dutasteride is extensively metabolized. After oral administration of dutasteride at a dose of 0.5 mg/day, 1-15.4% (on average 5.4%) is excreted in the feces as unchanged dutasteride, the rest as metabolites.
Traces of unchanged dutasteride (<0.1%) are detected in the urine. The final T½ of dutasteride is 3–6 weeks. Traces of dutasteride in blood plasma can be detected 4-6 months after the end of treatment.
Treatment and prevention of the progression of benign prostatic hyperplasia by reducing the size of the prostate gland, reducing the severity of disease symptoms, improving urine outflow, reducing the risk of acute urinary retention and, if necessary, surgical intervention.
In combination with tamsulosin - treatment and prevention of the progression of benign prostatic hyperplasia by reducing the size of the prostate gland, reducing the severity of the symptoms of the disease and improving the outflow of urine.
Avodart can be prescribed as monotherapy or in combination with α-receptor blocker tamsulosin (0.4 mg). Adult men (including elderly patients) The the recommended dose of Avodart is 1 capsule (0.5 mg) per day by mouth. The capsule is swallowed whole, do not open and do not chew, since contact with the contents of the capsule may irritate the mucous membrane of the oral cavity and pharynx.
Avodart can be taken without regard to meals. Despite the fact that a decrease in the severity of the symptoms of the disease can be noted shortly after taking the drug, for an objective assessment of the effectiveness of the drug, the treatment is continued for at least 6 months. For patients with renal failure, the dose does not need to be adjusted. Hepatic Insufficiency- The pharmacokinetics of dutasteride in patients with hepatic impairment has not been studied.
hypersensitivity to dutasteride, other 5-α-reductase inhibitors or other components of the drug. Severe liver failure. Avodart is not used in women and children.
According to clinical trials, Avodart monotherapy, During therapy, the following adverse reactions were observed according to clinical trials with a frequency of occurrence> 1% when using Avodart and placebo.
Dutasteride can be absorbed through the skin, so women and children should avoid contact with leaking capsules. If the liquid from the capsule gets on the skin, it should be washed off immediately with soap and water. The effect of liver failure on the pharmacokinetics of dutasteride has not been studied. Since dutasteride is extensively metabolized and its T½ is 3-5 weeks, the drug is used with caution in liver diseases.
Use in combination with tamsulosin. According to 4-year clinical studies, the incidence of heart failure was higher among patients treated with Avodart combination with α-adrenergic blockers, mainly tamsulosin, compared with patients who were not treated with this combination. According to 2 studies, the heart failure rate was low (≤1%) and variable within these studies. There were no imbalances in the incidence of cardiovascular side effects in any of the studies. A causal relationship between the use of Avodart (alone or in combination with α-adrenergic blockers) and the occurrence of heart failure has not been established.
Effect on prostate-specific antigen (PSA) and prostate cancer detection
Before starting treatment with dutasteride and periodically during treatment, a digital rectal examination of the patient and other studies should be performed to detect prostate cancer.
PSA concentration is an important component of a screening method for detecting prostate cancer. Avodart treatment can reduce the level of PSA in plasma with benign prostatic hyperplasia by approximately 50% after 6 months of treatment. Patients who are treated with Avodart should have a new baseline PSA level established after 6 months of treatment with the drug. PSA levels are recommended to be checked regularly.
Any sustained increase in PSA compared with the minimum values during treatment with Avodart may indicate the presence of prostate cancer (especially cancer of a high degree of malignancy) or failure to adhere to the Avodart regimen and needs to be carefully studied, even if the PSA values are within the normal range for men, which were not treated with 5-α-reductase inhibitors.
The use of Avodart does not affect the use of PSA levels for the diagnosis of prostate cancer after establishing its new baseline value. According to a 4-year clinical study involving patients with an increased risk of prostate cancer, an increase in PSA after establishing its new value (after 6 months of treatment) is more informative (especially for cancer of a high degree of malignancy) in men treated with Avodart. compared to taking a placebo.
The total serum PSA level returns to baseline for 6 months after discontinuation of treatment. The ratio of free PSA to total PSA remains constant even during treatment with Avodart. Therefore, when using the percentage of free PSA in a patient taking Avodart to diagnose prostate cancer, double the value of free PSA should not be.
Fertility. A study of the effect of dutasteride at a dose of 0.5 mg/day on the characteristics of the ejaculate in 27 healthy volunteers during 52 weeks of treatment and 24 weeks of follow-up revealed a decrease in the total count of sperm, ejaculate volume and sperm motility by 23; 26 and 18% compared with changes in the placebo group. Sperm concentration and morphology remained unchanged. After 24 weeks of follow-up, the average percentage of changes in the total sperm count in the dutasteride group remained 23% below the baseline. While the average values for all sperm parameters in all periods remained within normal limits and did not meet certain criteria for clinically significant changes (30%), in 2 patients of the dutasteride group, a decrease in the number of spermatozoa by more than 90% was noted compared with the initial level at the 52nd week of treatment and a partial restoration of their number after 24 weeks of subsequent observation. The clinical significance of the effect of dutasteride on sperm characteristics for individual patient fertility is unknown.
Dutasteride is contraindicated for use in women. The use of dutasteride for the treatment of women has not been studied since according to preclinical studies it was suggested that a decrease in the level of circulating dihydrotestosterone can lead to impaired development of the external genital organs in the male fetus.
The use is contraindicated. The ability to influence the reaction rate when driving vehicles or other mechanisms. Given the pharmacokinetic and pharmacodynamic properties, dutasteride does not affect the ability to drive a car and other mechanisms.
Since dutasteride is metabolized by the CYP 3A4 isoenzyme, plasma dutasteride concentration may increase in the presence of CYP 3A4 inhibitors, and dutasteride clearance decreases with the use of verapamil (37%) and diltiazem (44%) with CYP 3A4 inhibitors. However, the clearance of dutasteride does not decrease when used with another calcium channel antagonist, amlodipine.
A decrease in clearance and a corresponding increase in the severity of the action of dutasteride in the presence of CYP 3A4 inhibitors is not of great clinical significance due to the wide range of drug safety.
In vitro isoenzymes CYP 1A2, CYP 2C9, CYP2 C19, and CYP 2D6 do not participate in the metabolism of dutasteride in humans, dutasteride does not inhibit enzymes of the cytochrome P450 system in humans involved in the metabolism of drugs.
In vitro studies have shown that dutasteride does not displace warfarin, diazepam or phenytoin from its association with blood plasma proteins, just as these components do not replace dutasteride. The interaction of dutasteride with tamsulosin, terazosin, warfarin, digoxin, and colestyramine was studied. No clinically significant interaction was detected.
Although specific studies to study the interaction with other drugs have not been conducted, about 90% of all patients in clinical studies of dutasteride received other concomitant therapy. No clinically significant adverse reactions were noted with the simultaneous use of dutasteride with antihyperlipidemic drugs, ACE inhibitors, β-adrenergic blockers, calcium channel blockers, GCS, diuretics, NSAIDs, type V PDE inhibitors and quinolone antibiotics.
According to a study on the interaction of tamsulosin or terazosin in combination with Avodart for 2 weeks, no signs of pharmacokinetic or pharmacodynamic interaction were detected.
According to clinical studies, in volunteers, a single dose of dutasteride up to 40 mg/day (80 times the therapeutic dose) for 7 days did not cause undesirable manifestations, taking into account the safety of their use. In clinical studies, a dose of dutasteride of 5 mg/day was used for 6 months without additional adverse reactions compared with the use of dutasteride at a dose of 0.5 mg/day.
There is no specific antidote, therefore, in case of a possible overdose, symptomatic therapy is carried out.