Buy Avodart capsules 0.5 mg 30 pcs
  • Buy Avodart capsules 0.5 mg 30 pcs

Avodart® [Dutasteride]

GlaxoSmithKline
1083 Items
2019-09-19
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Clinical Pharmacology

A drug for the treatment of benign prostatic hyperplasia. Dutasteride is a double inhibitor of 5α-reductase. Suppresses the activity of isoenzymes 5α-reductase 1 and 2 types, which are responsible for the conversion of testosterone into 5α-dihydrotestosterone (DHT). Dihydrotestosterone is the main androgen responsible for the hyperplasia of the glandular tissue of the prostate gland.

The maximum effect of dutasteride on the reduction of DHT concentrations is dose-dependent and is observed 1-2 weeks after the start of treatment. After 1 and 2 weeks of dutasterid dosing at a dose of 500 mcg / day, the mean values ​​of serum dihydrotestosterone concentrations are reduced by 85% and 90%.

Indications

  • As monotherapy for the treatment and prevention of progression of benign prostatic hyperplasia by reducing its size, relieving symptoms, improving urination, reducing the risk of acute urinary retention and the need for surgical intervention.
  • As a combination therapy with alpha1-adrenergic blockers for the treatment and prevention of progression of benign prostatic hyperplasia by reducing its size, relieving symptoms, improving urination, reducing the risk of acute urinary retention and the need for surgery. The combination of dutasteride and alpha was mainly studied.1-blocker tamsulosin.

Composition

1 capsule contains:

Active ingredient: Dutasteride - 500 mcg.

Excipients: caprylic / capric acid mono-and diglycerides - 349.5 mg, butylhydroxytoluene - 35 μg.

The capsule shell composition: gelatin - 144.8 mg, glycerol - 70.8 mg, titanium dioxide - 1.78 mg, iron yellow oxide - 127 μg, medium-chain triglycerides - q.s., lecithin - qs.s., red ink for printing ** - q.s.

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Avodart® [Dutasteride]

Dosage and Administration

The drug can be taken regardless of the meal.

Capsules should be swallowed whole, not chewed and not opened, since the contents of the capsule can cause irritation of the mucous membrane of the oropharynx.

Benign prostatic hyperplasia (BPH)

Adult men (including the elderly) The recommended dose of Avodart® is 1 capsule (500 mcg) 1 time / day. Capsules should be taken whole.

Although improvement with the use of the drug comes fairly quickly, treatment should be continued for at least 6 months in order to objectively evaluate the therapeutic effect.

For the treatment of BPH, Avodart® may be administered as monotherapy or in combination with alpha.1-blockers.

Special patient groups

When taking 500 mcg / day, 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.

Currently there are no data on the use of Avodart® in patients with impaired liver function. Since dutasteride is exposed to intensive metabolism, and its half-life is 3-5 weeks, care must be taken when treating Avodart® patients with impaired liver function.

Adverse reactions

The adverse events presented below are listed depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows:

  • Very often (≥1 / 10).
  • Often (≥1 / 100 and <1/10).
  • Infrequently (≥1 / 1000 and <1/100).
  • Rarely (≥ 1/10 000 and <1/1000).
  • Very rarely (<1/10 000, including isolated cases).

Frequency categories were formed on the basis of clinical trials of the drug and post-registration observation. The frequency of occurrence of adverse events, formed on the basis of post-registration observation.

On the part of the immune system: very rarely, allergic reactions (including rash, pruritus, urticaria, localized edema) and angioedema.

On the part of the skin and subcutaneous fat: rarely, alopecia (mainly loss of body hair) or hypertrichosis.

Mental Disruption: very rarely - depressed.

From the reproductive system: very rarely - testicular pain, testicular edema.

Carefully: should be prescribed the drug for liver failure.

Drug interactions

In vitro, dutasteride is metabolized by the CYP3A4 isoenzyme of the cytochrome P450 enzyme system. In the presence of CYP3A4 inhibitors, dutasteride concentrations in the blood may increase.

With the simultaneous use of dutasteride with CYP3A4 inhibitors verapamil and diltiazem, a decrease in the clearance of dutasteride is noted. However, amlodipine, another calcium channel blocker, does not reduce the clearance of dutasteride. The decrease in clearance of dutasteride and the subsequent increase in its concentration in the blood while using this drug and CYP3A4 inhibitors is not significant due to the wide range of dutasteride safety limits, so there is no need to reduce its dose.

In vitro, dutasteride is not metabolized by the following human cytochrome P450 isoenzymes: CYP1A2, CYP2A6, CYP2E1, CYP2C8, CYP2C9, CYP2C19 and CYP2D6.

Dutasteride does not inhibit the in vitro enzymes of the human cytochrome P450 system involved in drug metabolism.

In vitro, dutasteride does not displace warfarin, acenocoumarol, fenprocumone, diazepam, and phenytoin from their sites of binding to plasma proteins, and these drugs, in turn, do not displace dutasteride.

In studies of the interaction of dutasteride with tamsulosin, terazosin, warfarin, digoxin, and colestiramine in humans, no clinically significant pharmacokinetic or pharmacodynamic interactions were observed.

When using dutasteride simultaneously with lipid-lowering drugs, ACE inhibitors, beta-blockers, calcium channel blockers, corticosteroids, diuretics, NSAIDs, type 5 phosphodiesterase inhibitors and quinolone antibiotics, no significant undesirable drug interactions were observed.

Pregnancy and Lactation

Impact on fertility: The effect of dutasteride at a daily dose of 500 mcg on sperm characteristics was studied in healthy volunteers aged 18–52 years.By the 52nd week of treatment, the average values ​​of the percentage reduction in the total sperm count, sperm volume, and sperm motility were 23%, 26%, and 18%, respectively, compared to baseline. The concentration of spermatozoa and their morphological characteristics did not change. After 24 weeks of follow-up, the average value of the percentage change in the total number of spermatozoa in the dutasteride group remained 23% lower compared with the initial level. The average value for all sperm parameters at all time points remained within the normal range and did not meet the specified criteria for a clinically significant change (30%); at the 52nd week of treatment in two volunteers in the dutasteride group, the total number of spermatozoa decreased by more than 90% compared with baseline, with partial recovery at 24th week of observation. Thus, the clinical significance of the effect of dutasteride on sperm indices and on individual patient fertility is unknown.

Pregnancy: dutasteride is contraindicated in women. Dutasteride has not been studied in women, because preclinical evidence suggests that the suppression of DHT may cause inhibition of the development of the external genital organs in the fetus.

Lactation: No data on the penetration of dutasteride into breast milk.

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 immediately wash the corresponding skin area with soap and water.

Liver dysfunction

Currently there are no data on the use of Avodart® in patients with impaired liver function. Since dutasteride undergoes intensive metabolism, and its half-life is 3-5 weeks, care must be taken when treating Avodart® 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 was higher in patients who received the combination of dutasteride and alpha1-blocker, mainly tamsulosin, than in patients who did not receive the combined treatment. In these two studies, the incidence of heart failure remained low (≤ 1%), with some variability between them. But in general, there was no discrepancy in the incidence of side effects from the cardiovascular system. The causal connection between treatment with dutasteride (as monotherapy or in combination with an alpha1-blocker) and the development of heart failure has not been established.

Effect on the detection of prostate-specific antigen (PSA) and prostate cancer (PCa)

Patients need to conduct a digital rectal examination, as well as use other methods of research of the prostate gland, before starting treatment with dutasteride and periodically repeat them during treatment to rule out the development of prostate cancer.

Determining serum PSA concentrations is an important component of screening for prostate cancer. After 6 months of dutasteride therapy, the average serum PSA level is reduced by about 50%. Patients taking dutasteride should have a new baseline PSA level determined after 6 months of therapy. In the future, it is recommended to regularly monitor the PSA level.

The use of dutasteride does not affect the diagnostic value of PSA as a marker for PCa. Any confirmed increase in the PSA level with respect to its lowest value in the treatment with dutasteride may indicate the development of prostate cancer (in particular, prostate cancer with a high degree of differentiation on the Gleason scale) or non-compliance with the dutasteride therapy regimen and should be carefully evaluated, even if these PSA levels remain at limits of normal values ​​for this age group of patientsnot taking inhibitors of 5α-reductase.

The overall PSA level returns to its original value within 6 months after dutasteride is discontinued.

The ratio of free PSA to total remains constant even during therapy with dutasteride. If the determination of the percentage of free PSA is additionally used to detect prostate cancer in men receiving dutasteride, correction of this value is not required.

The effect of long-term dutasterid administration on the development of breast cancer in men

The effect of long-term dutasterid administration on the development of breast cancer in men has not been found.

Prostate cancer and high grade tumors

A 4-year study (REDUCE) compared the use of placebo and dutasteride in 8231 volunteers aged 50 to 75 years, with a negative biopsy for the presence of prostate cancer and PSA levels from 2.5 ng / ml to 10 ng / ml initial examination.

In the course of the study, 6706 patients underwent puncture biopsy of the prostate gland and, on the basis of the obtained results, the degree of malignancy of the prostate gland was determined according to the Gleason scale. In the course of the study, 1517 patients were diagnosed with PCa. In most cases, both in the dutasterid group and in the placebo group, a highly differentiated prostate cancer was diagnosed (Gleason score 5-6). There were no differences in the number of cases of prostate cancer with a score of 7-10 on the Gleason score in the dutasteride group and the placebo group (p = 0.81).

After 4 years, there were more cases of prostate cancer with a score of 8-10 on the Gleason score in the dutasteride group (n = 29; 0.9%) compared with the placebo group (n = 19; 0.6%) (p = 0, 15). When evaluating biopsy data for 1-2 years, the number of patients diagnosed with prostate cancer with an estimate of 8–10 points on the Gleason scale was comparable in the dutasteride groups (n = 17; 0.5%) and placebo (n = 18; 0.5%) . When evaluating biopsy data for 3-4 years, more cases of prostate cancer were diagnosed with a score of 8-10 on the Gleason score in the dutasteride group (n = 12; 0.5%) compared with the placebo group (n = 1; <0.1 p="" the="" percentage="" of="" patients="" diagnosed="" with="" prostate="" cancer="" a="" score="" 8-10="" on="" gleason="" was="" stable="" for="" all="" time="" periods="" 1-2="" and="" 3-4="" years="" in="" dutasteride="" group="" 0="" 5="" each="" period="" while="" as="" placebo="" an="" estimate="" 8="" 10="" points="" lower="" 3="" 4="" than="" 1="" 2="" compared="" respectively="">

In a 4-year study (CombAT) of patients with benign prostatic hyperplasia, in which a prostate biopsy was not determined for all participants by the protocol, and all diagnoses of prostate cancer were based on a biopsy according to indications, prostate cancer with an estimated 8-10 Gleason score was diagnosed in 8 patients (<0.5%) while taking dutasteride, in 11 patients (<0.7%) while taking tamsulosin and 5 patients (<0.3%) with combination therapy with dutasterid and tamsulosin.

No causal relationship between the administration of dutasteride and the development of prostate cancer is highly established.

Men who take dutasteride should be regularly examined for the assessment of the risk of developing prostate cancer, including PSA levels.

Influence on ability to drive motor transport and control mechanisms

Reception of dutasteride does not affect driving a car or working with machinery.

Overdosage

Symptoms: with the appointment of dutasteride up to 40 mg / day once (80 times higher than the therapeutic dose) for 7 days, no significant side effects were noted. When conducting clinical trials, patients received dutasteride at a dose of 5 mg daily for 6 months, with no additional side effects to those observed while receiving 500 μg of dutasteride, were found.

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

  • Brand name: Avodart
  • Active ingredient: Dutasteride
  • Dosage form: Capsules
  • Manufacturer: GSK
  • Country of Origin: UK

Studies and clinical trials of Dutasteride (Click to expand)

  1. Effects of the dual 5 α-reductase inhibitor dutasteride on apoptosis in primary cultures of prostate cancer epithelial cells and cell lines
  2. Enzyme-linked immunosorbent assays for doping control of 5α-reductase inhibitors finasteride and dutasteride
  3. Selective and rapid liquid chromatography–tandem mass spectrometry assay of dutasteride in human plasma
  4. The pharmacokinetic modelling of GI198745 (dutasteride), a compound with parallel linear and nonlinear elimination
  5. Improvements in benign prostatic hyperplasia-specific quality of life with dutasteride, the novel dual 5α-reductase inhibitor
  6. Dutasteride, the dual 5α–reductase inhibitor, inhibits androgen action and promotes cell death in the LNCaP prostate cancer cell line
  7. The effects of the dual 5α-reductase inhibitor dutasteride on localized prostate cancer—results from a 4-month pre-radical prostatectomy study
  8. Inhibition of fatty acid synthase activity in prostate cancer cells by dutasteride
  9. Preliminary evaluation of the effect of dutasteride on PCA3 in post-DRE urine sediments: A randomized, open-label, parallel-group pilot study
  10. Effects of the 5 alpha-reductase inhibitor dutasteride on gene expression in prostate cancer xenografts
  11. Effects of dutasteride on the expression of genes related to androgen metabolism and related pathway in human prostate cancer cell lines
  12. Dutasteride and Prostate Cancer Risk
  13. Efficacy of neoadjuvant bicalutamide and dutasteride as a cytoreductive regimen prior to prostate brachytherapy
  14. Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia
  15. Long-term sustained improvement in symptoms of benign prostatic hyperplasia with the dual 5α-reductase inhibitor dutasteride: results of 4-year studies
  16. Long-term therapy with the dual 5α-reductase inhibitor dutasteride is well tolerated in men with symptomatic benign prostatic hyperplasia
  17. Effect of dutasteride on the symptoms of benign prostatic hyperplasia, and patient quality of life and discomfort, in clinical practice
  18. Blood loss and postoperative complications associated with transurethral resection of the prostate after pretreatment with dutasteride
  19. Biodegradable braided poly(lactic-co-glycolic acid) urethral stent combined with dutasteride in the treatment of acute urinary retention due to benign prostatic enlargement: a pilot study
  20. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial
  21. Can dutasteride delay or prevent the progression of prostate cancer in patients with biochemical failure after radical therapy? Rationale and design of the Avodart after Radical Therapy for Prostate Cancer Study
  22. REDUCE Trial Inspires Debate : Is dutasteride ready for widespread use as prevention for prostate cancer?
  23. Effect of the dual 5α-reductase inhibitor, dutasteride, on serum testosterone and body mass index in men with benign prostatic hyperplasia

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