Dryches Davipharm treatment for benign prostatic hyperplasia (3 blisters x 10 tablets)

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Patients with severe liver failure.

Caution when using

should carefully assess the benefits and risks before using coordinated treatment due to the ability to increase the risk of unwanted effects (including heart failure) and after considering alternative treatment plans including single therapy.

heart failure

The higher rate of heart failure in users combined dutasterid with alpha blockers, mainly tamsulosin, compared to non -combined users, but the rate of heart failure in two groups of patients is low (

affect prostate -specific antigens (PSA) and prostate cancer detection

Rectal test as well as other prostate cancer assessments must be performed before the beginning of treatment with dutasterid and periodically.

Serum PSA concentration is an important part of prostate cancer detection. Dutasterid causes a decrease in serum PSA concentration by about 50%, after 6 months of treatment.

Set a new PSA level in patients using dutasterid after 6 months of treatment. Recommendations to monitor PSA values ​​regularly afterwards. Any increase in PSA from the lowest value can be a sign of prostate cancer (especially rapid cancer) or do not comply with dutasterid and should be carefully evaluated, even though these values ​​are still in the normal range of men who do not use 5α-Reductase inhibitors. In the interpretation of PSA value in patients using dutasterid, it is advisable to find the previous PSA value when treated with dutasterid to compare.

Using Dutasterid does not affect the use of PSA to support the diagnosis of prostate cancer after the new level has been established.

Serum PSA concentration returns to the background level within 6 months after stopping treatment. The ratio of free PSA and PSA whole does not change even under the influence of dutasterid.

If the free PSA ratio is chosen to support the detection of prostate cancer in men who are using dutasterid, no need to adjust this value.

Prostate and fast growing tumor

In a study, the rate of prostate cancer Gleason 8 - 10 in men using dutasterids is higher than that of placebo users. The relationship between dutasterid and prostate cancer is unclear rapidly. The risk of prostate cancer should be assessed in men who use dutasterid regularly, including PSA tests.

Hepatic failure

There is no study using dutasterid in patients with liver disease. Should be cautious when using dutasterid for patients with mild to medium liver failure.

Breast cancer

Breast cancer has been reported in men using dutasterid. The patient should promptly report any change in the breast tissue such as tumor or nipples. It is unclear whether there is a causal relationship between long -term dutasteride and breast cancer in men.

Evaluation of other urinary diseases

Before the beginning of treatment with Dutasterid, other urinary diseases should be considered the same symptoms. Moreover, benign prostate hyperplasia can occur simultaneously with prostate cancer.

Men treat dutasterids should not donate blood for at least 6 months after the last dose. This is to prevent the reception of dutasterids in pregnant women through the path of blood transfusion.

Cautious excipients

Lactose -containing drugs, patients with rare genetic diseases galactose, lactase deficiency or glucose - galactose absorption disorders should not use this drug. The drug contains poly sorbate 80 can cause allergies and castor oil can cause nausea, vomiting, abdominal pain, diarrhea.

The ability to drive and operate machinery

Based on Dutasteride's pharmacokinetics and pharmacokinetical properties, Dutasteride treatment does not affect the ability to drive or operate machinery.

Pregnancy

as well as other 5α-Reductase inhibitors, dutasterid inhibits the conversion of testosteron into dihydrotestosteron and maybe, if used in pregnant women, will inhibit the development of external genital organs of the fetus. A small amount of dutasterid can be found in semen in subjects using 0.5 mg of dutasterid/day. It is unclear whether the male fetus has unwanted effects if the mother is exposed to the semen of the person being treated with dutasterid or not (the highest risk in the first 16 weeks of pregnancy). Contraindications for women.

As well as other 5α-Reductase inhibitors, when the patient's partner is pregnant or may be pregnant, it is recommended that patients avoid the partner exposed to semen by using condoms.

Reproduction

Dutasterid is reported to affect semen (reducing sperm, semen volume and sperm movement) in healthy men. It is impossible to rule out the possibility of drugs that affect the fertility of men.

Breastfeeding period

It is unknown whether dutasteride will excrete in breast milk.

Interactive drug

The drug can cause an increase in PSA level.

The influence of other drugs on Dutasterid's pharmacokinetics

Used with CYP3A4 and/or P-Glycoprotein inhibitors

dutasterid excreted mainly through metabolic, catalyst by CYP3A4 and 3. No official interactive studies with strong CYP3A4 inhibitors have been conducted. However, the serum concentration of dutasterid increases when used with Verapamil (medium inhibitors CYP3A4) or Diltiazem (P-Glycoprotein inhibitors).

Long-term use dutasterid with strong CYP3A4 inhibitors (such as ritonavir, indinavir, nefazodon, iTraconazole, oral ketoconazole) may increase serum dutasteride concentration, but often do not increase the inhibition effect of 5α-Reductase. However, it is advisable to consider reducing the frequency of using dutasterid if it is unwanted. It should be noted that in the case of enzyme inhibition, long selling time may be longer and need more than 6 months of treatment simultaneously before achieving a new stable state.

Use 12 g of Colestyramin 1 hour after using a single dose of Dutasterid 5 mg does not affect dynamic pharmacokinetics of dutasterid.

The effect of dutasterid on the pharmacokinetics of other drugs

dutasterid does not affect the pharmacokinetics of warfarin or digoxin. This shows that dutasterid does not inhibit/touch CYP2C9 or P-Glycoprotein transportation. In vitro research shows that Dutasterid does not inhibit the enzyme CYP1A2, CYP2A6, CYP2E1, CYP2C8, CYP2D6, CYP2C9, CYP2C19, CYP2B6 or CYP3A4.

In vitro, Dutasterids are not metabolized through CYP1A2, CYP2A6, CYP2E1, CYP2C8, CYP2C9, CYP2C19, CYP2B6 and CYP2D6.

dutasterid does not cause pharmacokinetic interaction with tamsulosin or terazosin.