Index of drugs

Treatment of signs and symptoms of benign prostatic hyperplasia.

1 hard capsule contains 4 mg or 8 mg of silodosin.

Α-adrenergic receptor antagonist. Silodosin is highly selective for α receptors_1A-adrenergic located mainly in the human prostate gland, the base of the bladder, the neck of the bladder, the prostatic bag and the prostatic part of the ureter. Blockade of these α receptors_1A-adrenergic causes relaxation of smooth muscles in these tissues, which reduces the resistance of the bladder, without affecting the contractility of the detrusor smooth muscles. This results in improved symptoms in the urine collection (irritation) and urine (barrier) phase, associated with benign prostatic hyperplasia. Silodosin has significantly lower affinity for α receptors_1B-renergic, mainly located in the circulatory system. It has been shownin vitrothat the α-linkage ratio_1A:α_1B Silodosin (162: 1) is extremely high. Oral silodosin is well absorbed and the absorption is proportional to the dose. Absolute bioavailability is about 32%. The food reduces C_max about 30%, increases t_max about 1 hour and has little effect on AUC. Silodosin is highly metabolized by glucuronidation (UGT2B7), alcohol and aldehyde dehydrogenase and oxidation pathways, mainly via CYP3A4. The main metabolite in the plasma, a glucuronide conjugate of silodosin, for which activity has been demonstratedin vitro, has an extended T_0,5 (about 24 h) and reaches about 4 times higher plasma concentrations than silodosin. Datain vitro indicate that silodosin does not have the inhibitory or inducing potential of cytochrome P450 enzyme systems. It binds 96.6% to plasma proteins and its main metabolite is 91%. Silodosin is mainly excreted as metabolites, very small amounts of unchanged drug are recovered in the urine. Final T_0,5 the parent drug and its glucuronide is about 11 h and 18 h, respectively.

Hypersensitivity to silodosin or to any of the excipients.

During cataract surgery in some patients taking α₁-blokers or previously treated α₁-blocks have been observed for a small pupil syndrome, which may lead to increased complications in the course of the operation; initiation of treatment is not recommended in patients planning a cataract surgery. It is recommended to discontinue the α treatment₁-blockers 1-2 weeks prior to cataract surgery, but the benefits of discontinuation of treatment or the optimal length of treatment interval before cataract surgery have not yet been established. It is not recommended for patients with orthostatic hypotension, patients with severe renal impairment (creatinine clearance <30 ml / min) and patients with severe hepatic impairment (data not available). Before starting treatment, patients suspected of benign prostatic hyperplasia should be examined to rule out the presence of prostate cancer; benign prostatic hyperplasia and prostate cancer can produce the same symptoms and occur simultaneously. Before treatment and then at regular intervals, the prostate should be examined with the finger through the rectum and, if necessary, the concentration of specific prostate antigen should be determined. Taking the drug leads to a reduction in the amount of sperm during orgasm, which may have a temporary effect on male fertility (this action disappears after discontinuation of the drug).

Not applicable - a drug intended for men.

Very often: reverse ejaculation, anaaculation. Common: dizziness, orthostatic hypotension, nasal congestion, diarrhea. Uncommon: decreased libido, nausea, dry mouth, erectile dysfunction. Not known: syncope, intraoperative laxis iris syndrome.

Orally. Adults: 8 mg once a day. Patients with moderate renal impairment (creatinine clearance 30-50 ml / min): the starting dose is 4 mg once a day, depending on the patient's response after one week of treatment, the dose may be increased to 8 mg once a day.Use in patients with severe renal impairment is not recommended.
Kaps. take with a meal, ideally at a fixed time each day.