Urorec capsules 8mg №30

Dosage form

Capsules

Composition

1 capsule contains: silodosin 8 mg.
Excipients: mannitol, pregelatinized starch (starch 1500 ™), pregelatinized starch (PCS ™ PC-10 starch), sodium lauryl sulfate, Magnesium stearate.
The composition of the gelatin capsule: gelatin, titanium dioxide, iron dye yellow oxide (E-172)

Packing

In the package 30 pcs.

Mechanism of action

Urorec is a highly selective competitive antagonist alpha 1a-adrenergic receptors, blocking postsynaptic alpha 1a adrenoreceptors, which are in the smooth muscles of the prostate gland, the bladder neck and the prostatic urethra. Reduces the tone of the smooth muscles of the prostate gland, bladder neck and prostatic urethra, improving the flow of urine. At the same time, the symptoms of obstruction and irritation associated with benign prostatic hyperplasia are reduced. Affinity for alpha | The 1a-adrenergic receptors located in the bladder are 162 times greater than their ability to interact with alpha-1b-adrenergic receptors, which are located in vascular smooth muscles. Due to its high selectivity, it does not cause a clinically significant reduction in blood pressure (BP) in patients with initially normal BP.

Indications and usage

Benign prostatic hyperplasia.

Contraindications

- Hypersensitivity to the active substance or any of the auxiliary
components or their intolerance
- Children under 18 years old
- Severe renal failure (creatinine clearance less than 30 ml / min)
- Severe hepatic impairment (insufficient clinical data)

With care: at an easy and moderate renal failure (clearance of creatinine from 30 to 50 ml / min.).

Pregnancy and Breastfeeding

Silodozin is for men only.

Dosage and administration

The recommended dose is 8 mg once, at the same time as a meal, preferably at the same time of day.It is necessary to swallow the capsule whole, preferably with a glass of water.
For the treatment of patients with moderate renal insufficiency (creatinine clearance> 30– <50 ml / min), it is recommended to take an initial dose of 4 mg per day during the first week, with good individual tolerance then you can increase the dose to 8 mg per day.

Special notes

As with other alpha1-adrenergic blockers in the treatment with silodosin, a decrease in blood pressure or orthostatic hypotension may be observed. At the first sign of orthostatic hypotension (dizziness, weakness), the patient must sit or lie down and remain in that position until the symptoms of orthostatic hypotension disappear.
Since benign prostatic hyperplasia and prostate tumors have similar symptoms and can develop together, patients with suspected benign prostatic hyperplasia need to be examined before prescribing the drug to exclude prostate tumors.
Patients taking or taking alpha1-blockers may experience flabby iris syndrome during cataract surgery, which can lead to complications during surgery. It is necessary to stop treatment with alpha1-adrenergic blockers 1-2 weeks before such an operation. Patients who are scheduled for cataract surgery are not recommended to start treatment with Urorec.
Influence on ability to drive motor transport and control mechanisms: No studies have been conducted on the effect on the ability to drive vehicles and equipment. However, patients should be informed about the possible manifestations of symptoms associated with orthostatic hypotension (eg, dizziness), and also warned that they should refrain from driving vehicles and equipment until the individual tolerance of the Urerek drug is ascertained.

Drug Interactions

Combination with other alpha-blockers is not recommended due to the possible potentiation of the action. The combined use of inhibitors of the isoenzyme CYP3A4 (ketoconazole, Clarithromycin, itraconazole, ritonavir) is not recommended, because increases the concentration of silodosin in the plasma.PDE5 inhibitors (sildenafil, tadalafil) when used together may increase the risk of dizziness. Antihypertensive drugs (beta-blockers, Calcium antagonists, drugs acting on the RAAS, diuretics) when used together, increase orthostatic hypotension.

Overdosage

Symptoms: pronounced decrease in blood pressure, compensatory tachycardia.
Treatment: gastric lavage, taking Activated carbon or osmotic laxative, symptomatic therapy aimed at increasing the BCC, vasoconstrictor drugs. Control kidney function. Dialysis is ineffective due to the intense binding of the drug to plasma proteins.

Storage conditions

The drug should be stored in a dry, protected from light, out of reach of children at a temperature not exceeding 30 ° C.