Urorec® [Silodosin]

Brand Record Chemical and Pharmaceutical Industry

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Available since: 2019-09-19

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Clinical Pharmacology

Urorec - a highly selective competitive antagonist alpha 1a-adrenergic receptors, blocks postsynaptic alpha 1a adrenergic receptors that 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 decrease in blood pressure (BP) in patients with initially normal BP.

Indications

Benign prostatic hyperplasia.

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)

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Dosage and Administration

The recommended dose - 8 mg once, at the same time with a meal, preferably at the same time of day. It is necessary to swallow the capsule whole, preferably with a glass of water.
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Adverse reactions

Undesirable reactions with an indication of the frequency are listed below: very often:> 10, often: from> 1/100 to <1/10, infrequently: from> 1/1000 to <1/100, rarely: from> 1/10 000 to < 1/1000, frequency unknown (available data do not allow to determine the frequency).
Nervous system
Often: dizziness.
Frequency unknown: syncope
The cardiovascular system
Often: orthostatic hypotension.
Respiratory system
Often: nasal congestion.
Gastrointestinal tract
Often: diarrhea.
Infrequently: nausea, dry mouth.
Reproductive system
Very often: retrograde ejaculation, anejaculation
Infrequently; decreased libido, erectile dysfunction
Intraoperative cider
Frequency unknown: Intraoperative syndrome of "flabby" iris during cataract operations.

Contraindications

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

Carefully
With mild to moderate renal failure (creatinine clearance from 30 to 50 ml / min).

Drug interactions

Combination with other alpha-blockers is not recommended due to the possible potentiation of the action.
The combined use of CYP3A4 isoenzyme inhibitors (ketoconazole, clarithromycin, itraconazole, ritonavir) is not recommended, since it increases the concentration of silodosin in plasma.
Phosphodiesterase-5 inhibitors (sildenafil, tadalafil) when used together may increase the risk of dizziness.
Antihypertensive drugs beta-blockers, calcium antagonists, drugs acting on the renin-angiotensin aldosterone system, diuretics, when used together, increase orthostatic hypotension.

Special instructions

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 should sit or lie down and remain in this 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. Treatment with Urorec® leads to a decrease in the amount of seminal fluid, which can affect male fertility. This effect disappears after discontinuation of the drug Urorec®.
Patients taking or taking alpha adrenoblockers may experience flabby iris syndrome during cataract surgery, which can lead to complications during surgery. It is necessary to stop treatment with alpha ^ adrenergic blockers 1-2 weeks before such an operation. Patients who are scheduled for cataract surgery are not recommended to start treatment with Urorec®,
No studies have been conducted to influence the ability to drive vehicles and equipment. However, patients should be informed about the possible manifestations of symptoms associated with orthostatic hypotension (for example, dizziness), as well as warned that they should refrain from driving vehicles and equipment until the individual tolerance of Urerek® to the patient is determined.

Overdosage

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