Omnic, 0.4 mg 30 pcs

Pharmgroup:

The alpha1-adrenoblocker.

Pharmic action:

Omnic selectively and competitively blocks the postsynaptic α1A-adrenoreceptors located in the smooth muscle of the prostate, bladder neck, and prostatic portion of the urethra, as well as α1D-adrenoreceptors located primarily in the bladder body. This leads to reduction of the tone of the smooth muscles of the prostate, bladder neck and prostatic part of the urethra and improvement of detrusor function.

This decreases symptoms of obstruction and irritation associated with benign prostatic hyperplasia. As a rule, therapeutic effect develops 2 weeks after the beginning of therapy, although some patients have less symptoms after the first dose.

Omnik’s ability to affect α1A-adrenoreceptors is 20 times greater than its ability to interact with α1B-adrenoreceptors, which are located in the smooth muscle of blood vessels. Due to this high selectivity, the drug does not cause any clinically significant reduction of systemic BP both in patients with arterial hypertension and in patients with normal baseline BP.

Indications

Dysuric disorders in benign prostatic hyperplasia (treatment).

Pharmacological effect

Pharmaceutical group:

alpha1-blocker.

Pharmaceutical action:

Omnic selectively and competitively blocks postsynaptic α1A-adrenergic receptors located in the smooth muscles of the prostate gland, bladder neck and prostatic urethra, as well as α1D-adrenergic receptors primarily located in the body of the bladder. This leads to a decrease in the tone of the smooth muscles of the prostate gland, bladder neck and prostatic urethra and improved detrusor function.

This reduces the symptoms of obstruction and irritation associated with benign prostatic hyperplasia. As a rule, the therapeutic effect develops 2 weeks after starting the drug, although some patients experience a decrease in the severity of symptoms after taking the first dose.

Omnic’s ability to act on α1A-adrenergic receptors is 20 times greater than its ability to interact with α1B-adrenergic receptors, which are located in vascular smooth muscle. Due to such high selectivity, the drug does not cause any clinically significant decrease in systemic blood pressure in both patients with arterial hypertension and in patients with normal baseline blood pressure.

Special instructions

As with the use of other α1-blockers, when treated with Omnic®, in some cases a decrease in blood pressure may be observed, which can sometimes lead to fainting. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until the signs disappear. During surgical interventions for cataracts while taking the drug, the development of intraoperative instability syndrome of the iris (narrow pupil syndrome) is possible, which must be taken into account by the surgeon for preoperative preparation of the patient and during the operation.

Before starting therapy with Omnic®, the patient should be examined to exclude the presence of other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before starting treatment and regularly during therapy, a digital rectal examination and, if required, a prostate specific antigen (PSA) determination should be performed.

Active ingredient

Tamsulosin

Composition

Active ingredient:

tamsulosin hydrochloride 0.4 mg;

Excipients:

MCC;

methacrylic acid copolymer (type C); polysorbate 80;

sodium lauryl sulfate;

triacetin;

calcium stearate;

talc;

gelatin;

indigotine;

titanium dioxide;

iron oxide yellow;

iron oxide red

Contraindications

hypersensitivity to tamsulosin or any other component of the drug;
orthostatic hypotension (including history);
severe liver failure.

With caution – severe renal failure (Cl creatinine

Side Effects

Rarely – dizziness, retrograde ejaculation; in isolated cases – orthostatic hypotension, tachycardia/palpitations, asthenia, headache.

From the gastrointestinal tract: rarely – nausea, vomiting, diarrhea, constipation.

In extremely rare cases, hypersensitivity reactions (skin rash, itching, angioedema) may occur.

Interaction

When prescribing Omnic® together with atenolol, enalapril or nifedipine, no interactions were found. With simultaneous use of Omnic® with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted, and with furosemide, a decrease in concentration (this does not require changing the dose of Omnic®, since the concentration of the drug remains within the normal range).

Diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.

In vitro studies did not reveal interactions at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride.

Diclofenac and warfarin may increase the elimination rate of tamsulosin.

Concomitant administration of other α1-adrenergic receptor antagonists may lead to a decrease in blood pressure.

Overdose

Symptoms: it is theoretically possible to develop an acute decrease in blood pressure and compensatory tachycardia.

Treatment: transfer the patient to a horizontal position, gastric lavage, administration of activated charcoal or an osmotic laxative (sodium sulfate); if there is no effect, prescribe drugs that increase blood volume, and, if necessary, vasoconstrictors; carrying out symptomatic therapy. Kidney function should be monitored. Dialysis is unlikely to be effective.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

4 years

Manufacturer

ZiO-Zdorovye CJSC, Russia