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).

Active ingredient

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

How to take, the dosage

Ingestion.

After breakfast with water, 1 capsule (0.4 mg) once daily.

The capsule should not be chewed because it may interfere with the rate of release of the drug.

Interaction

No interactions have been found with atenolol, enalapril or nifedipine when Omnic® is administered together. When concomitant use of Omnic® with cimetidine, a slight increase in plasma concentration of tamsulosin was observed, and with furosemide – a decrease in concentration (this does not require changing the dose of Omnic® , because the drug concentration remains within the normal range).

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

In in vitro studies, no interaction at the level of hepatic metabolism was found with amitriptyline, salbutamol, glibenclamide and finasteride.

Diclofenac and warfarin may increase the excretion rate of tamsulosin.

The concomitant administration of other α1-adrenoreceptor antagonists may decrease BP.

Special Instructions

As with other α1-adrenoblockers, treatment with Omnic® may occasionally cause a decrease in BP, which may sometimes lead to fainting. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and stay in this position until the signs disappear. In surgical interventions for cataract the development of intraoperative iris instability syndrome (syndrome of narrow pupil) is possible during the drug administration; the surgeon must take it into account during the preoperative preparation of the patient and during the operation.

Before starting therapy with Omnic®, the patient should be examined to rule out the presence of other conditions that may cause the same symptoms as benign prostatic hyperplasia. A finger rectal examination and, if required, a prostate specific antigen (PSA) determination should be performed before starting treatment and regularly during therapy.

Contraindications

With caution – severe renal impairment (creatinine Cl

Side effects

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

Gastrointestinal disorders: rarely – nausea, vomiting, diarrhea, constipation.

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

Overdose

Symptoms: theoretically it is possible to develop acute BP decrease and compensatory tachycardia.

Treatment: transfer patient to horizontal position, gastric lavage, prescription of activated charcoal or osmotic laxative (sodium sulfate); if no effect – prescription of means to increase the blood pressure, if necessary – vasoconstrictors; symptomatic therapy. Renal function should be monitored. The effectiveness of dialysis is unlikely.

Similarities