Omnic, 0.4 mg 10 pcs

The Omnic is an alpha-adrenolytic.

Pharmacodynamics

Blockade of α₁-adrenoreceptors by tamsulosin results in reduction of the tone of the smooth muscles of the prostate, bladder neck and prostatic part of the urethra and improvement of outflow of urine. Simultaneously both symptoms of emptying and symptoms of filling caused by increased tone of smooth muscles and detrusor hyperactivity in benign prostatic hyperplasia are reduced.

The ability of tamsulosin to affect α_1A-subtype adrenoreceptors is 20 times greater than its ability to interact with α_1B-subtype adrenoreceptors located in vascular smooth muscle. Due to its high selectivity, tamsulosin does not cause clinically significant reduction of systemic BP both in patients with arterial hypertension and in patients with normal baseline BP.

Pharmacokinetics

Absorption

Tamsulosin is well absorbed in the intestine and has almost 100% bioavailability. Absorption of tamsulosin slows down slightly after meals. The same level of absorption can be achieved if the patient takes the drug after the usual breakfast each time. Tamsulosin is characterized by linear kinetics. After a single oral dose of 0.4 mg of the drug, its C_max in plasma is reached after 6 h. After multiple oral doses of 0.4 mg per day, the equilibrium concentration is reached by day 5, with a value of about 2/3 that after a single dose.

Distribution

The binding to plasma proteins is 99%; the volume of distribution is small (about 0.2 L/kg).

Metabolism

Tamsulosin is slowly metabolized in the liver to form less active metabolites. Most of tamsulosin is present in plasma in unchanged form.

The ability of tamsulosin to slightly induce the activity of microsomal liver enzymes has been revealed in the experiment.

In mild to moderate hepatic insufficiency there is no need to adjust the dosing regimen.

Tamsulosin and its metabolites are primarily excreted in the urine, with about 9% of the drug excreted unchanged.

The T_1/2 of the drug is 10 hours with a single administration of 0.4 mg after a meal, and 13 hours with multiple administration.

In case of renal impairment, no dose reduction is required if the patient has severe renal impairment (creatinine Cl

Indications

Dysuric Disorders in Benign Prostatic Hyperplasia (Treatment).

Active ingredient

Composition

Active ingredient:

Tamsulosin hydrochloride 0.4 mg;

Supplementary substances:

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 this may affect the rate of release of the drug.

Interaction

No interactions have been found with atenolol, enalapril or nifedipine when Omnic® was administered together. When concomitant use of Omnic® with cimetidine, a slight increase in plasma concentration of tamsulosin and a decrease in concentration with furosemide were noted (this does not require changing the dose of Omnic®, since 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-adreno-blockers, 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 must 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 necessary, a prostate specific antigen (PSA) test 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:It is theoretically possible to develop an acute decrease in BP and compensatory tachycardia.

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

Similarities