Omnic Ocas, 0.4 mg 30 pcs

Omnik Okas is an antidisuric, alpha-adrenolytic.

Pharmacodynamics

Tamsulosin is a specific competitive blocker of postsynaptic α1-adrenoreceptors, especially subtypes α1A and α1D, responsible for relaxing the smooth muscle of the prostate, bladder neck and prostatic urethra.

Omnik Okas in a dosage of 0.4 mg increases the maximum rate of urination and also reduces the tone of the smooth muscles of the prostate and urethra, improving the flow of urine and thus reducing the severity of symptoms of emptying. Omnic Okas also reduces the severity of symptoms of filling, in the development of which detrusor hyperactivity plays an important role.

In long-term therapy, the effect on the severity of filling and voiding symptoms is maintained, reducing the risk of acute urinary retention and the need for surgical intervention.

The α1A-adrenoreceptor blockers may decrease BP by reducing peripheral resistance. No clinically significant decrease in BP has been observed with the use of Omnic Okas at a daily dose of 0.4 mg.

Pharmacokinetics

Intake. Omnic Okas is a matrix-based controlled-release tablet using a nonionic gel. This dosage form provides prolonged and slow release of tamsulosin and sufficient exposure with little variation in plasma tamsulosin concentrations over 24 hours.

Tamsulosin in the form of Omnic Okas tablets is absorbed in the intestine. Absorption is estimated at 57% of the administered dose. Food intake has no effect on the absorption of the drug. Tamsulosin is characterized by linear pharmacokinetics. After a single oral intake of Omnic Okas tablet on an empty stomach, the Cmax of tamsulosin in plasma is reached after 6 hours on average. In the equilibrium state, which is reached by the 4th day of use, the plasma concentration of tamsulosin reaches its highest value after 4-6 hours both on an empty stomach and after a meal. Plasma Cmax increases from approximately 6 ng/ml after the first dose to 11 ng/ml at equilibrium. The lowest plasma concentration of tamsulosin is 40% of the maximum plasma concentration on an empty stomach and after meals. There are significant individual differences among patients with respect to plasma concentrations of the drug after a single dose and multiple doses.

Distribution. Binding to plasma proteins is about 99%, Vd 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 blood plasma in unchanged form. The ability of tamsulosin to induce activity of microsomal liver enzymes is almost absent (experimental data).

In case of hepatic insufficiency no dosing regimen adjustment is required.

Extractions. Tamsulosin and its metabolites are primarily excreted in the urine, with approximately 4-6% of the drug excreted unchanged.

The T1/2 of tamsulosin in the form of Omnic Okas tablets on single administration and in equilibrium is 19 and 15 h, respectively.

Indications

Benign prostatic hyperplasia (treatment of urinary disorders).

Active ingredient

Composition

Active ingredient:

tamsulosin hydrochloride 0.4 mg;

Excipients:

Macrogoal 8000 – 40 mg;

Macrogoal 7000000 – 200 mg;

Magnesium stearate – 1.2 mg;

Shell:

Opadry yellow 03F22733 (hypromellose – 69.536%, macrogol 8000 – 13.024%, iron oxide yellow dye – 17.44%)

How to take, the dosage

Overly, regardless of meals, 1 tablet once a day.

The duration of use is not limited, the drug is prescribed as continuous therapy.

The tablet must be taken whole and must not be chewed, because this can affect the prolonged release of the active substance.

Interaction

When tamsulosin is administered together with atenolol, enalapril, nifedipine or theophylline, no interactions have been found. In concomitant use with cimetidine some increase in plasma concentration of tamsulosin was noted; with furosemide – a decrease, but it does not require changing the dose of the drug Omnic Okas, because the drug concentration remains within the normal range.

Diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not alter the free fraction of tamsulosin in human plasma 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 blockers may lead to hypotensive effects.

Special Instructions

In surgical procedures for cataract with the use of the drug, development of intraoperative iris instability syndrome (narrow pupil syndrome) is possible, which should be taken into account by the surgeon for preoperative preparation of the patient and during surgery.

Before starting therapy with Omnic Okas, the patient must be examined to rule out the presence of other diseases that may cause the same symptoms as benign prostatic hyperplasia. A finger rectal examination must be done before starting treatment and regularly during therapy and, if necessary, a specific prostatic antigen must be determined.

In case of renal insufficiency, no change in dose is required.

Influence on driving and operating ability

There are no data on adverse effects on the ability to drive vehicles and engage in potentially dangerous activities. However, due to the possibility of dizziness, until the patient’s individual reaction is determined, one should refrain from activities which require high concentration and quick psychomotor reactions, including driving vehicles.

Contraindications

With caution – chronic renal failure (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: decreased BP, compensatory tachycardia.

Treatment: symptomatic. BP and HR may be restored if the patient takes a horizontal position. If there is no effect, means increasing blood pressure and, if necessary, vasoconstrictors may be used. Renal function should be monitored. Dialysis is unlikely to be effective because tamsulosin binds intensively to plasma proteins.

In order to prevent further absorption of the drug, gastric lavage and administration of activated charcoal and osmotic laxatives are advisable.

Similarities