Omnic Okas, controlled-release pills 0.4mg, 10pcs

Composition

Active ingredient:

tamsulosin hydrochloride 0.4 mg;

Auxiliary substances:

macrogol 8000-40 mg;

macrogol

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%)

Pharmacological action

Omnik Ocas – anti-diuretic, alpha-adrenolytic.

Pharmacodynamics

Tamsulosin is a specific competitive blocker of postsynapticα1-adrenergic receptors, especially the α_1A and α_{1D subtypes}, which are responsible for the relaxation of smooth muscles of the prostate, bladder neck and prostatic part of the urethra. Omnik Ocas in a dosage of 0.4 mg increases the maximum speed of urination, and also reduces the smooth muscle tone of the prostate and urethra, improving the outflow of urine and thus reducing the severity of symptoms of emptying.

Omnik Ocas also reduces the severity of filling symptoms, in the development of which detrusor hyperactivity plays an important role.

With long-term therapy, the effect on the severity of filling and emptying symptoms remains, reducing the risk of acute urinary retention and the need for surgical intervention.

Alpha_{-1A blockers}can reduce blood pressure by reducing peripheral resistance. When using Omnik Ocas in a daily dose of 0.4 mg, there was a clinically significant decrease in the number of cases. AD was not noted.

Pharmacokinetics

Suction. Omnik Ocas is a matrix-based controlled release tablet using a non-ionic gel. This dosage form provides a long and slow release of tamsulosin and sufficient exposure with weak fluctuations in the concentration of tamsulosin in blood plasma for 24 hours.

Tamsulosin in the form of Omnik Ocas tablets is absorbed in the intestine. Absorption is estimated at 57% of the administered dose. Food intake does not affect the absorption of the drug.

Tamsulosin is characterized by linear pharmacokinetics. After a single oral use on an empty stomach pills Omnic Okas C_max tamsulosin in plasma is reached after an average of 6 h. At steady state, which is achieved by the 4th day of admission, the concentration of tamsulosin in plasma reaches the highest value after 4-6 h of fasting and after a meal. C_max in plasma is increased from approximately 6 ng/ml after the first dose to 11 ng/ml at steady state.

The lowest concentration of tamsulosin in plasma is 40% of the maximum concentration in fasting and postprandial plasma. There are significant individual differences among patients regarding the plasma concentrations of the drug after a single dose and multiple use.

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 the blood plasma in unchanged form. The ability of tamsulosin to induce the activity of microsomal liver enzymes is practically absent (experimental data).

In case of hepatic insufficiency, no dosage adjustment is required.

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

T_1/2 of tamsulosin in the form of Omnik Ocas tablets with a single dose and at steady state — 19 and 15 hours, respectively.

Indications

Benign prostatic hyperplasia (treatment of urinary disorders).

Contraindications

• hypersensitivity to tamsulosin or any other component of the drug;
• orthostatic hypotension;
• severe liver failure.

With caution-chronic renal failure (Cl creatinine

Side effects

Rarely — dizziness, retrograde ejaculation; in rare cases — orthostatic hypotension, tachycardia/palpitation, asthenia, headache.

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

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

Interaction

No interactions were observed when tamsulosin was co-administered with atenolol, enalapril, nifedipine, or theophylline. When used concomitantly with cimetidine, there was a slight increase in the concentration of tamsulosin in blood plasma;

with furosemide — a decrease, but this does not require changing the dose of Omnik Ocas, since the concentration of the drug 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 vitro studies showed no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and warfarin may increase the rate of tamsulosin elimination.

Concomitant use of other alpha_-1-adrenergic blockers may lead to a hypotensive effect.

How to take, course of use and dosage

Inside, regardless of food intake,1 tablet 1 time a day.

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

The tablet should be taken as a whole and should not be chewed, as this may affect the prolonged release of the Active ingredient.

Overdose

Symptoms:  decline Blood pressure, compensatory tachycardia.

Treatment:  symptomatic. Blood pressure and heart rate can be restored when the patient takes a horizontal position. In the absence of an effect, you can use agents that increase the BCC, and, if necessary, vasoconstrictors. Kidney function should be monitored. It is unlikely that dialysis will be effective, since tamsulosin binds intensively to plasma proteins.

To prevent further absorption of the drug, it is advisable to wash the stomach, take activated charcoal and osmotic laxatives.

Special instructions

During surgical interventions for cataracts while taking the drug, intraoperative instability of the iris (narrow pupil syndrome) may develop, which should be taken into account by the surgeon for preoperative preparation of the patient and during the operation.

Before starting therapy with Omnik Ocas, the patient should be examined in order to exclude the presence of other diseases that may cause the same symptoms as benign prostatic hyperplasia. Before starting treatment and regularly during therapy, a digital rectal examination and, if necessary, determination of a specific prostate antigen should be performed.

In case of renal insufficiency, no dose adjustment is required.

Influence on the ability to drive vehicles and mechanisms

There are no data on the negative impact 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 clarified, it is necessary to refrain from activities that require increased concentration and speed of psychomotor reactions, including driving vehicles.

Composition

Tablet Form of production

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Tamsulosin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For men, For adults

Indications

Prostatic Hyperplasia