Omnik Okas - instructions for use, dose, side effects, contraindications

macrogol 8000 - 40.0 mg, macrogol 7000000 - 200.0 mg, magnesium stearate - 1.2 mg; tablet shell - opadraj yellow 03F22733 - 7.25 mg (hypromellose - 69.536%, macrogol 8000 - 13.024%, iron dye yellow oxide - 17.440%).

Description:

Round, biconvex tablets, covered with a coating, from yellow to brownish-yellow, on one side it is squeezed out "04".

Pharmacotherapeutic group:α1-blocker

ATX: & nbsp

G.04.C.A.02 Tamsulosin

Pharmacodynamics:

Tamsulosin is a specific competitive blocker of postsynaptic α₁-adrenoceptors, especially α_1A and α₁_D subtypes responsible for relaxing the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra. Omnic 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 gland and urethra, improving the outflow of urine and thus reducing the severity of symptoms of emptying.Oknik Okas also reduces the severity of filling symptoms, in which the role of detrusor hyperactivity plays an important role.

With prolonged therapy, the effects on the symptoms of filling and emptying remain, reducing the risk of acute urinary retention and the need for prompt intervention.

Blockers α₁_A-adrenoceptors can reduce blood pressure by decreasing peripheral resistance. When using Omnic Okas in a daily dose of 0.4 mg of cases, there was no clinically significant reduction in blood pressure.

Pharmacokinetics:

Suction: Omnic Okas is a controlled release tablet based on a matrix using a non-ionic gel. This dosage form provides a sustained and slow release of tamsulosin, and sufficient exposure with a slight fluctuation in tamsulosin concentration in the blood plasma for 24 hours.

Tamsulosin in the form of tablets Omnic Okas is absorbed in the intestine. Absorption is estimated at 57% of the administered dose. Eating does not affect the absorption of the drug. Tamsulosin characterized by linear pharmacokinetics.After a single oral ingestion of Omnik Okas tablet, the maximum concentration of tamsulosin in plasma is reached on average after 6 hours. In the equilibrium state, which is reached by the 4th day of intake, the concentration of tamsulosin in plasma reaches its highest value in 4-6 hours, either on an empty stomach or after a meal. The maximum plasma concentration increases from about 6 ng / ml after the first dose to 11 ng / ml in the equilibrium state. The lowest concentration of tamsulosin in plasma is 40% of the maximum plasma concentration in the fasting and after meals. There are significant individual differences among patients with regard to the concentration of the drug in the plasma after a single dose and repeated administration.

Distribution: The connection with plasma proteins is about 99%, the volume of distribution is small (about 0.2 l / kg).

Metabolism: Tamsulosin It is slowly metabolized in the liver with the formation of less active metabolites. Most of the tamsulosin is present in plasma in unchanged form. The ability of tamsulosin to induce the activity of microsomal liver enzymes is practically absent (experimental data). With hepatic failure, there is no need for correction of the dosing regimen.

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

The half-life of tamsulosin in the form of Omnic Okas tablets is 19 and 15 hours, respectively, in a single administration and in an equilibrium state.

Indications:

Benign prostatic hyperplasia (treatment of urination disorders).

Contraindications:

- Hypersensitivity to tamsulosin or any other component of the drug.

- Orthostatic hypotension.

- Severe hepatic insufficiency.

Carefully:Chronic renal failure (creatinine clearance below 10 ml / min), severe liver dysfunction, hypotension.

Dosing and Administration:

Inside, 1 tablet 1 time per day, regardless of food intake. Duration of use is not limited, the drug is prescribed in the form of continuous therapy.

The tablet should be taken in its entirety, it can not be chewed, as this can affect the prolonged release of the active substance.

Side effects:

	Frequent (> 1%, <10%)	Infrequent (> 0,1%, <1%)	Rare (> 0.01%, <0.1%)	Very rare (<0.01%)
Disorders from the cardiovascular system		Palpitations, orthostatic hypotension
Disorders from the gastrointestinal tract		Constipation, diarrhea, nausea, vomiting
General condition disorders		Asthenia
Disturbances from the nervous system	Dizziness (1.3%)	Headache	Fainting
Disorders from the reproductive system		Violations of ejaculation		Priapism
Disturbances from the respiratory, thoracic and mediastinal organs		Rhinitis
Disturbances from the skin and subcutaneous tissue		Rash, itching, urticaria	Angioedema

Individual cases of intraoperative iris of the eye (narrow-pupil syndrome) are described in patients with cataract surgery who increase the risk of complications during and after surgery.

Overdose:

Symptoms: lowering of arterial pressure, compensatory tachycardia. Treatment is symptomatic. Arterial blood pressure and heart rate can be restored when patients are taken to a horizontal position. In the absence of effect, it is possible to use agents that increase the volume of circulating blood and, if necessary, vasoconstrictors. It is necessary to monitor kidney function.It is unlikely that dialysis will be effective, since tamsulosin intensively binds to plasma proteins.

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

Interaction:

When tamsulosin was prescribed together with atenolol, enalapril, nifedipine, or theophylline no interactions were found. With simultaneous use with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted; with furosemide - a decrease in concentration, however this does not require a change in the dose of Oknik Okas, since the drug concentration remains within the normal range. Diazepam, propranolol, trichloromethiazide, chloromadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma in vitro. In its turn, tamsulosin also does not change free fractions of diazepam, propranolol, trichloromethiazide and chloromadinone.

In studies in vitro no interaction was found at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin can increase the rate of excretion of tamsulosin.

Simultaneous assignment of other blockers α₁-adrenoceptors can lead to an antihypertensive effect.

Precautions for use

As with the use of other α₁- adrenoblockers, in Omnik Okas treatment, in some cases, there may be a decrease in blood pressure, which in rare cases can lead to a fainting condition. At the first signs of orthostatic hypotension (dizziness, weakness), the patient must sit or lie down and remain in this position until the signs disappear.

The withdrawal syndrome is absent.

Special instructions:

With surgical interventions for cataracts against the background of taking the drug, the development of intraoperative irrosis syndrome (narrow pupil syndrome) is possible, which should be taken into account by the surgeon for preoperative preparation of the patient and during the operation.

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

With renal failure, dose changes are not required.

Effect on the ability to drive transp. cf. and fur:Data on the negative impact on the ability to drive vehicles and engage in potentially hazardous activities are not available. Nevertheless, in connection with the possibility of dizziness, before determining the individual reaction of the patient should refrain from studies that require increased concentration and speed of psychomotor reactions, including driving.

Form release / dosage:Controlled-release tablets coated with 0.4 mg.

Packaging:

For 10 tablets in a blister of laminated foil PVC and aluminum foil, 1 or 3 blisters together with instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000849

Date of registration:24.02.2011 / 26.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:Astellas Farma Europe BVAstellas Farma Europe BV Netherlands

Manufacturer: & nbsp

ASTELLAS PHARMA EUROPE, B.V. Netherlands

ZIO-HEALTH, JSC Russia

Representation: & nbspASTELLAS PHARMA YUROP BV ASTELLAS PHARMA YUROP BV Netherlands

Information update date: & nbsp07.06.2017

Illustrated instructions

Instructions

Omnik Okas (Omnic Ocas)