Omnic Okas controlled release tablets 0.4 mg 30 pcs. in Moscow

Composition and release form

10 pcs in a blister made of PVC foil and aluminum foil laminated; in a cardboard pack 1 or 3 blisters.

Pharmacodynamics

Tamsulosin is a specific competitive blocker of postsynaptic α1-adrenergic receptors, especially the α1A and α1D subtypes, which are responsible for relaxing the smooth muscles of the prostate gland, bladder neck and prostatic urethra. Omnic Okas at a dosage of 0.4 mg increases the maximum speed of urination, and also reduces the tone of the smooth muscles of the prostate gland and urethra, improving the outflow of urine, etc. reducing the severity of bowel movements. Omnic Okas also reduces the severity of filling symptoms, in the development of which detrusor overactivity plays an important role.

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

α1A-adrenergic blockers may lower blood pressure by reducing peripheral resistance. When using the drug Omnic Okas in a daily dose of 0.4 mg, no cases of clinically significant decrease in blood pressure were observed.

Tamsulosin in the form of Okas: unobvious advantages

Within the framework of educational on-line programs, Doctor of Medical Sciences, Professor of the Institute of Urology and Human Reproductive Health of Sechenov University, Chairman of the Board of the Association of Specialists in Conservative Therapy in Urology “ASPECT”, Consultant urologist of the network of Family Clinics and Yusupov Hospital, specialist in conducting clinical drug research Leonid Grigorievich Spivak answered pressing questions from colleagues regarding the treatment of urological patients with urinary disorders.

Speaking about the multifactorial etiology of symptoms of impaired urination, Leonid Grigorievich noted that 49% of men aged 61 to 70 years go to the doctor with complaints of moderate or severe symptoms, while the majority of these patients are men with benign prostatic hyperplasia (BPH) . “Thanks to numerous studies, urologists have become well aware that if left untreated, patients with BPH experience significant deterioration,” the speaker recalled, “hence the logical conclusion that the earlier treatment is started, the better results can be achieved. As for the time to start therapy, there is no clear limit in this regard related to the patient’s age. However, in this regard, there are obvious trends, which are confirmed by an epidemiological study of patients with urinary disorders, conducted in 2021 under the leadership of Academician D.Yu. Pushkar in various medical centers in Russia. This work showed that symptoms do worsen as men age. At the same time, patients aged 60 to 70 years had severe symptoms of urinary disorders, and the number of patients with moderate symptoms (45%) did not differ in the age groups from 50 to 60 and from 60 to 70 years. It follows from this that in such a situation there is no point in leaving men with moderate symptoms without treatment and waiting until the symptoms worsen and there is a need for surgical intervention and installation of a cystostomy.”

In this case, what should be done in case of just emerging manifestations and mild symptoms? Answering this question, Professor L.G. Spivak said: “As follows from the recommendations of the European Society of Urology, the first thing to do is non-drug treatment, namely behavioral therapy methods. As for the latest Russian recommendations for the treatment of patients with BPH, they also note the leading role of behavioral therapy, which includes reducing fluid intake to reduce the frequency of urination (for example, before traveling or going to bed), eliminating caffeine and alcohol from the diet, using relaxation and double urination, massage of the bulbous urethra for the prevention of post-micturic dripping and other techniques. However, in practice, it is not easy to apply these recommendations, especially to patients who have concomitant therapy, incl. with the use of diuretics. And here the important task of the urologist is to optimize these prescriptions, review them together with the therapist, cardiologist and other specialists, which in reality is quite difficult to do. Moreover, unfortunately, even if these difficult tasks are performed, our patients do not receive the expected results. This is confirmed by the results of one of the studies, which showed that active surveillance, discussed above, is not always able to correct symptoms in patients with BPH. This work involved 400 men with risk factors for progression of BPH, who were actively monitored for four years. During this time, the number of patients with moderate and severe symptoms increased almost 5 times. This further reinforces the fact that BPH is a progressive condition. Therefore, no matter how the patient limits himself in fluids and coffee consumption, no matter how he massages the prostate, if the progression of BPH is not stopped, sooner or later behavioral therapy will cease to be effective in terms of the manifestation of symptoms. And this means that the man’s quality of life will deteriorate, and the urologist will be faced with a patient who already has clearly expressed symptoms, which will prevent him from achieving a significant effect. Therefore, non-drug treatment methods must be combined with medicinal ones, as stated in the 2021 European guidelines for the treatment of patients with BPH.”

Next, the speaker drew the attention of his colleagues to the statistics of prescriptions for patients with BPH: “It is no coincidence that monotherapy with α-blockers prevails today in the prescriptions of urologists both in Russia and throughout the world when treating patients with BPH, because at the start of therapy, such therapy allows you to quickly alleviate the symptoms of the disorder. urination. At the same time, according to research, the best balance between effectiveness and safety is the use of tamsulosin.”

Professor L.G. Spivak also noted that, according to statistics, half of all tamsulosin prescriptions are made up of the Omnic® Ocas® dosage form, which has a unique delivery technology that allows for a continuous release of the active substance throughout the entire gastrointestinal tract. “This is very important, since symptoms of impaired urination in our patients are constantly present, so the effectiveness of the drug used must demonstrate itself at any time of the day, throughout 24 hours,” the speaker emphasized.

Professor L.G. Spivak explained that the use of Omnic Ocas in a dose of 0.4 mg allows one to avoid sharp increases in the concentration of the active substance in the blood plasma and then reduce it to a minimum level, because the improved pharmacokinetic profile of the drug maintains this concentration at a constant level. In addition, Omnic Okas has been proven to reduce the severity of nocturia by 57%, which is, according to the speaker, the most important aspect of the use of symptomatic therapy. Also important for patients is the fact that the pharmacokinetics of Omnic Okas 0.4 mg does not depend on food intake. As for the frequency of side effects, studies show: when taking Omnic Okas, it is significantly lower than when taking tamsulosin capsules, which is considered the safest of α-blockers.

Professor L.G. Spivak cited the results of a Russian observational program dedicated to studying the effectiveness and safety of using the drug Omnic Okas in patients with impaired urination due to BPH in routine clinical practice, conducted under the leadership of Academician of the Russian Academy of Sciences O.B. Lorana: “This study showed that Omnic Ocas more than halved the severity of bowel movements and improved the quality of life of patients.”

In conclusion of his report, Leonid Grigorievich about the bladder, whose role in the symptoms of impaired urination is the most important. Therefore, when a man has already developed serious symptoms (sluggish stream of urine, difficulty urinating, frequent urges, nocturnal pollakiuria 3 or more times, episodes of acute urinary retention with a large volume of the pancreas and a large amount of residual urine), it is possible to relieve him of pancreatic hyperplasia only with using surgical treatment. And, unfortunately, after transurethral resection of the pancreas, 55.1% of patients require drug therapy. That is why it is very important not to be late in treating patients with impaired urination, given that the first line of therapy allows for a quick and safe onset of a positive effect. And if we consider that in the arsenal of a modern urologist today there is a drug with a controlled form of absorption, which also costs half as much as before, then the possibilities of helping our patients have become much wider.”

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BPH

Magazine

Newspaper "Moscow Urologist" No. 4-2020

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Pharmacokinetics

Suction. Omnic 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 slight fluctuations in tamsulosin plasma concentrations over 24 hours.

Tamsulosin in the form of Omnic Okas tablets is absorbed in the intestines. Absorption is estimated at 57% of the administered dose. Eating does not affect the absorption of the drug. Tamsulosin is characterized by linear pharmacokinetics. After a single oral administration of Omnic Ocas tablets on an empty stomach, the Cmax of tamsulosin in plasma is achieved on average after 6 hours. In the equilibrium state, which is achieved by the 4th day of administration, the concentration of tamsulosin in plasma reaches its highest value after 4–6 hours both on an empty stomach and after eating. Cmax in plasma increases from approximately 6 ng/ml after the first dose to 11 ng/ml at steady state. The lowest plasma concentration of tamsulosin is 40% of the maximum fasting and postprandial plasma concentration. There is significant individual variation among patients in plasma concentrations of the drug after a single dose and multiple doses.

Distribution. Plasma protein binding 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 liver failure, no dosage adjustment is required.

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

T1/2 of tamsulosin in the form of Omnic Okas tablets with a single dose and at steady state is 19 and 15 hours, respectively.

Pharmacological properties of the drug Omnic ocas

Pharmacodynamics. Tamsulosin selectively and competitively blocks postsynaptic α1-adrenergic receptors, especially α1A and α1D subtypes located in the smooth muscles of the prostate gland, bladder neck, prostatic urethra and detrusor. This causes a decrease in the tone of the smooth muscles of the prostate gland, bladder neck and prostatic urethra and an improvement in urine outflow. At the same time, the severity of symptoms of obstruction (emptying) and irritation (filling) of the bladder associated with benign prostatic hyperplasia decreases. The described effect of the drug on symptoms of obstruction and irritation persists with prolonged use. The ability of α1A-adrenergic receptor blockers to reduce blood pressure is associated with a decrease in peripheral vascular resistance. Omnic Okas in a daily dose of 0.4 mg does not cause a clinically significant decrease in systemic blood pressure both in patients with hypertension (arterial hypertension) and with normal initial blood pressure. Pharmacokinetics. Absorption. Omnic Okas is a prolonged-release tablet with a controlled release of the active substance based on a matrix using a non-ionic gel. This dosage form provides a prolonged and slow release of tamsulosin, which ensures exposure of the active substance with minor fluctuations over 24 hours. After oral administration, 57% of tamsulosin is absorbed in the intestine. The rate and extent of absorption do not depend on food intake. Tamsulosin has linear pharmacokinetics. After a single dose of Omnic Okas on an empty stomach, the maximum concentration of the active substance in the blood plasma is achieved after 6 hours. In the equilibrium state, which is achieved on the 4th day of taking the drug, the maximum concentration is observed after 4-6 hours, regardless of food intake. The maximum plasma concentration increases from 6 ng/ml after the first dose to 11 ng/ml at steady state. As a result of prolonged release, the minimum plasma concentration of tamsulosin is 40% of the maximum concentration, regardless of food intake. Distribution . Plasma protein binding - 99%. The volume of distribution is insignificant - up to 0.2 l/kg body weight. Metabolism. Tamsulosin hydrochloride is not subject to the first pass effect through the liver and is slowly metabolized in the liver to form pharmacologically active metabolites that retain high selectivity for α1A-adrenergic receptors. Most of the active substance is found in the blood unchanged. Excretion. Tamsulosin hydrochloride is excreted in the urine, 4–6% unchanged. The half-life of tamsulosin with a single dose and at steady state is 19 and 15 hours, respectively.

Side effects

Isolated cases of intraoperative instability of the iris (small pupil syndrome) during cataract surgery have been described, which increase the risk of complications during and after surgery.

Interaction

No interactions were observed when tamsulosin was administered together with atenolol, enalapril, nifedipine or theophylline. When used simultaneously with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was observed; with furosemide - a decrease, but this does not require a change in the dose of Omnic Ocas, since the concentration of the drug remains within the normal range. Diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichlormethiazide 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 elimination rate of tamsulosin.

Concomitant administration of other α1-adrenergic receptor blockers may lead to a hypotensive effect.

Omnic Okas instructions for use

Instructions for medical use of the drug Omnic Okas
Composition: 1 tablet contains tamsulosin hydrochloride 0.4 mg.
Other components: macrogol – 7,000,000, macrogol – 8,000, magnesium stearate, purified water, yellow opady. Release form: Film-coated, controlled-release tablets.

Pharmacotherapeutic group: Drugs used for benign prostatic hyperplasia. Alpha adrenergic receptor antagonists. ATC code G04C A02. Action of the medicine.

Pharmacodynamics: Omnic Ocas selectively and competitively blocks postsynaptic alpha1-adrenergic receptors, especially alpha1A and alpha1D subtypes, which are located in the smooth muscles of the prostate gland, bladder neck, prostatic urethra and detrusor. This leads to a decrease in the tone of the smooth muscles of the prostate gland, bladder neck and prostatic part of the urethra and improves urine output. At the same time, the symptoms of obstruction (emptying) and irritation (filling) associated with benign prostatic hyperplasia are reduced. The described effect on symptoms of obstruction and irritation persists with long-term use. The ability of alpha1A-blockers to lower blood pressure is associated with a decrease in peripheral resistance. Omnic Okas at a daily dose of 0.4 mg does not cause a clinically significant decrease in systemic blood pressure (blood pressure) both in patients with arterial hypertension and in patients with normal initial blood pressure.

Pharmacokinetics: Absorption. Omnic Okas is an extended-release, controlled-release tablet based on a matrix using a non-ionic gel. The Ocas formulation provides long-term, slow release of tamsulosin, resulting in exposure with slight fluctuations over 24 hours. After oral administration, 57% of tamsulosin is absorbed in the intestine. The rate and extent of absorption are independent of food intake. Tamsulosin exhibits linear pharmacokinetics. After a single dose of Omnic Okas on an empty stomach, the maximum concentration of the active substance in plasma is observed after 6 hours. In the same state, which is achieved on the fourth day of taking the drug, the peak concentration is observed after 4-6 hours, regardless of food intake. The peak plasma concentration increases from 6 ng/ml after the first dose to 11 ng/ml in the same state. As a result of sustained release, the nadir plasma concentration of tamsulosin is 40% of the maximum concentration, regardless of food intake. Distribution. Plasma protein binding – 99%. The distribution volume is insignificant - up to 0.2 l/kg. Metabolism. Tamsulosin hydrochloride is not susceptible to the “first origin” effect and is slowly metabolized in the liver to form pharmacologically active metabolites that have high selectivity for alpha1A adrenergic receptors. Most of the active substance is present in the blood unchanged. Excretion. Tamsulosin hydrochloride is excreted by the kidneys, 4-6% of the dose is excreted unchanged. The half-life of tamsulosin with a single dose and in the same condition is 19 and 15 hours, respectively.

Indications for use: Treatment of lower urinary tract symptoms in benign prostatic hyperplasia (difficulty starting urination, weak urine stream, dripping after urination, feeling of incomplete emptying of the bladder, frequent urge to urinate, urge to urinate at night, urgency of urination).

Directions for use and dosage: The recommended dose is 1 tablet daily, regardless of meals. The tablet should be swallowed whole, with milk or water; it should not be crushed or chewed as this will interfere with the long-term and controlled release of the active ingredient. The duration of treatment is determined individually.

Side effects: Central nervous system disorders: headache. Cardiovascular system disorders: palpitations, postural hypotension. Respiratory-mediastinal disorders: rhinitis. Disorders of the gastrointestinal system: constipation, diarrhea, nausea, vomiting. Skin and mucous membrane disorders: rash, urticaria, itching. From the reproductive system: retrograde ejaculation. General disorders: asthenia. Liquid (>0.1%, <0.1%): fainting, angioedema. Very thin (<0.1%): priapism.

Contraindications: Hypersensitivity to tamsulosin hydrochloride or to any other component of the drug; history of orthostatic hypotension; severe liver failure.

Overdose: There were no cases of acute overdose of the drug. Theoretically, after an overdose of the drug, there is the possibility of acute hypotension, which would require additional cardiotropic therapy, as well as monitoring and ensuring normal renal function. Dialysis is not indicated because tamsulosin binds to plasma proteins. To prevent further absorption of the drug, vomiting must be induced. You can also prescribe gastric lavage, activated charcoal or an osmotic laxative.

Features of use: Like other alpha1-blockers, Omnic Ocas should be used with caution to treat patients with a tendency to orthostatic hypotension. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or put down. Before using the drug, it is necessary to verify the diagnosis. Before starting treatment and regularly during therapy, a digital rectal examination should be performed and, if necessary, a specific prostate antigen (PSA) should be determined. Patients with impaired renal function will not require a dose reduction; the drug is prescribed with caution to patients with a decrease in creatinine clearance below 10 ml/min. There are no data regarding use in children. There are no data regarding the effect of the drug on the ability to drive vehicles and operate machinery.

Interaction with other drugs: No interaction is observed when tamsulosin hydrochloride is used concomitantly with atenolol, enalapril, nifedipine or theophylline. With simultaneous use of the drug with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted, and with furosemide - a decrease in concentration, but this does not require a change in the dose of Omnic Ocas. Diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma. Tamsulosin also does not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone. There was no effect on hepatic metabolism in in vitro studies with hepatic microsomal fractions that included amitriptyline, salbutamol, glibenclamide and finasterol. Diclofenac and valfarin, however, may increase the rate of elimination of tamsulosin. Concomitant treatment with other alpha1-adrenergic receptor antagonists can lead to a pronounced increase in the hypotensive effect.

Storage conditions and periods: Store out of the reach of children at a temperature of +15 to +25°C; Shelf life: 2 years.

Overdose

Symptoms: decreased blood pressure, compensatory tachycardia.

Treatment: symptomatic. Blood pressure and heart rate can be restored when the patient assumes a horizontal position. If there is no effect, you can use drugs that increase blood volume and, if necessary, vasoconstrictors. It is necessary to monitor kidney function. It is unlikely that dialysis will be effective because... Tamsulosin binds intensively to plasma proteins.

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

Overdose of the drug Omnic ocas, symptoms and treatment

Cases of acute overdose of the drug have not been described. Theoretically, after an overdose of the drug, there is the possibility of developing acute hypotension, which requires the administration of cardiotropic therapy, monitoring of the function of the cardiovascular system and renal function. To prevent further absorption of the drug, gastric lavage, the use of activated charcoal or an osmotic laxative are indicated. Dialysis is not advisable due to the significant binding of tamsulosin to plasma proteins.

special instructions

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

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

In case of renal failure, no dose change is required.

Impact on the ability to drive vehicles and machinery

There is no data on the negative impact on the ability to drive vehicles and engage in potentially hazardous activities. However, due to the possibility of dizziness, until the patient’s individual reaction is clarified, you should refrain from activities that require increased concentration and speed of psychomotor reactions, incl. from driving vehicles.