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

1. The mechanism of action of Omnic Okas and Omnik is the same. The only difference is the release of tamsulosin.
2. Omnic Okas is also characterized by better tolerability
3. Also, the drug with the prefix “Okas” is more expensive.

Omnik okas and Omnik are drugs that help effectively combat the main symptoms that occur against the background of prostate adenoma. Both drugs belong to the same group. They also have the same active ingredient, but these drugs still have some differences. Let's take a closer look at what both drugs are, what the difference is between them and which is better.

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.

Method of use

In tablets and capsules, the dosage of the active ingredient tamsulosin is 400 mcg. It is recommended to take one capsule once a day. It is preferable to drink it in the morning, after meals.

Okas tablets are also taken once. However, in this case there is no connection to food intake. This fact is also in favor of tablets.

The duration of treatment can only be determined by a doctor. Therefore, it is not recommended to interrupt therapy or change the dosage of the drug on your own.

Side effects of the drug Omnic ocas

Common side effects (1% but ≤10%) are dizziness (1.3%). Uncommon side effects (0.1%, but ≤1%) are headache, tachycardia, postural hypotension, rhinitis, constipation, diarrhea, nausea, vomiting, rash, urticaria, itching, retrograde ejaculation, asthenia. Rare side effects (0.01%, but ≤0.1%) are fainting, angioedema. Very rare (≤0.01%) - priapism. Cases of intraoperative instability of the iris (narrow pupil syndrome) during cataract surgery in patients taking tamsulosin for a long time have been described.

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.

Special instructions for the use of the drug Omnic ocas

Like other α1-adrenergic receptor blockers, Omnic Ocas should be used with caution in patients with a tendency to orthostatic hypotension. At the first symptoms of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid down. During surgery 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 during the preoperative preparation of the patient and the operation. 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 in the blood. Patients with impaired renal function do not reduce the dose of the drug; the drug is prescribed with caution to patients with creatinine clearance below 10 ml/min. There are no data on use in children. There is no evidence of adverse effects on the ability to drive vehicles or operate potentially dangerous machinery.

Comparative examination of drugs based on Tamsulosin

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Global generics market indicators

In the modern world, the healthcare systems of almost all countries are experiencing financial difficulties - according to experts from the World Health Organization (WHO), “not a single country has sufficient funds for healthcare.” In this regard, rational pharmacotherapy of diseases takes on new meaning as a way to optimize healthcare budgets. One of the ways to reduce the cost of treating patients is to reduce the cost of drugs, which is becoming possible thanks to the development of the generic drug market. The information portal FiercePharma has compiled a rating of the largest manufacturers of generic drugs, according to revenue from their sales in 2012. The Hatch-Waxman Act, signed in 1984, brought results 30 years later. Every year in the United States, doctors write approximately 4 billion prescriptions, of which 84% are prescriptions for generic drugs. Thus, patients and the government save billions of dollars. According to company revenues for 2012, the Israeli company Teva is in first place ($10.4 billion), followed by: Novartis ($8.7 billion), Mylan (5 ,9), Abbott (5.1), Actavis (4.4), Sanofi (2.4), Daiichi Sankyo (2.3), Hospira (2.2), Sun Pharma (2.1) and Aspen (1.9).

Generic drug production is growing worldwide. For example, Chinese pharmaceutical companies are expanding their presence in the largest generic market in the United States - in 2021, the US FDA approved almost 2 times more (38) biosimilars from Chinese pharmaceutical manufacturers than a year earlier. In 2021, India supplied 300 of the 927 generic drugs approved in the US. Accordingly, the more drugs lose patent protection, the more generics appear on the market.

The absence of costs for the synthesis of new molecules and clinical trials makes generic production an attractive way for small companies to enter the pharmaceutical business. Undoubtedly, the vast majority of companies strictly monitor all stages of drug production. However, in the Russian drug market, according to E.N. Khoseva. (Optimization of the system for monitoring the effectiveness and safety of domestically produced generic drugs, 2014), from 20 to 40% of counterfeit products circulate, which is most often characterized by a lack of active substance. The ability to freely purchase prescription drugs at a pharmacy without a doctor’s prescription, but only on the advice of friends and relatives, makes the use of drugs doubly dangerous for the health and life of patients.

A generic (generic), according to the WHO definition, is a reproduced medicinal product that has proven therapeutic interchangeability with the reproduced original drug (brand drug). It is assumed that generics should be produced by a manufacturer other than the original drug, after the expiration of the patent protection, and have a lower cost due to the absence of costs for the development of a unique formula, expensive clinical trials, and in some cases, marketing promotion and advertising. A doctor should prescribe a generic drug only if he is confident in its full pharmaceutical, biological and therapeutic equivalence to the original.

In urology, the most commonly prescribed drug is tamsulosin, a drug branded Omnic and Omnic Ocas.

Tamsulosin-based drugs: comparative examination

In 2021, a group of scientists from the Institutes of Inorganic Chemistry named after. A.V. Nikolaev SB RAS and molecular and cellular biology SB RAS Novosibirsk, with the participation of researchers from Novosibirsk State University, a chemical and pharmacological study of drugs based on tamsulosin was carried out - the original tamsulosin and 7 generic analogues. The purpose of this work was to conduct a comparative study of the technological and physicochemical characteristics of drugs based on tamsulosin hydrochloride, currently used in Russia, to identify differences, as well as possible violations of production technology, i.e. compliance of drugs with the original model and identification of deviations that potentially lead to changes in the therapeutic properties of the drug.

To achieve this goal, a comparative examination of the technological indicators of the capsules was carried out:

• "Omnic" - Astellas (Japan)
• "Proflosin" - Berlin Chemie Menarini (Germany)
• "Focusin" - Sanofi (France),
• "Tamsulosin-OBL" - CJSC "FP "Obolenskoye" (Russia),
• "Tamsulosin" - "Vertex" (Russia),
• "Tamsulosin-CANON" - KANOPHARMA PRODUCTION CJSC (Russia)
• "Omsulosin" - Ranbaxy (India)
• "Tulosin" - EGIS (Hungary)

and tablets:

• "Omnic Okas" - Astellas (Japan),
• Tamsulosin Retard - CJSC FP Obolenskoye (Russia).

The general characteristics of the tablets, the morphology of the film coating and the core material of the tablets, the state and chemical composition of the material of the tablets, the behavior of the tablets and their cores in disintegration tests, the study of sediment morphology and the phase composition of sediments were studied.

Indicators studied

It is known that the therapeutic effect of tamsulosin depends on compliance with 3 conditions: maintaining the drug content in the blood above the minimum therapeutic dose until the next dose of the drug (provided by the delayed release of the active substance - DV - from the dosage form); maintaining the drug content in the blood NOT higher than the maximum recommended dose (also ensured by the delayed release of DV and the gastro-resistant properties of the capsule shell); compliance of the dosage form with the declared composition and chemical structure of the active substance. Regarding the last point, within the framework of bioequivalence studies of generics there are no requirements for analyzing the form of the active substance, which opens the way to reducing the cost of drug production through the use of cheaper raw materials that have not undergone some stages of purification.

The tamsulosin delivery model also consists of 3 components:

• Composition of granules - the composition of the granules and their inert base should ensure uniform distribution of the active substance throughout the granule and the properties necessary for gradual release.
• Granule size - Each capsule should contain fractions of different sizes (from small to large in a certain range) to regulate the gradual release of the drug.
• The capsule shell must have a strictly gastro-resistant composition

In this regard, the researchers analyzed the following indicators:

1. Appearance of tablets and capsules
2. Average weight and deviation in weight of individual tablets
3. Crushing strength of tablets
4. Determination of particle size and shape
5. Identification of different phases and mixtures
6. Disintegration of tablets
7. Dissolution of an amount of substance over a certain period of time

Changing the parameters of any of the components of this complex balanced system “active substance - dosage form” will lead to a change in the entire model and requires a change in the design of the remaining components in order to maintain the pharmacokinetic properties of the drug similar to the original ones.

Results of equivalence studies

Omnik A study of the original drug Omnik revealed full compliance of the physical and chemical properties of the capsules with the declared design and composition. The release profile study demonstrated gradual release within the specified regulatory time frame according to the standards.

Fokusin A study of the generic drug Fokusin did not reveal any significant deviations in the physicochemical properties and composition of the capsules. However, when studying the release profile, pronounced deviations were established: in the first 2 hours, an insufficient amount of tamsulosin is released, and in 12 hours, an excessive amount is released. Thus, the first two conditions for the therapeutic effect of the drug are violated.

Proflosin A study of the generic drug Proflosin revealed a change in the distribution of granule size compared to the original drug: a wide, uneven distribution of granules of various sizes with a decrease in the average number of granules in the capsule. The release profile did not meet the standards and was similar to the profile of the drug Fokusin: an insufficient amount of tamsulosin was released in the first 2 hours, and an excess amount was released in 12 hours. Thus, there are deviations in the K2 component of the model drug and the first two conditions for the therapeutic effect of the drug are violated.

Tulosin and Omsulosin A study of generic drugs Tulosin and Omsulosin revealed a significant decrease in the average number of granules in capsules (more than 4 times), and in the case of Tulosin, an uneven size distribution. The release profile for both drugs differed significantly from the standard - complete release of tamsulosin occurred within 8 hours. Thus, there are deviations in the K2 component of the model drug and the first two conditions for the therapeutic effect of the drug are violated.

Tamsulosin CANON A study of the generic drug Tamsulosin CANON revealed significant changes in the composition, size and properties of pellets. Replacing the inert base of pellets with MCC with sucrose led to a significant change in the solubility of the drugs at low pH values ​​(deviations in the K3 component). The granules have a heterogeneous structure in the direction from the center to the surface (deviations in the K3 component), their number is reduced (more than 5 times), and the size distribution has only 2 pronounced peaks (deviations in the K2 component). The release profile differed sharply from the norm - tamsulosin was completely released within 4 hours. Thus, there are deviations in the K2 and K3 components of the model drug and the first two conditions for the therapeutic effect of the drug are violated.

Tamsulosin (Vertex) A study of the generic drug Tamsulosin (Vertex) revealed significant changes in the composition, size and properties of pellets. Replacing the inert base of pellets with MCC with sucrose led to a significant change in the solubility of the drugs at low pH values ​​(deviations in the K3 component). The number of granules in capsules is sharply reduced (more than 7 times) with a narrow size distribution (deviations in the K2 component). The active substance is localized only in the shell of the granules (deviations in the K3 component). The structure of the granules has been changed - a homogeneous dense structure with the presence of a small number of cavities (deviations in the K3 component). Release profile studies have shown that, although in the first 2 hours the amount of tamsulosin released is within the normal range, after 4 hours the active substance is completely released. Thus, there are deviations in the K12 and K3 components of the model drug and the first two conditions for the therapeutic effect of the drug are violated.

Tamsulosin-OBL A study of the generic drug Tamsulosin-OBL revealed significant changes in the composition, size and properties of the pellets. Replacing the inert base of pellets with MCC with sucrose led to a significant change in the solubility of the drugs at low pH values ​​(deviations in the K3 component). The number of granules in capsules is sharply reduced (more than 8 times) with a narrow size distribution (deviations in the K2 component). The active substance is localized only in the shell of the granules (deviations in the K3 component). The granules have a heterogeneous structure in the direction from the center to the surface (deviations in the K3 component). The release profile at 2 points out of four did not correspond to the standard. In addition, only for this generic drug were deviations in the plane of polarization recorded, which may indicate disturbances in the enantiomeric composition of the drug and requires additional research. Thus, there are deviations in the K2 and K3 components of the model drug, the first two conditions for the therapeutic effect of the drug are violated, and there is reason to assume possible violations of the third condition for the therapeutic effect of the drug.

Rice. 1. Comparison of the release profiles of the drugs Omnic, Proflosin, Focusin, obtained by researchers. Recommended release parameters for tamsulosin are indicated by dark blue bars.

Conclusion The summary results of the study are presented in table. 1. The drugs Omnik , Fokusin , Proflosin correspond to the declared manufacturing design.

Table 1. Summary table of research results

For the drugs Tulosin and Omsulosin , a pronounced decrease in the number of granules was detected, which requires changes in a number of physicochemical parameters to achieve the required release profile.

For the group of drugs Tamsulosin CANON , Tamsulosin (Vertex) and Tamsulosin-OBL , a serious change in the structure and composition of the granules was made, which is a prerequisite for serious disturbances in the dissolution profiles.

According to the results obtained, a significant decrease in the therapeutic effect of the drugs Tamsulosin CANON, Tamsulosin (Vertex), Tulosin and Omsulosin .

According to the results obtained, the therapeutic effect of the drugs Fokusin , Proflosin is not clear, but due to the non-equivalence of the release profiles to the required standards, it can be concluded that there is no physico-chemical, and, as a consequence, therapeutic equivalence with the original drug that meets the standard.

For the generic tamsulosin products studied, the researchers were unable to find any articles in the scientific literature on the development of a new sustained-release drug design for any of them.

The material was prepared by the scientific editor of Uroweb.ru V.A. Shaderkina

1. Khoseva E.N. Optimization of the system for monitoring the effectiveness and safety of domestically produced generic drugs. Auto. doc. dissertation Moscow, 2014. (about counterfeit)

Comments

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Interactions of the drug Omnic ocas

No interactions were observed with the simultaneous use of tamsulosin hydrochloride with atenolol, enalapril, nifedipine and theophylline. When the drug was used in combination with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was observed, and with furosemide - a decrease in concentration, but this does not require a change in the dose of Omnica 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. In vitro, there was no effect of tamsulosin on the level of metabolism of amitriptyline, salbutamol, glibenclamide and finasteride by microsomal liver enzymes. Diclofenac and warfarin may increase the rate of elimination of tamsulosin. Concomitant treatment with other α1-adrenergic receptor antagonists can lead to a pronounced increase in the hypotensive effect.

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.

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.

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.