Omnic ocas for the treatment of prostate diseases: reviews. Omnic Okas: instructions for use Release form and appearance

Reduces the tone of the smooth muscles of the prostate gland and urethra, improving the outflow of urine.
Drug: OMNIK® OKAS

Active substance of the drug: tamsulosin
ATX coding: G04CA02
CFG: A drug used for urinary disorders associated with benign hyperplasia prostate gland. Alpha1-blocker
Registration number: LS-000849
Registration date: 06.23.08
Owner reg. credential: ASTELLAS PHARMA EUROPE B.V. (Netherlands)

Release form of Omnic okas, drug packaging and composition.

Controlled-release, yellow to brownish-yellow film-coated tablets, round, biconvex, debossed with “04” on one side. 1 tab. tamsulosin hydrochloride 400 mcg
Excipients: macrogol 8000, macrogol 7,000,000, magnesium stearate.
Shell composition: Opadry yellow 03F22733 (hypromellose, macrogol 8000, iron oxide yellow dye), purified water.
10 pieces. - blisters (1) - cardboard packs.
10 pieces. - blisters (3) - cardboard packs.
The description of the drug is based on the officially approved instructions for use.

Pharmacological action of Omnic okas

Alpha1-adrenergic blocker. It is a specific competitive blocker of postsynaptic 1-adrenergic receptors, especially 1A and 1D subtypes located in the smooth muscles of the prostate gland, cervix Bladder, prostatic part of the urethra and detrusor. Reduces the tone of the smooth muscles of the prostate gland and urethra, improving the outflow of urine, and reduces the phenomena of bladder instability. This results in a reduction in the symptoms of obstruction (emptying) and irritation (filling) associated with benign prostatic hyperplasia. The described effects on symptoms of obstruction and irritation persist with long-term use.
1-adrenergic receptor antagonists can reduce blood pressure by reducing peripheral vascular resistance. When using the drug Omnic Okas in daily dose 400 mcg, no cases of clinically significant decrease in blood pressure were observed.

Pharmacokinetics of the drug.

Suction
Omnic Ocas is a matrix-based controlled release tablet using a non-ionic gel that provides a long and slow release of tamsulosin and gives sufficient exposure with slight fluctuations over 24 hours.
Tamsulosin in the form of Omnic Okas is absorbed from the gastrointestinal tract. Absorption is 57%. The absorption of tamsulosin in the form of Omnic Ocas is not affected by food intake. Tamsulosin is characterized by linear pharmacokinetics. After a single oral administration on an empty stomach of the drug at a dose of 400 mcg, the Cmax of tamsulosin in the blood plasma is achieved on average after 6 hours. In the equilibrium state, which is achieved by the 4th day of administration, the Cmax of tamsulosin in the blood plasma is achieved after 4-6 hours both when taken on an empty stomach and and after meals. There are significant individual differences in plasma concentrations after a single dose and repeated use.
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 unchanged. According to experimental studies, tamsulosin has virtually no ability to induce the activity of microsomal liver enzymes.
Removal
Tamsulosin and its metabolites are excreted mainly in the urine, with about 4-6% of the drug excreted unchanged.
When taking Omnic Ocas at a dose of 400 mcg once and at steady state, T1/2 is 19 hours and 15 hours, respectively.

Indications for use:

Benign prostatic hyperplasia (treatment of dysuria).

Dosage and method of administration of the drug.

Prescribed orally 400 mcg (1 tablet) 1 time/day, regardless of meals. The tablet should be taken whole, without chewing, to avoid affecting the prolonged release of the active substance.

Side effects of Omnic okas:

Criteria for assessing the frequency of development side effects: often - >1%,<10%; иногда — >0.1%, <1%; редко — >0.01%, <0.1%; очень редко — <0.01%.
From the cardiovascular system: sometimes - palpitations, postural hypotension.
From the digestive system: sometimes - constipation, diarrhea, nausea, vomiting.
From the side of the central nervous system: 1.3% - dizziness; sometimes - headache; rarely - fainting.
From the reproductive system: sometimes - ejaculation disorders; very rarely - priapism.
From the respiratory system: sometimes - rhinitis.
Allergic reactions: sometimes - skin rash, itching, urticaria; rarely - angioedema.
Other: sometimes - asthenia.

Contraindications to the drug:

Orthostatic arterial hypotension;
- severe liver failure;
- hypersensitivity to tamsulosin or any other component of the drug.
The drug should be used with caution in chronic renal failure (creatinine clearance less than 10 ml/min).

Special instructions for use of Omnik okas.

When using the drug Omnic Okas (as well as other alpha1-blockers), in some cases a decrease in blood pressure may be observed, which in rare cases leads to fainting. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until the signs of this condition disappear.
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 during surgery.
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, it is necessary to perform a digital rectal examination and, if necessary, determination of prostate specific antigen (PSA).
In case of renal failure, no dose adjustment is required.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, patients should be careful when driving vehicles and other activities that require high concentration and speed of psychomotor reactions.

Drug overdose:

Symptoms: acute arterial hypotension.
Treatment: to prevent further absorption of the drug, it is advisable to perform gastric lavage, prescribe activated charcoal and an osmotic laxative, for example, sodium sulfate; Blood pressure and heart rate may recover if the patient is placed in a horizontal position. If there is no effect, you can use drugs that increase blood volume and, if necessary, vasoconstrictors. Kidney function should be monitored. It is unlikely that dialysis will be effective because... Tamsulosin binds intensively to plasma proteins.

Interaction of Omnic okas with other drugs.

When tamsulosin was prescribed concomitantly with atenolol, enalapril, nifedipine or theophylline, no drug interactions were detected.
When used simultaneously with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was observed; with furosemide - a decrease in concentration, but this does not require a change in the dose of Omnica Ocas, since its concentration 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 β1-adrenergic receptor antagonists may lead to a hypotensive effect.

Terms of sale in pharmacies.

The drug is available with a prescription.

Storage conditions for the drug Omnic okas.

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life: 3 years.

3D images

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.

Description of the dosage form

A round, biconvex, film-coated tablet, yellow to brownish-yellow in color, with “04” embossed on one side.

pharmachologic effect

pharmachologic effect- antidysuric, alpha-adrenolytic.

Pharmacodynamics

Tamsulosin is a specific competitive blocker of postsynaptic α 1 -adrenergic receptors, especially the α 1A and α 1D 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.

α 1A-adrenergic receptor blockers can reduce 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.

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 on an empty stomach of Omnic Ocas tablets, the Cmax of tamsulosin in plasma is achieved on average after 6 hours. In an 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 for a single dose and at steady state is 19 and 15 hours, respectively.

Indications of the drug Omnic Okas

Benign prostatic hyperplasia (treatment of urinary disorders).

Contraindications

hypersensitivity to tamsulosin or any other component of the drug;

orthostatic hypotension;

severe liver failure.

Carefully— chronic renal failure (Cl creatinine<10 мл/мин), тяжелое нарушение функции печени, артериальная гипотензия.

Side effects

Side effects	Often (≥1%, <10%)	Infrequently (≥0,1%, <1%)	Rarely (≥0,01%, <0,1%)	Very rarely (<0,01%)
From the SSS side		palpitations, orthostatic hypotension
From the gastrointestinal tract		constipation, diarrhea, nausea, vomiting
General state		asthenia
From the nervous system	dizziness (1.3%)	headache	fainting
From the reproductive system		ejaculation disorders		priapism
From the respiratory system, chest and mediastinum		rhinitis
From the skin and subcutaneous tissue		rash, itching, urticaria	angioedema

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 Okas, 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 research in vitro no interaction was found at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and warfarin may increase the elimination rate of tamsulosin.

The simultaneous administration of other α 1 -adrenergic receptor blockers can lead to a hypotensive effect.

Directions for use and doses

Inside, regardless of food intake, 1 table. 1 time per day. The duration of use is not limited; the drug is prescribed as continuous therapy. The tablet must be taken whole; it cannot be chewed, because this may affect the sustained release of the active substance.

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.

Precautionary measures

As with the use of other α 1 -blockers, when treated with Omnic Okas, in some cases a decrease in blood pressure may be observed, which in rare cases can lead to fainting. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until these signs disappear.

There is no withdrawal syndrome.

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.

Conditions for dispensing from pharmacies

On prescription.

Storage conditions for the drug Omnic Okas

At a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life of the drug Omnic Okas

3 years.

Do not use after the expiration date stated on the package.

Synonyms of nosological groups

Category ICD-10	Synonyms of diseases according to ICD-10
N40 Prostatic hyperplasia	Prostate adenoma
	BPH
	Prostatic hypertrophy
	Prostate hypertrophy
	BPH
	Dysuric disorders caused by benign prostatic hyperplasia
	Dysuric disorder in benign prostatic hyperplasia
	Dysuria with prostate adenoma
	Benign prostatic hyperpalasia
	Benign prostatic hyperplasia
	Benign prostatic hyperplasia stages 1 and 2
	Benign prostatic hyperplasia stages 1 and 2 in combination with prostatitis
	Benign prostatic hyperplasia grade I
	Benign prostatic hyperplasia grade II
	Benign prostatic hypertrophy
	Prostate disease
	Acute urinary retention associated with benign prostatic hyperplasia
	Paradoxical ischuria

Medicines Omnik and Omnik Okas, instructions for use of which are below, are drugs intended to alleviate the patient’s condition with problems with urination (prostate adenoma, stones in the kidneys or ureter, chronic cystitis and much more).

Recently, one can increasingly encounter a disease such as prostatic hyperplasia, which leads not only to impaired urination, but also to the appearance of unpleasant sensations such as heaviness in the lower abdomen, pain, and burning.

Many drugs have been created that are designed to stop the problem; one of the most effective drugs of this kind is Omnic.

Omnic is intended to reduce irritation and relieve symptoms of obstruction in benign prostatic hyperplasia, according to the instructions for use.

When taking the drug, the manifestation of symptoms of impaired urination is significantly reduced, in addition, blood pressure is reduced, swelling goes away, and normal urine outflow is restored even in particularly advanced cases, this is described in the instructions.

You can find out how to use the drug Omnic to achieve maximum effect, as well as its dosage, contraindications and differences from Omnic Ocas below. Instructions for use are presented, and cheaper analogues of the drug, which are not much inferior in effectiveness to Omnic, will be considered, and general recommendations for the use of the drug will be given.

Release form and appearance

The drug is available in the form of tablets or capsules coated with a soluble coating, 10 pieces in each foil blister. A pack may contain 1 or 3 blisters. The drug Omnic is produced in the form of capsules, the drug Omnic Okas is made in tablets. Many people think that this is the only difference between the drugs, but this is not so. More details about how Omnik differs from Omnik Okas a little later.

Omnic Okas tablets have a round, biconvex shape, color from yellow to brownish-yellow. They also have a characteristic medicinal smell. On one side of the Omnic Ocas tablet the numbers 0 and 4 are extruded. Omnic capsules have granules inside, the color of which ranges from white to light yellow, while the capsule itself is green-olive.

Active ingredients

The main active ingredient of the drug is tamsulosin hydrochloride. The composition also includes auxiliary components: magnesium stearate, macrogol and others; the instructions for use in the package list these components.

Usually, the therapeutic effect of the medicine becomes obvious after two weeks of use, since the drug has a “cumulative” effect, but at the same time, there are cases when patients noted an improvement in their general condition after the first use of the drug, reviews say.

Omnic - indications for use

The drug Omnic is a drug intended for the treatment of urinary disorders due to diseases such as prostatic hyperplasia, prostate adenoma, stones in the ureter and kidneys, and so on, as stated in the official instructions for use. Reviews about the drug are mostly positive.

The drug is used on an ongoing basis - a course of treatment with the drug is unacceptable, since it will have absolutely no effect.

Most often, doctors prescribe Omnic as an auxiliary and symptomatic therapy designed to alleviate the course of the underlying disease, which cannot be treated or cannot be cured for a certain period of time.

Contraindications, side effects, overdose

All drugs have certain contraindications and side effects. Omnic is no exception. The instructions for use describe all these points.

Contraindications

Like all medicines, Omnic has a number of contraindications, in which the drug should be used with caution, or not used at all. Below we will look at cases when it is better not to use Omnic. Instructions for use of the drug highlight several conditions. Here are some indications that limit or completely prohibit the use of the drug:

1. Hypersensitivity to any component of the drug, as well as an allergic reaction to drugs in the past. In this case, the tablets should be used with extreme caution or in combination with anti-allergy tablets, according to the instructions for use.
2. Severe liver failure or severe impairment of its functioning. For such a disease, the doctor usually prescribes the use of the drug Omnic Okas. Thanks to its special mechanism of action, it does not load the liver with a large number of chemicals at once, but acts gradually, allowing the organ to work in a gentle manner.
3. Orthostatic and arterial hypotension - if you have previously had problems with blood pressure and blood vessels, it is best to choose another drug for use that does not have such contraindications, or even stop taking the medicine altogether, says the instructions for use.
4. Chronic kidney failure - as well as with liver failure, the drug should be taken under medical supervision and with extreme caution.

Side effects

The instructions state that the product may cause side effects of varying severity, for example:

• cardiopalmus;
• constipation or diarrhea;
• nausea, vomiting;
• dizziness, fainting;
• ejaculation disorder;
• difficulty breathing;
• rash, itching, allergic reactions and so on.

However, it is worth noting that despite all the side effects and restrictions on the use of the drug, there is no withdrawal reaction from the drug. That is, you can stop taking the pills at any time - according to the doctor’s decision or other circumstances, and you will not get worse, the instructions for use say.

Overdose

In case of an overdose of the drug, a decrease in blood pressure, tachycardia, dizziness, nausea, and spots in the eyes may occur. Usually, no special treatment is required for an overdose; the patient just needs to lie down and drink strong tea or coffee. If there is no improvement, it is possible to use medications that increase blood pressure (vasoconstrictors). You should also closely monitor your kidney function.

In addition, it would be advisable to perform gastric lavage (in case of severe overdose and obvious manifestations of symptoms), or take activated charcoal or other absorbent drugs. In addition, you can drink a laxative in order to minimize the amount of the drug absorbed by the body.

In order to avoid side effects and overdose of the drug, you must carefully follow all the recommendations of the doctor who prescribed Omnic to you, the instructions for use must be read carefully, and you must not exceed the dosage of the drug indicated by the doctor.

Method of storage and use, dosage of the drug

The medicine should be stored in a dry place, out of reach of children, at a temperature of no more than 25 °C; the shelf life should not exceed three years from the date of release of the drug. After the expiration date, the drug cannot be used - it must be completely discarded.

The drug is used strictly as prescribed by the attending physician - he can select the appropriate dosage for you, depending not only on the disease that needs to be stopped, but also on the general condition of the body, as well as the results of the examinations performed.

Standard Dosages and Applications

Typically, the drug is prescribed once a day, regardless of when you ate, if we are talking about capsules, or immediately after breakfast, if you take tablets.

It is not necessary to take the tablets in the morning; it is important to simply take them at the same time of day, since the active ingredient in the tablets gradually affects the body over 24 hours, while the capsules act almost instantly.

The tablet or capsule must be taken completely and cannot be divided or chewed. In addition, the drug does not have a specific period of use; as a rule, Omnic and Omnic Okas are prescribed for use on an ongoing basis or for a certain long period of time.

The difference between Omnic and Omnic Okas

Having seen two similar names, patients are often confused and cannot decide which drug the doctor prescribed for them. And they also wonder what are the differences between the drug Omnic and Omnic Ocas? What is the price, analogues, reviews?

It's simple: the differences between Omnic and Omnic Okas are only in the absorption and distribution of the drug in the body.

In other words, Omnic Okas usually has a milder effect on the body as a whole and on lowering blood pressure in particular, which is optimal for hypotensive patients. Thanks to the special coating of the tablets, the active component is released slowly and affects the body for 24 hours, while the Omnic product acts quickly and completely, immediately after the capsule shell dissolves. This means that Omnic Okas is intended for people suffering from problems such as moderate hypotension, diabetes mellitus, liver and kidney failure, or having other chronic diseases for which the drug should be used with caution. Otherwise, the principle of action of the product and its composition are absolutely identical, both in the number of components and in name.

If your doctor prescribed Omnic to you and you do not experience any side effects from its use, then it is not necessary to switch to Omnic Okas. Conversely, if you observe undesirable consequences of taking capsules, then you should start taking tablets to correct the effect of the medicine on your organs and systems.

Omnic - treatment price

Today, capsules in pharmacies in large Russian cities can be purchased for around 400 rubles for 10 pieces, while tablets will cost about 600 rubles. As you can see, the drug Omnix Okas is almost one and a half times more expensive than the usual drug.

A package of 30 pieces will cost the buyer the following amounts: capsules approximately 700-800 rubles, and tablets 1500-1700 rubles.

In general, the medicine, of course, is not critically expensive, but given the duration of use, the amount per year is very impressive and not always affordable for a person with an average income.

That is why many customers in pharmacies are interested in what can replace the product and what analogues Omnic Okas has that differ in cost but do not differ in effectiveness.

It turns out that the drug can be replaced with many drugs and dietary supplements - analogues with a similar effect, while the cost will be much lower.

Inexpensive analogs of Omnik and Omnik Okas

You can replace the drugs Omnik and Omnik Okas with the following products, the most popular in pharmacies:

1. Hyperprost- a drug that can be used in cases where Omnic replacement is required. The analogue is not only good value - no more than 250 rubles for 10 tablets, but also has less effect on changes in blood pressure, which means it may be suitable for people suffering from hypotension. In addition, you can find it in almost any pharmacy.
2. Omsulosin- the price of 30 tablets is no more than 500 rubles. Today this is the most popular analogue drug, since it is not only inexpensive, but also has a minimal number of side effects.
3. Proflosin- 30 tablets can be bought for no more than 400-450 rubles at any pharmacy.
4. Revokarin- an inexpensive analogue with excellent action, is an excellent budget alternative for replacement, the average price is 280 rubles for 10 tablets.
5. Sonizin- the price is low, the efficiency is good. For 10 tablets you need to pay about 250-300 rubles - an interesting analogue of Omnik.
6. Tamsulosin-Teva- 30 tablets will cost approximately 600-650 rubles, you need to use the product once a day at any time, the active ingredient of this medicine is completely similar to Omnik.

In addition, there are other, less well-known analogues of Omnic, which are also very effective for treatment, but they can be quite difficult to find in pharmacies - with rare exceptions. Such drugs include, for example, the following analogues:

• Tamzelin;
• Tamsulosin retard;
• Tamsulosin-OBL;
• Tamsulosin hydrochloride;
• Tamsulon-FS;
• Taniz ERAS;
• Taniz-K;
• Tulosin;
• Focusin and others.

And 7000000, magnesium stearate, purified water, shell – yellow opadry 03F22733.

Release form

Omnic Okas is produced in the form of controlled-release tablets No. 10 or No. 30 per package.

pharmachologic effect

Alpha-adrenolytic, antidysuric.

Pharmacodynamics and pharmacokinetics

The active ingredient of the drug Omnic Okas is tamsulosin – belongs to the group of drugs that are competitive specific blockers of postsynaptic alpha1-adrenergic receptors , which have a special affinity for their alpha1A and alpha1D subtypes, which are responsible for the relaxation of smooth muscle tissue prostate gland , prostatic department urethra and cervix Bladder . Orally administered dosage tamsulosin, equal to 400 mcg, increases speed urination and reduces muscle tone urethra And prostate gland , thereby improving urinary outflow and reducing the negative symptoms of unstable work Bladder . This effect of the drug leads to a decrease in symptoms irritation And obstruction related to , which persists even after long-term treatment.

Tamsulosin , like other alpha1A-adrenergic receptor antagonists, is capable of lower due to lowering peripheral resistance , although when taken daily 400 mcg tamsulosin clinically significant cases of such lowering blood pressure was not observed.

The dosage form of the drug Omnic Okas is a tablet with controlled (slow) releasing active ingredient, created on the basis of a matrix using nonionic gel . The use of such a tablet ensures a slow and prolonged release from it tamsulosin and its further sufficient exposure with minimal fluctuation in plasma concentrations of the drug over 24 hours.

Suction tamsulosin from Omnic Ocas tablets occurs in the intestines, where approximately 57% of the administered dose of the drug is absorbed. Parallel food intake does not affect absorption processes. For tamsulosin characterized by linear pharmacokinetics. When taken orally one tablet Omnic Okas on an empty stomach, plasma Cmax tamsulosin on average observed after 6 hours. By the fourth day of taking the tablets, an equilibrium state of tamsulosin is achieved with its highest serum concentration observed 4-6 hours after taking the drug, regardless of food intake. In this case, the plasma Cmax of the active ingredient increases to 11 ng/ml, compared to the 6 ng/ml observed after taking the first dose. The lowest serum content of the drug is equal to 40% of its maximum plasma concentration. Among patients undergoing therapy with Omnic Ocas, significant individual differences in plasma concentrations are observed. tamsulosin after its one-time and multiple doses.

Binding tamsulosin occurs approximately 99% with plasma proteins, Vd is approximately 0.2 l/kg.

For tamsulosin characterized by slow metabolic transformations in the liver with the release of less active products of the active ingredient. In a significant majority tamsulosin is in unchanged form. The drug has virtually no effect on the activity of liver microsomal .

When treatment with tamsulosin is discontinued, withdrawal syndrome does not develop.

Occasionally, while taking Omnic Okas tablets, sudden decreased blood pressure , which may cause fainting . In this regard, at the first manifestations orthostatic hypotension (feeling weaknesses , feeling dizziness ) the patient is recommended to take a sitting or lying position and remain in it until all negative symptoms disappear.

If a patient experiences side effects from treatment, such as dizzy , he is advised to refrain from driving and performing hazardous work.

Analogues of Omnic Okas

Level 4 ATX code matches:

Omnic Ocas tablets are indicated for use exclusively by men.

Compound

Active substance: tamsulosin hydrochloride 0.4 mg,
Excipients: macrogol 8000, macrogol 7000000, magnesium stearate; shell composition – opadry yellow 03F22733 (hypromellose, macrogol 8000, yellow iron oxide dye (E172)).

Description

A round, biconvex, film-coated tablet, yellow to brownish-yellow in color, with “04” embossed on one side.

Pharmacotherapeutic group

Drugs for the treatment of benign prostatic hyperplasia. Alpha adrenergic receptor antagonists.
ATX code: G04CA02

Pharmacological properties

Pharmacodynamics
Tamsulosin is a specific competitive blocker of postsynaptic α 1 -adrenergic receptors, especially α 1A and α 1D 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 flow 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 voiding symptoms. 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.
α 1A-adrenergic receptor antagonists can reduce 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.
Pharmacokinetics
Suction: Omnic Ocas is a matrix-based controlled release tablet using a non-ionic gel type. This dosage form provides a long and slow release of tamsulosin, resulting in sufficient exposure with slight fluctuations over 24 hours.
Tamsulosin in the form of 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 is characterized by linear pharmacokinetics. After a single oral administration on an empty stomach of 0.4 mg Omnica Ocas tablets, the maximum concentration of tamsulosin in plasma is achieved on average after 6 hours. In the steady state, which is achieved by the 4th day of administration, the concentration of tamsulosin in plasma reaches its peak after 4-6 hours, both on an empty stomach and after a meal. Peak plasma concentrations increase from approximately 6 ng/mL after the first dose to 11 ng/mL at steady state. As a result of the extended release of tamsulosin, the trough plasma concentration of tamsulosin is 40% of the peak 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.
The rate and extent of absorption of tamsulosin hydrochloride in the form of Okas is not affected by a low-fat meal. Absorption is increased by 64% and 149% (AUC and Cmax, respectively) after a high-fat meal compared to fasting.
Distribution: Plasma protein binding is about 99%, the volume of distribution 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. Tamsulosin has virtually no ability to induce the activity of microsomal liver enzymes (experimental data).
The results of in vitro studies showed that the CYP3A4 and CYP2D6 isoenzymes are involved in the metabolism of tamsulosin hydrochloride with a minor contribution of other CYP isoenzymes. Inhibition of the enzymes CYP3A4 and CYP2D6 may lead to increased concentrations of tamsulosin hydrochloride.
For mild to moderate liver failure, no dosage adjustment is required.
Removal: Tamsulosin and its metabolites are primarily excreted in the urine, with approximately 4-6% of the drug excreted unchanged.
The half-life of tamsulosin in the form of OCAs after a single dose and at steady state is 19 and 15 hours, respectively.

Indications for use

Benign prostatic hyperplasia (treatment of urinary disorders).

Contraindications for use

Hypersensitivity to tamsulosin or any other component of the drug.
- Orthostatic hypotension.
- Severe liver failure.
Carefully– chronic renal failure (creatinine clearance below 10 ml/min), arterial hypotension.

Directions for use and doses

Orally, 1 tablet 1 time per day, regardless of meals. The duration of use is not limited; the drug is prescribed as continuous therapy.
The tablet must be taken whole and should not be chewed as this may affect the prolonged release of the active substance.
In patients with impaired liver and kidney function
In case of renal failure, as well as in case of mild and moderate liver failure, no dosage adjustment is required.
Use in children
The safety and effectiveness of tamsulosin in children under 18 years of age have not been established. The drug is not indicated for the treatment of children under 18 years of age.

Precautions for use

As with the use of other α 1 -blockers, during treatment with Omnic Ocas, in some cases a decrease in blood pressure may be observed, which in rare cases can lead to fainting. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until the signs disappear.
Withdrawal syndrome: absent.
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. The advisability of discontinuing tamsulosin hydrochloride therapy 1-2 weeks before cataract or glaucoma surgery has not yet been proven. Cases of intraoperative instability of the iris occurred in patients who stopped taking the drug earlier before surgery. It is not recommended to initiate tamsulosin hydrochloride therapy in patients scheduled for cataract or glaucoma surgery. During the preoperative examination of patients, the surgeon and ophthalmologist should consider whether the patient is taking or has taken tamsulosin. This is necessary to prepare for the possibility of developing intraoperative iris instability syndrome during surgery.
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 prostate specific antigen (PSA) should be performed.
Tamsulosin hydrochloride should not be co-administered with strong CYP3A4 inhibitors in patients with impaired metabolism of the CYP2D6 isoenzyme. The drug should be used with caution in combination with strong and moderate CYP3A4 inhibitors.
It is possible that the remainder of the tablet is observed in the stool.

Overdose

Symptoms: decreased blood pressure, compensatory tachycardia.
Treatment symptomatic. Blood pressure and heart rate can be restored when the patient takes a horizontal position. If there is no effect, you can use drugs 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 is intensely bound to plasma proteins.
To prevent further absorption of the drug, it is advisable to lavage the stomach, take activated charcoal and an osmotic laxative, such as sodium sulfate.

Side effect

	Frequent (>1%, <10%)	Infrequent (>0,1%, <1%)	Rare (>0,01%, <0,1%)	Very rare (<0,01%)	Unknown frequency that cannot be estimated from the data provided
Cardiovascular disorders		palpitations, orthostatic hypotension
Gastrointestinal disorders		constipation, diarrhea, nausea, vomiting			Dry mouth*
General condition disorders		asthenia
Nervous system disorders	dizziness (1.3%)	headache	fainting
Visual disorders					blurred vision* visual impairment*
Reproductive system disorders	ejaculation disorders, incl. retrograde ejaculation and anejaculation			priapism
Respiratory, thoracic and mediastinal disorders		rhinitis			nose bleed*
Skin and subcutaneous tissue disorders		rash, itching, urticaria	angioedema	Stevens-Johnson syndrome	erythema multiforme* exfoliative dermatitis*

*Noted in the post-registration period.
Cases of intraoperative instability of the iris (narrow pupil syndrome) during cataract surgery in patients taking tamsulosin for a long time have been described. Frequency not set. Post-marketing use of the drug: In addition to the side effects described above, atrial fibrillation, arrhythmia, tachycardia and shortness of breath have been observed with the use of tamsulosin. Due to the fact that the data were obtained by spontaneous reports during the post-registration period, determining the frequency and cause-and-effect relationship of these events with tamsulosin is difficult.