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

Omnic

Omnic (INN tamsulosin) is an alpha-1-blocker used for the correction of dysuric disorders in prostate adenoma from the Dutch pharmaceutical company Astellas Pharma Europe. Available in capsules. Selectively inactivates alpha-1 receptors located in the smooth muscle tissue of the pelvic organs - prostate, cervical bladder, prostatic area of ​​the urethra. By reducing the excess tone of the smooth muscle “framework” of these tissue structures, normal evacuation of urine from the body through the urinary tract becomes possible. At the same time, obstructive manifestations and symptoms of irritation characteristic of prostate adenoma are leveled out. The therapeutic effect of the drug develops, as a rule, at the end of the second week from the start of the pharmacotherapeutic course. Omnic is a selective drug that interacts only to a small extent with the B subtype of alpha-1 adrenergic receptors, so it has virtually no effect on the level of systemic blood pressure, both in hypertensive patients and in individuals with normal initial blood pressure levels. After oral administration, Omnic is quickly and completely absorbed from the digestive tract. Peak plasma concentrations after taking the recommended single dose are achieved at 7 hours of tamsulosin's presence in the body. Metabolism of the active substance is slow. The half-life of the drug is 10 hours, and with regular course use it is 13 hours.

Excreted along with urine. Taken once a day after the morning meal. Side effects are relatively rare. These include vertigo, subjective tachycardia, headache, decreased appetite, and retrograde ejaculation. Contraindication to use is individual intolerance to tamsulosin. The drug should be used with caution in persons with liver disease and high blood pressure. The use of Omnic involves preliminary diagnosis to exclude diseases that have symptoms similar to prostate adenoma. Diagnostic testing includes rectal palpation and a blood test for prostate-specific antigen. In patients with kidney disease, no dose adjustment of Omnic is required. During treatment, activities that require attention and concentration should be minimized. Furosemide, when used together, somewhat suppresses the activity of Omnic, while cimetidine, on the contrary, increases it. Diclofenac accelerates the elimination of Omnic from the body. When using the drug together with other drugs from the alpha-1-blocker group, the antihypertensive effect may be enhanced, up to the point of fainting. At the first such signs, the patient should take a sitting or lying position and wait out the developed precollapse symptoms. Data on overdose with Omnic have not been reported in the medical literature to date.

• Magazine archive /
• 2017 /

The effectiveness of the use of drugs Omnic and Omnic Ocas in patients with lower urinary tract symptoms due to benign prostatic hyperplasia (multicenter observational program)

DOI: https://dx.doi.org/10.18565/urology.2017.5.42-47

BOO. Shalekenov, E.A. Kuandykov, S.B. Shalekenov

JSC "Kazakh Medical University of Continuing Education", Department of Urology and Andrology, Almaty, Kazakhstan

The purpose of this study was to examine the effectiveness and safety of 6-month use of Omnic and Omnic Ocas in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in routine urological practice in Kazakhstan. Design. The design of the project was a multicenter prospective observational program that involved the collection of data from patients with symptoms of urinary dysfunction due to BPH who received Omnic Ocas or Omnic as primary therapy. Materials and methods. The program included 1513 patients with a verified diagnosis of LUTS/BPH who were treated with Omnic Ocas or Omnik (tamsulosin) by urological specialists in medical institutions in the Republic of Kazakhstan. Study According to the protocol, 1381 patients completed the study. The average age of the patients was 63 years. The study program included three control visits: visit 1 (initial), during which the patient filled out the I-PSS questionnaire on symptoms and quality of life, determined the maximum urine flow rate (Qmax) according to uroflowmetry and prostate volume according to digital rectal study, the level of PSA in the blood plasma was assessed. Visit 2 and Visit 3 were carried out on average 3 and 6 months, respectively, after Visit 1 and reflected the assessment of the outcomes of the prescribed therapy during the observation period of the patient. Results. During the 6-month treatment, an improvement in clinical symptoms was noted on the I-PSS scale for patients of different age groups. The drug therapy used was more effective for patients with urine flow Discussion. The results of a significant improvement in urinary function in all patients with lower urinary tract symptoms and benign prostatic hyperplasia who took part in the study according to the protocol and received therapy with Omnic Ocas or Omnic (tamsulosin) (n=1381) indicate the following: in age groups “under 55 years”, “55–65 years” and “over 65 years” a decrease in symptoms was observed (the total score on the I-PSS scale after 6 months of therapy decreased by 41.6%), the feeling of incomplete emptying of the bladder after urination was reduced, the need to urinate more often than 2 hours after urination is reduced, and a decrease in the intermittency of the stream is noted. The therapy was well tolerated: adverse events were reported in 1.6% of patients. Thus, we can conclude that the drugs Omnik and Omnik Okas are highly effective in all age groups of patients with LUTS/BPH and the favorable safety profile of these drugs in routine clinical practice. Conclusion. The data obtained allow us to conclude that the drugs Omnik and Omnik Okas are highly effective in all age groups of patients with LUTS/BPH and the favorable safety profile of these drugs.

Key words: symptoms of urinary dysfunction, benign prostatic hyperplasia, tamsulosin, controlled absorption system for oral administration, α1-adrenergic receptors

Read the article in the Doctor's Library

Literature

1. McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011;185(5):1793–803.

2. Singh I., Agarwal V., Garg G. Tamsulosin and Darifenacin Versus Tamsulosin Monotherapy for BPH with Accompanying Overactive Bladder. J. Clin Diagnosis Res. 2015;9(6):PC08–11.

3. Yuan JQ, Mao C., Wong SY, Yang ZY, Fu XH, Dai XY, Tang JL Comparative Effectiveness and Safety of Monodrug Therapies for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Network Meta-analysis. Medicine (Baltimore). 2015;94(27):e974.

4. Bishr M., Boehm K., Trudeau V., Tian Z., Dell'Oglio P., Schiffmann J., Jeldres C., Sun M., Shariat SF, Graefen M., Saad F., Karakiewicz PI Medical management of benign prostatic hyperplasia: Results from a population-based study. Can Urol Assoc J 2016;10(1-2):55–59.

5. Carnevale FC, Antunes AA, da Motta Leal Filho JM et al. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010;33(2):355–361.

6. Michel MC et al. Cardiovascular Safety of the Oral Controlled Absorption System (OCAS) Formulation of Tamsulosin Compared to the Modified Release (MR) Formulation. Eur Urol. 2005;4(2 Suppl):53–60.

7. Chapple CR et al. Tamsulosin Oral Controlled Absorption System (OCAS) in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH): Efficacy and Tolerability in a Placebo and Active Comparator Controlled Phase 3a Study. Eur Urol. 2005;4(2 Suppl):25–32.

8. Yamada S., Suzuki M., Tanaka C. et al. Comparative study on alpha 1-adrenoceptor antagonist binding in human prostate and aorta. Clin Exp Pharmacol Physiol. 1994;21:405–411.

9. Shatylko TV Using uroflowmetry for diagnosis and evaluation of the effectiveness of treatment of urological diseases. Byulleten' meditsinskikh internet-konferentsii. 2012;2(2):137. Russian (Shatylko T.V. The use of uroflowmetry in the diagnosis and assessment of the effectiveness of treatment of urological diseases. Bulletin of medical Internet conferences. 2012;2(2):137).

About the authors / For correspondence

AUTHORIZATION: B. U Shalekenov – Doctor of Medical Sciences, Professor, Head. Department of Urology and Andrology JSC “Kazakh Medical University of Continuing Education” Almaty, Kazakhstan; e-mail

Urologist Ilya Sukhov

Good afternoon In the early stages of benign hyperplasia, I do not recommend using a remedy such as Omnik, which has received a number of disapproving reviews from doctors. It is aggressive and difficult for the entire body: in 45% of cases it causes severe hormonal changes.

In this case, I recommend taking Biomanix. The product normalizes blood circulation in the pelvis, reduces inflammation of the prostate, reduces pain symptoms and, at the same time, has a positive effect on potency (strengthens and prolongs erection). This product contains inhibitory substances and the following natural ingredients: carginine, muaki root, muira puama. The drug also supports high physical activity, strengthens the immune system, and has a general healing effect.

Urologist Andrey Derevyalov

Omnik effectively restores painless urination, reducing the number of urges to empty the bladder per day. It slows down prostate growth and hyperplasia , fights bacteria and reduces inflammation. I recommend taking this drug during complex therapy for benign hyperplasia and using it for at least two weeks. It is after this period that the first clinical results of therapy appear. Omnic has contraindications, the main ones being:

1. liver, kidney failure;
2. orthostatic collapse;
3. individual intolerance to the composition.

Before therapy, it is important to exclude the presence of other diseases, the symptoms of which can be confused with signs of hyperplasia.

OMNIK (capsules)

Back in another part of the country, the clinic told us that there was a similar drug with a similar effect and name.
And it was better for us to buy the second one... But by that time we had almost completed the course; nothing could be changed. I am writing this review from the point of view of the owners who observe the effect of this drug. Alas, the animal cannot say what it feels and how, so I want to write about what we observed. I hope the information is useful to you.

It is not difficult to buy the drug, you can do it without a prescription, but it was not available in every pharmacy. The cost is approximately 140 UAH (about 330 rubles). The box looks like this:

There is no special information on the sides. Be sure to check the expiration date.

The instructions are very large. But I advise everyone to read it, since the side effects are strong, and you need to know what will happen to you (your family). You can read part of the instructions in the photo:

There are no particular difficulties in application. We tried to give 1 capsule after breakfast at approximately the same time. I had to be careful about swallowing the medicine, since the capsule cannot be split.

Externally, the capsules differ from others, and therefore it is difficult to confuse them. The blister with them looks like this:

And the flip side:

Our application. We began to give this medicine as prescribed by the doctor during the disease crisis. On the 2nd day, it was easier for the dog to go to the toilet, but his general condition began to deteriorate. The temperature rose and did not fall. The husband decided to stop the drug after 4 days and look at the body’s reaction. The problem returned - it was impossible to urinate again. They chose the lesser of two evils and resumed the course again. The doctors who prescribed the drug said that the general poor condition of the body, as well as many possible side effects, is inevitable. But they won't be able to help with other drugs or treatments until this underlying crisis passes.

I had to wait for the entire course, about a month. The general condition was really bad. Yes, the dog began to go to the toilet easier and endure less. This became the main advantage of the medicine. But the stream was still thin and jerky, so I had to stand for a long time. We had a fever most days; the only difference was how high it was. The pet was very lethargic, he didn’t get up, let alone go for a walk. It was difficult to move his paws, so we tried, soon after breakfast, we started to have loose stools, so we calculated the time to go for a walk with him before lunch. Sometimes he refused to eat. In order not to put extra stress on the stomach and liver, we changed the diet.

Another property of the drug became no less serious. Despite the fact that it is considered an antibiotic and should kill all sorts of nasty things in the body, we had a slightly different effect. Yes, sometimes various bees, wasps, and insects tried to bite the dog; on a walk, sometimes he caught ostyuki (from a plant like a sharp grain). But often we found inflammation if it appeared and it went away quickly. And then what happened is unknown, but a lump began to form on our neck. It was getting bigger. Since at this time we often visited veterinarians, we were under supervision. The cause of the inflammation could not be determined. We were told that there was no point in opening it while we were using this drug. And at the end, “the inflammation will go away naturally.” So it actually happened that after finishing the course, on the 2nd day, an abscess opened in that place and additional treatment of the resulting wound was required. It’s hard for me to call it a coincidence, but I can’t explain the relationship either.

View the side effects indicated by the manufacturer in the table:

Bottom line. The effect after taking it lasted for a week. Then the problem returned, maybe just not with such force. I had to go to different veterinary hospitals in another city. I won’t say that the reception was in vain, but we are very glad that we no longer give it to our pet. You can read about a different drug prescribed in another review (“Prostatilen”).

Urologist Petr Yakimov

Hello! In my review, I do not recommend Omnic, since the drug often causes side effects, especially from the cardiovascular system (for example, tachycardia or orthostatic hypotension). I recommend taking this remedy in extremely rare cases when “softer” products are not effective.

Most of my patients benefit from Pantosagan, a natural product that has no special contraindications. It is effective in combination with other medications.

Among the advantages I can note:

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

Pharmacological action: Selectively blocks postsynaptic alpha1A-adrenergic receptors of the smooth muscles of the prostate gland, bladder neck and prostatic urethra. The ability to block alpha1A adrenergic receptors is 20 times greater than the effect on alpha1B adrenergic receptors of vascular smooth muscle (the effect on systemic blood pressure is negligible).

Reduces the tone of the smooth muscles of the prostate gland, bladder neck, prostatic urethra, improves urine flow, reduces symptoms of obstruction and irritation of the urinary tract in benign prostatic hyperplasia.

The therapeutic effect develops after 2 weeks.

After oral administration, it is almost completely absorbed from the gastrointestinal tract (absorption more than 90%). Eating increases bioavailability and Cmax, and reduces the time to reach Cmax. Cmax is achieved after 4–5 hours (when taken on an empty stomach) or 6–7 hours (when taken with food). The equilibrium concentration is established by the 6th day of course administration, its peak values ​​are 60–70% higher than Cmax after a single oral dose. Plasma protein binding (mainly alpha1-glycoprotein) is 94–99%, distributed throughout the blood and extracellular fluid (volume of distribution - 0.2 l/kg). Slowly biotransformed in the liver with the participation of cytochrome P450 isoenzymes (mainly CYP3A4 and CYP2D6) with the formation of active metabolites (retain selectivity for alpha1A-adrenergic receptors), circulates in the plasma mainly unchanged. T1/2 - 9–13 hours in healthy volunteers, 14–15 hours in patients during treatment. It is excreted primarily by the kidneys in the form of conjugates of metabolites with glucuronic and sulfuric acids (10% unchanged), partially with feces.

Administration of tamsulosin to male and female rats at doses of 43 mg/kg/day and 52 mg/kg/day, respectively, did not lead to an increase in the incidence of tumors, with the exception of a moderate statistically significant increase in the incidence of mammary fibroadenoma in female rats at doses greater than 5 .4 mg/kg.

Evaluation of potential carcinogenicity in mice at doses of 127 mg/kg/day (males) and 158 mg/kg/day (females) did not reveal a significant increase in the incidence of tumors in males, while in females, over 2 years Those receiving the highest doses of 45 mg/kg/day and 158 mg/kg/day found a statistically significant increase in the incidence of fibroadenoma and adenocarcinoma of the breast. At the highest doses used to evaluate carcinogenicity in mice, AUC values ​​in animals were 8 times higher than those in humans at a dose of 0.8 mg/day.

Reported cases of mammary tumors in female rodents are secondary and appear to be caused by tamsulosin-induced hyperprolactinemia.

No mutagenic activity was detected in a number of in vitro

and
in vivo.
In studies in male rats receiving single or multiple doses of tamsulosin 300 mg/kg/day (AUC in rats 50 times higher than that observed in humans at a dose of 0.8 mg/kg), a significant decrease in fertility was found, possibly due to changes in the composition of seminal fluid or ejaculation disorders. The effects were reversible, improvement was observed 3 days after taking a single dose and 4 weeks after the end of multiple doses (full recovery was observed after 9 weeks). No adverse effects on fertility were observed with multiple doses of 10 and 100 mg/kg/day (1/5 and 16 of the estimated human AUC values).

In female rats, a significant decrease in fertility was detected with single or repeated administration of the R-isomer or racemic mixture of tamsulosin at a dose of 300 mg/kg/day. The decrease in fertility after a single dose appeared to be due to impaired fertilization. With repeated administration of the racemic mixture at a dose of 10 or 100 mg/kg/day, no negative effect on fertility was detected in female rats.

Omnic caps with modif release 0.4 mg No. 100

Compound

Active substance: tamsulosin hydrochloride 400 mcg. Excipients: microcrystalline cellulose - 281.2 mg, copolymer of methacrylic acid and ethyl acrylate - 42.5 mg, polysorbate 80 - 1 mg, sodium lauryl sulfate - 0.3 mg, triacetin - 1.1 mg, talc - 0.8 mg, calcium stearate - 0.4 mg.

Pharmacokinetics

After oral administration, tamsulosin is quickly and almost completely absorbed from the gastrointestinal tract. After a single oral dose of 400 mcg, the Cmax of the active substance in plasma is achieved after 6 hours.

Plasma protein binding - 99%. Vd is insignificant and amounts to 0.2 l/kg.

Tamsulosin 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 present in the blood unchanged.

T1/2 of tamsulosin with a single dose is 10 hours, terminal T1/2 is 22 hours. It is excreted by the kidneys, 9% unchanged.

Indications for use

Benign prostatic hyperplasia.

Contraindications

Hypersensitivity to tamsulosin.

Directions for use and doses

Adults over 18 years of age and elderly patients:

Orally, after breakfast, with water, take 1 capsule (0.4 mg) 1 time per day.

It is not recommended to chew the capsule, as this may affect the rate of release of the drug.

Storage conditions

At a temperature not higher than 25 °C. Keep out of the reach of children.

Best before date

4 years. Do not use after expiration date.

special instructions

Use with caution in patients prone to arterial hypotension and with severe liver dysfunction.
Before starting tamsulosin therapy, the patient should be assessed for the presence of other diseases that may cause the same symptoms as benign prostatic hyperplasia. Before starting treatment and regularly during therapy, a digital rectal examination and, if required, determination of prostate specific antigen should be performed. In patients with impaired renal function, no change in dosage regimen is required.

Description

A drug used for urinary disorders associated with benign prostatic hyperplasia.

Dosage form

Modified-release hard gelatin capsules, size No. 2, orange body marked “701” and a graphic image of the company’s trademark, olive green cap marked “0.4”; The contents of the capsules are granules from white to white with a light yellow tint.

Use in children

Use from 18 years of age.

Action

α1-adrenergic receptor blocker; a drug for the symptomatic treatment of benign prostatic hyperplasia.

Selectively blocks postsynaptic α1A-adrenergic receptors of smooth muscles of the prostate gland, bladder neck, prostatic urethra. As a result, the tone of the smooth muscles of these formations decreases, and the outflow of urine is facilitated. At the same time, the symptoms of obstruction and irritation associated with benign prostatic hyperplasia are reduced. The therapeutic effect appears approximately 2 weeks from the start of treatment.

Tamsulosin's ability to block α1B-adrenergic receptors of vascular smooth muscles is much less pronounced, so the effect on systemic blood pressure is insignificant.

Side effects

From the cardiovascular system: rarely - dizziness, orthostatic hypotension, palpitations.

From the side of the central nervous system: headache, asthenia are possible.

From the reproductive system: rarely - retrograde ejaculation.

Use during pregnancy and breastfeeding

Omnic® 0.4 mg capsules are intended for use only in males.

Interaction

With simultaneous use of tamsulosin with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted, and with furosemide - a decrease in concentration; with other α1-blockers - a pronounced increase in the hypotensive effect is possible.

Diclofenac and indirect anticoagulants slightly increase the rate of elimination of tamsulosin.

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.

Other α1-blockers, acetylcholinesterase inhibitors, alprostadil, anesthetics, diuretics, levodopa, antidepressants, beta-blockers, slow calcium channel blockers, muscle relaxants, nitrates and ethanol may increase the severity of the hypotensive effect.

Overdose

There are no reports of cases of acute overdose with tamsulosin. However, theoretically, with an overdose, it is possible to develop an acute decrease in blood pressure and compensatory tachycardia, in which case symptomatic therapy is necessary.

Blood pressure and heart rate can be restored when a person assumes 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. Dialysis is unlikely to be effective as tamsulosin is highly bound to plasma proteins.

To prevent further absorption of the drug, it is advisable to lavage the stomach, take activated charcoal or an osmotic laxative, such as sodium sulfate.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.