Omnic, modified-release capsules 0.4mg, 10pcs

Composition

Active ingredient:

tamsulosin hydrochloride 0.4 mg;

Auxiliary substances:

MCC;

methacrylic acid copolymer (Type C);

polysorbate 80;

sodium lauryl sulfate;

triacetin;

calcium stearate;

talc;

gelatin;

indigotine;

titanium dioxide;

iron oxide yellow;

iron oxide red

Pharmacological action

Omnik – alpha-adrenolytic.

Pharmacodynamics

Blockade_{of α1}-adrenergic receptors with tamsulosin leads to a decrease in the smooth muscle tone of the prostate, bladder neck and prostatic part of the urethra and an improvement in the outflow of urine. At the same time, both emptying and filling symptoms associated with increased smooth muscle tone and detrusor hyperactivity in benign prostatic hyperplasia are reduced.

The ability of tamsulosin to act on the Α1A-subtype of adrenoreceptors is 20 times greater than its ability to interact with_{the Α1B}-subtype of adrenoreceptors, which are located in vascular smooth muscle. Due to its high selectivity, tamsulosin does not cause a clinically significant decrease in systemic blood pressure in both patients with arterial hypertension and patients with normal baseline blood pressure.

Suction

Tamsulosin is well absorbed in the intestine and has almost 100% bioavailability. Tamsulosin absorption slows down somewhat after a meal. The same level of absorption can be achieved if the patient takes the drug every time after a regular breakfast. Tamsulosin is characterized by linear kinetics. After a single oral use of 0.4 mg of the drug, its_cmax in plasma is reached in 6 hours. After repeated oral use of 0.4 mg per day, the equilibrium concentration is reached by day 5, while its value is approximately 2/3 higher than the value of this parameter after taking a single dose.

Distribution

Binding to plasma proteins is 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.

The experiment revealed the ability of tamsulosin to slightly induce the activity of microsomal liver enzymes.

In case of minor and moderate hepatic insufficiency, no dosage adjustment is required.

Deduction

Tamsulosin and its metabolites are mainly excreted in the urine, with about 9% of the drug excreted unchanged.

T_1/2 of the drug with a single dose of 0.4 mg after meals is 10 hours, with multiple doses — 13 hours.

In patients with renal insufficiency, no dose reduction is required if the patient has severe renal insufficiency (Cl creatinine

Indications

Dysuric disorders in benign prostatic hyperplasia (treatment).

Contraindications

• hypersensitivity to tamsulosin or any other component of the drug;
• orthostatic hypotension (including in the anamnesis);
• severe liver failure.

With caution — severe renal insufficiency (creatinine clearance

Side effects

Rarely — dizziness, retrograde ejaculation; in rare cases — orthostatic hypotension, tachycardia/palpitation, asthenia, headache.

From the gastrointestinal tract:  rarely — nausea, vomiting, diarrhea, constipation.

In extremely rare cases, hypersensitivity reactions (skin rash, pruritus, angioedema) may occur.

Interaction

When prescribing Omnik® No interactions were found with atenolol, enalapril, or nifedipine. When Omnika® was co-administered with cimetidine, there was a slight increase in the concentration of tamsulosin in blood plasma, and with furosemide-a decrease in the concentration (this does not require changing the dose of Omnika®, since the concentration of the drug remains within the normal range).

Diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin do not alter the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin also does not alter the free fractions of diazepam, propranolol, trichloromethiazide, and chlormadinone.

In vitro studies showed no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide, or finasteride.

Diclofenac and warfarin may increase the rate of tamsulosin elimination.

Concomitant use of other α1-adrenergic antagonists may lead to a decrease in blood pressure.

How to take, course of use and dosage

Inside. After breakfast, with water,1 capsule (0.4 mg) 1 time a day.

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

Overdose

Symptoms:  theoretically, it is possible to develop an acute decline Blood pressure and compensatory tachycardia.

Treatment:  transfer of the patient to a horizontal position, gastric lavage, use of activated carbon or osmotic laxative (sodium sulfate); in the absence of an effect-the appointment of agents that increase the BCC, if necessary — vasoconstrictors; carrying out symptomatic therapy. Renal function should be monitored. The effectiveness of dialysis is unlikely.

Special instructions

As with other alpha_-1-blockers, treatment with Omnik® may sometimes result in a reduction in the number of patients treated with the drug. Blood pressure, which can sometimes lead to fainting.

At the first sign of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until the signs disappear. During surgical interventions 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 for preoperative preparation of the patient and during the operation.

Before starting therapy with Omnik®, the patient should be evaluated in order to exclude 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 should be performed and, if necessary, prostate specific antigen (PSA) determination should be performed.

Form of production

Capsules

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

4 years

Active ingredient

Tamsulosin

Conditions of release from pharmacies

By prescription

Dosage form

long-acting capsules

Description

For men, For adults

Indications

Prostatic Hyperplasia