Omnik capsules 0.4mg №30

Dosage form

Modified release capsules

Composition

1 caps containstamsulosin hydrochloride 0.4 mg;
Excipients: microcrystalline cellulose, methacrylic acid copolymer, polysorbate 80, sodium lauryl sulfate, triacetin, Calcium stearate, talc, hard gelatin, indigotin E132, titanium dioxide E171, iron yellow oxide E172, iron red oxide E172.

Packing

30 pieces

Mechanism of action

Omnik - alpha1-blocker. It is a specific competitive blocker of postsynaptic α1-adrenoreceptors, especially α1A and α1D subtypes, which are in the smooth muscles of the prostate gland, bladder neck, prostatic urethra and detrusor. Reduces the tone of the smooth muscles of the prostate gland and urethra, improving the flow of urine, reduces the phenomenon of instability of the bladder. This leads to a reduction in the symptoms of obstruction (emptying) and irritation (filling) associated with benign prostatic hyperplasia. The described effect on the symptoms of obstruction and irritation persists with prolonged use. Α1-adrenoreceptor antagonists can reduce blood pressure by reducing the total peripheral vascular resistance.When using the drug OMNIK Okas in a daily dose of 400 μg, there were no cases of clinically significant reduction in blood pressure.

Benign prostatic hyperplasia (dysuria treatment).

Contraindications

Orthostatic 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).

Dosage and administration

Assign inside 400 mcg (1 tab.) 1 time / day, regardless of the meal. The pill should be taken whole without chewing, in order to avoid affecting the prolonged release of the active substance.

Adverse reactions

Cardiovascular: sometimes - palpitations, postural hypotension.
Gastrointestinal: sometimes - constipation, diarrhea, nausea, vomiting.
From the side of the central nervous system: dizziness, sometimes - headache, rarely - faint.
From the reproductive system: sometimes - violations of ejaculation, very rarely - priapism.
Respiratory: sometimes rhinitis.
Allergic reactions: sometimes - skin rash, itching, urticaria, rarely - angioedema.
Other: sometimes asthenia.

Special notes

As with other α1-adrenergic blockers, with Omnick, in some cases, a decrease in blood pressure can be observed, which sometimes can 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. In case of surgery for cataract on the background of the drug intake, the syndrome of intraoperative instability of the iris of the eye (narrow pupil syndrome) may develop, which must be taken into account by the surgeon for the preoperative preparation of the patient and during the operation. Before initiating Omnick therapy, the patient should be examined in order to exclude the presence of other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before treatment, and regularly during therapy, a digital rectal examination should be performed and, if required, the determination of prostate specific antigen (PSA).

In the appointment of the drug Omnik with Atenolol, Enalapril or Nifedipine interactions were found. With simultaneous use of omnik with cimetidine, a slight increase in plasma tamsulosin concentration was noted, and with Furosemide a decrease in concentration (this does not require a change in the omnik dose, since the drug concentration 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 change the free fractions of diazepam, propranolol, trichloromethiazide and chlormadinone. In in vitro studies, no interaction at the level of hepatic metabolism with amitriptyline, Salbutamol, glibenclamide, and Finasteride was detected. Diclofenac and warfarin may increase the rate of elimination of tamsulosin. The simultaneous appointment of other α1-adrenoreceptor antagonists can lead to a decrease in blood pressure.

Overdosage

Symptoms: acute hypotension.
Treatment: to prevent further absorption of the drug, it is advisable to wash the stomach, to appoint the reception of Activated carbon and osmotic laxative, for example, sodium sulfate; Blood pressure and heart rate can recover if the patient is placed in a horizontal position. In the absence of effect, it is possible to use agents that increase the bcc and, if necessary, vasoconstrictor agents. Kidney function should be monitored. Dialysis is unlikely to be effective since tamsulosin binds extensively to plasma proteins.

Storage conditions

The drug should be stored out of reach of children at a temperature not exceeding 25 ° C.