Omnik - instructions for use, dose, side effects, contraindications

Contents of the capsule: tamsulosin hydrochloride 0.4 mg, microcrystalline cellulose 281.2 mg, methacrylic acid and ethyl acrylate copolymer 42.5 mg, polysorbate-80 1.0 mg, sodium lauryl sulfate 0.3 mg, triacetin 1.1 mg, talc 0.8 mg , calcium stearate 0.4 mg; composition of the capsule shell *: gelatin 62.8 mg, titanium dioxide 0.89 mg, indigocarmine 0.004 mg, iron dye oxide yellow 0.5 mg, iron oxide red oxide 0.04 mg;

* - the identification code is applied to the capsule with black ink, which contains the iron dye ferric oxide black E-172 and shellac.

Description:Hard gelatin capsules of size 2, having an orange-colored body with the marking 701 and a graphic image of the trademark and olive-green color, a lid marked with 0.4. Capsules contain granules from white to white with a light yellow shade of color.

Pharmacotherapeutic group:α1-blocker

ATX: & nbsp

G.04.C.A.02 Tamsulosin

Pharmacodynamics:

Tamsulosin is a specific blocker of postsynaptic α1-adrenoreceptors, located in the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra. The blockade α₁adrenoreceptor tamsulosin leads to a decrease in the tone of the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra and improve the outflow of urine. Simultaneously, both emptying symptoms and filling symptoms are reduced, due to the increased tone of smooth muscles and detrusor hyperactivity in benign prostatic hyperplasia.

The ability of tamsulosin to affect α_1A subtype adrenoreceptors is 20 times greater than its ability to interact α_1B subtype of adrenergic receptors, which are located in the smooth muscles of the vessels. Due to its high selectivity, tamsulosin does not cause a clinically significant decrease in systemic arterial pressure (BP) in both patients with arterial hypertension and in patients with normal initial BP.

Pharmacokinetics:

Suction

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

Distribution

The connection with plasma proteins is 99%, the volume of distribution is small (about 0.2 l / kg).

Metabolism

Tamsulosin is slowly metabolized in the liver with the formation of less active metabolites. Most of the tamsulosin is present in plasma in unchanged form.

In the experiment, the ability of tamsulosin to induce insignificantly the activity of microsomal liver enzymes was revealed.

With a slight and moderate degree of hepatic insufficiency, there is no need for correction of the dosing regimen.

Excretion

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

The half-life of the drug with a single intake of 0.4 mg after a meal is 10 hours, with a multiple of 13 hours.

When renal failure is not required to reduce the dose, if the patient has severe renal failure (creatinine clearance less than 10 ml / min), tamsulosin should be administered with caution.

Indications:Treatment of dysuric disorders in benign prostatic hyperplasia.

Contraindications:

Hypersensitivity to tamsulosin or any other component of the drug.

Orthostatic hypotension (including anamnesis).

Severe hepatic insufficiency.

Carefully:

Severe renal insufficiency (creatinine clearance less than 10 ml / min).

Pregnancy and lactation:

Omnic® 0,4 mg in capsules is intended for use only in males.

Dosing and Administration:

Adults over 18 years, as well as elderly patients

Inside, after breakfast, washing down with water, take 1 capsule (0.4 mg) 1 time per day. Capsule is not recommended to chew, as this can affect the release rate of the drug.

In patients with impaired liver and kidney function

With renal failure, as well as with mild and moderate hepatic insufficiency, correction of the dosing regimen is not required.

Side effects:

	Frequent (> 1%, <10%)	Infrequent (> 0,1%, <1%)	Rare (> 0.01%, <0.1%)	Very rare (<0.01%)
Disorders from the cardiovascular system		Heart palpitations, postural hypotension
Disorders from the gastrointestinal tract		Constipation, diarrhea, nausea, vomiting
General condition disorders		Asthenia
Disturbances from the nervous system	Dizziness (1.3%)	Headache	Fainting
Violations from the reproductive system	Violations of ejaculation			Priapism
Disturbances from the respiratory, thoracic and mediastinal organs		Rhinitis
Disturbances from the skin and subcutaneous tissue		Rash, itching, urticaria	Angioedema	Stevens-Johnson Syndrome

Cases are described intraoperative instability of the iris of the eye (narrow-pupil syndrome) during surgery for cataract and glaucoma in patients taking tamsulosin.

Post-marketing application of the drug: in addition to the side effects described higher when used tamsulosin were observed atrial fibrillation, arrhythmia, tachycardia and shortness of breath. Because, that the data were obtained by spontaneous messages during the period after registration, the definition frequency and cause-effect connection of these phenomena with the reception tamsulosin is difficult.

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. Arterial pressure and heart rate can be restored when a person takes a horizontal position. In the absence of effect, it is possible to use agents 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 strongly associated with plasma proteins.

To prevent further absorption of the drug, it is advisable to wash the stomach, taking activated charcoal or osmotic laxative, for example sodium sulfate.

Interaction:

When Omnik® was prescribed, no interactions were found with atenolol, enalapril or theophylline.With the simultaneous use of Omnik with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted, and with furosemide a decrease in the concentration was noted, but this does not require a change in the Omnic dose, since the drug concentration remains within the normal range. Diazepam, propranolol, trichloromethiazide, chloromadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma in vitro. In its turn, tamsulosin also does not change free fractions of diazepam, propranolol, trichloromethiazide and chloromadinone.

Diclofenac and warfarin can increase the rate of excretion of tamsulosin.

Simultaneous administration of tamsulosin with strong inhibitors of isoenzyme CYP3A4 can lead to an increase in the concentration of tamsulosin. Simultaneous administration with ketoconazole (strong inhibitor CYP3A4) led to an increase AUC and Cmtamsulosin in 2.8 and 2.2 times, respectively.

Tamsulosin hydrochloride should not be used in combination with strong inhibitors CYP3A4 in patients with a metabolic isoenzyme disorder CYP2D6. The drug should be used with caution in combination with strong and moderate inhibitors CYP3A4.

Simultaneous administration of tamsulosin and paroxetine, a strong inhibitor CYP2D6, led to an increase in Cmah and AUC tamsulosin in 1.3 and 1.6 times, respectively, but this increase is clinically insignificant.

Simultaneous administration of other antagonists of α₁-adrenoceptor can lead to a decrease in blood pressure.

Special instructions:

As with other α₁-adrenoconvertors, in the treatment with Omnic®, in some cases there may be a decrease in blood pressure, which sometimes can lead to a fainting condition. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until these symptoms disappear.

When surgical interventions for cataracts or glaucoma against the background of taking the drug may develop a syndrome of intraoperative irrosis instability (narrow pupil syndrome), which must be taken into account by the surgeon for preoperative preparation of the patient and during the operation.

Before starting therapy with Omnic®, the patient should be examined to exclude the presence of other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before the start of treatment and regularly during therapy, a digital rectal examination and, if necessary, the definition of a prostatic specific antigen (PSA) should be performed.

Treatment with Omnic® for patients with severe renal insufficiency (creatinine clearance <10 ml / min) requires caution, since no studies have been conducted in this category of patients. In some patients taking or previously taking tamsulosin hydrochloride, during the surgery for cataract and glaucoma, there was a development of intraoperative iris of the iris (a narrow pupil syndrome) syndrome, which can lead to complications during surgery or in the postoperative period. The feasibility of canceling tamsulosin hydrochloride therapy 1-2 weeks before surgery for cataracts or glaucoma has not yet been proven.Cases of intraoperative iris of the iris occurred in patients who stopped taking the drug and at an earlier time before the operation. It is not recommended to begin therapy with tamsulosin hydrochloride in patients who are scheduled for surgery for cataracts or glaucoma. During the preoperative examination of the patients, the surgeon and the ophthalmologist must consider whether the patient is taking or taking the patient tamsulosin. This is necessary to prepare for the possibility of development during the operation of intraoperative iris of the eye.

Effect on the ability to drive transp. cf. and fur:

Studies on the effect of the drug on the ability to control the car and mechanisms were not conducted. Patients should be aware that when taking the drug dizziness may occur.

Form release / dosage:Capsules with modified release, 0.4 mg.

Packaging:

10 capsules in blisters made of polypropylene film and aluminum foil, 1, 3 or 10 blisters together with instructions for use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:4 years.Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013915 / 01

Date of registration:21.05.2008 / 11.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:Astellas Farma Europe BVAstellas Farma Europe BV Netherlands

Manufacturer: & nbsp

ASTELLAS PHARMA EUROPE, B.V. Netherlands

ZIO-HEALTH, JSC Russia

Representation: & nbspASTELLAS PHARMA YUROP BV ASTELLAS PHARMA YUROP BV Netherlands

Information update date: & nbsp07.06.2017

Illustrated instructions

Instructions

Omnik® (Omnic®)