Modified-release capsules are hard gelatinous, size 2, orange-colored body with the mark "701" and a graphic representation of the company's trademark, an olive-green lid marked "0.4"; the contents of the capsules are granules from white to white with a light yellow shade of color.
tamsulosin hydrochloride 400 Ојg
Auxiliary substances: microcrystalline cellulose - 281.2 mg, methacrylic acid and ethyl acrylate copolymer - 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.
The composition of the shell capsules *: gelatin - 62.8 mg, titanium dioxide - 0.89 mg, indigocarmine - 0.004 mg, iron oxide yellow oxide - 0.5 mg, iron oxide red oxide - 0.04 mg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
* on the capsule, the identification code is applied with black ink, which includes the ferric oxide black oxide (E172) and shellac.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
Alpha 1- adrenoblocker. Is tamsulosin a specific blocker of postsynaptic? 1- adrenoreceptors located in the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra. The blockade? 1- adrenoreceptor 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 muscle and detrusor hyperactivity in benign prostatic hyperplasia.
Is the ability of tamsulosin to affect? 1A subtype of adrenergic receptors is 20 times greater than its ability to interact with? 1B subtype of adrenergic receptors, which are located in the smooth muscle of the vessels. Due to its high selectivity, tamsulosin does not cause a clinically significant reduction in systemic BP in both patients with arterial hypertension and in patients with normal initial BP.
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.
The pharmacokinetics of tamsulosin is linear. After a single dose of the drug inside at a dose of 400 Ојg C max of the active substance in the plasma is achieved after 6 hours.
After repeated ingestion of the drug in a daily dose of 400 Ојg C ss is reached by the 5th day, while its value is 2/3 higher than the C max value after a single dose of the drug.
Binding to plasma proteins - 99%. V d small - about 0.2 l / kg.
Tamsulosin is slowly metabolized in the liver with the formation of less active metabolites. Most of the active substance is present in the blood in unchanged form.
In experimental studies, the ability of tamsulosin to induce insignificantly the activity of microsomal liver enzymes has been revealed.
With a slight and moderate degree of hepatic insufficiency, there is no need for correction of the dosing regimen.
Tamsulosin and its metabolites are excreted mainly mainly with urine, while about 9% of the dose is excreted unchanged.
T 1/2 with a single admission of 400 Ојg of tamsulosin after meals - 10 hours, with repeated admission - 13 hours.
When renal failure is not required to reduce the dose, if the patient has severe renal failure (CC less than 10 ml / min), the appointment of tamsulosin should be done with caution.
- treatment of dysuric symptoms in benign prostatic hyperplasia.
Adults over 18 years, as well as elderly patients
Inside, after breakfast, washing down with water, take 1 capsule (400 mcg) 1 time / day.
Capsule is not recommended to chew, tk. this can affect the release rate of the drug.
Patients with impaired hepatic and renal function: with renal failure , as well as with mild and moderate hepatic insufficiency , correction of the dosing regimen is not required.
Frequently (> 1%, <10%) Infrequently (> 0.1%, <1%) Rarely (> 0.01%, <0.1%) Very rarely (<0.01%)
From the side of the cardiovascular system
Heart palpitations Postural hypotension
From the digestive system
Constipation Diarrhea Nausea Vomiting
From the nervous system
Dizziness (1.3%) Headache Syncope
From the side of the reproductive system
Violations of ejaculation Priapism
From the respiratory system
From the skin and subcutaneous fat
Rash Itch Stevens-Johnson Syndrome
The cases of intraoperative instability of the iris of the eye (narrow pupil syndrome) in cases of cataract and glaucoma in patients taking tamsulosin are described.
Postmarketing drug use
In addition to the side effects described above, with tamsulosin, atrial fibrillation, arrhythmia, tachycardia and dyspnea were observed. Due to the fact that the data were obtained by the method of spontaneous messages during the period after registration, it is difficult to determine the frequency and cause-and-effect relationship of these phenomena with the administration of tamsulosin.
- Hypersensitivity to Tamulosin or any other component of the drug;
- Orthostatic hypotension (including in the anamnesis);
- marked hepatic insufficiency.
With caution: severe renal failure (CC less than 10 ml / min).
PREGNANCY AND LACTATION
Omnic В® preparation 400 Ојg in capsules is intended for use only in males.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be given to the drug for renal failure severe (CC less than 10 ml / min).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe hepatic insufficiency.
As with the use of others? 1- adrenoblokatorov, in the treatment with Omnik В® 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 must sit or and remain in this position until these symptoms disappear
With surgical interventions for cataracts or glaucoma, the development of intraoperative irrosis syndrome (narrow pupil syndrome) is possible on the background of taking the drug, which should be taken into account by the surgeon for preoperative preparation of the patient and during the operation.
Before starting therapy with Omnic В® , 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 Omnik В® for patients with severe renal insufficiency (CC <10 ml / min) requires caution, studies in this category of patients have not been conducted.
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 to undergo a cataract or glaucoma operation. During the preoperative examination, the patient and the ophthalmologist should consider whether the patient is taking or taking the tamsulosin. This is necessary to prepare for the possibility of development during the operation of intraoperative iris of the eye.
Impact on the ability to drive vehicles and manage machinery
Studies on the effect of the drug on the ability to control the car and mechanisms were not conducted. Patients should be aware that dizziness may occur when taking the drug.
There are no reports of cases of acute overdose of tamsulosin.
Symptoms: theoretically possible acute reduction of blood pressure and compensatory tachycardia.
Treatment: to prevent further absorption of the drug, it is advisable to perform gastric lavage, prescribe reception of activated carbon and osmotic laxative (for example, sodium sulfate). Blood pressure and heart rate can be restored if the patient is placed in a horizontal position. In the absence of effect, it is possible to use agents that increase BCC and, if necessary, vasoconstrictors. Kidney function should be monitored. It is unlikely that dialysis will be effective. tamsulosin binds intensely to plasma proteins.
In the appointment of Omnik В® along with atenolol, enalapril or theophylline interaction was not found. With the simultaneous use of Omnik В® with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted, and with furosemide - a decrease in concentration, but this does not require a change in the Omnik В® 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 tamsulosin fraction in human plasma in vitro.
In turn, tamsulosin also does not change the 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 the CYP3A4 isoenzyme may increase the concentration of tamsulosin. Simultaneous administration with ketoconazole (a strong inhibitor of CYP3A4) resulted in an increase in AUC and C max of tamsulosin by 2.8 and 2.2 times, respectively.
Tamsulosin hydrochloride should not be used in combination with strong inhibitors of CYP3A4 in patients with a metabolic disorder of the CYP2D6 isoenzyme. The drug should be used with caution in combination with strong and moderate inhibitors of CYP3A4.
Simultaneous administration of tamsulosin and paroxetine, a strong inhibitor of CYP2D6, resulted in an increase in C max and AUC of tamsulosin in 1.3 and 1.6 times, respectively, but this increase was clinically insignificant.
Simultaneous assignment of other antagonists? 1- adrenoreceptor can lead to a decrease in blood pressure.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 4 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.