Controlled-release tablets coated with a coating from yellow to brownish-yellow, round, biconvex, on one side are extruded "04".
1 tab.
tamsulosin hydrochloride 400 Ојg
Excipients: macrogol 8000 - 40 mg, macrogol 7 000 000 - 200 mg, magnesium stearate - 1.2 mg.
The composition of the shell: opadrai yellow 03F22733 - 7.25 mg (hypromellose - 69.536%, macrogol 8000 - 13.024%, iron-oxide oxide yellow - 17.44%).
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Alpha 1- adrenoblocker. Is tamsulosin a specific competitive blocker of postsynaptic? 1- adrenoreceptors, especially? 1A and? 1D subtypes responsible for relaxing the smooth muscles of the prostate gland, the neck of the bladder, the prostatic part of the urethra.
Omnik Okas in a dose of 400 mcg increases the maximum rate of urination, and also reduces the tone of the smooth muscles of the prostate and urethra, improving the outflow of urine and thus reducing the severity of symptoms of emptying. Oknik Okas also reduces the severity of filling symptoms, in which the role of detrusor hyperactivity plays an important role.
With prolonged therapy, the effects on the symptoms of filling and emptying remain, reducing the risk of acute urinary retention and the need for prompt intervention.
Blockers? 1A- adrenoreceptors can lower BP by decreasing peripheral resistance. When using Omnic Okas in a daily dose of 400 mcg, no clinically significant decrease in blood pressure was noted.
PHARMACOKINETICS
Suction
Omnic Okas is a matrix-controlled controlled release tablet using a non-ionic gel that provides a sustained and slow release of tamsulosin and gives sufficient exposure with weak fluctuations for 24 hours.
Tamsulosin in the form of tablets Omnic Okas is absorbed in the intestine. Absorption is 57%. Eating does not affect the absorption of the drug. Tamsulosin is characterized by linear pharmacokinetics. After a single oral administration of C max of tamsulosin in blood plasma is achieved on average after 6 hours. In the equilibrium state, which is reached by the 4th day of administration, C max of tamsulosin in blood plasma is achieved in 4-6 h as with fasting or after taking food. Cmax in blood plasma increases from about 6 ng / ml after the first dose to 11 ng / ml in the equilibrium state. The lowest concentration of tamsulosin in plasma is 40% of C max on fasting and after meals. There are significant individual differences in plasma concentrations after single administration and repeated use.
Distribution
Binding to plasma proteins is about 99%, V d is small - about 0.2 l / kg.
Metabolism
Tamsulosin is slowly metabolized in the liver with the formation of less active metabolites. Most of tamsulosin is present in blood plasma unchanged. According to experimental studies, the ability to induce the activity of microsomal liver enzymes in tamsulosin is practically absent.
When liver failure is not required correction of the dosing regimen.
Excretion
Tamsulosin and its metabolites are excreted mainly in the urine, while about 4-6% of the drug is excreted unchanged.
When Omnik Okas is taken in a dose of 400 mcg, once and in an equilibrium state, T 1/2 is 19 h and 15 h, respectively.
INDICATIONS
- benign prostatic hyperplasia (treatment of urination disorders).
DOSING MODE
Assign inside 400 mcg (1 tab.) 1 time / day, regardless of food intake.
Duration of use is not limited, the drug is prescribed in the form of continuous therapy.
The tablet should be taken whole, not chewing, tk. this can affect the prolonged release of the active substance.
With hepatic and renal failure, there is no need for correction of the dosing regimen.
SIDE EFFECT
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
General reactions
Asthenia
From the nervous system
Dizziness (1.3%) Headache Syncope
From the side of the reproductive system
Violations of ejaculation Priapism
From the respiratory system
Rhinitis
From the skin and subcutaneous fat
Rash Itching
Allergic reactions
Urticaria Angioedema
Individual cases of intraoperative iris of the eye (narrow pupil syndrome) in cataract surgery in patients taking tamsulosin, which increase the risk of complications during and after surgery, are described.
CONTRAINDICATIONS
- hypersensitivity to tamsulosin or any other component of the drug;
- Orthostatic hypotension;
- marked hepatic insufficiency.
With caution: chronic renal failure (CC less than 10 ml / min), severe violations of the liver, arterial hypotension.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be applied to the drug in chronic renal failure (CC less than 10 ml / min).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe hepatic insufficiency. With caution should apply the drug for severe violations of liver function.
SPECIAL INSTRUCTIONS
When Omnic Okas (like other alpha 1- adrenoblockers) is used, in some cases, a decrease in blood pressure may occur, which in rare cases leads 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 the signs of this condition disappear.
There is no withdrawal syndrome.
When surgical interventions for cataracts against the background of taking the drug may develop the syndrome of intraoperative instability of the iris (narrow-pupil syndrome), which should be taken into account for the surgeon for preoperative preparation of the patient during the operation.
Before starting therapy with Omnic Okas, 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 the start of treatment and regularly during therapy, a digital rectal examination and, if necessary, the determination of a specific antigen of the prostate (PSA) should be performed.
Impact on the ability to drive vehicles and manage machinery
Data on the negative impact on the ability to drive vehicles and engage in potentially hazardous activities are not available. Nevertheless, in connection with the possibility of dizziness, before determining the individual reaction of the patient should refrain from occupations that require increased concentration and speed of psychomotor reactions, including. from driving.
OVERDOSE
Symptoms: decreased blood pressure, compensatory tachycardia.
Treatment: to prevent further absorption of the drug, it is advisable to perform gastric lavage, prescribe reception of activated charcoal and osmotic laxative. 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.
DRUG INTERACTION
When tamsulosin was prescribed concomitantly with atenolol, enalapril, nifedipine or theophylline, no drug interaction was detected.
With simultaneous use with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted; with furosemide - a decrease in concentration, but this does not require a change in the dose of Oknik Okas, since its 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.
In studies in vitro, no interaction was found at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide, and finasteride.
Diclofenac and warfarin can increase the rate of excretion of tamsulosin.
Simultaneous assignment of other blockers? 1- adrenoreceptors can lead to an antihypertensive effect.
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 - 3 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.
