Description overdue on 08.13.2014
- Latin name: Fokusin
- ATC code: G04CA02
- Active substance: Tamsulosin (Tamsulosin)
- Manufacturer: Zentiva k.s (Czech Republic)
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Fokusin: instructions for use, dosage and method of
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Analogs
- Reviews
- Price, where to buy
Composition
In composition of the Fokusina includes:
- 0 to 4 mg tamsulosin (Tamsulosinum);
- methacrylate copolymer dispersion;
- microcrystalline cellulose;
- dibutyl ;
- polysorbate 80 ;
- silicon dioxide colloidal aqueous;
- talc.
The composition of the capsule shell:
- azorubin (E122);
- dye patent blue V (E131);
- gelatin.
Product form
The drug is available in the form of hard-coated gelatin shell capsule modified release. The capsules have a size №1, transparent body with dark blue cap and filled micropellets, the color of which varies from almost white to white.
One package may be as many 30 or 90 capsules.
Pharmacological action
Fokusin belong to the pharmacological group of drugs alpha-blockers, as well as to a group of medicines that have an impact on the course of metabolic processes in the prostate gland and adjust urodynamics.
The therapeutic effect of the drug is determined by the activity of being a part of tamsulosin hydrochloride Which is a white powder with a crystalline structure, poorly soluble in water, slightly soluble in glacial acetic acid and ethyl alcohol, and practically insoluble in ether.
Pharmacodynamics and pharmacokinetics
Like other Alpha-blockers , Has the ability to shield Fokusin alpha-receptors Localized on postsynaptic membranes And responsive to the action of neurotransmitter norepinephrine , That stands out from nerve endings from and mpaticheskih postganglionic neurons Ie efferent neurons the autonomic nervous system Forming synapse target organs.
It contained therein as an active ingredient tamsulosin Which is a typical representative of the group of selective alpha1-adrenergic blockers It prevents passage of impulses through the vasoconstrictor adrenergic synapses, thereby causing expansion arterioles and precapillaries .
Another effect that is due to the ability to tamsulosin competitively block alpha1-adrenergic receptors Located within the triangle " prostatic urethra - The lower tapered portion of the bladder (its neck) - prostatic smooth muscle ", and alfa1D-adrenergic receptors Which are located mainly in the muscular layer Bladder ( detrusor ) Is an improvement urodynamics at prostate cancer .
The clinical effect of taking notes Fokusina approximately two weeks after the start of treatment. On the background of the drug in patients to a considerable extent:
- increases clearance urethra ;
- increases clearance bladder neck ;
- is normalized blood supply to detrusor ;
- improving metabolism the muscles of the bladder ;
- decreases pressure in urethra ;
- are shot symptoms of obstruction urinary tract ;
- reduced symptoms of irritation caused BPH ;
- reduced resistance to current urine;
- normalized processes of of urination .
The ability to influence Fokusina alpha1-adrenergic receptors several times higher than its ability to interact with alfa1V-adrenergic receptors That are in the vascular smooth muscle.
Due to such a high selectivity of action of the drug does not cause clinically significant decrease Blood Pressure . Moreover similar effect celebrated as y patients with normal blood pressure And in patients diagnosed with arterial hypertension .
The suction process tamsulosin It is carried out gastrointestinal tract . Most active suction noted when the drug is taken immediately after a meal.
Indicator bioavailability tamsulosin It is almost 100%, and its kinetics is linear.
After a single dose of the recommended single dose of the drug if the patient is fed, the maximum plasma concentration of tamsulosin is celebrated for about six hours.
Steady state is reached after five days of continuous reception Fokusina. The indicator of the maximum plasma concentration tamsulosin ⅔ on average higher than that of after receiving a single dose recommended instructions.
This increase was observed in elderly patients, however, expect a similar effect in humans younger.
After oral administration about 99% of tamsulosin, enters the body, associated with plasma-screen proteins And its volume of distribution is about 0, 2 L / kg and is characterized as low.
Metabolism matter proceeds rather slowly, and the effect of "first pass", ie metabolism before reaching the systemic circulation when passing through the wall w eludochno tract and liver , Insignificant.
Main part tamsulosin It detected in plasma blood in unaltered, definitively substance biotransformiroetsa in liver .
Formed metabolites and tamsulosin unchanged (about 9% of the dose received by the body) is particularly active excreted in the urine .
Half-life of the substance after administration of a single dose if the patient is fed, is about 10 hours. With stable performance plasma concentrations tamsulosin its half-life increased to 13 o'clock.
Indications
Tablets prescribed to treat Fokusin dizuricheskih disorders Due d obrokachestvennoy hyperplasia ( adenoma ) prostate .
Contraindications
The drug is not prescribed in the following categories of patients:
- people who have found increased sensitivity to tamsulosin or other substances contained in the Fokusina;
- people who have signs of orthostatic hypotension (including history).
Not recommended the appointment of Fokusina patients with severe hepatic and / or kidney (when the rate of clearance creatinine below 10 ml / min) failure. This is due to the lack of data on the safety of the drug to patients with similar pathologies.
Side effects Fokusina
Like most other drugs, Fokusin in some cases may cause the development of unwanted side reactions of varying severity, which include:
- Disorder Nervous System Expressed as dizziness (common), headaches (rare), loss of consciousness (rare);
- dysfunction hearts and vascular system (occur infrequently and are expressed in the form of symptoms of postural (orthostatic) hypotension and enhanced well perceptible heartbeat);
- dysfunction Respiratory System , Organs located in the chest and anatomical space in the middle part of the chest cavity (the most frequent manifestation of this group of side effects - rhinitis);
- gastrointestinal disorders Which are expressed in the form of stool disorders, nausea and vomiting (these symptoms occur infrequently);
- disturbances of function of reproductive system Which may sometimes be expressed in the form R etrogradnoy ejaculation (i.e Ejaculation Characterized by ejection of semen in the reverse direction), and very rarely in the form of long painful erection Not associated with sexual arousal ( priapism ).
Other side actions that are marked on the background of reception of Fokusina, - it is infrequently arising asthenia , and pupillary constriction syndrome (unstable iris). The latter may develop during surgery Cataract in patients who have for a long time taken drugs tamsulosin .
Fokusin: instructions for use, dosage and method of
According to the instructions on the use of tablets Fokusin optimal dose for adults - 1 capsule per day.
The drug is recommended to be taken after breakfast or the first meal, standing or sitting. A tablet Swallows entirely, not razzhevyvaya (in Otherwise will be disrupted mechanism of modified release of tamsulosin), and washed down with plenty of fluid - of water or milk (not less than 150 ml of).
Overdose
In case of exceeding the permissible therapeutic dose Fokusina likely to develop symptoms of acute hypotension .
If this happens, in order to prevent further absorption tamsulosin the patient do a gastric lavage administered welcome Activated Carbon or a similar mechanism of action of drugs, laxatives with osmotic properties (e.g., Glauber's salt ).
During assist him patient should be in a horizontal position. If necessary, it can be assigned to administration vasoconstrictive drugs .
In parallel with the symptomatic treatment take measures to provide general support to the body of the patient and constantly monitor the performance of its functional state kidney .
In overdose Fokusinom dialysis does not belong to the category of appropriate procedures, as tamsulosin binds plasma proteins .
Cooperation
At simultaneous reception Fokusina with beta-blockers Atenolol And antihypertensive drugs Enalapril and Nifedipine , Any interaction medicines have neither noted.
Interactions with anti-ulcer drug Cimetidine provokes an increase plasma concentrations tamsulosin . The opposite effect is observed at the same time taking the drug with a diuretic Furosemide But it does not require dose adjustments Fokusina.
Studies conducted in vitro on liver microsomal fractions Relating to the enzyme system n itohroma P450 Showed that tamsulosin It has the ability to react with:
- tricyclic antidepressant Amitriptyline ;
- bronchodilators Salbutamol ;
- hypoglycemic agents Glibenclamide ;
- anticancer hormonal preparations Finasteride .
Simultaneous with the appointment of Fokusina Diclofenac and Warfarin provokes an increase in the rate of excretion from the body tamsulosin .
Anxiolytic Diazepam Beta-blocker propranolol, thiazide diuretics Trichlormethiazide and cholesterol-lowering the drug Simvastatin do not exert influence onto a free fraction was (i.e. that part which dissolved in the aqueous phase plasma ) tamsulosin in blood.
Combination with drugs antagonists a lfa1A-adrenergic receptors may contribute to strengthening expressiveness of the hypotensive effect of .
Terms of sale
The drug belongs to the category of funds that are dispensed from pharmacies by prescription.
Storage conditions
Keep out of reach of children. Other requirements for storage conditions are absent.
Shelf life
Usable within 2 years.
Analogs Fokusina
- Adenorm
- Omiks
- Omnic
Analogs Fokusina under which drugs are commonly understood as having the same International Non-proprietary name, or equally classified in accordance with the standards of the international system of exchange is:
- Adenorm ;
- Bazetu ;
- Omiks ;
- Omnic ;
- Omnimaks ;
- Ranoprost ;
- Tameks ;
- Tamsol ;
- Tamsonik ;
- Tamsulosin ;
- Taniz ;
- Tulozin ;
- Urofrin ;
- Flosin .
Reviews Fokusine
Many men with prostatitis or prostate cancer forced to take drugs tamsulosin .
Analyzing the responses of patients Fokusine, it can be concluded that most of them like the drug much more than Omnic - One of the most commonly prescribed analogs.
Reviews on the forums show that, choosing or Fokusin Omnic Many prefer the first because it is much less likely to provoke such an unpleasant phenomenon, as retrograde ejaculation .
And almost all patients reported a significant positive effect on its application: urination It does not cause such problems as to the course of treatment, and the urgency to it disappear.
For some of these, the most effective is a diagram according to which at Fokusin prostatitis or prostate cancer administered after treatment antibiotics .
Price Fokusina
Fokusina average price in Russia is:
- 470-500 rubles per pack of 30 capsules;
- 1070-1200 rubles per pack of 90 capsules.
In Ukraine, the drug can be purchased at a price:
- 150-170 hryvnia per pack of 30 capsules;
- 340-400 rubles per pack of 90 capsules.
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