Fokusin caps. with modif.vysv. 0.4mg 30 pc

Description

Composition
Active substance:
1 capsule contains: 0.4 mg of tamsulosin hydrochloride.
Excipients:
* Methacrylic acid-ethyl acrylate copolymer [1: 1] [30% dispersion] – 74.9 (in solid form), microcrystalline cellulose – 257.1 mg, dibutyl sebacate – 8.4 mg polysorbate 80 – 0.5 mg colloidal silicon dioxide – 3.7 mg talc – 0.3 mg. capsule shell: azorubin dye – 0.2%, patented blue dye – 0.12% gelatin – up to 100%. * One capsule is used for 30% dispersion of methacrylic acid and ethacrylate copolymer [1: 1] in an amount of 249.67 mg, which corresponds to 74.9 mg in the form of a solid.
Description:
Hard gelatin capsules №1. The body and lid: dark blue, transparent. Contents of capsules: white or almost white micropellets.
Product form:
Capsules containing 0.4 mg modified release. 10 capsules in blister PVC / PVDC / A1. At 3, 9 or 10 in the blister cardboard pack together with instructions for use.
Contraindications
Increased sensitivity to the drug;
Orthostatic hypotension (including history);
Severe hepatic insufficiency.
Age 18 years (effectiveness and safety have been established).
Carefully:
Chronic renal failure (creatinine clearance less than 10 mL / min);
Hypotension (including orthostatic);
The planned cataract surgery;
When used together with strong or moderately active inhibitors isoenzyme CYP3A4 (e.g., ketoconazole, voriconazole).
Indications
functional disorders of the treatment of benign prostatic hyperplasia.
Interaction with other drugs
The simultaneous use of tamsulosin with other alpha1-adrenoceptor blockers may result in a decrease in blood pressure. Diclofenac and oral anticoagulants (warfarin) is somewhat increase the elimination rate of tamsulosin. Cimetidine increases the concentration of tamsulosin in plasma and furosemide – reduces (substantial clinical significance has not). When the joint application of tamsulosin atenolol, enalapril, theophylline, or drug interactions signs were absent. Under conditions in vitro diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin did not result in the free fraction of tamsulosin in plasma change. Tamsulosin also had no effect on the free fraction of diazepam, propranolol, trichlormethiazide and chlormadinone. The combined use of tamsulosin and potent inhibitors of CYP3A4 isoenzyme may cause increased systemic exposure tamsulosin. Simultaneous administration of tamsulosin with ketoconazole (a potent inhibitor of isozyme CYP3A4) led to an increase in AUC and Cmax parameters tamsulosin 2.8 and 2.2 times, respectively. Tamsulosin should not be used in combination with potent inhibitors of CYP3A4 isozyme phenotype in patients with “slow metabolism” by isoenzyme CYP2D6. Care must be taken when used together with tamsulosin potent or moderately potent inhibitors isoenzyme CYP3A4.
Overdose
Symptoms: marked reduction of blood pressure
Treatment: kardiotropnyh therapy, monitoring of renal function, general supportive therapy, administration obemozameschayuschih solutions or vasoconstrictors. To prevent further absorption of tamsulosin may gastric lavage, activated charcoal or osmotic laxative.
pharmachologic effect
Pharmacological group:
Alpha1 adrenoblokator.
Pharmacodynamics:
Tamsulosin selectively and competitively blocks postsynaptic alpha 1 adrenergic receptors of the smooth muscles of the prostate, bladder neck and prostatic urethra and H-adrenoreceptors of the bladder that leads to a reduction in smooth muscle tone of the prostate, bladder neck and prostatic urethra, and improve the function of the detrusor reduction of obstruction and irritation symptoms associated with benign prostatic hyperplasia. Typically, the therapeutic effect develops after 2 weeks after starting the drug, although in some patients the decrease in symptoms is observed after the first dose. Tamsulosin ability to influence the alpha-adrenergic receptors is 20 times greater than its ability to act on the N-adrenergic receptors of vascular smooth muscle. With this high selectivity of the drug does not cause any clinically significant decrease in systemic blood pressure (BP) both in hypertensive patients and in patients with normal blood pressure source.
Pharmacokinetics:
Absorption: after oral administration of tamsulosin is rapidly and almost completely absorbed from the gastrointestinal tract (GIT), its bioavailability – almost 100%. After a single dose of the drug Fokusin® oral dose of 400 mg Cmax active substance in plasma obtained 6 hours.
Distribution: after 5 days of course taking the value C max of the active substance in blood plasma by 60 to 70% higher than the Cmax after a single dose. Binding to plasma proteins – 99%. The volume of distribution of tamsulosin slight (approximately 0.2 L / kg).
Metabolism: tamsulosin is not subjected to the effect of “first pass” and slowly biotransformed in the liver to produce pharmacologically active metabolites that retain high selectivity for the alpha-adrenoceptors. Most of the active substance present in the blood unchanged.
Excretion: tamsulosin excreted by the kidneys, 9% of the dose is excreted unchanged. T1 / 2 of tamsulosin with single dose – 10 hours, after multiple administration – 13 hours, the final half life time – 22 hours.
Conditions of supply of pharmacies
On prescription.
side effects
The frequency of adverse reactions reported in accordance with the classification of the Medical dictionary for regulatory activities (MedDRA):
Very often (> 10%),
Most (> 1% 0.1% 0.01%
Very rare: hypersensitivity reactions. – disorders of the nervous system
Common: dizziness.
Uncommon: headache Rare: syncope.
Frequency not known: sleep disturbance (insomnia or drowsiness). – Violations of the organ of vision
Frequency unknown: blurred vision, blurred vision. – Violations of the heart
Uncommon: palpitations.
Frequency not known: tachycardia. – Violations of the vessels
Uncommon: orthostatic hypotension. – Disorders of the respiratory system, organs, thoracic and mediastinal disorders
Uncommon: Rhinitis.
Frequency unknown: nosebleeds. – Violations of the gastrointestinal tract
Rare: nausea, vomiting, constipation or diarrhea. – Violations of the skin and subcutaneous tissue
Uncommon: skin rash, pruritus, urticaria.
Rare: angioedema.
Very rare: Stevens-Johnson syndrome.
Frequency unknown: erythema multiforme, exfoliative dermatitis. – Violations of the genital and breast
Very rare: priapism.
Frequency unknown: ejaculation disorders, including retrograde ejaculation, decreased libido. – General disorders and injection site
Uncommon: asthenia syndrome.
Frequency not known: back pain, chest pain, dry mouth.
special instructions
Before the start of therapy with Fokusin® neohodimo exclude the presence of other diseases, which can cause the same symptoms as benign prostatic hyperplasia. Before beginning treatment and at regular intervals during treatment should be conducted prostate examination (DRE examination, determination of prostate specific antigen (PSA). As with other alpha1-adrenoceptor antagonists, in the treatment of drug Fokusin® in individual cases may experience a decrease in blood pressure, which can lead to fainting. Fokusin® The drug should be used with caution in patients with a predisposition to orthostatic hypotension. at first signs of orthostatic eskoy hypotension (dizziness, weakness) the patient must sit or lay With the development of angioedema, and other immunological reactions such as Stevens-Johnson syndrome, the preparation should be discontinued immediately patient should be followed until elimination of the disease state;.. reassignment tamsulosin is not allowed. During surgery, cataract surgery in some patients treated with tamsulosin hydrochloride at the time of surgery or etc. Shlomo, there has been a development intraoperative iris instability eye syndrome (syndrome narrow pupil). Occurrence syndrome intraoperative instability of the iris can lead to increased risk of complications from organ of vision during and after surgery. Tamsulosin hydrochloride should not be used in combination with potent inhibitors of CYP3A4 isozyme phenotype in patients with “slow metabolism” by isoenzyme CYP2D6. Tamsulosin is not for use in women.
Effects on ability to drive and engage in other potentially hazardous activities.
Caution should be exercised when driving and occupations that require high concentration and psychomotor speed reactions. In the event of dizziness should refrain from car driving and other potentially hazardous activities.
Storage conditions
It does not require any special storage conditions.
Keep out of the reach of children.
Dosing and Administration
The drug is administered at 400 mg (1 capsule) per day. Capsules are taken after the first meal is not liquid, squeezed with sufficient water. Fokusin® may be administered as monotherapy, or in combination with inhibitors of 5 alpha – reductase inhibitors (finasteride, dutasteride).
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist