Active substanceAlfuzosinAlfuzosin
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    VERTEKS, AO     Russia
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  • Dosage form: & nbspcontrolled release tablet
    Composition:

    1 tablet contains:

    active substance: alfuzosin hydrochloride 5 mg

    Excipients: cellulose microcrystalline, calcium hydrophosphate dihydrate (calcium phosphate disubstituted 2-water), povidone medium molecular weight (polyvinylpyrrolidone medium molecular weight), magnesium stearate for the pharmaceutical industry, hydrogenated hydrogenated oil, hypromellose (hydroxypropylmethylcellulose), giprolose (hydroxypropyl cellulose), talc, titanium dioxide, iron oxide dye yellow.

    Description:The tablets covered with a cover of light yellow with a weak brownish shade of color, round biconcave. On the fracture is white or almost white.
    Pharmacotherapeutic group:Alpha-1-blocker
    ATX: & nbsp

    G.04.C   Drugs for the treatment of benign prostatic hyperplasia

    Pharmacodynamics:

    Selective blocker alpha 1-adrenergic receptors (mainly in the prostate gland, urethra and triangle of the bladder). Reduces pressure in the urethra and reduces resistance to urine flow, eases urination and eliminates dysuria, including with prostatic hyperplasia. In therapeutic doses does not affect the alpha 1-adrenergic receptors of blood vessels.

    Pharmacokinetics:

    After ingestion of 5 mg, the maximum concentration (10.3 ng / ml) in the plasma is achieved after 3 hours. Bioavailability is 45-53%. Eating does not affect the absorption of the active substance. The connection with plasma proteins is 90%. The half-life is 8 hours.

    Metabolised in the liver. It is allocated, basically with bile and with kalovymi masses in the form of inactive metabolites and kidneys in the form of inactive metabolites (15-30%) and in unchanged form (11%). In older people, absorption is faster, maximum concentration and bioavailability is higher, the volume of distribution is lower, the elimination half-life remains unchanged. In chronic renal failure, the volume of distribution and total clearance increase as a result of reduced binding to plasma proteins.Due to the high degree of metabolism, even with severe chronic renal failure (creatinine clearance - 15-40 ml / min), cumulation does not occur. With chronic heart failure, pharmacokinetic parameters do not change.

    Indications:

    Functional disorders of urination with benign prostatic hyperplasia.

    Contraindications:

    Hypersensitivity, orthostatic hypotension (in the anamnesis), simultaneous reception of other alpha-adrenoblockers.

    Carefully:Ischemic heart disease, chronic renal failure, concomitant therapy with antihypertensive drugs, elderly age (over 75 years).
    Dosing and Administration:

    Inside, without chewing, 5 mg in the morning and evening, begin treatment with an evening reception. The daily dose is 10 mg. Elderly and patients receiving antihypertensive therapy, appoint 5 mg / day in the evening, if necessary, increase the dose to 10 mg / day (not more).

    Side effects:

    From the digestive system: dry mouth, nausea, epigastric pain, diarrhea.

    From the nervous system: headache, dizziness, weakness, drowsiness, asthenic syndrome.

    From the side of the cardiovascular system: tachycardia, orthostatic hypotension, in patients with ischemic heart disease - exacerbation of symptoms of angina pectoris.

    Allergic reactions: skin rashes, itching.

    Other: tinnitus, swelling, skin hyperemia.

    Overdose:

    Symptoms: lowering blood pressure. Treatment: the introduction of vasoconstrictor, solutions of high molecular substances, an increase in the volume of circulating blood. Dialysis is ineffective.

    Interaction:

    It is not compatible with other alpha1-blockers. Strengthens the effect of antihypertensive drugs, including calcium channel blockers and general anesthetics (possible instability of blood pressure for anesthesia).

    Special instructions:

    Care should be taken when prescribing patients with ischemic heart disease. If the therapy worsens the course of angina, the drug is canceled. When combined with antihypertensive drugs, especially calcium channel blockers, correction of the dose of the latter is necessary because of a possible reduction in blood pressure, up to the development of collapse.

    Effect on the ability to drive transp. cf. and fur:It should be individually addressed the issue of the possibility of transport management due to the presence of dizziness, lowering blood pressure and asthenia, especially at the beginning of treatment with the drug.
    Form release / dosage:

    Controlled-release tablets coated with 5 mg.

    Packaging:

    For 10 tablets in a planar cell package. 6 contour packs with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    List B.

    Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    2 years.

    At the end of the expiration date the drug should not be used.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000174/08
    Date of registration:23.01.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp18.07.2017
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