Active substanceIsosorbide mononitrateIsosorbide mononitrate
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  • Dosage form: & nbspCapsules - retard.
    Composition:In 1 capsule retard contains:
    Active substance: 50 mg of isosorbide-5-mononitrate.
    Excipients: sucrose, corn starch, ethylcellulose, stearic acid, talc, red dye 4 R (E 124), quinoline yellow (E 104), titanium dioxide, gelatin.
    Description:Hard gelatin capsules, pinkish orange, containing white granules, type "2" of medium size.
    Pharmacotherapeutic group:Antianginal agent, nitrate.
    ATX: & nbsp

    C.01.D.A.14   Isosorbide mononitrate

    Pharmacodynamics:The active substance of the preparation Monochinkwe retard - isosorbide - 5 - mononitrate has a vasodilating and antianginal effect. At the molecular level, it acts due to the formation of nitric oxide (NO) and cyclic guanosine monophosphate (cGMP), a decrease in calcium concentration in smooth muscle cells. Reduces preload (by expanding the peripheral veins) and afterload (due to a decrease in the overall peripheral vascular resistance), reduces the need for myocardium in oxygen, dilates the coronary arteries and improves coronary blood flow, promotes its redistribution into the ischemic areas, reduces the terminal diastolic volume of the left ventricle and reduces systolic the tension of its walls.Increases tolerance to physical activity of patients with IHD, reduces pressure in a small circle of blood circulation.
    Special formula Monochinkwe retard with delayed release of the active substance ensures that after a single daily dose, the concentration in the blood provides a therapeutic effect for 24 hours. This drug is especially recommended for long-term therapy of coronary heart disease.
    Pharmacokinetics:The drug is quickly and completely absorbed into the intestine after ingestion. Bioavailability with oral administration is from 90 to 100%. Does not have the effect of "first pass through the liver." The level of drug concentration in the blood plasma is approximately the same for oral and parenteral administration. The maximum concentration is achieved in the blood plasma after 1 -1.5 hours. after administration. The half-life is approximately 5 hours, which is about 8 times higher than that of isosorbide dinitrate. Isosorbide-5-mononitrate is excreted through the kidneys exclusively in the form of metabolites. Approximately 2% is displayed unchanged.
    Indications:Prophylaxis and long-term therapy of angina pectoris of III-IV functional class,
    Restorative treatment after myocardial infarction,
    Treatment of chronic heart failure (as part of combination therapy).
    Contraindications:- hypersensitivity to isosorbides (mono-, dinitrate, and other organic nitrates),
    - acute circulatory disorders (shock, vascular collapse), hemorrhagic stroke,
    - acute stage of myocardial infarction,
    - simultaneous use of the inhibitor of phosphodiesterase sildenafil (Viagra®, Viagra), because sildenafil potentiates the hypotensive effect of nitrates,
    - severe arterial hypotension (systolic blood pressure less than 90 mm Hg, diastolic blood pressure less than 60 mm Hg).
    - states after a craniocerebral injury,
    - children under 18 years of age
    - closed angle glaucoma
    - deficiency of glucose-6-phosphate dehydrogenase.
    Pregnancy and lactation:During pregnancy, the drug can be prescribed only in case of emergency, when the benefit to the mother exceeds the potential risk to the fetus. If there is a need to take the drug during lactation, then breastfeeding should be discontinued.
    Dosing and Administration:In the absence of other prescriptions, 1 capsule of Monochinkwe retard is prescribed 1 time a day in the morning after eating, without chewing and washing down with a small amount of liquid. The dose can be adjusted by the attending physician in accordance with the patient's condition.
    Side effects:In the recommended dosage, no significant side effects are described. However, as with other nitrates, a nitrate headache is possible at the beginning of the treatment. When continuing therapy, it usually decreases after a few days.
    After the first dose or after increasing the dose, blood pressure may decrease and / or develop orthostatic hypotension, which can be accompanied by tachycardia, dizziness, and general weakness.
    Very rarely there may be nausea, vomiting, reddening of the face and skin allergic reactions.
    Overdose:No cases of overdose were reported. However, when symptoms of an overdose occur, the usual measures are recommended: induce vomiting and rinse the stomach. It is necessary to control whether the patient did not take any other medicines at the same time, and monitor hypodynamic parameters.
    Interaction:When used with other vasodilators, antihypertensive drugs, beta-blockers, calcium channel blockers, antipsychotic drugs, tricyclic antidepressants, with the phosphodiesterase inhibitor sildenafil (Viagra ®), as well as with alcohol, potentiation of the antihypertensive effect of the Monochinkwe retard preparation is possible.
    Special instructions:In the case of hypertension, the drug should be taken only under medical supervision.
    The drug is not used to stop angina attacks.
    The drug is used alone or in combination with beta-adrenoblockers, calcium channel blockers, ACE inhibitors, cardiac glycosides or diuretics.
    Effect on the ability to drive transp. cf. and fur:When taking the drug, it is possible to reduce the ability to respond quickly, and therefore, it is not recommended to drive vehicles and engage in other potentially hazardous activities.
    Form release / dosage:Capsules retard for 50 mg.
    Packaging:One cardboard box contains 2 blisters (each with 15 capsules) together with the Instruction for Use (No. 30).
    Storage conditions:Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:3 years.
    The expiration date of the drug is shown on a folding cardboard box and on the blister itself.
    After the expiration of this period, the drug can not be used.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014357 / 01-2002
    Date of registration:22.10.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Instituto Luzofarmaco d'Italia SpAInstituto Luzofarmaco d'Italia SpA Italy
    Manufacturer: & nbsp
    Information update date: & nbsp2016-12-12
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