Dinisorb (Dinisorb)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIsosorbide dinitrateIsosorbide dinitrate
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    • Dosage form: & nbspconcentrate for solution for infusion
    Composition:1 ml of the solution contains isosorbide dinitrate active substance - 1 mg; auxiliary substances - 0.9% solution of sodium chloride in water for injection.
    Description:Transparent, colorless or slightly yellowish liquid, odorless.
    Pharmacotherapeutic group:vasodilator - nitrate
    ATX: & nbsp

    C.05.A.E.02   Isosorbide dinitrate

    C.01.D.A.08   Isosorbide dinitrate

    Pharmacodynamics:
    Peripheral vasodilator with predominant effect on venous vessels. Antianginal remedy. The mechanism of action is associated with the release of the active substance of nitric oxide in the smooth muscles of the vessels. Nitric oxide causes activation of guanylate cyclase and increases the level of cGMP, which leads to relaxation of smooth muscles. Arterioles and precapillary sphincters relax less than large arteries and veins.This is partly due to reflex reactions, as well as less intense formation of nitric oxide from the molecules of the active substance in the arteriolar walls. Reduces the need for myocardium in oxygen by reducing preload (widening peripheral veins and reducing blood flow to the right atrium) and postnagruzki (reducing the overall peripheral vascular resistance), as well as with a direct coronary expansive action. Reduces the flow of blood to the right atrium, helps reduce pressure in the "small" circle of blood circulation and regression of symptoms with pulmonary edema. Promotes redistribution of coronary blood flow in the area with reduced blood supply.
    Increases tolerance to physical activity in patients with coronary heart disease, angina pectoris.

    Pharmacokinetics:
    Since Dinisorba solution is used intravenously, there is no effect of "first passage" through the liver.
    Metabolised in the liver with the formation of 2 active metabolites. It is excreted by the kidney almost completely in the form of metabolites of isosorbide-5-mononitrate (75-85%) with a half-life of 5 hours and isosorbide-2-mononitrate (15-25%) with a half-life of 2.5h. The half-life of isosorbide dinitrate, administered intravenously, is 20 minutes.

    Indications:Acute left ventricular failure, acute myocardial infarction (without severe arterial hypotension), angina with confirmed spasm, unstable angina, control of blood pressure at its elevation before and during surgical operations, especially in cardiovascular surgery.
    Contraindications:Increased sensitivity to isosorbide dinitrate, other nitro compounds or other components of the drug, severe arterial hypotension (systolic blood pressure (BP) less than 100 mm Hg, diastolic blood pressure less than 60 mm Hg), acute circulatory disturbance (collapse, shock) , cardiogenic shock, toxic pulmonary edema, hemorrhagic stroke, glaucoma (risk of increased intraocular pressure), severe anemia, thyrotoxicosis, severe chronic heart failure, hepatic insufficiency (risk of developing methhemogens obinemii) simultaneous reception of phosphodiesterase type 5 inhibitors (such as sildenafil, vardenafil or tadalafil), since they potentiate the hypotensive effect of nitrates, craniocerebral trauma, age to 18 years (efficacy and safety of use not established).
    Carefully:
    - with hypertrophic obstructive cardiomyopathy, constrictive pericarditis, and cardiac tamponade;
    - with acute myocardial infarction with a decreased filling pressure of the left ventricle (systolic blood pressure must be reduced to 90 mm Hg);
    - with aortic and / or mitral stenosis;
    - with a tendency to orthostatic reactions (a sharp decrease in blood pressure when the position of the body changes);
    - in diseases that are accompanied by increased intracranial pressure (in the anamnesis increased pressure when injected into a vein of nitroglycerin (a chemically related substance) in large doses);
    - anemia.

    Pregnancy and lactation:The use of dinisorb during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the risk to the fetus and / or the baby.
    Dosing and Administration:
    The dosage is set individually according to the patient's clinical condition and hemodynamic parameters.
    Enter the vein slowly.The recommended starting dose is 1-2 mg / hour. depending on the response of the patient (under condition of monitoring of blood pressure, heart rate, electrocardiogram and diuresis). The maximum dose is 8-10 mg / hour.
    For patients with heart failure, usually higher doses are required - in some cases up to 50 mg / h. The average dose is approximately 7.5 mg / hour. Patients who used to take organic nitrates (for example, isosorbide dinitrate, isosorbide-5-mononitrate), a higher dose can be administered to achieve the desired hemodynamic effect. The maximum dose is 120 mg.
    Preliminary, 0.5-1.0 ml of Dinisorb is diluted in 10-20 ml of physiological sodium chloride solution.

    Side effects:
    From the cardiovascular system: dizziness, headache ("nitrate"), tachycardia, transient hyperemia of the facial skin, a feeling of heat, a decrease in blood pressure, in some cases - increased attacks of angina (paradoxical reaction), collapse.
    From the digestive system: nausea, vomiting, the appearance of a feeling of mild burning tongue, dry mouth.
    From the central nervous system: drowsiness, blurred vision; rarely - ischemia of the brain.
    Allergic reactions: a skin rash is possible.
    Other: it is possible to develop tolerance (including cross-over to other nitrates,) exfoliative dermatitis.

    Overdose:
    Symptoms: a decrease in blood pressure (systolic blood pressure below 90 mm Hg), collapse, fainting, headache, dizziness, palpitations, visual disorders, hyperthermia, convulsions, skin hyperemia, increased sweating, nausea, vomiting, diarrhea, with high doses of isosorbide dinitrate - methemoglobinemia (cyanosis, anoxia), hyperpnoea, dyspnoea, bradycardia, increased intracranial pressure, paralysis, coma.
    Treatment: discontinue further administration of the drug. It is necessary to lower the head of the bed and raise the patient's legs. As a rule, blood pressure is normalized within 15-20 minutes after discontinuation of the drug administration.
    In case of severe arterial hypotension and / or shock, the volume of circulating blood should be compensated. In exceptional cases, to maintain blood circulation, you can enter norepinephrine (noradrenaline) and / or dopamine.

    The introduction of epinephrine (adrenaline) and related compounds is contraindicated!

    With methemoglobinemia, depending on the degree of severity, the following antidotes are recommended:
    1. Ascorbic acid: 1.0 g orally or as sodium salt intravenously.
    2. Oxygenotherapy, hemodialysis, exchange blood transfusion.

    Interaction:
    Pharmacodynamic: under the influence of beta-adrenostimulyatorov, alpha-adrenoblokatorov (prazozin, dihydroergotamine, etc.), it is possible to reduce the expression of the antianginal effect of isosorbide dinitrate (tachycardia and excessive blood pressure decrease).
    When a combination of amiodarone, propranolol, blockers of "slow" calcium channels (BCC) (verapamil, nifedipine and others), acetylsalicylic acid and isosorbide dinitrate, an antianginal effect may increase. When joint application of isosorbide dinitrate with antihypertensive drugs, vasodilators, antipsychotics (antipsychotics), tricyclic antidepressants, procainamide, ethanol, quinidine, beta adrenoblockers, slow calcium channel blockers, dihydroergotamine and type 5 phosphodiesterase inhibitors, hypotensive effect may increase .
    It is advisable to use caution while using sapropterin, which is a coenzyme of nitric oxide synthetase, with all vasodilating agents that are associated with nitric oxide, including classical donators of nitric oxide (for example, nitroglycerine, isosorbide dinitrate, isosorbide mononitrate, sodium nitroprusside, molsidomine) and etc.

    Special instructions:
    Not effective in heart failure due to cardiac tamponade and toxic pulmonary edema.
    Avoid abrupt discontinuation of the drug, reduce the dose gradually. It is necessary to monitor blood pressure and heart rate (heart rate).
    In case of precipitation of crystals (turbidity), the drug should not be used.
    Form release / dosage:
    Concentrate for the preparation of solution for infusion.
    Packaging:
    For 10 ml (1 mg / ml) in ampoules. 5 ampoules in the outline of the cell. 2 contour squares with instructions for use in a pack of cardboard.
    Storage conditions:At a temperature of no higher than 30 ° C. Keep out of the reach of children.
    Shelf life:5 years. Do not use after the expiration date!
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003821/08
    Date of registration:LSR-003821/08
    Manufacturer: & nbsp
    Information update date: & nbsp23.12.2013
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