Name:
Monocaps caps.20mg in a box. pack No. 10×3
Description:
Peripheral vasodilator with a predominant effect on venous vessels, antianginal agent. The main active ingredient isosorbide mononitrate 20 mg. Release form Capsules Dosage 20 mg During therapy, control of blood pressure and heart rate is necessary. With prolonged use of Monocaps, tolerance may develop, and therefore it is recommended that after 3-6 weeks of regular use of the drug, take a break for 3-5 days, replacing Monocaps with other antianginal drugs for this time. If necessary, use the drug against the background of arterial hypotension, you should simultaneously administer drugs with a positive inotropic effect. In case of intolerance to Monocaps, in no case do not take the drug again. Do not abruptly stop treatment with Monocaps. This must be done gradually to avoid the undesirable consequences of abrupt discontinuation of treatment (“withdrawal” syndrome). The drug is not prescribed to children under 18 years of age. Pharmacological properties The active substance of the drug “Monocaps” is isosorbide mononitrate. Isosorbide mononitrate is a peripheral vasodilator with a predominant effect on venous vessels, an antianginal agent. Increases the content of nitric oxide in the endothelium, stimulates guanylate cyclase and the formation of c-GMP, reduces the concentration of calcium in smooth muscle cells. It causes a decrease in myocardial oxygen demand due to a decrease in preload (dilation of peripheral veins and a decrease in blood flow to the right atrium) and afterload (decrease in OPSS), and also has a coronary dilating effect. It improves coronary blood flow, promotes its redistribution to ischemic areas, reduces the final diastolic volume of the left ventricle and reduces the systolic tension of its walls. Increases exercise tolerance in patients with coronary artery disease, angina pectoris. Reduces pressure in the pulmonary circulation. When taking isosorbide mononitrate, the antianginal effect appears within 30 minutes after ingestion and lasts 2-6 hours. The bioavailability of isosorbide mononitrate does not depend on the characteristics of the diet (caloric content, high or low fat content) and meal times. Pharmacokinetics: After oral administration of isosorbide, mononitrate is rapidly and completely absorbed from the gastrointestinal tract. Bioavailability is 90-100%. Plasma concentration is directly proportional to the dose taken. Isosorbide mononitrate is almost completely biotransformed in the liver with the formation of inactive metabolites by denitration to isosorbide or by conjugation with glucuronic acid and the formation of inactive 2-glucuronide. It is excreted by the kidneys mainly in the form of metabolites, 2% – unchanged. T1 / 2 is 4-5 hours. The pharmacokinetics of isosorbide mononitrate does not change in elderly and senile patients, as well as in patients with chronic renal and hepatic insufficiency. Indications for use Monocaps is indicated for the prevention of angina attacks in the post-infarction period. It is used as part of combination therapy in the treatment of chronic heart failure, some forms of pulmonary hypertension and cor pulmonale. Method of administration and doses The frequency of administration and duration of treatment are set individually. Monocaps is taken orally after meals, 20-40 mg per dose 2-3 times a day with an interval of 7-8 hours. Use during pregnancy and lactation During pregnancy and lactation, Monocaps should be used with extreme caution, only on the urgent prescription of a doctor, after a thorough assessment of the benefits and possible risks, since there is not enough experience with the use of this drug during pregnancy and during breastfeeding. Experimental studies on animals have not revealed a damaging effect on the fetus. Interaction with other drugs It is possible to increase the hypotensive effect when taken simultaneously with other vasodilators, antihypertensives, beta-blockers, slow calcium channel blockers, diuretics, angiotensin-converting enzyme (ACE) inhibitors, antipsychotics (neuroleptics) and tricyclic antidepressants, novocainamide, ethanol , phosphodiesterase inhibitors, including sildenafil, vardenafil, tadalafil. The simultaneous use of isosorbide mononitrate with dihydroergotamine can lead to an increase in the concentration of dihydroergotamine in the blood plasma and, thus, enhance its antihypertensive effect. When combined with amiodarone, propranolol, “slow” calcium channel blockers (verapamil, nifedipine, etc.), the antianginal effect may be enhanced. Under the influence of beta-adrenergic stimulants, alpha-blockers (dihydroergotamine, etc.), a decrease in the severity of the antianginal effect (tachycardia, excessive decrease in blood pressure) is possible. Barbiturates accelerate metabolism and reduce the concentration of isosorbide mononitrate in the blood. Reduces the effect of vasopressors. When combined with M-anticholinergics (atropine, etc.), the likelihood of an increase in intraocular pressure increases. Adsorbents, astringents and enveloping agents reduce the absorption of isosorbide mononitrate in the gastrointestinal tract. The therapeutic effect of norepinephrine (norepinephrine) is reduced when taken simultaneously with nitro compounds. It should be borne in mind that the drug interactions described above are also possible if these drugs were used shortly before treatment with Monocaps was started. Contraindications hypersensitivity to the drug and other organic nitrates; acute circulatory disorders (shock, vascular collapse); cardiogenic shock, if correction of the end diastolic pressure of the left ventricle is impossible with the help of intra-aortic counterpulsation or due to the introduction of agents that have a positive inotropic effect; hemorrhagic stroke; acute myocardial infarction with reduced filling pressure of the left ventricle; severe arterial hypotension (systolic blood pressure less than 90 mm Hg, and diastolic blood pressure less than 60 mm Hg, central venous pressure below 4-5 mm Hg), hypovolemia; simultaneous administration of phosphodiesterase inhibitors, including sildenafil, vardenafil, tadalafil, as they potentiate the hypotensive effect of the drug; acute myocardial infarction with severe arterial hypotension; anemia (severe); hereditary galactose intolerance, lactase deficiency or malabsorption syndrome of glucose and galactose; toxic pulmonary edema; lactation period; age up to 18 years (efficacy and safety have not been established). Use with caution in hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade; with reduced filling pressure of the left ventricle, for example, with acute myocardial infarction (risk of lowering blood pressure and tachycardia, which can increase ischemia), a decrease in left ventricular function (left ventricular failure). Systolic blood pressure should not be allowed to fall below 90 mm Hg; with aortic and / or mitral stenosis; with a tendency to arterial hypotension (orthostatic disturbances in the regulation of blood circulation); in heart failure with low filling pressure of the left ventricle; with glaucoma (risk of increased intraocular pressure); in diseases accompanied by an increase in intracranial pressure (previously, an increase in pressure was noted only with intravenous administration of high doses of nitroglycerin), including with hemorrhagic stroke, a recent head injury; with severe anemia; with severe renal failure; with liver failure (risk of developing methemoglobinemia). Composition of Isosorbide mononitrate 20 mg. OverdoseSymptoms: pronounced decrease in blood pressure with orthostatic dysregulation, palpitations, weakness, dizziness, lethargy, headache, redness of the skin, nausea, vomiting, diarrhea, collapse, fainting, hyperthermia, convulsions, sweating, methemoglobinemia (cyanosis, anoxia), hyperpnea, dyspnea , increased intracranial pressure, paralysis, coma. Treatment: gastric lavage; with a pronounced decrease in blood pressure and / or a state of shock, fluid should be administered; in exceptional cases, infusions of norepinephrine and / or dopamine can be performed to improve blood circulation. The introduction of epinephrine (adrenaline) and related compounds is contraindicated. Depending on the severity, the following antidotes are used in cases of methemoglobinemia: Vitamin C: 1 g orally or as the sodium salt intravenously. methylene blue: up to 50 ml of 1% methylene blue solution intravenously. toluidine blue: initially 2-4 mg/kg body weight strictly intravenously; then, if necessary, repeated injections of 2 mg/kg of body weight are possible with an interval between injections of one hour. oxygen therapy, hemodialysis, exchange transfusion. Side effects From the side of the cardiovascular system: at the beginning of treatment, a headache (“nitrate” headache) may occur, which, as a rule, decreases after a few days of therapy; dizziness, flushing of the skin of the face, feeling of heat, tachycardia. Sometimes at the first dose of the drug or after increasing the dose, a decrease in blood pressure and / or orthostatic hypotension is observed, which may be accompanied by a reflex increase in heart rate, lethargy, as well as dizziness and a feeling of weakness. In rare cases, increased angina attacks (paradoxical reaction to nitrates), orthostatic collapse. There have been cases of collaptoid states, sometimes with bradyarrhythmia and syncope. From the gastrointestinal tract: nausea, vomiting, there may be a slight burning sensation of the tongue, dry mouth. From the side of the central nervous system: stiffness, drowsiness, blurred vision, decreased ability to quick mental and motor reactions (especially at the beginning of treatment). In rare cases, cerebral ischemia. Allergic reactions: skin rash, in some cases – exfoliative dermatitis. Other: development of tolerance (including cross to other nitrates). To prevent the development of tolerance, continuous high doses of the drug should be avoided. In some cases, exfoliative dermatitis (severe cases of exudative erythema multiforme, widespread impetigo and toxicoderma). The use of Monocaps can lead to transient hypoxemia due to the relative redistribution of blood flow to hypoventilated alveolar segments. This may be a trigger for ischemia in patients with coronary heart disease. Storage conditions Do not use after the expiry date stated on the packaging. Store in a place protected from moisture and light at a temperature of 15°C to 25°C. Store out of the reach of children. Buy Monocaps capsules 20mg No. 10×3 Price for Monocaps capsules 20mg No. 10×3
INN | ISOSORBIDE MONONITRATE |
---|---|
The code | 18 114 |
Barcode | 4 810 046 002 472 |
Dosage | 20mg |
Active substance | Isosorbide mononitrate |
Manufacturer | Minskintercaps UP RB, Belarus |
Indications Applications | Monocaps is indicated for the prevention of angina attacks in the post-infarction period. It is used as part of combination therapy in the treatment of chronic heart failure, some forms of pulmonary hypertension and cor pulmonale. |
Contraindications | hypersensitivity to the drug and other organic nitrates; acute circulatory disorders (shock, vascular collapse); cardiogenic shock, if correction of the end diastolic pressure of the left ventricle is impossible with the help of intra-aortic counterpulsation or due to the introduction of agents that have a positive inotropic effect; hemorrhagic stroke; acute myocardial infarction with reduced filling pressure of the left ventricle; severe arterial hypotension (systolic blood pressure less than 90 mm Hg, and diastolic blood pressure less than 60 mm Hg, central venous pressure below 4-5 mm Hg), hypovolemia; simultaneous administration of phosphodiesterase inhibitors, including sildenafil, vardenafil, tadalafil, as they potentiate the hypotensive effect of the drug; acute myocardial infarction with severe arterial hypotension; anemia (severe); hereditary galactose intolerance, lactase deficiency or malabsorption syndrome of glucose and galactose; toxic pulmonary edema; lactation period; age up to 18 years (efficacy and safety have not been established). Use with caution in hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade; with reduced filling pressure of the left ventricle, for example, with acute myocardial infarction (risk of lowering blood pressure and tachycardia, which can increase ischemia), a decrease in left ventricular function (left ventricular failure). Systolic blood pressure should not be allowed to fall below 90 mm Hg; with aortic and / or mitral stenosis; with a tendency to arterial hypotension (orthostatic disturbances in the regulation of blood circulation); in heart failure with low filling pressure of the left ventricle; with glaucoma (risk of increased intraocular pressure); in diseases accompanied by an increase in intracranial pressure (previously, an increase in pressure was noted only with intravenous administration of high doses of nitroglycerin), including with hemorrhagic stroke, a recent head injury; with severe anemia; with severe renal failure; with liver failure (risk of developing methemoglobinemia). |
Side effects | From the side of the cardiovascular system: at the beginning of treatment, a headache ("nitrate" headache) may occur, which usually decreases after a few days of therapy; dizziness, flushing of the skin of the face, feeling of heat, tachycardia. Sometimes at the first dose of the drug or after increasing the dose, a decrease in blood pressure and / or orthostatic hypotension is observed, which may be accompanied by a reflex increase in heart rate, lethargy, as well as dizziness and a feeling of weakness. In rare cases, increased angina attacks (paradoxical reaction to nitrates), orthostatic collapse. There have been cases of collaptoid states, sometimes with bradyarrhythmia and syncope. From the gastrointestinal tract: nausea, vomiting, there may be a slight burning sensation of the tongue, dry mouth. From the side of the central nervous system: stiffness, drowsiness, blurred vision, decreased ability to quick mental and motor reactions (especially at the beginning of treatment). In rare cases, cerebral ischemia. Allergic reactions: skin rash, in some cases – exfoliative dermatitis. Other: development of tolerance (including cross to other nitrates). To prevent the development of tolerance, continuous high doses of the drug should be avoided. In some cases, exfoliative dermatitis (severe cases of exudative erythema multiforme, widespread impetigo and toxicoderma). The use of Monocaps can lead to transient hypoxemia due to the relative redistribution of blood flow to hypoventilated alveolar segments. This may be a trigger for ischemia in patients with coronary heart disease. |
Use during pregnancy and lactation | unknown |
Age category | 18+ |
Application Gender | Any |
Release Form | Capsules |
Main Active Substances | Isosorbide mononitrate 20 mg. |
Composition Means | Isosorbide mononitrate 20 mg. |
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