Monosan tablets 20 mg No. 10x3

Monosan ® /Monosan®

International nonproprietary name (INN):

isosorbide mononitrate

Dosage form

Pills.

Compound

1 tablet contains:

Active substance

: isosorbide-5-mononitrate 20 or 40 mg (trituration of isosorbide-5-mononitrate and monohydralactose in a ratio of 80%:20% 25 mg or 50 mg).

Excipients

: microcrystalline cellulose, corn starch, magnesium stearate, granulated lactose, talc.

Description

Round, flat tablets of white or almost white color with a score line on one side.

Pharmacotherapeutic group: Vasodilating agent, nitrate.

ATX code: C01DA14.

pharmachologic effect

The active component is a peripheral vasodilator (“vaso” - vessels + “dilator” - dilator), which acts primarily on venous vessels. The drug can stimulate the production of a special relaxing endothelial factor - nitric oxide in the vascular endothelium.

Under the influence of this factor, the intracellular enzyme guanylate cyclase is activated, which leads to an increase in the vasodilating mediator - cGMP.

As a result, the need of myocardial cells for O2 decreases, which is explained by a decrease in afterload and preload . pronounced coronary-dilating effect .

The active substance can reduce blood flow to the right atrium, reducing pressure in the pulmonary circulation and reducing the severity of negative symptoms during pulmonary edema . In areas with reduced blood circulation, a redistribution of coronary blood flow is noted under the influence of Monosan.

In patients who suffer from angina pectoris , heart disease tolerance (resistance) to physical activity increases markedly. Headaches often occur with the use of nitrates, which is explained by the ability of medications to expand the lumens of blood vessels in the dura mater and brain.

Monosan is able to reduce the rate of intraplatelet synthesis of Thx, as well as inhibit platelet aggregation. Cross tolerance is characteristic. Sensitivity to the active substance is restored quite quickly after a break in treatment.

Pharmacological properties of the drug Monosan

Monosan (isosorbide-5-mononitrate) is an organic nitrate, one of the metabolites of isosorbide dinitrate. Monosan increases the content of nitric oxide in the endothelium, stimulates guanylate cyclase and the formation of cGMP. The antianginal effect is associated with a decrease in the myocardial oxygen demand due to a decrease in preload (the drug causes expansion of the peripheral veins, due to which blood is retained in the volumetric bed; the return of blood to the heart is reduced, as a result of which the pressure in the pulmonary artery decreases, the pulmonary circulation is partially unloaded and decreases end-diastolic pressure in the left ventricle) and afterload (dilation of the arteries leads to a decrease in peripheral vascular resistance), as well as with direct vasodilation of the coronary arteries. In addition, a decrease in preload reduces left ventricular wall tension, which leads to an increase in subendocardial and intramural circulation as a result of a decrease in end-diastolic and end-systolic pressure in the left ventricle. Under the influence of the drug, cardiac output increases in patients with heart failure in response to a decrease in resistance in the arterial system (however, in the absence of heart failure, cardiac output does not change and may even decrease slightly). Monosan inhibits platelet aggregation, reduces intraplatelet synthesis of thromboxane, and increases exercise tolerance in patients with coronary artery disease. The maximum concentration of Monosan in the blood plasma after oral administration is achieved after 1 hour. Bioavailability is almost 100%. When isosorbide-5-mononitrate first passes through the liver, no biological transformation occurs; does not bind to blood plasma proteins. The half-life is 4–6 hours. The pharmacokinetics of isosorbide-5-mononitrate does not depend on the presence of cardiac, renal and liver failure. Monosan is metabolized in the liver to isosorbide and mononitrate-2-glucuronide. Both metabolites are pharmacologically inactive and are excreted by the kidneys. 2% of the drug is excreted unchanged in the urine.

Pharmacodynamics and pharmacokinetics

After oral administration, the antianginal effect is registered within 30-45 minutes and can last for almost 10 hours. The active substance is quickly and completely absorbed from the lumen of the digestive tract. Isosorbide mononitrate has a high bioavailability rate of 100%, which is explained by the absence of a first-pass effect through the hepatic system.

The Tmax indicator after administration is 1 hour. Plasma concentration varies only slightly due to individual differences. The individual level of the active substance in the blood plasma is 100 mg/ml. There is no binding to plasma proteins. Pharmacokinetics in dosages from 10 to 80 mg are characterized by linearity.

metabolized in the renal system, in contrast to Isosorbide dinitrate , which is metabolized in the hepatic system. As a result of metabolic reactions, 3 components are formed: 2 isosorbide-5-mononitrate glucuronides and isosorbide. The half-life is 4-5 hours. 2% is excreted unchanged through the renal system, 98% in the form of glucuronic metabolites. The renal clearance rate is 115 ml/min. The pharmacokinetics of the drug does not change significantly with renal and hepatocellular failure .

Overdose of the drug Monosan, symptoms and treatment

It is observed extremely rarely. Due to the fact that the nitrate ion interacts with hemoglobin, even after the use of organic nitrates in high doses, the concentration of nitrate ions in the blood plasma remains low enough that severe methemoglobinemia can develop. Symptoms : reflex tachycardia, weakness, dizziness, nausea, vomiting, diarrhea, flushing, headache, feeling of fear, orthostatic hypotension, in severe cases - cyanosis. Treatment: symptomatic - oxygen inhalation, raising the lower extremities upward, in case of taking a large number of tablets - gastric lavage. In the presence of methemoglobinemia, which is manifested by cyanosis, slow intravenous administration of methylene blue at a dose of 1 mg/kg body weight.

Contraindications

• vascular collapse;
• shock;
• arterial hypovolemia and arterial hypotension (decrease in systolic blood pressure to 100 mm Hg; drop in diastolic blood pressure below 60 mm Hg; decrease in venous central pressure to 4-5 mm Hg);
• cardiac tamponade;
• acute stage of myocardial infarction (with severe arterial hypotension);
• left ventricular failure and low diastolic blood pressure;
• toxic pulmonary edema;
• breast-feeding;
• angle-closure form of glaucoma ;
• diseases that provoke an increase in intracranial pressure (traumatic brain injury, hemorrhagic stroke and others);
• individual hypersensitivity;
• Age limit: up to adulthood.

Relative contraindications:

• constrictive pericarditis;
• tendency to orthostatic disorders of vascular regulation;
• mitral stenosis;
• elderly age;
• severe renal failure;
• liver failure (the risk of developing methemoglobinemia increases);
• hypertrophic cardiomyopathy (increased angina attacks);
• thyrotoxicosis;
• severe anemia;
• aortic stenosis.

Contraindications to the use of the drug Monosan

Hypersensitivity to nitrates, shock states, myocardial infarction in the acute period with low end-diastolic pressure, arterial hypotension (systolic pressure ≤100 mm Hg, diastolic pressure ≤60 mm Hg, central venous pressure ≤4–5 mmHg), cardiac tamponade, inadequate cerebral perfusion. During pregnancy and breastfeeding. Age up to 15 years. Conditions accompanied by increased intracranial pressure (including hemorrhagic stroke, after a head injury), with angle-closure glaucoma with high intraocular pressure.

Side effects

Digestive tract:

• burning sensation in the tongue area;
• vomit;
• feeling of dry mouth;
• nausea.

The cardiovascular system:

• tachycardia;
• feeling of heat in the body;
• facial skin hyperemia;
• nitrate headaches;
• pronounced drop in blood pressure ;
• dizziness;
• orthostatic collapse;
• increased frequency and intensification of angina attacks (a kind of paradoxical reaction).

Nervous system:

• slowing down the speed of motor and mental reactions;
• increased drowsiness ;
• stiffness;
• blurred visual perception.

Other reactions:

• establishment of tolerance (cross form - in relation to other nitrates);
• exfoliative dermatitis;
• specific skin rashes.

Side effects of the drug Monosan

headache, dizziness, arterial hypotension, orthostatic collapse, tachycardia, methemoglobinemia, exacerbation of glaucoma, increased intracranial pressure, changes in the speed of mental reactions, dry mouth, nausea, vomiting, flushing of the facial skin, general weakness, fatigue are the most typical side effects. Sometimes, with a sharp decrease in blood pressure, paradoxical “nitrate” reactions are possible - increased attacks of angina. In patients predisposed to allergic reactions, rash, itching, skin hyperemia, and exfoliative dermatitis are possible. Tolerance often develops.

Monosan, instructions for use (Method and dosage)

Tablets are used only per os. The manufacturer recommends taking the tablets with water and swallowing them whole. Assessing the severity of the underlying disease and concomitant pathology, the treating doctor selects a treatment regimen.

Treatment begins with taking 10-20 mg of Monosan 1-3 times a day. From the 3-4th day of treatment, the dosage regimen is adjusted depending on the clinical effect, possibly increasing to 20-40 mg twice a day. In some cases, the amount of medication is increased to 80 mg/day - the maximum daily dosage.

Use of the drug Monosan

Adults and teenagers over 15 years old. The doctor determines the dose and frequency of administration individually. Treatment is started with low doses (10–20 mg 1–2 times a day), which are increased during treatment if necessary. In most cases, 20 or 40 mg are prescribed 2 times a day. If necessary, the single dose can be increased to 40–60 mg (in special cases up to 80 mg) at the same frequency of administration. The maximum single dose is 80 mg, the maximum daily dose is 160 mg. The tablets can be divided in half without crushing, washed down with a sufficient amount of liquid.

Overdose

Fainting, collapse, dizziness, redness of the skin, dyspnea, hyperpnea, methemoglobinemia , diarrhea syndrome , headaches, lethargy, weakness, reflex tachycardia, hyperthermia, visual disturbances, paralysis, increased intracranial pressure , convulsions, coma, vomiting, nausea, increased sweating.

General recommendations: place the patient in a horizontal position, perform gastric lavage procedures, prescribe enterosorbent medications , monitor vital signs, and correct them if necessary.

Specific therapy: in case of shock and severe arterial hypotension, blood volume is replenished. Dopamine and/or Norepinephrine infusion is performed in exceptional cases to improve blood circulation.

Adrenaline , Epinephrine and other related compounds is unacceptable When diagnosing methemoglobinemia hemodialysis , oxygen therapy , exchange blood transfusion are performed, and ascorbic acid in the form of sodium salt.

Monosan tablets 20 mg No. 10x3

Name

Monosan.

Description

White, flat tablets with a score.

Main active ingredient

Isosorbide mononitrate

Release form

Pills.

Dosage

20 mg.

special instructions

Pharmacological group

Peripheral vasodilators used in the treatment of heart disease. Organic nitrates.

Pharmacological properties

Monosan® is a drug that dilates blood vessels. Causes a decrease in venous return and reduces the load when blood enters the right ventricle of the heart. In large doses, it causes a decrease in peripheral vascular resistance due to the expansion of small arteries. Reduces the work of the left ventricle and reduces oxygen consumption in the heart muscle. At the same time, it directly expands the coronary arteries of the heart.

Indications for use

Preventive treatment of angina (including in the post-infarction period.

Directions for use and doses

Treatment with Monosan® begins with low doses, which are increased during treatment if necessary. Usually Monosan® is taken 2 times a day (for example, in the morning, after waking up and in the afternoon) 1 tablet of 20 mg or 40 mg. In order to prevent the development of tolerance to nitrates, the second tablet should be taken no earlier than after 8 hours. To prevent loss of effectiveness, you should avoid prescribing high doses of Monosan and taking it more than 2 times a day. It is recommended to determine and use the minimum effective dose. It is recommended to take the tablets after meals, without chewing them and drinking plenty of liquid. If a dose is missed, it is recommended to take the next dose at the usual time. Do not take a double dose to make up for a missed dose. Elderly patients Elderly patients usually do not require dose adjustment. However, it is recommended to prescribe the drug with caution, starting with minimal doses, taking into account the state of renal, liver, cardiovascular function and concomitant drug therapy. Patients with impaired liver and kidney function It is recommended to start therapy with minimal doses and take into account concomitant drug therapy. Children The safety and effectiveness of isosorbide mononitrate in children has not been established. If a dose of the drug is missed, it is recommended to take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Use during pregnancy and lactation

Data on the use of isosorbide mononitrate during pregnancy and breastfeeding are insufficient to establish effectiveness for the mother and safety for the fetus or child. As a precaution, it is recommended to avoid prescribing Monosan® during pregnancy and breastfeeding. If the need to take isosorbide mononitrate has been carefully assessed by a physician, breastfeeding should be discontinued.

Impact on the ability to drive vehicles and other mechanisms

Monosan®, especially at the initial stage of treatment, can affect activities that require increased attention (for example, driving vehicles and operating machinery).

Precautionary measures

Monosan® is not used for acute attacks of angina and acute myocardial infarction! During treatment, monitoring of blood pressure and heart rate is necessary. After taking isosorbide mononitrate, arterial hypotension may develop, especially in an upright position. The drug should be used with caution in patients who are weakened and/or prone to developing hypotension. Hypotension caused by nitrates may be accompanied by paradoxical bradycardia and progression of angina. Frequent and/or high doses of isosorbide mononitrate may cause the development of tolerance. In these cases, it is recommended to discontinue isosorbide mononitrate for 24-48 hours or, after 3-6 weeks of regular use, take a break for 3-5 days, replacing during this time with other antianginal agents. Abrupt withdrawal of the drug should be avoided (the dose should be reduced gradually). If intolerance to Monosan occurs, do not repeat the dose under any circumstances. During treatment with Monosan you should avoid drinking alcohol. As with treatment with other nitrates, taking Monosan may be accompanied by headaches, which decrease after a few days. It is not recommended to change the medication regimen in order to avoid headaches, as this may reduce the antianginal effect. Aspirin or acetaminophen may be used to reduce nitrate-induced headaches without reducing the underlying effect. Monosan® should be administered with caution to patients suffering from malnutrition and severe liver and kidney damage. The drug contains lactose, so it should not be used in patients with rare hereditary diseases such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. The drug, especially at the initial stage of treatment, may have a negative impact on activities that require concentrated attention and quick decision-making. This type of activity can be performed only after special permission from a doctor.

Interaction with other drugs

Vasodilators, other antihypertensive drugs (such as slow calcium channel blockers, beta-blockers, diuretics, angiotensin-converting enzyme inhibitors, etc.), antipsychotics, tricyclic antidepressants, procainamide and quinidine may enhance the hypotensive effect of isosorbide mononitrate. The antihypertensive effect of Monosan is also enhanced by a phosphodiesterase inhibitor such as 5-sildenafil, so their simultaneous use is contraindicated. When used in combination with M-anticholinergics (atropine, etc.), the likelihood of increased intraocular pressure increases. Adsorbents, astringents and enveloping drugs reduce the absorption of isosorbide mononitrate in the gastrointestinal tract. The simultaneous use of isosorbide mononitrate with dihydroergotamine may lead to an increase in the concentration of dihydroergotamine in the blood plasma and, thus, enhance its hypotensive effect. The use of alcohol enhances the hypotensive effect of the drug.

Contraindications

Monosan® should not be taken if there is hypersensitivity to the substances included in the drug, or combined with medications for the treatment of erectile dysfunction (such as sildenafil (Viagra), tadalafil, vardenafil, etc.). Monosan® should not be taken in cases of acute heart attack (angina attack, myocardial infarction), acute circulatory failure (shock, sharp decrease in blood pressure), cardiac tamponade, marked decrease in blood pressure (systolic blood pressure below 90 mm Hg). This drug is not prescribed to patients with diseases called “angle-closure glaucoma”, “constrictive pericarditis”, “hypertrophic obstructive cardiomyopathy”, as well as narrowing of the blood outflow pathways from the heart (aortic and mitral stenosis), a marked decrease in the number of red blood cells and hemoglobin (anemia), increased intracranial pressure. Monosan® is contraindicated in hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, as well as during pregnancy and lactation. Monosan® is not intended for use in children and adolescents under 18 years of age. Particular caution is required if there are serious circulatory disorders in the brain (severe cerebrovascular insufficiency).

Compound

1 tablet contains: Active substance: isosorbide mononitrate 20 mg or 40 mg (in the form of diluted isosorbide mononitrate), Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, talc, magnesium stearate.

Overdose

Symptoms: marked decrease in blood pressure with orthostatic vasodilation, palpitations, weakness, dizziness, lethargy, headache, redness of the skin, nausea, vomiting, diarrhea, collapse, fainting, hyperthermia, convulsions, sweating, methemoglobinemia (cyanosis, anoxia), hyperpnea, dyspnea , intracranial pressure disorder, paralysis, coma. Treatment: gastric lavage, activated carbon. If hypotension develops, the patient should be placed in a supine position with legs elevated; in case of a marked decrease in blood pressure and/or a state of shock, fluids should be administered; in exceptional cases, infusions of norepinephrine and/or dopamine can be performed to improve blood circulation. Administration 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 in the form of sodium salt intravenously. Methylene blue: up to 50 ml of 1% methylene blue solution intravenously. Toluidine blue: first 2-4 mg/kg body weight strictly IV; then, if necessary, repeated administrations of 2 mg/kg body weight are possible with an interval between administrations of one hour. Oxygen therapy, hemodialysis, exchange transfusion.

Side effect

From 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, facial flushing, feeling of heat, tachycardia. Sometimes, when first taking 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 attacks of angina (paradoxical reaction to nitrates), orthostatic collapse. There have been cases of collaptoid states, sometimes bradyarrhythmia and fainting. From the gastrointestinal tract: nausea, vomiting, a slight burning sensation of the tongue, dry mouth. From the central nervous system: stiffness, drowsiness, blurred vision, decreased ability for rapid mental and motor reactions (especially at the beginning of treatment). In rare cases, cerebral ischemia. Allergic reactions: skin rash. Other: development of tolerance (including cross-tolerance to other nitrates). To prevent the development of tolerance, continuous use of high doses of the drug should be avoided. In some cases - exfoliative dermatitis (severe cases of exudative erythema multiforme, spread of impetigo and toxicoderma). With long-term use, methemoglobinemia is possible, as well as an increase in the level of catecholamines and vanillin-succinic acid in the urine. The use of the drug Monosan® 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 artery disease.

Storage conditions

Store in a place protected from moisture and light at a temperature of 15-25°C. Keep out of the reach of children.

Buy Monosan tab 20mg in blister pack. No. 10x3 in the pharmacy

Price for Monosan tablet 20 mg in blister pack. №10x3

Instructions for use for Monosan tablet 20 mg in blister pack. №10x3

Interaction

The active substance can increase the concentration of dihydroergotamine in the blood. A decrease in the effectiveness of vasopressor drugs has been recorded. Barbiturates are able to reduce the concentration of isosorbide and accelerate its biological transformation.

Potentiation of the hypotensive effect of isosorbide mononitrate is recorded with simultaneous treatment with Tadalafil , tricyclic antidepressants, antipsychotics, Vardenafil , Sildenafil , diuretics, beta-blockers, vasodilators, PDE-5 inhibitors.

The antianginal effect is enhanced by treatment with Propranolol , Amiodarone and drugs from the CCB group ( Nifedipine , Verapamil ). When interacting with nitro compounds, the therapeutic effect of Norepinephrine (Norepinephrine) is significantly reduced.

Enveloping medications, astringents and adsorbents reduce the absorption rate of isosorbide. M-anticholinergic agents ( Atropine ) can increase intraocular pressure during simultaneous therapy with nitrates. A decrease in the severity of the antianginal effect (fall in blood pressure, increase in pulse) is observed during treatment with alpha-blockers and beta-blockers.

Interactions of the drug Monosan

When used simultaneously with antihypertensive drugs, antidepressants (MAO inhibitors), drugs containing ethyl alcohol, and dihydroergotamine, the hypotensive effect of Monosan may be enhanced. Concomitant use with sildenafil and other PDE inhibitors is contraindicated due to the risk of uncontrolled hypotension. Opioid analgesics significantly enhance the analgesic effect of Monosan in patients during the acute period of myocardial infarction. When taking heparin and Monosan simultaneously, the antiplatelet effect is enhanced. Atropine and other M-anticholinergic drugs, as well as sympathomimetics, reduce the effectiveness of Monosan.

special instructions

The medication is not used to relieve angina attacks. Monitoring blood pressure and heart rate is mandatory. If the drug must be used against the background of arterial hypotension, then at the same time it is necessary to prescribe drugs that have a positive inotropic effect.

With frequent use of the drug in high doses, tolerance develops. In such cases, after 3-6 weeks of therapy, a temporary break of 24-48 hours is required, or for 3-5 days with the prescription of other antianginal drugs.

The dosage reduction should be done gradually. The same applies to drug withdrawal; the dose is reduced in stages. Drinking alcohol-containing drinks is prohibited. The drug can slow down the speed of motor and mental reactions, which can affect the control of vehicles and complex mechanisms.

Special instructions for the use of the drug Monosan

Psychomotor reactions may be slowed down, which should be taken into account when driving vehicles and engaging in potentially hazardous activities. Caution should be used in patients with low body weight (dystrophy), cerebrovascular accident, increased intracranial pressure, severe cerebral atherosclerosis, closed-angle glaucoma, severe anemia, severe liver dysfunction (due to the threat of methemoglobinemia), severe renal dysfunction. , patients with hyperthyroidism, with aortic or mitral stenosis, with hypertrophic cardiomyopathy, patients prone to orthostatic disorders of circulatory regulation. Not prescribed during the acute period of myocardial infarction and to eliminate acute attacks of angina. Monosan does not affect blood glucose levels, so it can be prescribed for diabetes. With prolonged use of Monosan, tolerance may develop. There is no experience with the use of the drug during pregnancy, breastfeeding, or in children (clinical trials have not been conducted).

Analogues of Monosan

Level 4 ATC code matches:
Nitrospray

Nitroglycerine

Efox

Nitromint

Pectrol

Isoket

Erinite

Cardiket

Sustak Forte

Nitrosorbide

• Monocinque;
• Cardiket;
• Isoket;
• Pectrol;
• Efox.

Reviews about Monosan

Regular use of the drug can significantly reduce the frequency of angina attacks. Patients note that the severity of attacks of chest pain during treatment is significantly reduced, and tolerance/resistance to physical activity also increases.

of breath decreases , the feeling of lack of oxygen disappears, and improves the quality of life. The drug is well tolerated and rarely causes negative side effects described in the corresponding section.

Monosana price, where to buy

In Russia, the drug costs about 100 rubles.

The cost of the medication varies depending on the dosage and pharmacy chain.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Monosan tablets 20 mg 30 pcs. Pro.Med.Cs
  84 rub. order
• Monosan tablets 40 mg 30 pcs. Pro.Med.Cs

  RUB 152 order

Pharmacy Dialogue

• Monosan (tab. 20 mg No. 30) Pro.Med.Cs.

  78 RUR order

• Monosan (tab. 40 mg No. 30) Pro.Med.Cs.

  146 RUR order

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PaniPharmacy

• Monosan tablets Monosan tablets.
  40 mg No. 30, PRO.MED.CS Praha 116 UAH. order
• Monosan tablets Monosan tablets. 20 mg No. 30, PRO.MED.CS Praha

  76 UAH order

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