Monosan tablets 20mg, No. 30

Ischemic heart disease: prevention of angina attacks;

Chronic heart failure (as part of combination therapy);

The tablets should be taken orally, after meals, swallowed whole with a small amount of liquid.

The dose of the drug and the frequency of administration are set individually, depending on the severity of the disease.

Start with 10-20 mg 1-3 times a day (a dose of 10 mg corresponds to 1/2 tablet of 20 mg).

Depending on the severity of the clinical effect from 3-4 days, the dose can be increased to 20-40 mg 2 times a day, increasing the dose, if necessary, up to 60 mg / day (for 20 mg tablets) and up to 80 mg / day. (for 40 mg tablets).

The maximum daily dose is 80 mg.

1 tablet contains:
Active ingredient:
isosorbide-5-mononitrate 20 (trituration of isosorbide-5-mononitrate and lactose monohydrate in a ratio of 80%: 20% - 25 mg).
Excipients:
microcrystalline cellulose, corn starch, magnesium stearate, granulated lactose, talc.

Hypersensitivity to organic nitrates or other components of the drug;

Acute circulatory disorders (shock, vascular collapse);

Cardiogenic shock, if a sufficiently high end-diastolic pressure in the left ventricle is not provided by using intra-aortic counterpulsation or by introducing agents that have a positive inotropic effect;

Toxic pulmonary edema;

Severe arterial hypotension (systolic blood pressure less than 100 mm Hg, diastolic blood pressure less than 60 mm Hg)

Concomitant use of phosphodiesterase-5 inhibitors, including sildenafil, vardenafil, tadalafil, since they potentiate the antihypertensive effect of nitrates;

Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

Age up to 18 years (efficacy and safety have not been established).

Carefully:

Hypertrophic cardiomyopathy, constrictive pericarditis, pericardial tamponade;

Low filling pressure in acute myocardial infarction, left ventricular failure. A decrease in systolic blood pressure of less than 90 mm Hg should be avoided. Art.).

Aortic and / or mitral stenosis;

The tendency to orthostatic disorders of vascular regulation;

Angle-closure glaucoma;

Thyrotoxicosis;

Severe anemia;

Diseases accompanied by increased intracranial pressure (including hemorrhagic stroke, traumatic brain injury);

Severe renal failure;

Liver failure;

Pregnancy and lactation
For safety reasons, Monosan can be used during pregnancy and lactation only strictly according to the doctor's prescription, after a thorough assessment of the benefits and possible risks, since there is currently insufficient data on the consequences of its use in pregnant and lactating mothers. If a nursing mother still takes Monosan, it is necessary to monitor the baby for the development of possible effects from the drug.

Trade name: Monosan

International non-proprietary name:

isosorbide mononitrate

Dosage form:

pills

Composition:

1 tablet contains:
Active ingredient:
isosorbide-5-mononitrate 20 or 40 mg (trituration of isosorbide-5-mononitrate and lactose monohydrate 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 off-white color, scored on one side.

Pharmacotherapeutic group:

vasodilator, nitrate

Pharmacological properties
Pharmacodynamics
Peripheral vasodilator with a predominant effect on the venous vessels. Stimulates the formation of nitric oxide (endothelial relaxing factor) in the vascular endothelium, which causes activation of intracellular guanylate cyclase, resulting in an increase in cGMP (mediator of vasodilation). Reduces myocardial oxygen demand by reducing preload and afterload. Has a coronary dilating effect. Reduces blood flow to the right atrium, helps to reduce pressure in the pulmonary circulation and regression of symptoms in pulmonary edema. Promotes redistribution of coronary blood flow in areas with reduced blood circulation. Increases exercise tolerance in patients with coronary heart disease (CHD), angina pectoris. Expands the vessels of the brain, dura mater,which may be accompanied by a headache. Inhibits platelet aggregation, reduces intraplatelet thromboxane synthesis. As with other nitrates, cross-tolerance develops. After cancellation (a break in treatment), sensitivity to it quickly recovers. The antianginal effect occurs within 30-45 minutes after ingestion and lasts up to 8-10 hours.

Pharmacokinetics
After oral administration of isosorbide, mononitrate is rapidly and completely absorbed from the gastrointestinal tract (GIT). It has a high bioavailability - about 100%, since there is no 'first pass' effect through the liver. The maximum concentration in blood plasma after ingestion of the drug is achieved within an hour. Individual differences in plasma concentration after oral administration of the drug are small. The effective blood level of isosorbide mononitrate is about 100 mg / ml. The drug does not bind to blood plasma proteins. Pharmacokinetics at doses of 10-80 mg is linear, and, unlike isosorbide dinitrate, is metabolized not in the liver, but in the kidneys, where isosorbide and two glucuronides isosorbide-5-mononitrate are formed. The half-life is about 4-5 hours. Excreted by the kidneys, mainly in the form of glucuronic metabolites,2% - unchanged. The renal clearance of the drug is 115 ml / min. In hepatocellular and renal failure, the pharmacokinetics of isosorbide mononitrate does not change significantly.

Indications for use

Ischemic heart disease: prevention of angina attacks;

Chronic heart failure (as part of combination therapy);

Contraindications

Hypersensitivity to organic nitrates or other components of the drug;

Acute circulatory disorders (shock, vascular collapse);

Cardiogenic shock, if a sufficiently high end-diastolic pressure in the left ventricle is not provided by using intra-aortic counterpulsation or by introducing agents that have a positive inotropic effect;

Toxic pulmonary edema;

Severe arterial hypotension (systolic blood pressure less than 100 mm Hg, diastolic blood pressure less than 60 mm Hg)

Concomitant use of phosphodiesterase-5 inhibitors, including sildenafil, vardenafil, tadalafil, since they potentiate the antihypertensive effect of nitrates;

Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

Age up to 18 years (efficacy and safety have not been established).

Carefully

Hypertrophic cardiomyopathy, constrictive pericarditis, pericardial tamponade;

Low filling pressure in acute myocardial infarction, left ventricular failure. A decrease in systolic blood pressure of less than 90 mm Hg should be avoided. Art.).

Aortic and / or mitral stenosis;

The tendency to orthostatic disorders of vascular regulation;

Angle-closure glaucoma;

Thyrotoxicosis;

Severe anemia;

Diseases accompanied by increased intracranial pressure (including hemorrhagic stroke, traumatic brain injury);

Severe renal failure;

Liver failure;

Pregnancy and lactation
For safety reasons, Monosan can be used during pregnancy and lactation only strictly according to the doctor's prescription, after a thorough assessment of the benefits and possible risks, since there is currently insufficient data on the consequences of its use in pregnant and lactating mothers. If a nursing mother still takes Monosan, it is necessary to monitor the baby for the development of possible effects from the drug.

Method of administration and dosage
Tablets should be taken orally, after meals, swallowed whole with a small amount of liquid.

The dose of the drug and the frequency of administration are set individually, depending on the severity of the disease.

Start with 10-20 mg 1-3 times a day (a dose of 10 mg corresponds to 1/2 tablet of 20 mg).

Depending on the severity of the clinical effect from 3-4 days, the dose can be increased to 20-40 mg 2 times a day, increasing the dose, if necessary, up to 60 mg / day (for 20 mg tablets) and up to 80 mg / day. (for 40 mg tablets).

The maximum daily dose is 80 mg.

Side effect
From the side of the cardiovascular system: 'nitrate' headache, dizziness, transient flushing of the skin of the face, a feeling of heat, tachycardia, a marked decrease in blood pressure (BP). In rare cases - increased angina attacks (paradoxical reaction), orthostatic collapse.
On the part of the digestive system: nausea, vomiting, a slight burning sensation of the tongue may appear, 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).
Allergic reactions: skin rash, in some cases - exfoliative dermatitis.
Others: development of tolerance (including cross-over to other nitrates).

Overdose
Symptoms:
Collapse, fainting, reflex tachycardia, weakness, dizziness, lethargy, headache, visual disturbances, hyperthermia, skin redness, increased sweating, nausea, vomiting, diarrhea, methemoglobinemia (cyanosis), with anoxia, anoxia , dyspnea, increased intracranial pressure, convulsions, paralysis, coma.
Treatment:
In addition to general recommendations such as gastric lavage and placing the patient in a horizontal position with raised legs, vital signs should be monitored and, if necessary, adjusted. Patients with severe arterial hypotension and / or in a state of shock should replenish the circulating blood volume; in exceptional cases, norepinephrine and / or dopamine infusions can be used to improve blood circulation.
Administration of epinephrine (adrenaline) and related compounds is contraindicated. With methemoglobinemia, depending on the severity, intravenous ascorbic acid in the form of sodium salt is prescribed (previously, methylthioninium chloride (methylene blue) 0.1-0.15 ml / kg of 1% solution up to 50 ml was used); oxygen therapy, hemodialysis, exchange blood transfusion.

Interaction with other medicinal products
Increases the concentration of dihydroergotamine in blood plasma.
Reduces the effect of vasopressors.
Barbiturates accelerate biotransformation and reduce the concentration of isosorbide mononitrate in the blood.
When used together with other vasodilators, angiotensin-converting enzyme inhibitors, beta-blockers, blockers of 'slow' calcium channels, diuretics, antipsychotics or tricyclic antidepressants, with phosphodiesterase-5 inhibitors, including sildenafil, and possibly etaardolom antihypertensive action of isosorbide mononitrate.
When combined with amiodarone, propranolol, blockers of 'slow' calcium channels (verapamil, nifedipine, etc.), an increase in the antianginal effect is possible. Under the influence of beta-adrenostimulants, alpha-blockers (dihydroergotamine, etc.), a decrease in the severity of the antianginal effect (tachycardia, excessive decrease in blood pressure) is possible.
When combined with m-anticholinergics (atropine, etc.), the likelihood of increased intraocular pressure increases.
Adsorbents, astringents and coating agents reduce the absorption of isosorbide mononitrate in the gastrointestinal tract.
The therapeutic effect of norepinephrine (norepinephrine) decreases when taken simultaneously with nitro compounds.

Special instructions
The drug is not used to relieve angina attacks.
During the period of therapy, it is necessary to control blood pressure and heart rate. If necessary, use the drug against the background of arterial hypotension, you should simultaneously take drugs with a positive inotropic effect. Frequent administration and high doses can cause the development of tolerance; in this case, after 3-6 weeks of regular intake, it is recommended to cancel the drug for 24-48 hours, or a break in the treatment with Monosan for 3-5 days with its replacement for this time with other antianginal drugs.
It is necessary to avoid abrupt withdrawal of the drug and reduce the dose gradually.
During the period of drug treatment, alcohol consumption should be excluded.
A decrease in the ability to quick mental and motor reactions is possible, therefore, you should drive with caution and engage in potentially hazardous activities during the period of drug therapy.

Release form
Tablets of 20 mg and 40 mg.
10 tablets in a blister; 3 blisters together with instructions for use in a cardboard box.

Storage conditions
List B.
In a dry, dark place and out of reach of children, at a temperature of 15 - 25 ? C.

Shelf life is
4 years.
Do not use after the expiry date indicated on the package!

Terms of dispensing from pharmacies
Prescription