Monocinque pills 40mg №30

Indications

- prevention of angina attacks in patients with coronary artery disease, including after myocardial infarction;

- treatment of chronic heart failure (as part of combination therapy).

Dosage and administration

Inside, after eating with water, not liquid.

The frequency of treatment and the duration of treatment are set individually. It is expedient to start therapy with a dose of 20 mg (1/2 tab.) 2 times / day. Then gradually increase the dose to therapeutic - 40 mg (1 tab.) At the reception 2-3 times / day with an interval of 7-8 hours. The maximum daily dose is 120 mg.

Adverse effects

When taking the drug in therapeutic doses of any significant side effects, as a rule, does not develop.

Very often (≥10%): A "nitrate" headache may occur at the beginning of treatment, and with continued therapy usually goes away within a few days.

Often (≥1% - <10%): after the first dose or after increasing the dose of the drug, a decrease in blood pressure and / or development of orthostatic hypotension may occur, which may be accompanied by tachycardia, dizziness, as well as weakness.

From the nervous system: stiffness, drowsiness, blurred vision, reduced ability to quickly mental and motor responses (especially at the beginning of treatment).

Rarely (≥0.1% - <1%): nausea, vomiting, a slight burning sensation of the tongue, dry mouth, facial flushing and skin allergies may occur. A pronounced decrease in blood pressure, accompanied by worsening of symptoms of angina (paradoxical reaction to nitrates). Cases of collaptoid states have been noted, sometimes with bradyarrhythmia and syncope.

Selected cases (<0.01%): exfoliative dermatitis.

Contraindications

- acute circulatory disorders (shock, vascular collapse);

- acute myocardial infarction with severe hypotension;

- cardiogenic shock, if a sufficiently high end diastolic pressure in the left ventricle is not ensured by the use of intra-aortic counterpulsation or by administering agents that have a positive inotropic effect;

- toxic pulmonary edema;

- Anemia (severe form);

- severe arterial hypotension (systolic blood pressure less than 90 mm Hg, diastolic blood pressure less than 60 mm Hg);

- simultaneous administration of phosphodiesterase inhibitors, incl. Sildenafil, vardenafil, tadalafil, because they potentiate the antihypertensive effect of nitrates;

- hereditary intolerance to galactose, lactase deficiency or malabsorption syndrome of glucose and galactose;

- children's and teenage age up to 18 years (efficiency and safety are not established);

- Hypersensitivity to nitrates or other components of the drug.

WITH caution

- hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade;

- low filling pressure in acute myocardial infarction, left ventricular failure. It should not be allowed to lower systolic blood pressure below 90 mm Hg;

- aortic and / or mitral stenosis;

- The tendency to orthostatic disorders of vascular regulation;

- glaucoma (risk of increased intraocular pressure);

- severe renal failure;

- liver failure (risk of developing methemoglobinemia);

- hemorrhagic stroke;

- thyrotoxicosis;

- Diseases accompanied by increased intracranial pressure;

- Recently transferred craniocerebral injury.

Use during pregnancy and lactation

For security reasons Monocinque ^® can be used during pregnancy and lactation only strictly by doctor's prescription, after a thorough assessment of the benefits and possible risks, since there are currently insufficient data on the consequences of its use in pregnant and lactating mothers.

If a nursing mother still takes Monocinque^®, it is necessary to establish observation of the child for the development of possible effects from the drug.

Application for violations of the liver

With caution in liver failure (risk of developing methemoglobinemia).

Application for violations of kidney function

With caution in severe renal failure.

Use in children

Contraindicated in children and adolescents under 18 years of age.

Special notes

Monochinkve^® should not be used for the relief of acute strokes and acute myocardial infarction.

During the period of therapy, control of blood pressure and heart rate is necessary.

Avoid abrupt withdrawal of the drug (gradually reduce the dose).

Possible development of tolerance to Monocinque^® or cross-tolerance to other nitro compounds (reduced drug efficacy due to previous use of other nitro compounds). To prevent the development of tolerance to action Monocinque^® its continuous administration in high doses should be avoided.

In patients with blood circulation lability, symptoms of acute circulatory failure may develop already at the first dose of the drug.

"Nitrate" headaches can be largely prevented if at the start of therapy 1/2 pill is taken. Monocinque^® in the morning and in the evening.

During the period of drug treatment should be excluded the use of ethanol.

Influence on ability to drive motor transport and control mechanisms

During treatment, it is not recommended to drive vehicles or engage in other potentially hazardous activities that require a quick psychomotor reaction.

Overdosage

Symptoms: lowering blood pressure with orthostatic dysregulation, reflex tachycardia, and headache. Weakness, dizziness, hot flashes, nausea, vomiting, and diarrhea may occur. In high doses (more than 20 mg / kg of body weight), methemoglobinemia, cyanosis, dyspnea, and tachypnea should be expected due to the formation of nitrite ions due to isosorbide mononitrate metabolism. Very high doses can lead to an increase in intracranial pressure with the appearance of cerebral symptoms. In chronic overdose, it is possible to increase the level of methemoglobin. although the clinical significance of this has not yet been definitively established.

Treatment: gastric lavage, the patient should be laid in a horizontal position with raised legs. It is necessary to monitor the main indicators of vital functions and, if necessary, adjust. Patients with severe hypotension and / or in a state of shock should be injected with a liquid; in exceptional cases, norepinephrine (norepinephrine) and / or dopamine can be infused 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:

1. Vitamin C: 1 g by mouth or in the form of sodium salt IV.

2. methylene blue: up to 50 ml of a 1% solution of methylene blue in / in

3toluidine blue: first, 2–4 mg / kg body weight IV; then, if necessary, repeated administrations of 2 mg / kg body weight are possible with an interval between administrations of 1 hour.

Oxygen therapy, hemodialysis, exchange transfusion are also carried out.

Drug interaction

When used with other vasodilators, antihypertensive drugs, ACE inhibitors, beta-blockers, slow Calcium channel blockers (BMCC), diuretics, antipsychotics (neuroleptics) or tricyclic antidepressants, with phosphodiesterase inhibitors, including phosphodiesterase inhibitors, including. sildenafil, vardenafil, tadalafil, and also with ethanol may increase the antihypertensive effect of the drug Monocinque^®.

Barbiturates speed up metabolism and reduce the concentration of isosorbide mononitrate in the blood.

Reduces the effect of vazopressorov.

When combined with Amiodarone, propranolol, BMCC (verapamil, Nifedipine, etc.), an antianginal effect may be enhanced.

Under the influence of beta-adrenostimulyatorov, alpha-adrenergic blockers (dihydroergotamine) may decrease antianginal effect (tachycardia and excessive reduction of blood pressure).

In combined use with m-holinoblokatorami (atropine) increases the likelihood of increasing intraocular pressure.

Adsorbents, astringents and enveloping drugs reduce the absorption of isosorbide mononitrate from the gastrointestinal tract.

The therapeutic effect of norepinephrine (norepinephrine) is reduced while taking it with nitro compounds.

Terms and conditions of storage

The drug should be stored in a dark, out of reach of children at a temperature not higher than 25 ° C.