Monosan, tablets 40 mg 30 pcs

Monosan is an antianginal drug. Peripheral vasodilator with predominant effect on venous vessels. It stimulates formation of nitric oxide (endothelial relaxing factor) in vascular endothelium, causing activation of intracellular guanylate cyclase, consequence of which is increase of cGMP level (mediator of vasodilation).

Limits myocardial oxygen demand by reducing preload and postload. It has coronary dilator effect. Reduces blood flow to the right atrium, helps to reduce pressure in the small circle of circulation and regression of symptoms in pulmonary edema.
Promotes redistribution of coronary blood flow in areas with decreased blood supply. Increases exercise tolerance in patients with coronary artery disease and angina pectoris.

Dilates cerebral vessels, dura mater, which may be accompanied by headache.As with other nitrates, cross-tolerance to the drug develops

. After withdrawal (discontinuation of treatment), sensitivity to the drug is quickly restored. Antianginal effect develops 30-45 minutes after taking the drug and lasts up to 8-10 hours.

Pharmacokinetics:

Absorption is high and bioavailability is 100%. Time to reach therapeutic concentration (100 ng/ml) – 30 min. TCmax – 1-1.5 h, for retard forms – 8 h. Binding to plasma proteins – less than 4%. It is denitrated to form isosorbide or combined with glucuronide. T1/2 – 5 hours. It is excreted by kidneys as glucuronides.

Indications

– prevention of angina attacks in patients with CHD;
– chronic heart failure (in combination therapy);
– pulmonary hypertension, pulmonary heart (in combination therapy).

Active ingredient

Composition

1 tablet contains:

Active ingredients:

isosorbide-5-monononitrate 40 mg.

Associates:

Microcrystalline cellulose,

Corn starch,

magnesium stearate,

granulated lactose,

talc.

How to take, the dosage

It is set individually depending on the severity of the disease.

The initial single dose of Monosan is 10-20 mg, the frequency of administration is 1-3 times a day.

Depending on the severity of the clinical effect, from the 3rd-5th day of therapy the single dose of the drug can be increased to 40-60 mg at the same frequency of administration.

The maximum daily dose is 80 mg.

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

Interaction

In co-administration, Monosan increases the plasma concentration of dihydroergotamine.

In co-administration, barbiturates accelerate biotransformation and decrease the plasma concentration of isosorbide mononitrate.

. When co-administering isosorbide mononitrate with antihypertensive agents, peripheral vasodilators, antipsychotics (neuroleptics), tricyclic antidepressants, novokainamide, ethanol, quinidine, beta-adrenoblockers, slow calcium channel blockers, dihydroergotamine, sildenafil may increase the hypotensive effect.

When combining amiodarone, propranolol, slow calcium channel blockers (verapamil, nifedipine, etc.), acetylsalicylic acid and isosorbide mononitrate may increase the antianginal effect.

When co-administration with beta-adrenergic stimulants, alpha-adrenoblockers may decrease the strength of the antianginal effect (development of tachycardia, excessive BP reduction).

When combined with m-cholinoblockers (atropine) the possibility of increased intraocular pressure increases.

In concomitant use, adsorbents, astringents and coagulants decrease absorption of isosorbide mononitrate from the gastrointestinal tract.

Special Instructions

Monosan is not used to stop angina attacks.

The BP and HR should be monitored during therapy.

If it is necessary to use the drug against a background of arterial hypotension, drugs with a positive inotropic effect should be taken simultaneously.

Frequent use and use in high doses can cause development of tolerance; in this case after 3-6 weeks of regular use it is recommended to cancel Monosan for 24-48 h or to take a 3-5 day break in therapy with replacement of the drug for this time with other antianginal drugs.

An abrupt withdrawal of the drug should be avoided and the dose should be reduced gradually.

Impact on driving and operating machinery

At the time of using the drug the patient’s psychomotor reactions may decrease, so caution should be exercised while driving vehicles and engaging in potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

– arterial hypotension and arterial hypovolemia (systolic BP below 100 mmHg, diastolic BP below 60 mmHg, central venous pressure below 4-5 mm Hg.Shock, vascular collapse;
– Left ventricular insufficiency with low diastolic pressure;
– Acute myocardial infarction (with significant arterial hypotension);
– cardiac tamponade;
– shock;
– toxic pulmonary edema;
– diseases accompanied by increased intracranial pressure (including hemorrhagic and pulmonary edema).
– diseases accompanied by increased intracranial pressure (including hemorrhagic stroke, craniocerebral trauma);
– closed-angle glaucoma;
– lactation (breastfeeding);
– children and adolescents under 18 years of age;
– hypersensitivity to components of the preparation Monosan and other nitrates.

With caution: in case of aortic and/or mitral stenosis, in tendency to orthostatic disorders of vascular regulation, in constrictive pericarditis, elderly patients, in severe anemia, thyrotoxicosis, in hypertrophic cardiomyopathy (angina pectoris may increase), in liver insufficiency (risk of methemoglobinemia), expressed renal failure.

Side effects

Cardiovascular system: “nitrate” headache, dizziness, transient facial hyperemia, fever, tachycardia, marked BP decrease; rarely – paradoxical exacerbation of angina attacks, orthostatic collapse.

Digestive system disorders: nausea, vomiting, dry mouth, and possibly a mild burning sensation of the tongue.

CNS disorders: stiffness, drowsiness, blurred vision, decreased ability to quick mental and motor reactions (especially at the beginning of treatment); rarely – brain ischemia.

Allergic reactions: skin rash; rarely – exfoliative dermatitis.

Others: development of tolerance (including cross-tolerance to other nitrates).

Overdose

Symptoms: headache, dizziness, palpitations, hyperthermia, skin hyperemia, sweating, nausea, vomiting, diarrhea, methemoglobinemia (cyanosis, anoxia), hyperpnea, dyspnea, bradycardia, seizures, visual disturbances, increased intracranial pressure, collapse, syncope, paralysis, coma.

Treatment: gastric lavage; in case of methemoglobinemia – oral or IV ascorbic acid 1 g, IV 1% solution of methylthioninium chloride (methylene blue) in a dose of 1-2 mg/kg of body weight. Symptomatic therapy in severe arterial hypotension – IV phenylephrine (epinephrine and related compounds are ineffective).

Pregnancy use

The use of Monosan in pregnancy is possible only in cases when the estimated benefit to the mother exceeds the potential risk to the fetus.

Similarities