Monosan® 20 mg, 40 mg
tablets
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- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Isosorbide mononitrate 20 mg or 40 mg in 1 tablet.
- Indication group:
- vasodilator
The following information is for health professionals only.
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Characteristics:
Isosorbide mononitrate dilates the capacity veins and large arteries, which decrease the venous return, the input load of the cardiac ventricle, and the work of the left ventricle, thus decreasing oxygen consumption in the cardiac muscle by vasodilatation of the epicardial coronary arteries it increases the supply of the oxygen to the myocardium.
Indications:
Prophylaxis and long term treatment of angina pectoris. A component of the complex therapy of chronic cardiac insufficiency (together with diuretics, cardiotonics, and ACE inhibitors).
Contraindications:
Hypersensitivity of organic nitrates and components of the preparation, acute myocardial infarction, acute circulatory failure (shock, hypotensive colaps conditions), grave hypotension (pressure lower than 90/60 mm hg), hypovolemia, children bellow 15 years of age. Only in the cases when it is absolutely essential, Monosan® 20 mg, 40 mg can be administered in hypetrophic obstructive cardiomyopathy, constrictive pericarditis, in diseases accompanied by increased intracranial pressure, in the period of gravidity and lactation. Caution is necessary also in patiens with serious disorders of the liver function (danger of methemoglobinemia) and in increased intraocular pressure.
Undesirable effects:
Particulary at the beginning of treatment and in larger doses there occur headaches, orthostatic hypotension, vertigo, reddening in the face and palpitation. Occasionally nausea, vomiting and skin allergic reaction may take place.
Interactions:
Vasodilating substances, Ca2+ channel blockers, and other antihypertensive agents, tricyclic antidepressants, neuroleptic and alcohol strengthen the hypotensive effect of the preparation Monosan® 20 mg, 40 mg , dihydroergotamine decreases its vasodilating effect. Concomitant administration of sildenafil (a preparation used to treat erectile disorders) with nitrates may result in serious cardiovascular complication.
Caution:
The preparation may, particulary at the beginning of treatment, unfavourably affect the activities requiring increased attention and quick decision making. Monosan® 20mg, 40 mg is not suitable for the treatment of acute fits of angina pectoris. Recommended asymmetrical dosing decreases the risk of the development of tolerance.
Dosage:
It is recommended to start the treatment with a smaller dose, which can be icreased according to response to treatment. Usual daily dose of Monosan® 20 mg, 40 mg is 20-40 mg 2 times a day with a period without administration of at least 12 hours between the last evening dose and the first morning dose (e.g. 8-15 hours) .The highest daily dose is 120 mg. Tablets are taken after meals, unchewed and sufficiently washed down.
Package:
30, 50 or 100 tablets of 20 mg,
30, 50 or 100 tablets of 40 mg.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: July 9, 2003.
The preparation available on medical prescription only.