Monolong (capsules of durable action 0.04)
International nonproprietary name
Isosorbide mononitrate
Pharmacotherapeutic Group
Cardiovascular drugs. Nitrates.
Formulation
One capsule contains 40 mg or 60 mg of isosorbide mononitrate (capsules of durable action).
Pharmacological Action
Pharmacodynamics
Isosorbide-5-mononitrate is an active metabolite of isosorbide dinitrate. It possesses vasorelaxant antianginal effect. It is characterized with apparent vasorelaxant action making a strong impact on venous system and trivial effect on arterial blood circulation. As a preparation of durable action isosorbide-5-mononitrate provides for permament level of nitrates in blood with prognosticated clinical picture. It increases the content of nitrogen oxide in epithelial cells. It reduces concentration of calcium in cells of smooth muscles. It raises tolerance to exercise stress of patients with coronary heart disease (CHD), reduces pressure in pulmonary circulation.
Pharmacokinetics
The preparation is good at intake absorption. It is not bound with plasma proteins. It is excreted unchanged by kidneys. There exists direct dependence of isosorbide-5-mononitrate concentration in blood serum from dose of drug intake.
Therapeutic Indications
Stenocardia (prophylaxis and therapy)
Direction for Use and Dosage Schedule
The preparation is intended for intake. Usual dose as a rule is 1 capsule (40-60 mg) a day. Seldom the dose may be increased up to 80 mg a day.
Particular Indications
It is not recommended to use the preparation during work for drivers and those people which profession is connection with heightened concentration of attention.
Contraindications
Hightened sensitivity or idiosyncrasy to nitrates or nitrites.
Adverse Reaction
The most frequent complications at isosorbide-5-mononitrate intake are headache and vasodilatation of skin accompanied by accidental reddening. Sometimes giddiness, palpitation, weakness and other symptoms of cerebral ischemia, connected with orthostatic hypotension, may be observed.
Some patients possessing particular sensitivity to hypotensive effect of nitrates may have serious adverse reactions, such as nausea, vomiting, anxiety, involuntary urination, tachycardia, syncope, hypotension and collapse that may happen even at preparation intake in usual therapeutic dose.
Precautions
Continuous intake of nitrates may cause tolerance to their action. Drug withdrawal for a week with the following repeated prescription may recover its effectiveness. Sometimes cross tolerance to other nitrates and nitrites becomes evident. Combined intake of organic nitrates and calcium antagonists may cause apparent orthostatic hypotension. Monolong should be prescribed with care to patients in past history of whom is recent cerebral hemorrhage as well as at hyperthyroidism. At drug withdrawal after long-term ingestion dosage should be lowered gradually in order to prevent from possible aggravation of stenocardia attacks.
As long as isosorbide-5-mononitrate may increase intracranial pressure it should be prescribed with particular care at cerebral hemorrhage, craniocerebral injury and orthostatic hypotension. Intake safety of isosorbide-5-mononitrate during the first days after acute myocardial infarction is not determined.
Therapeutic application during pregnancy and breast-feeding period: may be used only by life-saving indications, when expected treatment effect prevails over potential risk for fetus or newborn infant.
Interaction with other drugs
Vasodilative agents, antihypertensive drugs, beta-adrenergic blocking agents, calcium antagonists, neuroleptics, tricyclic antidepressants, sildenaphyl and alcohol potentiate hypotension. Their simultaneous intake causes increase of dihydroergotamine level in blood serum.
OverDose
Symptoms:
Enhancement of intensity ofadverse reactions.
Treatment: monitoring of vitally important functions, symptomatic therapy.
Form of Production
Capsules retard 40 mg. 10 capsules being in contour cellular packs. 3 contour cellular packs in a parcel.
