Monocinque tab 40mg 30 pc

Description

Composition
Active substance:
1 tablet contains: Isosorbide-5-mononitrate – 40 mg ;.
Excipients:
Lactose monohydrate, microcrystalline cellulose, corn starch, talc, magnesium stearate.
Description:
White round tablets with the mark on one side.
Product form:
Tablets of 40 mg.
15 tablets in blisters (the blister PVC / aluminum foil).
2 blisters together with instructions for use in a cardboard package.
Contraindications
Increased sensitivity to organic nitrates or other components of the formulation; acute circulatory disorders (shock, circulatory collapse); acute myocardial infarction with severe arterial hypotension; cardiogenic shock if not provided sufficiently high end-diastolic pressure in the left ventricle through the application of intraaortic counterpulsation either by administration of agents that have a positive inotropic action; toxic pulmonary edema; anemia (severe); marked hypotension (systolic blood pressure less than 90 mmHg, the diastolic blood pressure less than 60 mmHg….); concomitant use of phosphodiesterase inhibitors, including sildenafil, vardenafil, tadalafil, as they potentiate the antihypertensive effect of nitrates; hereditary galactose intolerance, lactase deficiency syndrome or malabsorption of glucose and galactose; childhood and adolescence to 18 years (effectiveness and safety have been established).
Be wary hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade; low filling pressure in acute myocardial infarction, left ventricular failure. Do not allow the reduction of systolic blood pressure below 90 mm Hg. Article .; aortic and / or mitral stenosis; tendency to orthostatic disturbances of vascular regulation; glaucoma (risk of increased intraocular pressure); severe renal impairment; with hepatic insufficiency (risk of methemoglobinemia); hemorrhagic stroke; hyperthyroidism; diseases accompanied by increased intracranial pressure; recently transferred craniocerebral injury.
Dosage
40 mg
Indications
Prevention of angina attacks in patients with coronary heart disease, including after myocardial infarction; Treatment of chronic heart failure (in a combination therapy).
Interaction with other drugs
When applied with other vasodilators, antihypertensive agents, angiotensin converting enzyme (ACE) inhibitors, beta-blockers, blockers “slow” calcium channel (BCCI), diuretic, antipsychotic agents (neuroleptics) or tricyclic antidepressants, with phosphodiesterase inhibitors, including sildenafil , vardenafil, tadalafil, as well as with ethanol may increase antihypertensive action Monochinkve® drug.
Barbiturates accelerate metabolism and reduce the concentration of isosorbide mononitrate in the blood.
It reduces the effect of vasopressors.
In combination with amiodarone, propranolol, BCCI (verapamil, nifedipine, etc.) May increase antianginal effect.
Under the influence of beta-agonists, alpha-blockers (dihydroergotamine et al.) May be reduced antianginal effects (tachycardia and excessive lowering of blood pressure).
The combined use of a M-holinoblokatorami (atropine, etc.) Increases the probability of increased intraocular pressure.
Adsorbents, binders and overlying drugs reduce the absorption of isosorbide mononitrate from the gastrointestinal tract.
The therapeutic effect of norepinephrine (noradrenaline) is reduced while reception with nitro compounds.
Overdose
symptoms:
Lowering blood pressure with orthostatic dysregulation, reflex tachycardia, and headache. It may appear weakness, dizziness, “tides” heat, nausea, vomiting and diarrhea. At high doses (20 mg / kg body weight) should expect methemoglobinemia, cyanosis, dyspnea and tachypnea from the formation of nitrite ions as a result of metabolism of isosorbide mononitrate. Very high doses can lead to increased intracranial pressure with the occurrence of cerebral symptoms.
In chronic overdose may cause a higher level of methemoglobin, although the clinical significance of this has not been definitively established.
Therapy:
In addition to general recommendations, such as gastric lavage, and the patient lying down in a horizontal position (legs raised high), should monitor the main indicators of vital signs and adjust if necessary.
Patients with severe arterial hypotension and / or in shock should be administered liquid; in exceptional cases, to improve blood circulation can be performed infusion noradrenaline (norepinephrine), and / or dopamine.
Introduction of epinephrine (adrenaline) and related compounds is contraindicated.
Depending on the severity, the following antidotes are used in cases of methemoglobinemia:
Vitamin C 1 g orally or in the form of the sodium salt intravenously.
Methylene blue: to 50 ml of a 1% solution of methylene blue intravenously.
Toluidine blue: initially 24 mg / kg body weight intravenously: then, if necessary, may be repeated administration of 2 mg / kg body weight at an interval between administrations of one hour.
Oxygen therapy, hemodialysis, exchange transfusion.
pharmachologic effect
Pharmacological group:
Vasodilating agent – nitrate.
Pharmacodynamics:
Peripheral vasodilator with a predominant influence on the venous vessels. It has a vasodilating and antianginal effects.
Decreases preload (due to expansion of peripheral veins) and afterload (due to a decrease in total peripheral vascular resistance) reduces myocardial oxygen demand, expanding coronary artery and improves coronary blood flow, facilitates its redistribution in the ischemic area, reduces the end-diastolic volume of the left ventricle and decreases systolic voltage of its walls. Increases exercise tolerance in patients with coronary heart disease (CHD), lowers blood pressure in the pulmonary circulation.
Isosorbide mononitrate is relaxation of the muscles of the bronchi, the urinary tract, muscle of the gallbladder, biliary tract and esophagus, as well as small and large intestines, including the sphincters.
At the molecular level, nitrates act by formation of nitric oxide (NO) and cyclic guanozilmonofosfata (cGMP), which is considered a mediator of relaxation. The ingestion of isosorbide-5-mononitrate antianginal effect is already apparent after 30 minutes and lasts for 2-6 hours.
Pharmacokinetics:
It is rapidly and completely absorbed after oral administration. Bioavailability is 90 to 100%. The maximum plasma concentration is reached after about 1-1.5 hours. Therapeutic concentrations of isosorbide-5-mononitrate in the blood is reached after 30 minutes and 250 ng / ml, for 4 th hour – 414 ng / ml for the 12-th hour – 199 ng / ml (ie concentration drop.. slow). Isosorbide-5-mononitrate is almost completely metabolized in the liver is not exposed to the effect of “first pass” through the liver (unlike isosorbide dinitrate). Metabolites – pharmacologically inactive. Isosorbide-5-mononitrate is excreted by the kidneys almost exclusively in the form of metabolites. Approximately 2% is excreted unchanged. The half-life of 4-5 h., which is 8 times higher than that of isosorbide dinitrate.
It describes the development of tolerance and cross-tolerance with other nitro compounds by prolonged continuous treatment with high doses of isosorbide-5-mononitrate. To prevent the reduction or loss of effectiveness, to avoid continuous high doses of the drug.
Pregnancy and breast-feeding
For security reasons Monochinkve® can be used during pregnancy and lactation only strictly prescribed by a doctor after a thorough evaluation of the benefits and possible risks, because to date, little is known about the consequences of its use in pregnant women and nursing mothers. If a nursing mother still takes Monochinkve®, you must install a child observation for the development of the possible effects of the drug.
Conditions of supply of pharmacies
On prescription.
side effects
Before the drug at therapeutic doses of any significant side effects usually do not develop.
Very often (> 10%): “Nitrate” headache can occur in the beginning of the treatment, and with continued therapy usually lasts for several days.
Frequent (> 1% –
From the nervous system: stiffness, drowsiness, blurred vision, decreased ability to rapid mental and motor reactions (especially at the beginning of treatment).
Rarely (> 0.1% –
Marked reduction in blood pressure is accompanied by a worsening angina (paradoxical response to nitrates).
Cases of collaptoid states, sometimes with bradyarrhythmia and syncope.
Individual cases (
special instructions
Monochinkve® should not be used for the relief of acute attacks of angina and acute myocardial infarction.
During therapy requires the control of blood pressure and heart rate.
abrupt discontinuation should be avoided (the dose reduced gradually).
Perhaps the development of tolerance to Monochinkve® or cross tolerance to other nitro compounds (reducing drug efficacy due to prior use of other nitro compounds). To prevent the development of tolerance to the action Monochinkve®, should be avoided in continuous receiving high doses.
In patients with labile circulation may develop symptoms of acute circulatory failure, already at the first dose. “Nitrate” Headaches can be largely prevented if at the beginning of therapy, take 1/2 tablet Monochinkve® morning and evening.
In the period of treatment should be to exclude the use of ethanol.
Effects on ability to drive and use machines:
During treatment is not recommended to drive and engage in other potentially hazardous activities that require a rapid psychomotor reactions.
Storage conditions
In the dark place at a temperature not higher than 25 C.
Keep out of the reach of children!.
Dosing and Administration
Inside, the food, drinking water, without chewing.
Frequency of administration and duration of treatment are determined individually.
Therapy should start with half a tablet (20 mg), 2 times a day. Then gradually increase to therapeutic dose: 1 tablet (40 mg) to receive 2-3 times a day at intervals of 7-8 hours.
The maximum daily dose is 120 mg.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist