Mono Mak - instructions for use, dose, side effects, contraindications

Composition:Active substance:
1 tablet Mono Mack 20 mg contains the active ingredient isosorbide mononitrate 20 mg.
1 tablet Mono Mac 40 mg contains the active substance isosorbide mononitrate 40 mg.
Excipients:
Lactose monohydrate, microcrystalline cellulose, magnesium stearate, talc.

Description:White round biconvex tablets with a risk on one side and engraved "20" or "40" on the other.

Pharmacotherapeutic group:Vasodilator - nitrate.

ATX: & nbsp

C.01.D.A.14 Isosorbide mononitrate

Pharmacodynamics:Has vasodilator and antianginal effect.
Reduces preload (by expanding the peripheral veins) and afterload (due to a decrease in the overall peripheral vascular resistance), reduces the need for myocardium in oxygen, dilates the coronary arteries and improves coronary blood flow, promotes its redistribution into the ischemic areas, reduces the terminal diastolic volume of the left ventricle and reduces systolic the tension of its walls. Increases tolerance to physical exertion of patients with coronary heart disease (CHD), reduces pressure in a small circle of blood circulation.
Isosorbide mononitrate causes relaxation of the musculature of the bronchi, urinary tract, gallbladder muscles, biliary tract and esophagus, as well as the small and large intestine, including sphincters.
At the molecular level, nitrates act through the formation of nitric oxide (N0) and cyclic guanosyl monophosphate (cGMP), which is considered to be a mediator of relaxation.

Pharmacokinetics:Quickly and completely absorbed in the intestine after ingestion. Bioavailability ranges from 90 to 100%. Isosorbide mononitrate almost completely metabolized in the liver. Metabolites are pharmacologically inactive. Isosorbide mononitrate is excreted by the kidneys almost exclusively in the form of metabolites. Approximately 2% is displayed unchanged. The half-life is 4-5 hours.
Tolerance: A decrease in efficacy was observed despite the absence of a change in dosage and a constant level of nitrate in the blood. The observed tolerance decreases within 24 hours of continuing therapy.
There was no development of tolerance when taking the drug with interruptions.

Indications:Prophylaxis and long-term therapy of angina pectoris.
Treatment of chronic heart failure (as part of combination therapy).
Increased pressure in a small circle of blood circulation (pulmonary hypertension).

Contraindications:- hypersensitivity to organic nitrates or other components of the drug;
- Acute circulatory disorders (shock, vascular collapse);
- cardiogenic shock, unless a sufficiently high end-diastolic pressure is provided inleft ventricle by applying intra-aortic counterpulsation or by introducing agents that have a positive inotropic effect;
- severe arterial hypotension (systolic blood pressure less than 90 mm Hg, diastolic blood pressure less than 60 mm Hg);
- simultaneous administration of phosphodiesterase inhibitors, including sildenafil, vardenafil, tadalafil, as they potentiate the antihypertensive effect of nitrates;
- hereditary intolerance to galactose, a deficiency of lactase or a syndrome of malabsorption of glucose and galactose;
The effectiveness and safety of the drug in children under 18 years of age is not established.

Carefully:- hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade;
- low filling pressure for acute myocardial infarction, impaired left chamber function (left ventricular failure). Do not lower the systolic blood pressure below 90 mm Hg. p.
aortic and / or mitral stenosis;
- the tendency to orthostatic disorders of vascular regulation;
- hemorrhagic stroke;
- Glaucoma (risk of increased intraocular pressure); severe anemia;
- thyrotoxicosis;
- severe renal insufficiency;
- Hepatic insufficiency (risk of development of methaemoglobinaemia);
- diseases accompanied by increased intracranial pressure (until now a further increase in intracranial pressure was observed only with intravenous administration of high doses of nitroglycerin).

Pregnancy and lactation:For safety reasons, Mono Mack can be used during pregnancy and lactation only strictly according to the prescription of the doctor, after a thorough evaluation of the benefits and possible risks, since there is currently insufficient data on the effects of its use in pregnant and lactating mothers. If the nursing mother still accepts Mono Mack, it is necessary to establish observation of the child for the development of possible effects from the drug.

Dosing and Administration:Inside, after eating with water.
Mono Mack 20 mg:
To begin therapy it is expedient with small doses of a preparation: on 1/2 tablets (10 mg) 2 times a day. Then gradually increase the dose to therapeutic: 1-2 tablets (20-40 mg) 1-2 doses per day.If necessary, increase the dose to 3 tablets (60 mg) per day.
Mono Mack 40 mg:
Take 1/2 tablet (20 mg) 2 times a day or 1 tablet (40 mg) 1 time per day. In some cases, the dose can be increased to 2 tablets (80 mg) in 2 divided doses per day. To achieve the full effect, the second tablet of 40 mg (with a daily dose of 80 mg) should be taken no later than 8 hours later. The duration of treatment is determined by the doctor.

Side effects:Very often (≥ 10%): A "nitrate" headache may occur at the beginning of the treatment. When continuing therapy, it usually decreases after a few days.
Often (≥ 1% - <10%): After the first dose or after increasing the dose, blood pressure may decrease and / or develop orthostatic hypotension, which can be accompanied by tachycardia, dizziness, and weakness; stiffness, drowsiness, blurred vision, decreased ability to rapid mental and motor reactions (especially at the beginning of treatment).
Rarely (≥ 0.1% - <1%): There may be nausea, vomiting, reddening of the face and skin allergic reactions, the appearance of a feeling of slight burning of the tongue, dry mouth. A marked decrease in blood pressure, accompanied by a weighting of the symptoms of angina (a paradoxical reaction to nitrates).
There were cases of collapoid states, sometimes with bradyarrhythmia and syncope.
Individual cases (<0.01%):
In individual cases, the emergence of exfoliative dermatitis. The development of tolerance, as well as cross-tolerance with other nitrocompounds in long-term continuous treatment with high doses of isosorbide mononitrate, is described. To prevent a decrease or loss of efficacy, continuous intake of high doses of the drug should be avoided.
Notes:
The use of Mono Mack can lead to transient hypoxemia due to the relative redistribution of blood flow to the hypoventicular alveolar segments. This may be the trigger mechanism of ischemia in patients with coronary heart disease.
Increasing the dose and / or changing the intake intervals can lead to a decrease or loss of efficacy.

Overdose:Symptoms:
Reduction of blood pressure with orthostatic dysregulation, reflex tachycardia and headache. Asthenia, dizziness, hot flashes, nausea, vomiting and diarrhea can develop.
In high doses (more than 20 mg / kg body weight) it is necessary to expect the appearance of methemoglobinemia, cyanosis, dyspnoea due to the formation of nitrite ions due to the metabolism of isosorbide mononitrate.
Very high doses can lead to an increase in intracranial pressure with the onset of cerebral symptoms.
In chronic overdose, an increase in the level of methemoglobin is possible, although the clinical significance of this has not yet been established.
Therapy:
In addition to general recommendations, such as gastric lavage and placement of the patient in a horizontal position (legs are high), the basic indicators of vital functions should be monitored and, if necessary, adjusted. Patients with severe arterial hypotension and / or shock should be injected with fluid; In exceptional cases, to improve blood circulation, infusions of norepinephrine and / or dopamine may be administered.
The introduction of epinephrine (adrenaline) and related compounds is contraindicated.
Depending on the degree of severity, in the cases of methemoglobinemia the following antidotes are used:
1. Vitamin C: 1 g inside or in the form of sodium salt intravenously;
2. Methylene blue: up to 50 ml of 1% solution of methylene blue intravenously;
3. toluidine blue: first 2-4 mg / kg body weight is strictly intravenous; then, if necessary, repeated administration of 2 mg / kg body weight with an interval betweenintroductions in one hour;
4. Oxygen therapy, hemodialysis, exchange blood transfusion.

Interaction:When used with other vasodilators, antihypertensive agents, angiotensin converting enzyme inhibitors, beta adrenoblockers, calcium channel blockers, diuretics, neuroleptics or tricyclic antidepressants, with phosphodiesterase inhibitors including sildenafil, vardenafil, tadalafil, and also with ethanol, potentiation of the antihypertensive effect of Mono Poppy.
With the simultaneous use of Mono Mack and dihydroergotamine, an increase in the level of dihydroergotamine in the blood plasma and the potentiation of hypertensive action can occur.
With the simultaneous use of Mono Mack with procainamide and quinidine, an increase in the hypotensive effect is possible.
Barbiturates accelerate metabolism and reduce the concentration of isosorbide mononitrate in the blood.
When combined with amiodarone, propranolol, BCCK (verapamil, nifedipine, etc.), it is possible to enhance the antianginal effect.
Under the influence of beta-adrenostimulants, alpha-adrenoblockers (dihydroergotamine, etc.), it is possible to decrease the antianginal effect (tachycardia and excessive blood pressure decrease).
The therapeutic effect of norepinephrine (norepinephrine) decreases with simultaneous intake with nitrocompounds.
When combined with m-holinoblokatorami (atropine and others) increases the likelihood of increased intraocular pressure.
Adsorbents, astringent and enveloping drugs reduce the absorption of isosorbide mononitrate in the digestive tract.

Special instructions:Mono Mack should not be used to stop acute attacks of angina and acute myocardial infarction.
During the treatment with the drug should be excluded from the use of ethanol. It should be avoided abrupt withdrawal of the drug (dose gradually reduce).

Effect on the ability to drive transp. cf. and fur:During treatment it is not recommended to drive vehicles and engage in other potentially dangerous activities requiring a fast psychomotor reaction.

Form release / dosage:Tablets of 20 and 40 mg.

Packaging:For 10 tablets in a blister, 3 or 5 blisters together with instructions for use in a cardboard bundle.

Storage conditions:At a temperature of no higher than 25 ° C.
List B. Keep out of reach of children.

Shelf life:5 years.
Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012831 / 01

Date of registration:19.11.2007

Expiration Date:Unlimited

The owner of the registration certificate:Pfizer Manufakchuring Deutschland GmbH Pfizer Manufakchuring Deutschland GmbH Germany

Manufacturer: & nbsp

PFIZER MANUFACTURING DEUTSCHLAND, GmbH Germany

Representation: & nbspPfizer H. Si. Pi. CorporationPfizer H. Si. Pi. Corporation

Information update date: & nbsp2016-12-11

Illustrated instructions

Instructions

Mono Mack (Mono Mack)