Iso-micron 0.1% concentrate for a solution of 10 ml of ampoule No. 10

Author Ольга Кияница

2017-05-11

Amount in a package 10
Product form Pills
Manufacturer Farmak OJSC (Ukraine, Kiev)
Registration certificate UA/3186/02/02
The main medicament Iso-mik
morion code 66478

Iso-mik instructions for use

pharmachologic effect

Iso-mik anti-anginal drug. Iso-mik contains the active component of isosorbide dinitrate - a medicinal substance of the group of organic nitrates. Iso-mic promotes relaxation of the smooth muscle vascular layer (mainly veins), which leads to a decrease in the overall peripheral resistance and blood flow to the right atrium (due to the widening of the peripheral veins), a decrease in pre- and post-loading on the heart, and a decrease in myocardial oxygen demand. In addition, the antianginal effect of the drug is carried out by increasing the lumen of coronary vessels and redistribution of coronary blood flow in favor of ischemic sites. The mechanism of action of isosorbide dinitrate is associated with the release of nitric oxide, which in the smooth muscle layer of the vessels activates the guanylate cyclase and increases the level of cGMP, which leads to relaxation of smooth muscles. The effect of nitric oxide on precapillary sphincters and arterioles is less pronounced than the effect on arteries and veins. The drug helps reduce pressure in a small circle in patients with pulmonary hypertension.

Iso-mik improves tolerance to physical activity in patients with IHD.

When applying sublingual forms of the drug (spray and tablets containing 5 mg of active substance), the therapeutic effect develops within 2-5 minutes and lasts for 1-2 hours. The maximum plasma concentration of isosorbide dinitrate is reached within 5-6 minutes.
With parenteral administration, the effect develops within 1-2 minutes after the onset of infusion.
When using oral forms of the drug, the duration of the therapeutic effect is about 4-5 hours. The maximum plasma concentration of isosorbide dinitrate is reached within 2 hours. When administered orally, the effect of "first passage through the liver" is noted, bioavailability is about 22%.

Isosorbide dinitrate is metabolized in the body with the formation of 2 pharmacologically active metabolites, the half-life of which is 5 and 2.5 hours. The half-life of isosorbide dinitrate is from 1 to 5 hours, depending on the method of application. With prolonged therapy, the half-life of the active ingredient generally increases. Within 24 hours 80-100% of the received dose of isosorbide dinitrate is excreted by the kidneys.

Indications for use

Tablets and spray Iso-Mik are designed to prevent attacks of angina in patients with coronary heart disease.

In addition, the spray and tablets are used to treat patients with chronic heart failure and pulmonary hypertension syndrome.

Sublingual tablets containing 5 mg of isosorbide dinitrate, as well as a spray can be prescribed for relief of angina attacks.

Parenteral forms of Iso-mik are intended for the treatment of patients with acute conditions, including acute myocardial infarction (including cases complicated by left ventricular failure), acute left ventricular failure of any genesis, and pre-infarction in patients with unstable angina.

Mode of application

Tablets Iso-Mik 5:

Designed for sublingual use. Iso-mic 5 is recommended to be used before the expected physical or emotional load. The tablet should be kept under the tongue until completely dissolved. In acute cases, you should chew the tablet.

A single dose for adults is usually 1-2 tablets.

Iso-mic 5 is taken 3-4 times a day. The duration of therapy is determined by the attending physician.

Tablets Iso-Mik 10 and Iso-Mik 20:

Are intended for oral administration. The tablet is swallowed with a small amount of drinking water. Do not chew the tablet. Between the doses of a single dose of Iso-Meek it is recommended to observe an interval of at least 4 hours. Therapy should be started with a minimal dose, if necessary, the dose is gradually increased. Duration of therapy and dose of isosorbide dinitrate is determined by the attending physician individually.

Adults usually appoint 10-20 mg isosorbide dinitrate 2-3 times a day or 10 mg isosorbide dinitrate 4-5 times a day.

With increased demand for nitrates, the daily dose can be increased to 60-120 mg of isosorbide dinitrate.

Solution for injection Iso-mic:

The drug is dissolved in the infusion solution and injected intravenously by the system. When the drug is diluted, the final concentration of isosorbide dinitrate should be 0.01% or 0.02% (to dissolve 400 ml of isotonic sodium chloride solution, 50 or 100 ml solution for Iso-Mik injections respectively). The dose of the drug is determined individually.
Adults with ischemic heart disease are usually prescribed isosorbide dinitrate at 2-7 mg / h. In severe cases, the dose is increased to 10 mg / h.

Adults with heart failure can be prescribed up to 50 mg of isosorbide dinitrate per hour.

The duration of therapy with the injection solution depends on the patient's condition. During the therapy it is necessary to control blood pressure, ECG, heart rate and diuresis.

Concentrate for preparation of infusion solution Iso-mik:

The drug should be used immediately after preparation. The final solution is intravenously dripped. To prepare an infusion solution with an isosorbide concentration of 0.01% dinitrate, 1 ml of concentrate should be diluted with isotonic sodium chloride solution to 100 ml. The dose is selected individually depending on the patient's condition.

Adults usually prescribed 1-2 mg isosorbide dinitrate per hour. If necessary, the dose is gradually increased.

Adults with heart failure can be prescribed up to 50 mg of isosorbide dinitrate per hour.
The duration of therapy with the injection solution depends on the patient's condition. During the therapy it is necessary to control blood pressure, ECG, heart rate and diuresis.

Spray sublingual Iso-mic:

The preparation is intended for spraying under the tongue. During spraying, you should hold your breath or breathe through your nose. Observe the interval of 30 seconds between spraying the spray.
Adults usually appoint 1 to 3 doses of Iso-Mik. In case the therapeutic effect is insufficient, after 5 minutes, re-apply the drug. It is allowed not more than 3 applications of a single dose of a spray for 1 hour. When re-applying the drug for a short period of time, you should carefully monitor blood pressure.

For prevention it is recommended to use a single dose of a spray 3-4 times a day.

Regardless of the form of Iso-my preparation, patients may develop tolerance to nitrates, in which case it is necessary to increase the dose of the drug or the frequency of application. In addition, with the development of tolerance, it is recommended to abandon the use of nitrates within 24-36 hours, replacing them with alternative drugs. After 36 hours, you can resume taking nitrates.
With prolonged therapy, it is recommended to take similar breaks every 4-6 weeks.

Side effects

During the period of therapy with Isom-ix in patients, it is possible to develop such undesirable effects caused by isosorbide dinitrate:

From the vessels and the heart: reflex tachycardia, a feeling of heat, hyperemia of the face and upper body, lowering blood pressure right up to collapse. In isolated cases, the development of angina attacks is possible. When applying the spray, it is possible to develop short-term hypoxemia.
From the side of the central nervous system: weakness, dizziness, disturbance of sleep and wakefulness, reduced visual acuity, brain ischemia.

From the gastrointestinal tract: vomiting, nausea, dryness of the oral mucosa. When using the drug in the form of a spray and sublingual tablets, a burning and tingling sensation in the mouth is possible. In addition, with the use of a spray, it is possible to develop heartburn, which is associated with relaxation of the sphincter.

Allergic reactions: urticaria, skin itching.

Others: Tolerance to nitrates. Predominantly at the beginning of therapy, it is possible to develop a "nitrate" headache, in which case it is recommended to adjust the dose of isosorbide dinitrate or to prescribe non-narcotic analgesics.

Contraindications

Iso-mic is not prescribed for patients with hypersensitivity to the components that make up the drug, as well as other nitrates.

It is forbidden to take Iso-Mik along with sildenafil and ethyl alcohol.
Iso-mik is not used in the treatment of patients with acute vascular insufficiency, severe arterial hypotension, constrictive pericarditis, cardiac tamponade, cardiogenic shock (in the absence of correction of the end diastolic pressure of the left ventricle) and hypertrophic obstructive cardiomyopathy.

Isosorbide dinitrate is not prescribed for patients with severe anemia, angle-closure glaucoma, toxic pulmonary edema, and hyperthyroidism, as well as patients who have recently suffered craniocerebral trauma and hemorrhagic stroke.

Only after a thorough analysis of the risk / benefit ratio, the Iso-Mik preparation can be administered to patients with acute myocardial infarction with reduced filling pressure, cerebral circulatory disorders and increased intracranial pressure, as well as mitral or aortic stenosis.
Parenteral forms of isosorbide dinitrate are not used for severe violations of liver and kidney function, as well as severe anemia.

In pediatric practice, as well as for the therapy of pregnant and lactating women, the Iso-Mik preparation can be used only for vital indications.

It is advisable to use caution when prescribing isosorbide dinitrate to patients with a tendency to develop orthostatic hypotension.

When taking Iso-Mik it is not recommended to manage potentially unsafe mechanisms and drive a car if isosorbide dinitrate causes the patient to develop dizziness and reduce visual acuity.

Pregnancy

Iso-Mik is not recommended for pregnant and lactating women. The appointment is possible only for life indications.

Drug Interactions

Combined use of nitrates and sildenafil is prohibited.

Isosorbide dinitrate can increase plasma concentrations and increase the toxicity of dihydroergotamine.

Iso-mik, when combined, decreases the effectiveness of myotonic agents and heparin.
Sympathomimetics for combined use can reduce the severity of the antianginal effect of Iso-mik.

Vasodilating and antihypertensives, calcium channel blockers, tricyclic antidepressants, beta-adrenergic blockers, ethyl alcohol, antipsychotics, narcotic analgesics, antipsychotics, dihydroergotamine and quinidine combined with Iso-mik may increase the hypotensive effect of isosorbide dinitrate.
It is not recommended to use infusion systems made of polyurethane or polyvinyl chloride, for the introduction of parenteral forms of Iso-Mik preparation (polypropylene, polyethylene, glass and polytetrafluoroethylene systems are allowed).

Overdose

High doses of isosorbide dinitrate can cause the development of arterial hypotension (including orthostatic hypotension) and reflex tachycardia. In addition, with an overdose, it is possible to develop methemoglobinemia, headache, nausea, palpitation.

There is no specific antidote. When taking too high doses of Izo-mik, symptomatic therapy and measures aimed at maintaining the function of the cardiovascular system are carried out. With a decrease in blood pressure, an isotonic solution of sodium chloride is introduced to restore the volume of circulating blood, with severe hypotension, dopamine or norepinephrine may be administered.

In the development of methemoglobinemia, oral administration of 1g of ascorbic acid is prescribed, intravenous administration of 50 ml of 1% methylene blue solution, and if necessary, oxygen therapy is administered.

Form of issue

Spray in bottles of dark glass to 15ml, in a cardboard bundle 1 bottle.

Concentrate for the preparation of a solution for infusion in ampoules of 2 ml or in bottles of 5 ml, in a carton pack of 10 ampoules or 5 bottles.

Solution for injection in ampoules of dark glass by 10ml, in a cardboard bundle 10 ampoules.

Tablets sublingual, containing 5 mg of active substance, in polymer bottles of 50 pieces, in a cardboard bundle 1 bottle.

Tablets containing 10 or 20 mg of active substance, in contour cell packs of 10 pieces, in a cardboard bundle of 50 tablets (5 contour mesh packages).

Tablets containing 10 or 20 mg of active substance, in polymer bottles of 30 pieces, in a cardboard bundle 1 bottle.

Storage conditions

The Iso-Mik should be stored away from open fire in dry rooms with a temperature that does not exceed 25 degrees Celsius.

Shelf life of Iso-mik in the form of a sublingual spray is 4 years.

Shelf life of Iso-mik in the form of tablets, solution for injection and concentrate for the preparation of a solution for infusions is 3 years.


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