Nitromintum

Nitromintum – the vasodilating medicine applied at treatment of stenocardia.

Form of release and structure

Nitromintum is released in the form of an aerosol of hypoglossal dosed: almost colourless or colourless, transparent, without deposit (in aluminum cylinders on 180 doses (10 g), on 1 cylinder in a cardboard pack complete with a raspylitelny head and a dispensing pump).

Is a part of 1 dose:

• Active agent: nitroglycerine – 0,4 mg (in the form of 1% of solution);
• Auxiliary components: propylene glycol, ethanol.

Indications to use

• Stenocardia (for the purpose of stopping and prevention of attacks, including before an exercise stress);
• Acute left ventricular failure (along with other medicines).

Contraindications

Absolute:

• Shock;
• Collapse;
• Age up to 18 years;
• Hypersensitivity to components of drug and other organic nitrates.

Relative (Nitromintum is appointed with care in the presence of the following diseases / states):

• Orthostatic hypotension;
• Heavy anemia and thyrotoxicosis;
• Intracranial hypertensia;
• The acute circulatory unefficiency which is followed by the expressed arterial hypotension (systolic pressure less than 90 mm hg);
• Hypertrophic cardiomyopathy;
• Hemorrhagic stroke;
• Migraine;
• Chronic heart failure and acute myocardial infarction with the low filling pressure of a left ventricle;
• Craniocereberal injuries;
• Heavy liver and/or renal failure;
• Epilepsy;
• Alcoholism;
• Closed-angle glaucoma.

The feeding and pregnant women Nitromintum can apply only after ratio assessment advantage/risk to health of mother and the child.

Route of administration and dosage

Nitromintum is applied sublingual.

Before the first use of drug the dispensing pump needs to be filled, having removed a protective cap and having pressed several times the dosing valve (before emergence of an aerosol). After a long break in use of Nitromintum there can be a need for a pump refill. The cylinder during use needs to be held vertically, the spraying head up. It is not necessary to stir up a cylinder before use.

By each pressing the dosing valve from the cylinder supplied with the mechanical pump 1 dose (0,4 mg of nitroglycerine) in the form of an aerosol is released.

To stop a stenocardia attack sublingual enter 0,4-0,8 mg (1-2 doses) of drug, it is desirable in a sitting position.

During drawing an aerosol it is necessary to hold the breath. An interval between single doses – about 30 seconds. After administration of drug it is necessary to hold a mouth closed several seconds. In case of need it is possible to enter 1 more dose. As much as possible within 15 minutes it is possible to accept 3 doses.

In 5-10 minutes prior to loading for the purpose of the prevention of development of an attack of stenocardia apply 1 dose of Nitromintum.

Sublingual put to patients with an acute left ventricular failure, the developing fluid lungs 4 doses of drug (1,6 mg) for a short period under strict control of a hemodynamics (systolic arterial pressure has to exceed 100 mm hg). If necessary in 10 minutes the drug can be administered repeatedly in the same dose.

Correction of the mode of dosing for elderly patients is not required.

Side effects

• Central nervous system: weakness; seldom – a disorientation, psychotic reactions, uneasiness, block;
• Alimentary system: dryness in a mouth; seldom – abdominal pains, vomiting, nausea;
• Cardiovascular system: lowering of arterial pressure, headache, dizziness, tachycardia, heat; seldom (mainly, especially at overdose) – an orthostatic collapse, cyanosis;
• Allergic reactions: seldom – skin rash, an itch;
• Local reactions: burning under language, a dermahemia;
• Others: seldom – a sight illegibility, a methemoglobinemia, a hypothermia.

Special instructions

Nitromintum strengthens removal with urine of vanilinmindalny acid and catecholamines.

For the period of therapy it is necessary to exclude alcohol intake.

At the beginning of use of Nitromintum it is recommended to abstain from control of motor transport and performance of potentially dangerous types of the works demanding the increased concentration of attention and bystry psychomotor reactions. During further treatment the doctor defines extent of restrictions individually.

Medicinal interaction

Higher doses of nitroglycerine can be required by the patients receiving earlier organic nitrates (dinitrate of isosorbide or mononitrate of isosorbide).

At simultaneous use of Nitromintum with some medicines there can be following effects:

• The FDE5 inhibitors specific to a cyclic guanozinmonofosfat (FDE5) and applied at treatment of disturbances of erectile function (for example, vardenafit, sildenafit, tadalafit): strengthening of hypotensive effect of Nitromintum (simultaneous use is contraindicated);
• Inhibitors of an angiotensin-converting enzyme, procaineamide, other vazodilatator and anti-hypertensive drugs (blockers of slow calcium channels, beta adrenoblockers), tricyclic antidepressants, neuroleptics, monoamine oxidase inhibitors: strengthening of hypotensive effect of nitroglycerine;
• Digidroergotamin: increase in its concentration in blood serum and strengthening of its vasoconstrictive effect that can reduce effect of Nitromintum. The combination of these drugs with diseases of coronary vessels demands respect for extra care from patients that is connected with probability of narrowing of coronary vessels and development of ischemia;
• Heparin: decrease in its anticoagulating effect;
• Sapropterin (nitrogen oxide sintetaza coenzyme): increase in risk of development of arterial hypotension;
• Norepinephrinum (noradrenaline): decrease in its therapeutic effect;
• Barbiturates: acceleration of metabolism and decrease in concentration of nitro compounds in a blood plasma;
• Amiodaronum, propranolol, blockers of slow calcium channels (nifedipine, verapamil): strengthening of anti-anginal effect;
• Beta-adrenergic agonists, alpha adrenoblockers (dihydroergotamine): decrease in expressiveness of anti-anginal effect (excessive lowering of arterial pressure, tachycardia).

Terms and storage conditions

To store far from heat sources, in protected from light, the place, unavailable to children, at a temperature of 15-25 °C.

Period of validity – 3 years.