Nitro POL infuz - instructions for use, dose, side effects, contraindications

Nitroglycerin has an antianginal effect. Reduces the need for myocardium in oxygen by reducing pre- and postnagruzki on the heart (expands the venous and arterial vessels). Nitroglycerine causes a decrease in elevated central venous pressure, as well as pressure in the vessels of the small circle of circulation, a decrease in pulmonary and systemic vascular resistance. Heart rate (heart rate) usually increases slightly, which is a reflex response to lowering blood pressure (BP).With heart failure due to a decrease in preload (widening of the peripheral veins and a decrease in the flow of blood to the right atrium), the drug promotes discharge of the myocardium. Nitroglycerine promotes redistribution of coronary blood flow in the area with reduced blood circulation.

Pharmacokinetics:

With intravenous administration, the "primary" hepatic metabolism is excluded - nitroglycerine immediately enters the systemic circulation. Rapidly metabolized in the liver with the formation of di- and mononitrates, the final metabolite is sodium glycerin. It is excreted by the kidneys in the form of metabolites. The total ground clearance is 30-78 l / min, the half-life is 1-3 min.

Indications:

Acute myocardial infarction (including complicated by acute LV deficiency); unstable and postinfarction angina; pulmonary edema, stenocardia (refractory to other types of therapy), controlled hypotension during surgical interventions to reduce bleeding in the operating field.

Contraindications:

Nitro Pol® infusion should not be used with: hypersensitivity to the drug and other nitro compounds, intracranial hypertension, isolated mitral stenosis, aortic stenosis,subaortic stenosis, cardiogenic shock, toxic pulmonary edema, acute vascular disturbances (shock collapse), uncontrolled hypovolemia at normal or low pressure in the pulmonary artery in patients with heart failure, hypotension with a low systolic blood pressure (can exacerbate the condition, causing paradoxical bradycardia and angina pectoris), cardiac tamponade, constrictive pericarditis, severe anemia, bleeding in the brain, it is not recommended for use in children under the age of 18 years due to the lack of data on efficiency and safety.

Due to the significant hypotensive action and significant side effects (syncope, myocardial infarction), drugs to treat erectile dysfunction (inhibitors of phosphodiesterase-5 sildenafil, vardenafil, tadalafil) should not be used against the background of therapy with drugs of the nitroglycerin group.

Carefully:

Hypertrophic obstructive cardiomyopathy, atherosclerosis, recently transferred head trauma, acute myocardial infarction with low filling pressure of the left ventricle, severe kidney and / or liver failure, hyperthyroidism,closed-angle glaucoma, diabetes mellitus.

Pregnancy and lactation:

Use during pregnancy and during lactation should be carried out under medical supervision if the potential benefit of treatment for the mother exceeds the risk to the fetus or child.

Dosing and Administration:

Selection of the dose and rate of administration is carried out individually, taking into account the arterial pressure, heart rate, central venous pressure, ECG, etc.

The initial rate of administration is 0.5-1 mg / h, the maximum rate is 8-10 mg / h (see dilution table and infusion table).

The duration of administration of the drug depends on the dynamics of clinical symptoms and hemodynamic parameters and ranges from several hours to 3 days.

Note: When carrying out the infusion with Nitro Pol® infusion, use soft tubes made of polyethylene or polytetrafluoroethylene. The use of infusion soft tubes from polyvinyl chloride leads to significant losses of the active substance due to adsorption.

Table of dilutions

Number of acting matter nitroglycerin	Dilutions	5 mg	10 mg	20 mg	30 mg	40 mg	50 mg
The volume of the infusion solution (Nitro Pol® infusion) to be diluted	Dilutions	5 ml	10 ml	20 ml	30 ml	40 ml	50 ml
The volume of the infusion solution, intended for breeding	1/10	50 ml	100 ml	200 ml	300 ml	400 ml	500 ml
	1/20	100 ml	200 ml	400 ml	600 ml	800 ml	1000 ml
	1/40	200 ml	400 ml	800 ml	1200 ml	1600 ml	2000 ml
The volume of the infusion solution obtained as a result of breeding Nitro Paul® infusion	1/10	55 ml	110 ml	220 ml	330 ml	440 ml	550 ml
	1/20	105 ml	210 ml	420 ml	630 ml	840 ml	1050 ml
	1/40	205 ml	410 ml	820 ml	1230 ml	1640 ml	2050 ml

* - 0.9% solution of sodium chloride or 5% dextrose (glucose) solution can be used as the infusion solution for the dilution of the preparation Nitro Pol® infusion.

Infusion table

Breeding	1/10		1/20		1/40
Required rate of administration nitroglycerin per hour	INFUSION
Required rate of administration nitroglycerin per hour	ml / hour	drops at minute	ml / hour	drops at minute	ml / hour	drops at minute
0.5 mg	5,5	2	10,5	3-4	20,5	6-7
0.75 mg	8,25	3	15,75	5	30,75	10
1.0 mg	11,0	3-4	21,0	7	41,0	13-14
1.25 mg	13,75	4-5	26, 25	8-9	51,25	17
1.5 mg	16,5	5-6	31,5	10-11	61,5	20-21
2.0 mg	22,0	6-7	42,0	14	82,0	26-27
2.5 mg	27,5	9	52,5	17	102,5	34
3.0 mg	33,0	11	63	21	123,0	41
3.5 mg	38,5	12-13	73,5	24-25	143,5	47-48
4.0 mg	44,0	13	84,0	28	164,0	53
4.5 mg	49,5	14-15	94,5	31-32	184,5	59-60
5.9 mg	55,0	18	105,0	35	205	68
5.5 mg	60,5	20	115,5	38-39	225,5	74-75
6.0 mg	66,0	22	126	42	246	82
7.0 mg	77,0	25-26	147	49	287,0	95-96
8.0 mg	88,0	28-29	168,0	56	328,0	108-109
9.0 mg	99,0	31-32	189,0	63	369,0	121-122
10.0 mg	110,0	36	210	70	-	-

Side effects:

Perhaps the development of tolerance to nitroglycerin, as well as the development of group tolerance to nitrates (a decrease in the effectiveness of the drug in the previous treatment with other nitrates).

From the side of the cardiovascular system: weakness, skin flushing, tachycardia, palpitations, marked decrease in blood pressure, unpleasant sensations behind the sternum, orthostatic collapse, cyanosis.

With a marked decrease in blood pressure, paradoxical bradycardia may occur and the symptoms of angina pectoris may increase, the feeling of heat, dryness of the oral mucosa can occur.

From the digestive system: nausea, vomiting, pain in the abdomen.

From the central nervous system: anxiety, anxiety, psychotic reactions, fainting, dizziness, "nitrate" headache, inhibition, general weakness, disorientation.

Allergic reactions: skin rash, itching.

Local Reactions: hyperemia of the skin, burning, dermatitis.

Other: blurred vision, hypothermia, methemoglobinemia.

Overdose:

Symptoms: marked decrease in blood pressure (less than 90 mm Hg), with orthostatic dysregulation, reflex tachycardia, pulsating headache; can develop asthenia, dizziness, increased drowsiness, a feeling of heat, nausea, vomiting and diarrhea; at application of high doses (more than 20 mg / kg) - a collapse, a cyanosis, a methemoglobinemia, a dyspnea and tachypnea. At very high doses, an increase in intracranial pressure is possible.

Treatment: discontinue further administration of the drug. It is necessary to lower the head of the bed and lift the patient.As a rule, blood pressure is normalized within 15-20 minutes after discontinuation of the drug, then you can continue the introduction, after re-selection of the infusion rate.

In the case of a marked decrease in blood pressure and / or shock, the volume of circulating blood should be compensated; in exceptional cases, to maintain blood circulation, you can enter norepinephrine (noradrenaline) and / or dopamine.

Depending on the degree of severity, the following antidotes are suggested for use in the case of methemoglobinemia:

1. Ascorbic acid: 1 g orally or intravenously.

2. Oxygen therapy, hemodialysis, exchange blood transfusion.

Interaction:

Simultaneous use with vasodilators, antihypertensives, angiotensin converting enzyme (ACE) inhibitors, beta-blockers, slow calcium channel blockers, procainamide, tricyclic antidepressants, monoamine oxidase inhibitors (MAO), phosphodiesterase-5 inhibitors, and also ethanol enhances the hypotensive effect.

Against the background of quinidine and procainamide, orthostatic collapse may occur. The appointment with dihydroergotamine can lead to an increase in its content in the blood and lead to an increase in blood pressure (increasing the bioavailability of dihydroergotamine).

Simultaneous administration of nitroglycerin and heparin reduces the effectiveness of the latter (after drug cancellation, there may be a significant reduction in blood clotting, which may require a reduction in the dose of heparin).

Special instructions:

In case of acute myocardial infarction or acute heart failure, Nitro Pol® infusion should be used only under condition of careful clinical observation of the patient. To prevent the increase in angina attacks, sharp abolition should be avoided.

For prevention of undesirable blood pressure reduction, it is necessary to select the rate of drug administration individually and methodically (see "Method of administration and dose"). Reduction of blood pressure can be observed not only during the selection of the rate of administration of the drug Nitro Pol® infusion, but also later, against the background of initially stabilized blood pressure . Therefore, the control of blood pressure and heart rate should be carried out at least 3-4 times per hour during the entire infusion of the drug Nitro Pol® infusion.

Patients previously treated with organic nitrates (isosorbide dinitrate, isosorbide mononitrate) may require a higher dose to obtain the desired hemodynamic effect.

Severity of headache against the background of the introduction of the drug Nitro Pol® infusion can be reduced by reducing its dose and / or concurrent administration of Validol.

If blurred vision is retained or strongly pronounced, treatment should be discontinued.

Patients with diabetes mellitus or reduced glucose tolerance should take into account that Nitro Pol® infus in the maximum daily dose contains 10.7 g of dextrose, which corresponds to 1 bread unit.

Effect on the ability to drive transp. cf. and fur:

Care should be taken when driving vehicles and working with mechanisms that require increased concentration.

Form release / dosage:Concentrate for the preparation of solution for infusion, 1 mg / ml.

Packaging:

Ampules of dark glass 5, 10, 25 ml of 10 ampoules, in a cardboard box with an attached instruction for use.

Vials of 50 ml of colorless glass, ukuporennyh red rubber stopper with an aluminum cap and polypropylene cap for 1 bottle in a cardboard box with an attached instruction for use.

Storage conditions:

Store at a temperature not exceeding 25 FROM.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the solution after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N012560 / 01

Date of registration:08.04.2009

Expiration Date:Unlimited

Date of cancellation:2018-02-09

The owner of the registration certificate:G.Pol-Boscamp GmbH & Co.KGG.Pol-Boscamp GmbH & Co.KG Germany

Manufacturer: & nbsp

G.POHL-BOSKAMP, GmbH & Co.KG Germany

Representation: & nbspPaul-Boscamp, LLCPaul-Boscamp, LLCRussia

Information update date: & nbsp09.02.2018

Illustrated instructions

Instructions

Nitro POL® infusion (Nitro POHL® infus)