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The concentrate for the solution for infusion "Norepinephrine tartrate Agetan 2 mg / ml (without sulfites)" is indicated for emergency (immediate) restoration of blood pressure in cases of acute hypotension.

Structure

The active substance is norepinephrine (1 ml of the concentrate contains 2 mg of norepinephrine tartrate; one ampoule contains 8 mg of norepinephrine tartrate, which corresponds to 4 mg of norepinephrine base).

Excipients: sodium chloride, sodium hydroxide or hydrochloric acid, water for injection.

Contraindications

  1. The use of norepinephrine concentrate 1 mg / ml for the preparation of infusion solutions is contraindicated for patients with hypersensitivity (allergic reaction) to norepinephrine or to any auxiliary substances.
  2. Arterial hypotension due to insufficient blood volume (hypovolemia, decreased circulating blood volume).
  3. The use of pressor amines with cyclopropane or halotane anesthesia can cause severe cardiac arrhythmias. Because of the possible increased risk of ventricular fibrillation, norepinephrine should be used with caution in patients who receive these or any other sensitizing drugs for the heart or who have increased hypoxia (oxygen deficiency) or hypercapnia (increased levels of carbon dioxide in the blood or tissues).

Mode of application

Adult patients

Initial infusion rate (intravenous administration): The initial infusion rate should be from 10 ml / hour to 20 ml / hour (from 0.16 ml / min to 0.33 ml / min). This is equivalent to from 0.8 mg / hour to 1.6 mg / hour of norepinephrine tartrate (or from 0.4 mg / hour to 0.8 mg / hour of norepinephrine base).

Dose selection

Immediately after the installation of the norepinephrine infusion, the dose should be selected relative to the pressor effect that is observed. There is significant variation in the dose required to achieve and maintain normal blood pressure in patients. The main goal is to establish a low normal systolic blood pressure (100-120 mmHg) or to achieve an appropriate average blood pressure (more than 65-80 mmHg, depending on the patients condition).

If other solutions are used, dose calculation should be carefully performed before starting treatment.

Duration of treatment and monitoring

Treatment with norepinephrine should be continued until vasoactive drug support is indicated. The patient should be closely monitored and supervised during the entire period of treatment with norepinephrine.

Infusion cannot be stopped suddenly, it should be stopped gradually to avoid a sharp decrease in blood pressure.

Elderly patients

Elderly patients may be especially sensitive to the effects of norepinephrine.

Application method

For intravenous administration only.

Norepinephrine should be administered using central venous devices to minimize the risk of extravasation (outflow of the drug from the vessel into the surrounding tissue) and basement tissue necrosis.

Norepinephrine concentrate 1 mg / ml must be diluted before intravenous administration of 5% dextrose or physiological glucose solution. It should not be mixed with other drugs.

The final concentration of the infusion solution should be 80 mg / liter of norepinephrine tartrate, which is equivalent to 40 mg / liter of norepinephrine base.

Breeding instructions

Add 2 ml of norepinephrine 1 mg / ml to 48 ml of 5% glucose (or isotonic glucose solution) for injection with a syringe infusion pump or add 20 ml of norepinephrine 1 mg / ml to 480 ml of 5% glucose (or isotonic glucose solution) for administration through a dropper.

In both cases, the final concentration of infusion solutions is 80 mg / liter of norepinephrine tartrate, which is equivalent to 40 mg / liter of norepinephrine base. If other solutions are used, dose calculation should be carefully performed before starting treatment.

Blood pressure control

Measure blood pressure every two minutes at the start of the infusion until the desired blood pressure is reached. Then, every 5 minutes, when the desired blood pressure is reached, if it is necessary to continue the administration. The rate of infusion should be monitored, as well as carefully monitor the patients condition during the entire period of treatment with norepinephrine (norepinephrine).

Application features

Pregnant women

Norepinephrine can negatively affect placental blood flow and cause fetal bradycardia. It can also affect uterine contractions in pregnant women and lead to fetal asphyxiation in late pregnancy. So, you should carefully weigh whether the expected benefits to the mother outweigh the potential risk to the fetus.

There is no information regarding the use of norepinephrine during lactation.

Children

Safety and effectiveness when using the drug in children have not been determined.

Overdose

In case of overdose, the following may be observed: vasoconstriction of the skin, pressure sores, vascular insufficiency, arterial hypertension.

In case of adverse reactions associated with excessive dosage, it is recommended to reduce the dose if possible.

Side effects

From the vessels: arterial hypertension and tissue hypoxia; ischemic lesions due to the strong vasoconstrictor action can result in cooling and pallor of the limbs and face.

From the side of the heart: tachycardia, bradycardia (possibly as a reflex result of increasing blood pressure), arrhythmia, palpitations, increased contraction of the heart muscle (myocardium) as a result of ß-adrenergic effect on the heart (inotropic and chronotropic), acute heart failure.

From the side of the central nervous system: anxiety (anxiety), sleep disturbance (insomnia), confusion (eclipse) of consciousness, headache, psychotic state, weakness, tremor, impaired attention and alertness, anorexia, nausea and vomiting.

From the urinary system: urinary retention.

From the respiratory system: respiratory failure or shortness of breath, shortness of breath (shortness of breath).

Local reactions: irritation and necrosis at the injection site are possible.

On the part of the organs of vision: acute glaucoma; very often occurs in patients who are anatomically susceptible to closing the iris-corneal angle (angle of the anterior chamber of the eyeball).

With prolonged use of vasopressors (vasoconstrictor drugs) to maintain blood pressure in the absence of restoration of the volume of circulating blood, the following symptoms may occur:

  • severe narrowing of peripheral and visceral vessels;
  • decreased renal blood flow;
  • decreased urination;
  • hypoxia (oxygen deficiency);
  • increased serum lactate.

In case of hypersensitivity (an allergic reaction) or overdose, the following symptoms may appear more often: arterial hypertension, photophobia, chest pain, sore throat, pallor, excessive sweating and vomiting.

The vasopressor effect (resulting from vascular adrenergic action) can be reduced by the combined use of an α-blocker (phentolamine mesylate), while the use of ß-blockers (propranolol) can lead to a decrease in the stimulating effect of the drug on the heart and to an increase in pressor effect (through reduced expansion of arterioles) that occurs as a result of ß1-adrenergic stimulation.

Long-term use of any potent vasopressor can result in a decrease in plasma volumes, which must be constantly adjusted using appropriate water-electrolyte replacement therapy. If plasma volumes are not adjusted, arterial hypotension may occur again when noradrenaline is discontinued, or blood pressure may be maintained at the risk of severe narrowing of the peripheral and visceral vessels with a decrease in blood flow.

Interaction

The drug should not be mixed with other drugs, except 5% glucose or isotonic glucose solution.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life is 2 years.

Tags: Norepinephrine