Expiration date: 05/2026

The composition and form of issue:

Concentrate for preparation of solution for intravenous injection. 1 ml contains:

norepinephrine tartrate monohydrate (in terms of norepinephrine tartrate) 2 mg/ml

Excipients: sodium chloride sodium hydroxide or hydrochloric acid (pH = 3,0–4,5) water for injections 

in ampoules of 4 or 8 ml pack contoured plastic 5 ampoules in a cardboard pack 2 packs.

Description pharmaceutical form:

Clear, colorless liquid.

Pharmacokinetics:

Not absorbed in the digestive tract. At/in the introduction rapidly reaches Cmax in plasma (2-3 min).

Metabolized in the liver, kidney and plasma, with the participation of MAO and catechol-O-methyltransferase (COMT) to nearly inactive metabolites, which are excreted through the kidneys.

Description pharmacological action:

Agonist &alphal - and alpha2-adrenergic receptors. He weakly excites &beta1 - and almost does not affect beta2-adrenergic receptors. It has a powerful vasoconstrictor effect, leading to increased blood pressure.

Indications:

Acute hypotension, that accompanies the cardiovascular collapse and shock (to restore and maintain AD — in/in perfusion).

Contraindications:

• severe hypersensitivity to the drug
  
• hypotension caused by hypovolemia. The exception in these cases is the need for the introduction of the drug to maintain the blood flow in the coronary arteries of the heart and arteries of the brain until the end of therapy aimed at restoration of the BCC
  
• thrombosis of mesenteric and peripheral vessels in connection with the risk of aggravating ischemia and increase the zone of infarction
  
• holding ftorotanovy and cyclopropane General anesthesia (in connection with risk of development of ventricular tachycardia and fibrillation)
  
• severe hypoxia and hypercapnia.
  

With caution:

• severe left ventricular failure, acute heart failure, recent myocardial infarction
  
• simultaneous reception MAO inhibitors imipraminovogo and triptolemos series (in connection with risk of development of a pronounced and prolonged increase in BP)
  
• the development of symptoms of cardiac arrhythmia (in this case, it is necessary to decrease the dose of the drug). If a polymorphic arrhythmia or the development of bursts of extrasystoles dose should be substantially reduced or eliminated treatment.
  
• If necessary, the simultaneous application of Noradrenaline Agean and transfusion of blood or plasma the drug is administered separately.
  

Application of pregnancy and breast-feeding:

Pregnancy is not a limitation to the use of Norepinephrine Agean. At the time of treatment should stop breastfeeding (no experience with the drug in lactating women).

Side effects:

With the introduction of Norepinephrine Agetn can cause the following symptoms:

• ischemia up to necrosis caused by vasoconstriction and tissue hypoxia, but also due to the extravasation
  
• arrhythmia
  
• reflex bradycardia
  
• anxiety
  
• shortness of breath
  
• tremor
  
• transient headache
  
• retrosternal or pharyngeal pain
  
• vegetative reaction, pallor, sweating, vomiting, tachycardia. In particularly sensitive patients increased blood pressure may be accompanied by headache, photophobia, stabbing retrosternal pain, pallor, increased sweating and vomiting.
  

With prolonged use a correction dose to prevent recurrent hypotension when the drug is removed.

Drug interactions:

The main undesirable effects in combination with some groups of drugs relate to pharmacodynamics.

When combined with inhaled anesthetic agents can cause serious ventricular arrhythmias (increased excitability of the heart).

When combined with serotonergic and adrenergic antidepressants, as well as derivatives of imipramine and amitriptyline may develop paroxysmal hypertension with the risk of cardiac arrhythmias due to adrenoblokirutego effect on the sympathetic nervous system.

Contraindicated combination of Norepinephrine Agean with selective and non-selective MAO inhibitors, linezolid, because thus there is a synergistic amplification of the Pressor actions of norepinephrine that require careful medical supervision.

Method of application and dose:

In/in, preferably in a vein of the elbow bend.

The concentrate should be diluted in 5% glucose solution or 0.9% sodium chloride solution. Do not mix with other drugs. With the introduction of Norepinephrine Agean you need to constantly monitor BP and HR.

After dilution of the concentrate solution should be used within 12 h

Individual dose depends on clinical condition of the patient. The recommended initial dose and rate of administration of 0.1 to 0.3 &MiG/kg/min of norepinephrine tartrate. The maximum dose and rate of administration used in the treatment of septic and hemorrhagic shock, can reach 3-5 &MiG/kg/min.

Overdose:

Symptoms: there may be spasm of the blood vessels of the skin, collapse, anuria, marked increase in blood pressure.

Treatment: manifestations of overdosage, the dose should be reduced.