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Noradrenaline (as base) parenteral

Presentation

Parenteral formulations of noradrenaline.

Drugs List

  • noradrenaline (base) 2mg/2ml concentrate for solution for infusion ampoule
  • noradrenaline (base) 4mg/4ml concentrate for solution for infusion ampoule
  • noradrenaline (base) 4mg/50ml solution for infusion
  • noradrenaline (base) 8mg/50ml solution for infusion
  • noradrenaline (base) 8mg/8ml concentrate for solution for infusion
  • SINORA 8mg/50ml solution for infusion
  • Therapeutic Indications

    Uses

    Hypotension - acute

    Indicated for use as an emergency measure in the restoration of blood pressure in cases of acute hypotension.

    Noradrenaline 0.08mg/ml and 0.16mg/ml solutions for infusion are indicated in adults weighing over 50kg for the ongoing treatment of hypotensive emergencies with escalating noradrenaline dose requirements.

    Dosage

    Adults

    Acute Hypotension (concentrate for solution for infusion)
    The initial rate of infusion of the diluted solution should be between 10ml/hour and 20ml/hour (0.16ml/minute to 0.33ml/minute). This is equivalent to noradrenaline base 0.4mg/hour to 0.8mg/hour (or noradrenaline acid tartrate 0.8mg/hour to 1.6mg/hour).

    Titration of dose
    The dose should be titrated in steps of 0.05 to 0.1micrograms/kg/minute (of noradrenaline base). The aim should be to establish a low normal systolic blood pressure (100mmHg to 120mmHg) or to achieve an adequate mean arterial blood pressure (greater than 65mmHg to 80mmHg). Continue treatment as long as vasoactive drug support is indicated.

    On going treatment of acute hypotension in adults weighing greater than 50kg (0.08mg/ml and 0.16mg/ml solutions)
    The initial dose of noradrenaline base should be between 0.05 and 0.15 micrograms/kg/minute (using less concentrated solutions).

    The maintenance dose of noradrenaline base is between 0.05 and 1.5 micrograms/kg/minute.

    Children

    Acute hypotension (septic shock); Shock secondary to excessive vasodilation (unlicensed)
    20 to 100nanograms (base)/kg/minute by continuous intravenous infusion. Titrate according to response.
    Maximum dose: 1microgram (base)/kg/minute.

    Note: 1mg of noradrenaline base is equivalent to 2mg of noradrenaline acid tartrate. Dose expressed as the base.

    Neonates

    Acute hypotension (septic shock); Shock secondary to excessive vasodilation (unlicensed)
    20 to 100nanograms (base)/kg/minute by continuous intravenous infusion. Titrate according to response.
    Maximum dose: 1microgram (base)/kg/minute.

    Note: 1mg of noradrenaline base is equivalent to 2mg of noradrenaline acid tartrate. Dose expressed as the base.

    Administration

    For intravenous infusion via a central venous catheter.

    The infusion should be at a controlled rate using either a syringe pump or a drip counter.

    Contraindications

    Hypertension
    Hypovolaemia

    Precautions and Warnings

    Children under 18 years
    Elderly
    Restricted sodium intake
    Breastfeeding
    Diabetes mellitus
    Hyperthyroidism
    Hypotension - if treating myocardial infarction
    Pregnancy
    Prinzmetal's angina
    Severe hypercapnia
    Severe hypoxia
    Thromboembolic disorder

    Sodium content of formulation may be significant
    Not all available brands are licensed for all age groups
    Not all available brands are licensed for all body weights
    Treatment to be initiated by specialist
    Do not mix with other drugs or substances
    Do not use if solution is discoloured or particulates are apparent
    If extravasation occurs follow local policy & seek expert help immediately
    Infusion should be withdrawn gradually to avoid unnecessary hypotension
    Monitor blood pressure continuously
    Consider the use of fluid and electrolyte replacement
    Monitor cardiac function
    Life threatening arrhythmias may occur during anaesthesia and surgery
    Reduce dose if cardiac arrhythmias occur
    Use in conjunction with appropriate blood volume replacement

    Monitor blood pressure every 2 minutes at the start of the infusion until the desired blood pressure is obtained, and then every 5 minutes; continue treatment as long as vasoactive drug support is indicated.

    Caution is required during syringe or infusion relay to avoid haemodynamic instability.

    Pregnancy and Lactation

    Pregnancy

    Use noradrenaline with caution during pregnancy.

    The manufacturer advises caution if noradrenaline is used during pregnancy as it may impair placental perfusion, and can exert a contractile effect on the uterus. This may lead to foetal asphyxia in late pregnancy. Noradrenaline readily crosses the placenta, consistent with its relatively low molecular weight. Studies have shown noradrenaline may induce foetal hypoxia and bradycardia.

    Lactation

    Use noradrenaline with caution during breastfeeding.

    The manufacturer of noradrenaline does not make a recommendation regarding breastfeeding. There is limited information regarding the use of noradrenaline during breastfeeding. It is not known if noradrenaline is excreted in human breast milk, but poor bioavailability and short half life mean it is unlikely to cause an adverse effect in a breastfed infant. High intravenous doses of noradrenaline may reduce milk production or milk letdown.

    Side Effects

    Anorexia
    Anxiety
    Bradycardia
    Cardiac arrhythmias
    Cardiac insufficiency
    Cardiomyopathy
    Confusion
    Dyspnoea
    Extravasation necrosis
    Glaucoma (closed angle)
    Headache
    Hypertension
    Hypoxia
    Increased blood lactate levels
    Insomnia
    Irritation (injection site)
    Nausea
    Necrosis (injection site)
    Palpitations
    Peripheral ischaemia
    Peripheral ischaemic gangrene
    Plasma volume depletion
    Psychosis
    Reduced renal blood flow
    Respiratory insufficiency
    Tachycardia
    Tremor
    Urinary retention
    Vasoconstriction
    Vomiting
    Weakness

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: April 2019

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product characteristics: Noradrenaline (Norepinephrine) 0.08mg/ml solution for infusion. Aguettant Ltd. Revised May 2018.

    Summary of Product characteristics: Noradrenaline (Norepinephrine) 1mg/ml concentrate for solution for infusion. Aguettant Ltd. Revised October 2018.

    Summary of Product characteristics: Noradrenaline (Norepinephrine) 1mg/ml concentrate for solution for infusion. Pfizer UK Ltd. Revised May 2018.

    Summary of Product characteristics: Sinora 0.08mg/ml solution for infusion. Sintetica Limited. Revised March 2020.

    Summary of Product characteristics: Sinora 0.16mg/ml solution for infusion. Sintetica Limited. Revised March 2020.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 April 2020

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Norepinephrine Last revised: 03 December 2018
    Last accessed: 18 April 2019

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