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Phenylephrine parenteral

Presentation

Injections of phenylephrine.

Drugs List

  • phenylephrine 10mg/1ml injection
  • phenylephrine 1mg/10ml solution for injection ampoule
  • phenylephrine 2mg/20ml solution for injection vial
  • phenylephrine 500microgram/10ml injection
  • phenylephrine 8mg/100ml infusion bag
  • Therapeutic Indications

    Uses

    Hypotension - acute

    Treatment of hypotension during epidural, spinal and general anaesthesia.

    Unlicensed Uses

    Priapism

    Dosage

    Adults

    10mg/ml solution
    Subcutaneous or intramuscular injection
    2mg to 5mg with further doses of 1mg to 10mg if necessary, depending on response.

    Slow intravenous injection
    100micrograms to 500micrograms as a 0.1% solution repeated as necessary after at least 15 minutes.

    Intravenous infusion
    10mg in 500ml of glucose 5% injection or sodium chloride 0.9% injection at a rate of up to 180micrograms/minute, reduced to 30micrograms/minute to 60micrograms/minute according to response.

    100micrograms/ml solution
    Intravenous bolus injection
    50micrograms to 100micrograms, which can be repeated until the desired effect is attained. One bolus dose should not exceed 100micrograms.

    Continuous infusion
    Initial dose: 25micrograms/minute to 50micrograms/minute. The doses may be increased up to 100micrograms/minute or decreased to maintain the systolic blood pressure close to the normal value.
    Doses between 25micrograms/minute and 100micrograms/minute have been assessed to be effective.

    80micrograms/ml solution
    Intravenous bolus injection
    50micrograms to 100micrograms, which can be repeated until the desired effect is attained. One bolus dose should not exceed 100micrograms.

    Continuous infusion
    Initial dose: 25micrograms/minute to 50micrograms/minute. The doses may be increased up to 100micrograms/minute or decreased to maintain the systolic blood pressure close to the normal value.
    Doses between 25micrograms/minute and 100micrograms/minute have been assessed to be effective.

    50micrograms/ml solution
    Intravenous bolus injection
    50micrograms to 100micrograms, which can be repeated until the desired effect is attained. One bolus dose should not exceed 100micrograms.

    Continuous infusion
    Initial dose: 25micrograms/minute to 50micrograms/minute. The doses may be increased or decreased to maintain the systolic blood pressure close to the normal value.
    Doses between 25micrograms/minute and 100micrograms/minute have been assessed to be effective.

    Priapism (unlicensed)
    Using a 200?micrograms/ml solution, give 100micrograms to 200micrograms by intracavernosal injection every 5 to 10?minutes.
    Maximum dose: 1mg per course.

    Children

    10mg/ml solution
    Subcutaneous or intramuscular injection
    100micrograms/kg.

    The following alternative dosing schedule may be suitable:

    Acute hypotension
    Subcutaneous or intramuscular injection
    Children aged 12 to 18 years
    Initial dose: 2mg to 5mg (maximum 5mg per dose). Follow, if necessary after at least 15 minutes, by further doses of 1mg to 10mg
    Children aged 1 to 12 years
    100micrograms/kg every 1 to 2 hours as needed (maximum 5mg per dose).

    By slow intravenous injection (unlicensed)
    Dilute to a concentration of 1mg/ml with water for injections.
    Children aged 12 to 18 years
    100micrograms to 500micrograms. Repeat as necessary after at least 15 minutes.
    Children aged 1 to 12 years
    5micrograms/kg to 20micrograms/kg (maximum 500micrograms per dose). Repeat as necessary after at least 15 minutes.

    By intravenous infusion (unlicensed)
    Dilute to a concentration of 20micrograms/ml (with glucose 5% or sodium chloride 0.9%) and administer via a central venous catheter as a continuous infusion using a controlled infusion device.
    Children aged 16 to 18 years
    Initial dose: Up to 180micrograms/minute. Reduce to 30micrograms/minute to 60micrograms/minute according to response.
    Children aged 1 to 16 years
    100 to 500nanograms/kg/minute. Titrate according to response.

    Administration

    Consult product literature for specific information regarding administration.

    For priapism (unlicensed indication)
    For intracavernosal injection administration.

    Contraindications

    Within 2 weeks of discontinuing MAOIs
    Long QT syndrome
    Pregnancy
    Severe hypertension
    Severe hyperthyroidism
    Severe peripheral vascular disease
    Torsade de pointes

    Precautions and Warnings

    Children under 18 years
    Elderly
    Family history of long QT syndrome
    Restricted sodium intake
    Angina
    Arterial aneurysm
    Arteriosclerosis
    Bradycardia
    Breastfeeding
    Cardiac arrhythmias
    Cardiogenic shock
    Cardiovascular disorder
    Cerebral ischaemia
    Diabetes mellitus
    Electrolyte imbalance
    First degree atrioventricular block
    Hepatic cirrhosis
    History of torsade de pointes
    Hypercapnia
    Hypertension
    Hyperthyroidism
    Hypovolaemia
    Hypoxia
    Ischaemic heart disease
    Narrow angle glaucoma
    Peripheral vascular disease
    Prinzmetal's angina
    Recent myocardial infarction
    Renal impairment
    Second degree atrioventricular block
    Severe cardiac failure
    Tachycardia
    Thrombosis

    Correct electrolyte disorders before treatment
    Sodium content of formulation may be significant
    Not all available brands are licensed for all routes of administration
    Not all available products are licensed for all age groups
    Not all routes are licensed for all age groups
    Administer carefully - extravasation may cause tissue necrosis
    If extravasation occurs follow local policy & seek expert help immediately
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor arterial pressure
    Monitor serum electrolytes
    Consider dose adjustment in hepatic cirrhosis
    Consider dose reduction in renal impairment

    When phenylephrine is used to treat priapism (unlicensed indication) extreme caution is required when treating patients with coronary heart disease, hypertension, cerebral ischaemia, or those taking antidepressants.

    Phenylephrine has a longer duration of action than noradrenaline and an excessive vasopressor response may cause a prolonged rise in blood pressure. Monitor blood pressure and flow rate of infusion frequently.

    Phenylephrine can induce a reduction in cardiac output. Therefore, care should be exercised in administering to patients with arteriosclerosis, the elderly and to patients with impaired cerebral or coronary circulation.

    In patients with reduced cardiac output or coronary vascular disease, vital organs should be closely monitored and dose reduction should be considered when systemic blood pressure is near the lower end of the target.

    In patients with serious heart failure or cardiogenic shock, phenylephrine may cause deterioration in the heart failure as a consequence of the induced vasoconstriction (increase in afterload).

    Phenylephrine may precipitate angina in patients with angina pectoris.

    Pregnancy and Lactation

    Pregnancy

    Phenylephrine is contraindicated in pregnancy.

    The manufacturer does not recommend using phenylephrine during pregnancy. Available reports indicate that alpha-adrenergic receptor agonists slow uterine blood flow. It is also noted that sympathomimetic amines are uterogenic in some animal species, but human teratogenicity has not been suspected. An association between use of phenylephrine in the first trimester and minor defects has been found, with malformations such as inguinal hernia and clubfoot. Administration in late pregnancy or during labour may cause foetal hypoxia and bradycardia. Phenylephrine may also interact with oxytocics or ergot derivatives to produce severe persistent maternal hypertension. Rupture of a cerebral vessel is possible (Briggs, 2015).

    To date, the safety of phenylephrine injection has not been established during human pregnancy. Therefore potential risks of use of phenylephrine in pregnancy or by women intending to become pregnant, cannot be ruled out.

    Lactation

    Use phenylephrine with caution in breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking phenylephrine. Due to the low molecular weight of phenylephrine (around 167), passage into breast milk is expected (Briggs, 2015). LactMed (2018) suggests that intravenous administration of phenylephrine might decrease milk production. The manufacturer notes that administering phenylephrine to mothers may expose the neonate to a risk of cardiovascular and neurological effects but in the event of a single bolus injection during childbirth, breastfeeding is possible.

    Side Effects

    Agitation
    Angina pectoris
    Anginal pain
    Anxiety
    Arrhythmias
    Blanching
    Bradycardia
    Cardiac arrest
    Cerebral haemorrhage
    Changes in glucose metabolism
    Confusion
    Coolness of skin
    Difficulty in micturition
    Dizziness
    Dyspnoea
    Dysuria
    Excitability
    Extravasation necrosis
    Eye disorder
    Flushing
    Glaucoma (closed angle)
    Headache
    Hypersalivation
    Hypersensitivity reactions
    Hypertension
    Hypertensive crisis
    Hypotension
    Hypoxia
    Immune disorder
    Increased blood pressure
    Insomnia
    Local reaction at injection site
    Metabolic changes
    Mydriasis
    Myocardial ischaemia
    Nausea
    Nervousness
    Pallor
    Palpitations
    Paraesthesia
    Peripheral ischaemia
    Piloerection
    Psychosis
    Pulmonary oedema
    Reflex bradycardia
    Skin tingling
    Sweating
    Syncope
    Tachycardia
    Torpor
    Tremor
    Urinary retention
    Vertigo
    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: May 2016

    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: Phenylephrine 0.08mg/ml solution for injection/infusion. Altan Pharma Limited. Revised February 2020.

    Summary of Product Characteristics: Phenylephrine 0.1mg/ml solution for injection ampoules. Martindale Pharma Ltd. Revised February 2019.

    Summary of Product Characteristics: Phenylephrine 50micrograms/ml solution for injection in Pre-filled syringe. Aguettant Ltd. Revised November 2015.

    Summary of Product Characteristics: Phenylephrine 100micrograms/ml solution for injection or infusion. Aguettant Ltd. Revised January 2020.

    Summary of Product Characteristics: Phenylephrine injection BP 10mg/ml. Amdipharm Mercury Company Ltd. Revised March 2016.

    Summary of Product Characteristics: Phenylephrine 10mg/ml solution for injection or infusion. Beacon Pharmaceuticals. Revised March 2011.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 November 2021

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
    Phenylephrine. Last revised: 31 October 2018
    Last accessed: 04 August 2022

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