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Enoximone parenteral

Presentation

Injection containing enoximone

Drugs List

  • enoximone 100mg/20ml concentrate for solution for injection
  • PERFAN 100mg/20ml concentrate for solution for injection
  • Therapeutic Indications

    Uses

    Cardiac failure - especially if output reduced & filling pressure increased

    Unlicensed Uses

    Heart failure associated with cardiac surgery

    Dosage

    Adults

    Slow intravenous injection

    Initial dose: 0.5mg/kg to 1mg/kg, followed by 0.5mg/kg every 30 minutes until a satisfactory response is gained or a total of 3mg/kg has been administered.
    The injection rate should not exceed 12.5mg/minute.
    Maintenance dose: Up to 3mg/kg, can be repeated every 3 to 6 hours if necessary, adjusted according to the response (up to a maximum dose of 24mg/kg over 24 hours).

    Intravenous infusion

    Initial dose: 90 micrograms/kg/minute over 10 to 30 minutes until the required haemodynamic response is achieved.
    Maintenance dose: 5 to 20 micrograms/kg/minute (by continuous or intermittent infusion, up to a maximum dose of 24mg/kg over 24 hours).

    Children

    Congestive cardiac failure, low output following cardiac surgery (unlicensed)
    Children aged 1 month to 18 years
    Initial loading dose: 500 micrograms/kg by slow intravenous injection over at least 15 minutes.
    To be followed by: 5 to 20 microgram/kg/minute by continuous intravenous infusion over 24 hours adjusted according to response (up to a maximum of 24mg/kg over 24 hours).

    Neonates

    Congestive cardiac failure, low output following cardiac surgery (unlicensed)
    Initial loading dose: 500 micrograms/kg by slow intravenous injection over at least 15 minutes.
    To be followed by: 5 to 20 microgram/kg/minute by continuous intravenous infusion over 24 hours adjusted according to response (up to a maximum of 24mg/kg over 24 hours).

    Administration

    For intravenous administration after dilution.

    Enoximone may be administered by slow intravenous injection or intravenous infusion.

    Contraindications

    None known

    Precautions and Warnings

    Children under 18 years
    Aortic stenosis
    Breastfeeding
    Cardiac arrhythmias
    Hepatic impairment
    Hypertrophic cardiomyopathy
    Left ventricular outflow obstruction
    Mitral stenosis
    Obstructive valvular heart disease
    Pregnancy
    Renal impairment

    Reduce dose in patients with hepatic impairment
    Reduce dose in patients with renal impairment
    Contains alcohol
    Contains propylene glycol: may cause irritation
    Dilute injection before use - avoid glass containers or syringes
    If extravasation occurs follow local policy & seek expert help immediately
    Monitor platelets before starting and during treatment
    Monitor serum potassium levels before treatment
    Monitor blood pressure
    Monitor central venous pressure
    Monitor ECG
    Monitor fluid and electrolyte status
    Monitor heart rate
    Monitor hepatic enzymes
    Monitor renal function
    Monitor serum potassium regularly
    Discontinue if hepatic enzymes (AST or ALT) become persistently raised
    Discontinue treatment if arrhythmias occur
    Interrupt or reduce dose if significant gastrointestinal disturbances occur

    If the patient develops severe supraventricular and ventricular arrhythmias during treatment, enoximone should be immediately discontinued and appropriate anti-arrhythmic therapy should be instituted.

    Pregnancy and Lactation

    Pregnancy

    Use enoximone with caution in pregnancy.

    Enoximone should not be used during pregnancy unless clearly necessary

    The manufacturer reports that no animal teratogenicity was reported following oral therapy. Reproduction studies performed in rats at doses up to 300 mg/kg/day and 100 mg/kg/day have revealed reductions in maternal food consumption, maternal body weight gain and in pup weight at weaning and sexual maturity when enoximone was administered throughout pregnancy.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Use enoximone with caution in breastfeeding.

    It is not known whether enoximone is excreted into human breast milk. At the time of writing, there is no published experience concerning the use of enoximone during breastfeeding.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Altered liver enzymes values
    Chills
    Decrease in haemoglobin and haematocrit
    Diarrhoea
    Dizziness
    Ectopic beats
    Fever
    Fluid retention
    Headache
    Hypotension
    Increase in blood urea or creatinine
    Increase in serum glucose
    Increased uric acid level
    Insomnia
    Leucocytosis
    Lower limb pain
    Nausea
    Oliguria
    Painful extremities
    Phlebitis (injection site)
    Supraventricular arrhythmias
    Thrombocytopenia
    Upper limb pain
    Urinary retention
    Ventricular fibrillation
    Ventricular tachycardia
    Vomiting

    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: July 2014

    Reference Sources

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Perfan injection 100mg/20ml concentration for solution for injection. Myogen GmbH. Revised May 2012.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 28 June 2017

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