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Isosorbide dinitrate parenteral

Updated 2 Feb 2023 | Parenteral nitrates

Presentation

Parenteral presentation of isosorbide dinitrate

Drugs List

  • ISOKET 10mg/10ml concentrate for solution for injection
  • isosorbide dinitrate 10mg/10ml concentrate for solution for injection
  • isosorbide dinitrate 25mg/50ml injection
  • isosorbide dinitrate 50mg/50ml concentrate for solution for injection
  • Therapeutic Indications

    Uses

    Intracoronary use during angioplasty and to prevent/relieve coronary spasm
    Treatment of unresponsive LVF, either post MI or of various aetiology
    Treatment severe/unstable angina

    Dosage

    Adults

    Intravenous
    Dosage should be adjusted according to patient response.

    2 mg to 12 mg per hour.
    Doses up to 20 mg an hour may be necessary.

    Monitor blood pressure and pulse closely during administration.

    Intracoronary
    1 mg bolus injection prior to balloon inflation.

    Further doses must not exceed 5 mg in a 30 minute period.

    Elderly

    (See Dosage; Adult).

    Administration

    For intravenous infusion or intracoronary injection only.

    Contraindications

    Children under 18 years
    Aortic stenosis
    Cardiac tamponade
    Cerebrovascular haemorrhage
    Circulatory failure
    Constrictive pericarditis
    Head trauma
    Hypertrophic obstructive cardiomyopathy
    Hypotension
    Hypovolaemia
    Left ventricular failure with low filling pressure
    Mitral stenosis
    Narrow angle glaucoma
    Raised intracranial pressure
    Severe anaemia
    Toxic pulmonary oedema

    Precautions and Warnings

    Hypothermia
    Predisposition to narrow angle glaucoma
    Breastfeeding
    Cardiogenic shock
    Hypothyroidism
    Hypoxia
    Malnutrition
    Pregnancy
    Recent myocardial infarction
    Severe hepatic disorder
    Severe renal impairment

    Sodium content of formulation may be significant
    Monitor blood pressure
    Monitor heart rate
    Cross tolerance to other nitrates may develop
    Tolerance may develop with continued use
    Hypotensive effect enhanced by alcohol

    Pregnancy and Lactation

    Pregnancy

    Use isosorbide dinitrate with caution in pregnancy.

    Safety in pregnancy has not been established although there are no data that indicate a potential hazard.

    Schaeffer (2007) notes that nitrates may be used in pregnancy for appropriate indications and Briggs (2011) comments that nitrates lower maternal blood pressure.

    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 isosorbide dinitrate with caution in breastfeeding.

    At the time of writing there are limited reports of its use during breastfeeding. There is data to suggest that nitrates are excreted in breast milk and may cause methaemoglobinaemia in infants.

    The molecular weight is low enough for its transfer to breast milk to be expected, but its short half-life would suggest minimal effect on the nursing infant.

    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

    Abdominal pain
    Apprehension
    Diaphoresis
    Dizziness
    Flushing
    Headache
    Heartburn
    Methaemoglobinaemia
    Muscle twitch
    Nausea
    Palpitations
    Postural hypotension
    Restlessness
    Retrosternal discomfort
    Syncope
    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: October 2015

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on 6 October 2015.

    Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press Accessed on 6 October 2015.

    Summary of Product Characteristics: Isosorbide dinitrate 0.05% solution for injection. South Devon Healthcare. Revised December 1999.
    Summary of Product Characteristics: Isosorbide dinitrate 0.1% concentrate for solution for injection. South Devon Healthcare. Revised November 2012.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

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