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Fluorescein sodium parenteral

Presentation

Solution for injection of fluorescein (as fluorescein sodium).

Drugs List

  • ANATERA 500mg/5ml injection
  • fluorescein 441.5mg/5ml injection
  • fluorescein 500mg/5ml (10%) injection
  • Therapeutic Indications

    Uses

    Colouring agent for retinal angiography

    Dosage

    Luminescence usually appears in the retina and choroidal vessels in 7 to 20 seconds.

    Adults

    Standard imaging systems
    5ml rapidly into the antecubital vein.

    Highly sensitive imaging systems (e.g. using scanning laser ophthalmoscope)
    2ml rapidly into the antecubital vein.

    Patients with Renal Impairment

    Dialysed patients
    2.5ml (half a vial).

    Contraindications

    Children under 18 years
    Breastfeeding

    Precautions and Warnings

    Allergic disposition
    Cardiopulmonary disorder
    Restricted sodium intake
    Diabetes mellitus
    End stage renal disease
    Pregnancy
    Renal dialysis

    Contains more than 1 mmol (23 mg) sodium per dose
    Dialysis patients may require dose reduction
    Advise patient blurred vision may affect ability to drive/operate machinery
    Before initiating therapy enquire about previous hypersensitivity reactions
    For intravenous use only
    If extravasation occurs follow local policy & seek expert help immediately
    Resuscitation facilities must be immediately available
    Monitor for hypersensitivity reactions during infusion
    Advise patient of possible colour changes to skin and body secretions
    Monitor for hypersensitivity reactions for 30 minutes after administration
    May affect results of some laboratory tests
    May affect urine test results
    May affect X-ray images

    Any pre-existing systemic condition(s) impacting renal function could pose additional risk to the patient. The physician must exercise medical judgement based on increased serum creatinine, patient's age, medical history, and current health status to determine potential risk vs benefit prior to use of fluorescein.

    Literature suggests Fluorescein Angiography (FA) may cause contrast-induced Nephropathy (CIN) based on increased serum creatinine. CIN is a possible risk factor for end-stage renal disease progression.

    Pregnancy and Lactation

    Pregnancy

    Use fluorescein sodium with caution in pregnancy.

    Studies of fluorescein in pregnant women have not revealed any unwanted foetal effects. Fluorescein crosses the placenta and passage to the foetus due to systemic circulation is expected but is unlikely to produce unwanted effects.

    The manufacturers note that it is preferable to avoid its use, unless the benefit of the procedure outweighs any risk to the foetus.

    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

    Fluorescein sodium is contraindicated breastfeeding.

    Fluorescein enters human breast milk. Due to the photosensitivity of fluorescein, there is a risk of photo toxicity, especially in neonates, but this is considered unlikely to be a problem by most authorities. However, it may be advisable to temporarily avoid breastfeeding to allow the fluorescein to clear from the milk, or to avoid phototherapy in the infant. The manufacture advises breastfeeding should be discontinued for 7 days and the milk should be pumped off and discarded during this period.

    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 discomfort
    Abdominal pain
    Anaphylactic reaction
    Anaphylactic shock
    Angina pectoris
    Angioedema
    Asthenia
    Asthma
    Bradycardia
    Bronchospasm
    Cardiac arrest
    Cardiovascular collapse
    Cerebrovascular accident
    Chest pain
    Chills
    Cold sweat
    Convulsions
    Cough
    Dizziness
    Dysgeusia
    Dysphasia
    Dyspnoea
    Eczema
    Erythema
    Extravasation
    Feeling hot
    Headache
    Hot flushes
    Hyperhidrosis
    Hypersensitivity reactions
    Hypertension
    Hypoaesthesia
    Hypotension
    Laryngeal oedema
    Loss of consciousness (transient)
    Malaise
    Myocardial infarction
    Nasal oedema
    Nausea
    Oedema
    Pain
    Pallor
    Paraesthesia
    Pruritus
    Pulmonary oedema
    Rash
    Respiratory arrest
    Respiratory failure
    Shock
    Sneezing
    Syncope
    Tachycardia
    Throat tightness
    Thrombophlebitis
    Tremor
    Urticaria
    Vasodilation
    Vasospasm
    Vertebrobasilar insufficiency
    Vomiting
    Yellow discolouration of skin
    Yellow urine

    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: November 2017

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    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.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Anatera 100mg/ml solution for injection. Alcon Laboratories (U.K.) Ltd. Revised March 2022.

    Summary of Product Characteristics: Fluorescein Sodium 100mg/ml, Solution for Injection. Serb SA. Revised July 2015.

    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
    Fluorescein Last revised: September 7, 2013
    Last accessed: November 16, 2017

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