Fluorescein sodium parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection of fluorescein (as fluorescein sodium).
Drugs List
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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