Caution is to be exercised in patients with a history of allergy or bronchial
asthma. An emergency tray including such items as 0.1% epinephrine for intravenous
or intramuscular use; an antihistamine, soluble steroid, and aminophylline for
intravenous use; oxygen should always be available in the event of possible
reaction to fluorescein injection.1 Use only if container is undamaged.
If serious intolerance reactions occurred during a first angiography or if a
history of severe allergic reactions has been revealed, any further indication
of fluores-cein angiography should be considered with caution: the usefulness
of the diagnosis should be weighed against the risk of a serious hypersensitivity
Sodium fluorescein may cause serious intolerance reactions: these are always
unpredictable but are more common amongst patients who have experienced a poorly
tolerated injection of the product (except for symptoms of nausea and vomiting)
or who present with a history of allergy: food or drug-induced urticaria, asthma,
eczema, hay fever; those intolerance reactions may not be detected by a fluorescein
test, which is of no value and may even be dangerous. A visit with a specialist
in allergy may clarify the diagnosis.
Under different circumstances, which should be clarified by questioning the
patient, the physician may need to administer premedication (although this may
not prevent serious accidents):
- this comprises principally anti-H1 antihistamines via the oral route, the
corticosteroids prior to the fluorescein injection.
- at present, it is not deemed useful to perform this premedication in all
patients, given the very small percentage of accidents.
However, because of the risk of hypersensitivity reactions, the following measure
should be taken throughout the procedure:
- the patient must be monitored by the ophthalmologist performing the procedure,
throughout the procedure and for 30 minutes after its completion;
- venous access should be kept open for at least 5 minutes, so that any accident
can be immediately treated;
- the resources necessary for emergency resuscitation must be available, based
on the insertion of a second venous line to allow vascular filling (polyionic
solution or colloidal plasma substitute), and the intravenous injection of
adrenaline at an appropriate dose (cf. Interactions with other medicinal products
and other forms of interaction).
Furthermore, in subjects identified as being at risk, but in whom the procedure
is shown to be essential, it must be carried out in the presence of a specialist
in resuscitation, particularly when the patient is under beta-blocker therapy,
including in the form of eye drops such as adrenaline.
Finally, because of the alkaline pH of the solution, the fluorescein solution
must not be injected outside the vein; it is important to ensure that the needle
is correctly inserted in the vein before starting the fluorescein injection.
If the product leaks into surrounding tissues, the injection should be stopped
Special precautions for use
A higher risk of adverse reactions in any patient receiving beta-blockers
or ACE inhibitors.
In dialyzed patients, use half a 5-mL ampule (10%).
To prevent nausea in predisposed subjects, inject the product very slowly.
Safety and effectiveness in pediatric patients have not been established.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
There have been no long-term studies done using fluorescein in animals to evaluate
Use In Pregnancy
Avoid angiography on patients who are pregnant, especially those in first trimester.
There have been no reports of fetal complications for fluorescein injection
Fluorescein has been demonstrated to be excreted in human milk. Caution should
be exercised when AK-FLUOR®(Fluorescein Injection, USP) is administered
to a nursing woman.
No overall differences in safety or effectiveness have been observed between
elderly and younger patients.
Skin will attain a temporary yellowish discoloration. Urine attains a bright
yellow color. Discoloration of the skin fades in 6 to 12 hours; urine fluorescence
in 24 to 36 hours.
1. Schatz, Burton, Yannuzzi, Rabb. Interpretation of Fundus Fluorescein Angiography, p. 38, C.V. Mosby Co., St. Louis, MO, 1978