Fluorescein sodium can induce serious intolerance reactions. These reactions of intolerance are always unpredictable but they are more frequent in patients who have previously experienced an adverse reaction after fluorescein injection (symptoms other than nausea and vomiting), in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic rhinitis or in patients with history of bronchial asthma. The benefit of the fluorescein angiography should be balanced with the risk of severe hypersensitivity reactions (with fatal outcome in some cases). Intradermal skin tests have limited predictive value for serious intolerance reactions to Fluorescein. Fluorescein intolerance reactions can occur following a negative intradermal skin test.
The benefit to risk of the angiography procedure should also be considered in patients with pre-existing conditions such as cardiovascular disease, diabetes mellitus, and multiple concomitant drug therapies (in particular beta-blockers, see Interactions).
Detailed questioning of each patient must be carried out before the angiography to evaluate any prior history of cardiopulmonary disease or allergy or concomitant medications (see Interactions).
The risk of hypersensitivity reactions with fluorescein sodium requires: Fluorescein should only be administered in facilities with personnel trained in resuscitation and with appropriate material and equipment for emergency resuscitation. Patients should be given a 2nd intravenous line, allowing volume therapy and the intravenous injection of adrenaline and other standard resuscitation drugs (see Interactions).
Close monitoring of the patient by the ophthalmologist performing the examination, throughout the examination and for at least 30 minutes thereafter; Maintaining the infusion line for at least 5 minutes, to treat a possible severe adverse reaction without delay; In addition, in patients identified as being at risk of hypersensitivity reactions, but in whom a fluorescein angiography is considered to be essential, it is recommended to carry out the procedure with the equipment and personnel trained in emergency resuscitation in the treatment room.
Extravasation should be avoided due to the high pH of fluorescein solution which can result in severe local tissue damage (severe pain in the arm for several hours, sloughing of the skin; superficial phlebitis). The correct intravenous position of the needle tip must be ascertained. When extravasation occurs, the injection should be immediately discontinued. Appropriate measures must be taken to treat damaged tissue and to relieve pain.
Effects on Ability to Drive and Use Machines: The patient must be made aware that after application and until visual acuity returns to normal, driving a vehicle or operating dangerous machinery is not recommended.