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Ak-Fluor

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Ak-Fluor

Warnings
Precautions

WARNINGS

Care must be taken to avoid extravasation during injection as the high pH of fluorescein solution can result in severe local tissue damage. The following complications resulting from extravasation of fluorescein have been noted to occur: sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. When significant extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissues and to relieve pain should be implemented. Do not mix or dilute with other solutions or drugs in syringe. Flush intravenous cannulas before and after drugs are injected to avoid physical incompatibility reactions. Rare cases of death due to anaphylaxis have been reported (See PRECAUTIONS).

PRECAUTIONS

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 accident.

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 immediately.

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.

Pediatric Use

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 carcinogenic potential.

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 during pregnancy.

Nursing Mothers

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.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Patient Warning

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.

REFERENCE

1. Schatz, Burton, Yannuzzi, Rabb. Interpretation of Fundus Fluorescein Angiography, p. 38, C.V. Mosby Co., St. Louis, MO, 1978

Last reviewed on RxList: 9/23/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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