FOR INTRAVENOUS USE

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 tissue and to relieve pain should be implemented. Rare cases of death due to anaphylaxis have been reported (See PRECAUTIONS).

General

Caution is to be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should be available in the event of possible reaction to FLUORESCITE® (fluorescein) Injection 10%. Use only if the container is undamaged.

Laboratory Information

If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. Fluorescein sodium should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Fluorescein sodium has been demonstrated to be excreted in human milk. Caution should be exercised when fluorescein sodium is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have been established.

Geriatric Use

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

Last reviewed on RxList: 10/7/2008
This monograph has been modified to include the generic and brand name in many instances.