Fluorescein

Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

• The normal adult dose of Fluorescein Injection 10%, is 5 mL (500 mg) and of Fluorescein Injection 25%, is 2 mL (500 mg) via intravenous administration. (
  2.1 Dosing

  Adult Dose

  The recommended dosage of Fluorescein Injection 10% (100 mg/mL) and of Fluorescein Injection 25% (250 mg/mL) is 500 mg via intravenous administration.

  Pediatric Dose

  For children, the dose is 7.7 mg/kg (actual body weight) up to a maximum of 500 mg, via intravenous infusion calculated on the basis of 35 mg for each 10 lbs. (4.54 kg) of body weight.
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• For children, the dose should be calculated on the basis of 35 mg for each ten pounds of body weight (7.7 mg/kg body weight). (
  2.2 Preparation for Administration

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not mix or dilute with other solutions or drugs. Discard unused portion.
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• Do not mix or dilute with other solutions or drugs. (
  2.2 Preparation for Administration

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not mix or dilute with other solutions or drugs. Discard unused portion.
  )

Fluorescein Injection 10%, 100 mg/mL in a 5 mL single-dose vial.

Fluorescein Injection 25%, 250 mg/mL in a 2 mL single-dose vial.

Caution should be exercised when fluorescein sodium is administered to a nursing woman. (

• Respiratory reactions. (
  5.1 Respiratory Reactions

  Caution should be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should always be available.

  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.
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• Severe local tissue damage. (
  5.2 Severe local tissue damage

  Extravasation during injection can result in severe local tissue damage due to high pH of fluorescein solution. 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 nerve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. When extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented.

  [see ADMINISTRATION and ADVERSE REACTIONS ]

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