AK-FLUOR- fluorescein sodium injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

fluorescein sodium (UNII: 93X55PE38X) (fluorescein - UNII:TPY09G7XIR)

Available from:

Akorn

INN (International Name):

fluorescein sodium

Composition:

fluorescein sodium 100 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. AK-FLUOR® is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported [see Warnings and Precautions (5.1) and Adverse Reactions (6.2) ]. 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. 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 patients have been included in clinical studies. No overall differences in safety or effectiveness have been observed between pediatric and adult patient

Product summary:

AK-FLUOR® (fluorescein injection, USP) 10% is supplied in a single-dose 5 mL glass vial with a gray bromobutyl serum siliconized stopper and orange flip-off cap. It contains a sterile dark reddish orange solution of fluorescein sodium. (NDC 17478-253-10) 5 mL, single dose vials in a package of 12. AK-FLUOR® (fluorescein injection, USP) 25% is supplied in a single-dose 2 mL glass vial with a gray bromobutyl serum siliconized stopper and orange flip-off cap. It contains a sterile dark reddish orange solution of fluorescein sodium. (NDC 17478-250-20) 2 mL, single dose vials in a package of 12. AK-FLUOR® should be stored at 20° to 25°C (68° to 77°F). Do not freeze.

Authorization status:

New Drug Application

Summary of Product characteristics

AK-FLUOR- FLUORESCEIN SODIUM INJECTION
AKORN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AK-FLUOR 10% AND AK-
FLUOR 25% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
THE PRODUCTS IN AK-
FLUOR 10% AND AK-FLUOR 25%.
AK-FLUOR (FLUORESCEIN INJECTION, USP) 10% AND AK-FLUOR (FLUORESCEIN
INJECTION, USP)
25%
INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 1976
INDICATIONS AND USAGE
AK-FLUOR
is indicated in diagnostic fluorescein angiography or angioscopy of
the retina and iris
vasculature. (1)
DOSAGE AND ADMINISTRATION
The normal adult dose of AK-FLUOR
10% is 5 mL (500 mg) and of AK-FLUOR
25% is 2 mL (500 mg)
via intravenous administration. (2.1)
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)
Do not mix or dilute with other solutions or drugs. (2.2)
DOSAGE FORMS AND STRENGTHS
AK-FLUOR (fluorescein injection, USP) 10%, 100 mg/mL in a 5 mL single
dose vial (3)
AK-FLUOR (fluorescein injection, USP) 25%, 250 mg/mL in a 2 mL single
dose vial (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this product. (4.1)
WARNINGS AND PRECAUTIONS
Respiratory reactions.(5.1)
Severe local tissue damage. (5.2)
ADVERSE REACTIONS
The most common adverse reactions include skin discoloration, urine
discoloration, nausea, vomiting, and
gastrointestinal distress. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AKORN OPERATING COMPANY
LLC AT 1-
800-932-5676 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH (6)
USE IN SPECIFIC POPULATIONS
Caution should be exercised when fluorescein sodium is administered to
a nursing woman. (8.3)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing
2.2 Preparation for Administration
2.3 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
®
®
®
®
®
®
®
®
®
®
®
4.1 Hypersensitivity
5 WARNINGS AND PRECAUTIONS
5.