ALTAFLUOR- fluorescein sodium and benoxinate hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENOXINATE HYDROCHLORIDE (UNII: 0VE4U49K15) (BENOXINATE - UNII:AXQ0JYM303), FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR)

Available from:

Altaire Pharmaceuticals Inc.

INN (International Name):

BENOXINATE HYDROCHLORIDE

Composition:

BENOXINATE HYDROCHLORIDE 4 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. Altafluor Benox is contraindicated in patients with known hypersensitivity to any component of this product. Risk Summary   There are no available data on the use of Altafluor Benox in pregnant women to inform any drug associated risk. Adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. Altafluor Benox should be given to a pregnant woman only if clearly needed. Risk Summary    There are no data on the presence of fluorescein sodium or benoxinate hydrochloride in human milk after ocular administration of Altafluor Benox, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Altafluor Benox a

Product summary:

Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a sterile, yellow to orange-red solution supplied in a 5 mL glass bottle with a sterilized dropper. NDC #59390-218-05 Storage : Store in refrigerator at 2° to 8°C (36° to 46°F).  After opening, Altafluor Benox can be stored up to one month if stored at room temperature or until the expiration date on the bottle if stored in refrigerated conditions. Keep tightly closed.

Authorization status:

New Drug Application

Summary of Product characteristics

ALTAFLUOR- FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE SOLUTION
ALTAIRE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALTAFLUOR BENOX SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ALTAFLUOR BENOX.
ALTAFLUOR BENOX (FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE
OPHTHALMIC SOLUTION) 0.25%/0.4% FOR
TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
Altafluor Benox (fluorescein sodium and benoxinate hydrochloride
ophthalmic solution) 0.25%/0.4% is a combination
disclosing agent and local ester anesthetic indicated for procedures
requiring a disclosing agent in combination with a
topical ophthalmic anesthetic. (1)
DOSAGE AND ADMINISTRATION
Instill 1 to 2 drops topically in the eye as needed to achieve
adequate anesthesia. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing fluorescein sodium 2.5 mg/mL (0.25%)
and benoxinate hydrochloride 4 mg/mL (0.4%). (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of this product. (4)
WARNINGS AND PRECAUTIONS
Corneal toxicity: Prolonged use or abuse may lead to corneal
epithelial toxicity and manifest as epithelial defects which
may progress to permanent corneal damage. (5.1)
Corneal injury: Patients should not touch the eye for approximately 20
minutes after using anesthetic as accidental
injuries can occur due to insensitivity of the eye. (5.2)
ADVERSE REACTIONS
The most common ocular adverse events are: stinging, burning and
conjunctival redness. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALTAIRE
PHARMACEUTICALS, INC., AT 1-800-258-2471 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS:
4 CONTRAINDICATIONS:
5 WARNINGS AND PRECAUTIONS
5.1 CORNEAL TOXICITY
5.2 CORNEAL INJURY DUE TO INSENSITIVITY
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIO