FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Oceanside Pharmaceuticals

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is contraindicated in patients with known hypersensitivity to any component of this product. Risk Summary There are no available data on the use of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% in pregnant women to inform any drug associated risk. Adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% 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 Fluorescein Sodium and Beno

Product summary:

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is supplied as a sterile, aqueous, topical ophthalmic solution with a fill volume of 5 mL in a 6 mL amber glass bottle and a black polypropylene cap with a sterilized rubber dropper bulb and glass pipette. NDC 68682-732-05 Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. After opening, 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 Authorized Generic

Summary of Product characteristics

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE- FLUORESCEIN
SODIUM AND BENOXINATE HYDROCHLORIDE SOLUTION/ DROPS
OCEANSIDE PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUORESCEIN SODIUM
AND BENOXINATE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.3%/0.4% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUORESCEIN SODIUM
AND BENOXINATE
HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.3%/0.4%.
FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE OPHTHALMIC SOLUTION,
0.3%/0.4%, FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution,
0.3%/0.4% is a combination of
fluorescein sodium, a disclosing agent and benoxinate hydrochloride, a
local ester anesthetic indicated for
procedures in adult and pediatric patients 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 2.6 mg/mL (0.3%) and
benoxinate hydrochloride 4.4
mg/mL (0.4%). (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of this product. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common ocular adverse events are: stinging, burning and
conjunctival redness. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT OCEANSIDE
PHARMACEUTICALS AT 1-800-
321-4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2020
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 POPULATIONS
8.1 Pregnancy
Corneal Toxicity: Prolonged use or abuse may lead to corneal
epithelial toxicity and manifest as
epithelial