FLURESS- 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:

Akorn, Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For procedures requiring a disclosing agent in combination with an anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures. Known hypersensitivity to any component of this product.

Product summary:

Fluress® is supplied as 5 mL contained in a 10 mL plastic dropper bottle with a separate sterile dropper applicator. (NDC 17478-640-10)

Authorization status:

unapproved drug other

Summary of Product characteristics

FLURESS- FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE SOLUTION/
DROPS
AKORN, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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FLURESS
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution,
USP
(0.25%/0.4%)
RX ONLY Sterile
DESCRIPTION:
Fluress
(Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution,
USP) is a sterile
ophthalmic solution combining a disclosing agent with an anesthetic
agent.
Fluorescein sodium is a disclosing agent with molecular formula C
H Na O , molecular weight
376.28, and chemical structure:
CHEMICAL NAME:
Spiro[isobenzofuran-1 (3_H_), 9'-[9_H_]xanthene]-3-one.
3'6'-dihydroxy, Disodium salt
Benoxinate Hydrochloride is an anesthetic agent with molecular formula
C17H28N2O3•HCl, molecular
weight 344.88, and chemical structure:
CHEMICAL NAME:
Benzoic acid, 4-amino-3-butoxyl-,2-(diethylamino) ethyl ester,
monohydrochloride
®
®
20
10
2
5
EACH ML CONTAINS:
ACTIVES: Benoxinate Hydrochloride 4 mg (0.4%). Fluorescein Sodium 2.5
mg (0.25%).
PRESERVATIVE: Chlorobutanol 10 mg (1%).
INACTIVES: Boric Acid, Povidone, Sodium Hydroxide and/or Hydrochloric
Acid may be added to adjust
pH (4.3 to 5.3), and Purified Water USP.
CLINICAL PHARMACOLOGY:
Fluress
is the combination of a disclosing agent with a rapidly acting
anesthetic agent of short
duration.
INDICATIONS AND USAGE:
For procedures requiring a disclosing agent in combination with an
anesthetic agent such as tonometry,
gonioscopy, removal of corneal foreign bodies and other short corneal
or conjunctival procedures.
CONTRAINDICATIONS:
Known hypersensitivity to any component of this product.
WARNINGS:
NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY.
Prolonged use of a topical ocular anesthetic is not recommended. It
may produce permanent corneal
opacification with accompanying visual loss.
KEEP OUT OF REACH OF CHILDREN.
PRECAUTIONS:
Fluress
(Fluorescein Sodium and Benoxi