These highlights do not include all the information needed to use Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% safely and effectively. See full prescribing information for Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4%. FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.25%/0.4% (STERILE) Initial U.S. Approval: 2017

ALTAFLUOR by

Drug Labeling and Warnings

ALTAFLUOR by is a Prescription medication manufactured, distributed, or labeled by Altaire Pharmaceuticals Inc., Altaire Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALTAFLUOR- fluorescein sodium and benoxinate hydrochloride solution 
Altaire Pharmaceuticals Inc.

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FULL PRESCRIBING INFORMATION

1.       INDICATIONS AND USAGE:

For procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.

2.       DOSAGE AND ADMINISTRATION:

Usual Dosage: Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating.

Deep Ophthalmic Anesthesia: Two drops in each eye at 90 second intervals for three instillations.

Note: Because the “blink” reflex is temporarily eliminated, it is suggested that the eye be covered with a patch following this procedure.

3.       DOSAGE FORMS AND STRENGTHS:

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is a yellow to orange-red mobile solution (strongly fluorescent) containing Fluorescein Sodium 0.25% and Benoxinate Hydrochloride 0.4%.

4.       CONTRAINDICATIONS:

Known hypersensitivity to any component of this product.

5.       WARNINGS AND PRECAUTIONS

5.1       Topical Ophthalmic Use Only

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is not indicated for injection.

5.2       Avoid Prolonged Use

Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

5.3       Use Sparingly

This product should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism.

5.4       Long Term Toxicity

The long-term toxicity is unknown; prolonged use may possibly delay wound healing.

5.5       Systemic Toxicity

Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity manifested by central nervous system stimulation followed by depression may occur. Anaphylactic reactions have been reported with ocular administration of fluorescein although they more frequently occur with intravenous administration of fluorescein.

5.6       Protection of Eye During Anesthesia

Protection of the eye from irritation, chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Patients should be advised to avoid touching the eye until the anesthesia has worn off.

5.7       Interaction with Tonometer Cleaning Agents

Tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use.

6.       ADVERSE REACTIONS:

Occasional temporary stinging, burning and conjunctival redness have been reported after use of ocular anesthetics, as well as a rare, severe, immediate-type, apparent hyper-allergic corneal reaction, with acute, intense and diffuse epithelial keratitis, a gray ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and sometimes, iritis with descemetitis. Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.

8.       USE IN SPECIFIC POPULATIONS

8.1       Pregnancy:

Risk Summary: Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution is not absorbed systemically following ophthalmic administration, and maternal use is not expected to result in fetal exposure to the drug. There are no human data that establish the presence or absence of drug-associated risk.  

8.2       Lactation:

Risk Summary:  Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution is not absorbed systemically by the mother following ophthalmic administration, and breastfeeding is not expected to result in exposure of the child to Fluorescein Sodium and Benoxinate Hydrochloride. There are no data that assess the effects of the drugs and/or their active metabolite(s) on the breastfed child.   

8.4       Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

11.       DESCRIPTION

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is a disclosing agent with rapid anesthetic action of short duration.

Fluorescein Sodium is represented by the following structural formula.

     

     

C20H10Na2O5                                                   Mol. Wt. 376.27

Chemical Name: Spiro [isobenzofuran-1 (3H),9’-9[9H] xanthene]-3-one, 3’,6’ dihydroxy, disodium salt.

Benoxinate Hydrochloride is represented by the following structural formula:

     

C17H28N2O3 HCl                                                 Mol. Wt. 344.88

Chemical Name: 2-(Diethylamino) etyl 4-amino-3butoxybenzoate monohydrochloride.

EACH mL CONTAINS: ACTIVES: Fluorescein Sodium 2.5 mg (0.25%), Benoxinate Hydrochloride 4 mg (0.4%); INACTIVES: Povidone, Boric Acid, Water for Injection. Hydrochloric Acid may be added to adjust pH (4.3 – 5.3). PRESERVATIVE: Chlorobutanol 1.1%.

12.       CLINICAL PHARMACOLOGY

This product is the combination of a disclosing agent with a rapidly acting anesthetic of short duration.

16.       HOW SUPPLIED/STORAGE AND HANDLING:

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is supplied in a glass bottled with a sterilized dropper in the following size: 5mL

Storage: Store in refrigerator at 2°-8°C (36°-46°F).  Can be stored at room temperature for up to 1 month. Keep tightly closed.

17.       PATIENT COUNSELING INFORMATION

Protection of the eye from irritation, chemicals, foreign bodies and rubbing during the period of anesthesia is very important.

Patients should be advised to avoid touching the eye until the anesthesia has worn off.

DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR MISSING

KEEP OUT OF REACH OF CHILDREN

     

FOR USE IN THE EYES ONLY

Rev. 02/2017                                    

Manufactured by:
ALTAIRE Pharmaceuticals, Inc.
Aquebogue, NY 11931

PRINCIPAL DISPLAY PANEL

ALTAFLUOR
Fluorescein Sodium and
Benoxinate Hydrochloride
Ophthalmic Solution, USP 
0.25%/0.4%
(Sterile)
5 mL
Rx Only

ALTAFLUOR 
fluorescein sodium and benoxinate hydrochloride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59390-206
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENOXINATE HYDROCHLORIDE (UNII: 0VE4U49K15) (BENOXINATE - UNII:AXQ0JYM303)	BENOXINATE HYDROCHLORIDE	4 mg  in 1 mL
FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR)	FLUORESCEIN	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
CHLOROBUTANOL (UNII: HM4YQM8WRC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59390-206-05	5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/01/2017	04/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA208582	01/01/2017	04/19/2018

Labeler - Altaire Pharmaceuticals Inc. (786790378)

Establishment
Name	Address	ID/FEI	Business Operations
Altaire Pharmaceuticals, Inc.		786790378	MANUFACTURE(59390-206)

Revised: 2/2017

Document Id: 00ccefd8-c305-40ed-812e-de93048c9dad

34391-3

Set id: 36009e1e-4b69-4cb0-bd3a-3c6115c1fcf9

Version: 8

Effective Time: 20170204