ALTAFLUOR- fluorescein sodium and benoxinate hydrochloride solution
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Patient Information

Accidental InjuryPrecaution

Advise patients not to touch their eyes for approximately 20 minutes after application. Their eyes will be insensitive due to the effect of the anesthetic, and care should be taken to avoid accidental injuries.

Rev. 12/2017

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

1. No Title 1572547182
2. No Title 1572450405
3. Description:
4. Clinical Pharmacology:
5. Indications And Usage:
6. Contraindications:
7. Warnings:
8. Precautions:
9. Adverse Reactions:
10. Use In Specific Populations
11. Dosage And Administration:
12. How Supplied:
13. Storage:
14. Principal Display Panel
15. Highlights Of Prescribing Information
16. Indications And Usage
17. Dosage And Administration
18. Dosage Forms And Strengths
19. Contraindications
20. Warnings And Precautions
21. Adverse Reactions
22. 5 Warnings And Precautions
23. 8 Use In Specific Populations
24. 12. Clinical Pharmacology
25. 13 Nonclinical Toxicology
26. 1 Indications And Usage
27. 2 Dosage And Administration
28. 3 Dosage Forms And Strengths:
29. 4 Contraindications:
30. 5 Warnings And Precautions
31. 6 Adverse Reactions
32. 8 Use In Specific Populations
33. 11 Description
34. 12. Clinical Pharmacology
35. 13 Nonclinical Toxicology
36. 14 Clinical Studies
37. 16 How Supplied/storage And Handling

No Title 1572547182 ⮝

ALTAFLUOR

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP 0.25%/0.4% (Sterile)

Rx Only

For Use in the Eyes Only

No Title 1572450405 ⮝

ALTAFLUOR

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP 0.25%/0.4% (Sterile)

Rx Only

For Use in the Eyes Only

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:

Mol. Wt.= 376.27
C20H10Na2O5

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

Benoxinate Hydrochloride is represented by the following structural formula:

Mol. Wt.= 344.88
C17H28N2O3 HCl

Chemical Name: 2-(Diethylamino) ethyl 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%.

Clinical Pharmacology: ⮝

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

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.

Contraindications:  ⮝

Known hypersensitivity to any component of this product.

Warnings:  ⮝

Not for Injection. Topical Use Only. Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss. Avoid contamination-do not touch tip of sterile dropper used to dispense solution to any surface. Replace container closure immediately after using.

Precautions:  ⮝

This product should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. The long-term toxicity is unknown; prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity manifested by central nervous systems stimulation followed by depression may occur. Protection of the eye from irritation, chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Patients should be advised to avoid touching the eye until the anesthesia has worn off.

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.

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.

Use In Specific Populations ⮝

Pregnancy: Pregnancy Category C.

Animal reproductive studies have not been conducted with Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4%. It is also not known whether Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

Caution should be exercised when Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

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.

How Supplied:  ⮝

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

Storage:  ⮝

Store in a refrigerator at 2 -8 C (36 -46 F), can be stored at room temperature for up to 1 month. Keep tightly closed.

FOR USE IN THE EYES ONLY.

DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR MISSING.
KEEP OUT OF REACH OF CHILDREN

Rev. 05/2014
MG #15857

Manufactured by:
[LOGO]
ALTAIRE PHARMACEUTICALS, INC.
Aquebogue, NY 11931 USA

Principal Display Panel ⮝

NDC 59390-218-05
ALTAFLUOR
BENOX
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:59390-218 Route of Administration OPHTHALMIC

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

Inactive Ingredients Ingredient Name Strength CHLOROBUTANOL (UNII: HM4YQM8WRC) 11 mg in 1 mL POVIDONE (UNII: FZ989GH94E) HYDROCHLORIC ACID (UNII: QTT17582CB) BORIC ACID (UNII: R57ZHV85D4) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59390-218-05 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/01/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208582 03/01/2018

Labeler - Altaire Pharmaceuticals Inc. (786790378)

Revised: 12/2017 Document Id: f4e52f2c-44bf-44b1-9cf6-99621018fd46 34391-3 Set id: 54017304-e680-4129-b52a-69cb9810af76 Version: 2 Effective Time: 20171230 Altaire Pharmaceuticals Inc.

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

5 Warnings And Precautions ⮝

5.1 Corneal Toxicity

5.2 Corneal Injury Due to Insensitivity

8 Use In Specific Populations ⮝

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

12. Clinical Pharmacology ⮝

12.2 Pharmacodynamics

13 Nonclinical Toxicology ⮝

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

1 Indications And Usage  ⮝

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.

2 Dosage And Administration  ⮝

Instill 1 to 2 drops of Altafluor Benox in the eye as needed.

3 Dosage Forms And Strengths:  ⮝

Altafluor Benox is a yellow to orange-red ophthalmic solution containing fluorescein sodium 2.5 mg/mL (0.25%) and benoxinate hydrochloride 4 mg/mL (0.4%).

4 Contraindications:  ⮝

Altafluor Benox is contraindicated in patients with known hypersensitivity to any component of this product.

5 Warnings And Precautions  ⮝

5.1 Corneal Toxicity

Prolonged use or abuse may lead to corneal epithelial toxicity which may manifest as epithelial defects and progress to permanent corneal opacification with accompanying visual loss.

5.2 Corneal Injury Due to Insensitivity

Patient should not touch the eye for approximately 20 minutes after using this anesthetic as accidental injuries can occur due to insensitivity of the eye.

6 Adverse Reactions  ⮝

The following ocular adverse reactions are described elsewhere in the labeling:

• Corneal Toxicity [see Warnings and Precautions (5.1)]
  
• Corneal Injury due to Insensitivity [see Warnings and Precautions (5.2)]

The following adverse reactions have been identified following use of fluorescein sodium and benoxinate hydrochloride ophthalmic solution 0.25% / 0.4%: ocular hyperemia, burning, stinging, eye irritation, blurred vision and punctate keratitis. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

8 Use In Specific Populations  ⮝

8.1 Pregnancy

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.

8.2 Lactation

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 and any potential adverse effects on the breastfed infant from Altafluor Benox.

8.4 Pediatric Use

The safety and effectiveness of Altafluor Benox have been established for pediatric patients. Use of Altafluor Benox is supported in pediatric patients by evidence from adequate and well controlled studies.

8.5 Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

11 Description  ⮝

Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a sterile disclosing agent in combination with a short-acting ester anesthetic for topical ophthalmic use.

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-3-butoxybenzoate monohydrochloride.

Each mL contains: Actives: fluorescein sodium 2.5 mg (0.25%) equivalent to fluorescein 2.2 mg (0.22%), benoxinate hydrochloride 4 mg (0.4%) equivalent to benoxinate 3.6 mg (0.36%); Inactives: povidone, hydrochloric acid, boric acid, sodium hydroxide, water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.3 5.3). Preservative: chlorobutanol 11mg (1.1%).

12. Clinical Pharmacology  ⮝

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

12.2 Pharmacodynamics

Maximal corneal anesthesia usually occurs in about 5-45 seconds and lasts about 20 minutes after single administration. The anesthetic effect may be extended by subsequent administration 10-20 minutes after the last administration.

13 Nonclinical Toxicology  ⮝

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of Altafluor Benox have not been conducted.

14 Clinical Studies  ⮝

Controlled clinical studies in adults and pediatric patients have demonstrated that topical administration of fluorescein sodium and benoxinate hydrochloride ophthalmic solution 0.25%/0.4% enables visualization and corneal anesthesia sufficient to enable applanation tonometry, tear fluid dynamics evaluation and short conjunctival and corneal procedures. Maximal corneal anesthesia usually occurs in about 5-45 seconds and lasts about 20 minutes after single administration.

16 How Supplied/storage And Handling  ⮝

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.