Altafluor

Fluorescein Sodium And Benoxinate Hydrochloride

Altaire Pharmaceuticals Inc.
Human Prescription Drug
NDC 59390-218

Altafluor also known as Fluorescein Sodium And Benoxinate Hydrochloride is a human prescription drug labeled by 'Altaire Pharmaceuticals Inc.'. National Drug Code (NDC) number for Altafluor is 59390-218. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Altafluor drug includes Benoxinate Hydrochloride - 4 mg/mL Fluorescein Sodium - 2.5 mg/mL . The currest status of Altafluor drug is Active.

Drug Information:

Drug NDC:	59390-218
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Altafluor
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Fluorescein Sodium And Benoxinate Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Altaire Pharmaceuticals Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	BENOXINATE HYDROCHLORIDE - 4 mg/mL FLUORESCEIN SODIUM - 2.5 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	OPHTHALMIC
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	01 Mar, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	NDA208582
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Altaire Pharmaceuticals Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2099132 2099522
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	0VE4U49K15 93X55PE38X
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Diagnostic Dye [EPC] Dyes [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
59390-218-05	5 mL in 1 BOTTLE, DROPPER (59390-218-05)	01 Mar, 2018	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Altafluor

Fluorescein Sodium And Benoxinate Hydrochloride

Solution
Altaire Pharmaceuticals Inc.
NDC: 59390-218

Product Elements:

Altafluor fluorescein sodium and benoxinate hydrochloride fluorescein sodium fluorescein benoxinate hydrochloride benoxinate chlorobutanol povidone hydrochloric acid boric acid sodium hydroxide water

Indications and Usage:

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. 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 )

Warnings and Cautions:

5 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 ) 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.

Dosage and Administration:

2 dosage and administration instill 1 to 2 drops of altafluor benox in the eye as needed. instill 1 to 2 drops topically in the eye as needed to achieve adequate anesthesia. ( 2 )

Dosage Forms and Strength:

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%). ophthalmic solution containing fluorescein sodium 2.5 mg/ml (0.25%) and benoxinate hydrochloride 4 mg/ml (0.4%). ( 3 )

Contraindications:

4 contraindications: altafluor benox is contraindicated in patients with known hypersensitivity to any component of this product. known hypersensitivity to any component of this product. ( 4 )

Adverse Reactions:

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. 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.

Use in Specific Population:

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 motherâs 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 Read more...

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.

Use in Pregnancy:

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.

Pediatric Use:

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.

Geriatric Use:

8.5 geriatric use no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Description:

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: c 20 h 10 na 2 o 5 mol. wt. 376.27 chemical name: spiro [isobenzofuran-1 (3 h ),9â-9[9 h ] xanthene]-3-one, 3â,6â dihydroxy, disodium salt. benoxinate hydrochloride is represented by the following structural formula: c 17 h 28 n 2 o 3 â¢ 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 â 5.3). preservative: chlorobutanol 11mg (1.1%). 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. benoxinate hydrochloride is represented by the following structural formula:

Clinical Pharmacology:

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.

Pharmacodynamics:

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.

Nonclinical Toxicology:

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.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

13.1 carcinogenesis, mutagenesis, impairment of fertility long-term studies to evaluate the carcinogenic potential of altafluor benox have not been conducted.

Clinical Studies:

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.

How Supplied:

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 2Â° to 8Â°c (36Â° to 46Â°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.

Information for Patients:

17 patient counseling information accidental injury precaution 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

Package Label Principal Display Panel:

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 ndc 59390-218-05 altafluor benox fluorescein sodium and benoxinate hydrochloride ophthalmic solution, usp 0.25%/0.4% (sterile) 5 ml rx only

Comments/ Reviews:

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