ALTAFLUOR

Main information

  • Trade name:
  • ALTAFLUOR- fluorescein sodium and benoxinate hydrochloride solution
  • Composition:
  • BENOXINATE HYDROCHLORIDE 4 mg in 1 mL
  • Administration route:
  • OPHTHALMIC
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALTAFLUOR- fluorescein sodium and benoxinate hydrochloride solution
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • 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. Known hypersensitivity to any component of this product.   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. Caution should be exercised when Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is administered to a nursing woman. Safety and effectiveness in pediatric patients have not been established.
  • Product summary:
  • 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.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • unapproved drug other
  • Authorization number:
  • 59390-206-05
  • Last update:
  • 14-06-2019

Summary of Product characteristics: dosage, interactions, side effects

ALTAFLUOR- fluorescein sodium and benoxinate hydrochloride solution

Altaire Pharmaceuticals 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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ALTAFLUOR

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

H Na O

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

H N O · 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

ALTAFLUOR

Fluorescein Sodium and

Benoxinate Hydrochloride

Ophthalmic Solution, USP

0.25%/0.4%

(Sterile)

ALTAFLUOR

fluorescein sodium and benoxinate hydrochloride solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 39 0 -20 6

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENO XINATE HYDRO CHLO RIDE (UNII: 0 VE4U49 K15) (BENOXINATE -

UNII:AXQ0 JYM30 3)

BENOXINATE

HYDROCHLORIDE

4 mg in 1 mL

FLUO RESCEIN SO DIUM (UNII: 9 3X55PE38 X) (FLUORESCEIN - UNII:TPY0 9 G7XIR)

FLUORESCEIN

2.5 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PO VIDO NES (UNII: FZ9 8 9 GH9 4E)

BO RIC ACID (UNII: R57ZHV8 5D4)

Altaire Pharmaceuticals Inc.

WATER (UNII: 0 59 QF0 KO0 R)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

CHLO RO BUTANO L (UNII: HM4YQM8 WRC)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:59 39 0 -20 6 -

5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

UNAPPROVED DRUG OTHER

0 6 /21/20 0 0

Labeler -

Altaire Pharmaceuticals Inc. (786790378)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Altaire Pharmaceuticals, Inc.

78 6 79 0 378

MANUFACTURE(59 39 0 -20 6 )

Revised: 9/2015