NDC 42254-023 Flurbiprofen Sodium

NDC Product Code 42254-023

NDC CODE: 42254-023

Proprietary Name: Flurbiprofen Sodium What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used before certain types of eye surgery (such as cataract removal). It prevents the pupil of the eye from narrowing. This effect makes it easier for the doctor to examine the inside of the eye, to remove the cataract, and to replace it with a new lens. Flurbiprofen belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs).

NDC Code Structure

  • 42254 - Rebel Distributors Corp

NDC 42254-023-25

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 2.5 mL in 1 BOTTLE, DROPPER

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Flurbiprofen Sodium with NDC 42254-023 is a product labeled by Rebel Distributors Corp. The generic name of Flurbiprofen Sodium is . The product's dosage form is and is administered via form.

Labeler Name: Rebel Distributors Corp

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • THIMEROSAL (UNII: 2225PI3MOV)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rebel Distributors Corp
Labeler Code: 42254
Start Marketing Date: 05-29-1997 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Flurbiprofen Ophthalmic

Flurbiprofen Ophthalmic is pronounced as (flur'' bi proe' fen)

Why is flurbiprofen ophthalmic medication prescribed?
Flurbiprofen ophthalmic is used to prevent or reduce changes in the eye that may occur during eye surgery. Flurbiprofen ophthalmic is in a class of medications called non...
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Flurbiprofen Sodium Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Sterile

Pregnancy category C. Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg (approximately 333 times the human daily topical dose) and above.

Description

Flurbiprofen sodium ophthalmic solution, USP 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use. Chemical Name: Sodium (±)-2-(2-fluoro-4-biphenylyl)-propionate dihydrate. Structural Formula:Contains: Active: flurbiprofen sodium 0.03% (0.3mg/mL). Preservative: thimerosal 0.005%. Inactives: citric acid; edetate disodium; polyvinyl alcohol 1.4%; potassium chloride; purified water; sodium chloride; and sodium citrate. May also contain hydrochloric acid and/or sodium hydroxide to adjust the pH. The pH of flurbiprofen sodium ophthalmic solution 0.03% is 6.0 to 7.0. It has an osmolality of 260 - 330 mOsm/kg.

Clinical Pharmacology

Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, flurbiprofen sodium ophthalmic solution 0.03% has been shown to inhibit the miosis induced during the course of cataract surgery. Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure.

Indications And Usage

Flurbiprofen sodium ophthalmic solution 0.03% is indicated for the inhibition of intraoperative miosis.

Contraindications

Flurbiprofen sodium ophthalmic solution 0.03% is contraindicated in individuals who are hypersensitive to any components of the medication.

Warnings

With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thrombocyte aggregation. There have been reports that flurbiprofen sodium ophthalmic solution 0.03% may cause increased bleeding of ocular tissues including hyphemas in conjunction with ocular surgery. There exists the potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

General Precautions

General: Wound healing may be delayed with the use of flurbiprofen sodium ophthalmic solution 0.03%. It is recommended that flurbiprofen sodium ophthalmic solution 0.03% be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

Drug Interactions

Drug interactions: Interaction of flurbiprofen sodium ophthalmic solution 0.03% with other topical ophthalmic medications has not been fully investigated. Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with flurbiprofen sodium ophthalmic solution 0.03%.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Carcinogenesis, Mutagenesis, Impairment of fertility: Long-term studies in mice and/or rats have shown no evidence of carcinogenicity with flurbiprofen. Long-term mutagenicity studies in animals have not been performed.

Pregnancy

Pregnancy:

Nursing Mothers

Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from flurbiprofen sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

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

Adverse Reactions

Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of flurbiprofen sodium ophthalmic solution 0.03%. Other adverse reactions reported with the use of flurbiprofen sodium ophthalmic solution 0.03% include: fibrosis, miosis, and mydriasis. Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported.

Overdosage

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

Dosage And Administration

A total of four (4) drops of flurbiprofen sodium ophthalmic solution 0.03% should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.

How Supplied

Flurbiprofen sodium ophthalmic solution, USP is available for topical ophthalmic administration as a 0.03% sterile solution, and is supplied in a white opaque low density polyethylene bottle with a controlled dropper tip and a gray high impact polystyrene cap in the following size: 2.5 mL in 5 mL bottle - NDC 42254-023-25 Note: Store at 15°-25°C (59°-77°F). Rx OnlyRevised January 2004 © 2004 PACIFIC PHARMAIrvine, CA 92612, U.S.A. 71587PY11P Relabeled by:Rebel Distributors CorpThousand Oaks, CA 91320

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