Flurbiprofen Sodium
Amici Pharmaceuticals Llc
Human Prescription Drug
NDC 69292-722Flurbiprofen Sodium is a human prescription drug labeled by 'Amici Pharmaceuticals Llc'. National Drug Code (NDC) number for Flurbiprofen Sodium is 69292-722. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Flurbiprofen Sodium drug includes Flurbiprofen Sodium - .3 mg/mL . The currest status of Flurbiprofen Sodium drug is Active.
Drug Information:
| Drug NDC: | 69292-722 |
| 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: | Flurbiprofen Sodium |
| 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: | Flurbiprofen Sodium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Amici Pharmaceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| 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: | FLURBIPROFEN SODIUM - .3 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: | ANDA |
| 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: | 31 Mar, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 2026 |
| 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: | ANDA074447 |
| 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: | AMICI PHARMACEUTICALS LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1243585
|
| 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: | Z5B97MU9K4
|
| 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: | Anti-Inflammatory Agents
Non-Steroidal [CS]
Cyclooxygenase Inhibitors [MoA]
Nonsteroidal Anti-inflammatory Drug [EPC]
|
| 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 |
|---|
| 69292-722-25 | 1 BOTTLE, DROPPER in 1 CARTON (69292-722-25) / 2.5 mL in 1 BOTTLE, DROPPER | 31 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. |
Product Elements:
Flurbiprofen sodium flurbiprofen sodium flurbiprofen sodium flurbiprofen citric acid monohydrate edetate disodium hydrochloric acid potassium chloride water sodium chloride sodium citrate, unspecified form sodium hydroxide thimerosal polyvinyl alcohol (100000 mw)
Drug Interactions:
Drug interactions: interaction of flurbiprofen sodium ophthalmic solution 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.
Indications and Usage:
Indications and usage flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.
Warnings:
Warnings with some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. there have been reports that flurbiprofen sodium ophthalmic solution may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. there is 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: topical nonsteroidal anti-inflammatory drugs (nsaids) may slow or delay healing. topical corticosteroids are also known to slow or delay healing. concomitant use of topical nsaids and topical steroids may increase the potential for healing problems. it is recommended that flurbiprofen sodium ophthalmic solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
Dosage and Administration:
Dosage and administration a total of four (4) drops of flurbiprofen sodium ophthalmic solution should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.
Contraindications:
Contraindications flurbiprofen sodium ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of the medication.
Adverse Reactions:
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. other adverse reactions reported with the use of flurbiprofen sodium ophthalmic solution include: fibrosis, hyphema, miosis, mydriasis, and ocular hyperemia. increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported (see warnings ). to report suspected adverse reactions, contact bausch + lomb, a division of valeant pharmaceuticals north america llc, at 1-800-321-4576 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Drug Interactions:
Drug interactions: interaction of flurbiprofen sodium ophthalmic solution 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.
Use in Pregnancy:
Pregnancy: 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 300 times the human daily topical dose) and above. there are no adequate and well-controlled studies in pregnant women. flurbiprofen sodium ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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.
Overdosage:
Overdosage overdosage will not ordinarily cause acute problems. if accidentally ingested, drink fluids to dilute.
Description:
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: c 15 h 12 fnao 2 â¢2h 2 o mol. wt. 302.27 each ml contains: active: flurbiprofen sodium 0.03%. inactives: citric acid, edetate disodium, polyvinyl alcohol 1.4%, potassium chloride, purified water, sodium chloride, sodium citrate. hydrochloric acid and/or sodium hydroxide may be added to adjust ph (6.0 â 7.0). preservative: thimerosal 0.005%. chemical structure
Clinical Pharmacology:
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 has been shown to inhibit the miosis induced during the course of cataract surgery. result
Read more...s from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure.
Carcinogenesis and Mutagenesis and 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.
How Supplied:
How supplied flurbiprofen sodium ophthalmic solution, usp 0.03% is supplied in a plastic bottle with a controlled drop tip in the following size: 2.5 ml - ndc 69292-722-25 do not use if imprinted âprotective sealâ with yellow is not intact. symbol
Package Label Principal Display Panel:
Principal display panel ndc 69292-722-25 flurbiprofen sodium ophthalmic solution, usp 0.03% (sterile) for ophthalmic use only rx only 2.5 ml bausch + lomb carton.jpg