Diclofenac Sodium
Nucare Pharmaceuticals,inc.
Human Prescription Drug
NDC 68071-1653Diclofenac Sodium is a human prescription drug labeled by 'Nucare Pharmaceuticals,inc.'. National Drug Code (NDC) number for Diclofenac Sodium is 68071-1653. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Diclofenac Sodium drug includes Diclofenac Sodium - 1 mg/mL . The currest status of Diclofenac Sodium drug is Active.
Drug Information:
| Drug NDC: | 68071-1653 |
| 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: | Diclofenac 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: | Diclofenac Sodium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nucare 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: | DICLOFENAC SODIUM - 1 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: | 14 Feb, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 Jan, 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: | ANDA078031 |
| 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: | NuCare Pharmaceuticals,Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 854801
|
| 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. |
| UPC: | 0368071165357
|
| UPC stands for Universal Product Code. |
| UNII: | QTG126297Q
|
| 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]
Decreased Prostaglandin Production [PE]
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 |
|---|
| 68071-1653-5 | 5 mL in 1 BOTTLE (68071-1653-5) | 09 Jan, 2020 | 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:
Diclofenac sodium diclofenac sodium polyoxyl 35 castor oil boric acid tromethamine sorbic acid edetate disodium water diclofenac sodium diclofenac
Indications and Usage:
Indications and usage diclofenac sodium ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.
Warnings:
Warnings the refractive stability of patients undergoing corneal refractive procedures and treated with diclofenac sodium ophthalmic solution has not been established. patients should be monitored for a year following use in this setting. 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 ocularly applied non-steroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. there is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
General Precautions:
General precautions all 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. use of topical nsaids may result in keratitis. in some susceptible patients continued use of topical nsaids may result in epithelial breakdown, corneal thinning, corneal infiltrates, corneal erosion, corneal ulceration, and corneal perforation. these events may be sight-threatening. patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical nsaids and should be closely monitored for corneal health. postmarketing experience with topical nsaids suggests that patients experiencing complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries withi
Read more...n a short period of time may be at increased risk for corneal adverse events, which may become sight-threatening. topical nsaids should be used with caution in these patients. postmarketing experience with topical nsaids also suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for occurrence and severity of corneal adverse events. it is recommended that diclofenac sodium ophthalmic solution, like other nsaids, be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery. results from clinical studies indicate that diclofenac sodium ophthalmic solution has no significant effect upon ocular pressure. however, elevations in intraocular pressure may occur following cataract surgery.
Dosage and Administration:
Dosage and administration cataract surgery one drop of diclofenac sodium ophthalmic solution should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the postoperative period. corneal refractive surgery one or two drops of diclofenac sodium ophthalmic solution should be applied to the operative eye within the hour prior to corneal refractive surgery. within 15 minutes after surgery, one or two drops should be applied to the operative eye and continued 4 times daily for up to 3 days.
Contraindications:
Contraindications diclofenac sodium ophthalmic solution is contraindicated in patients who are hypersensitive to any component of the medication.
Use in Pregnancy:
Pregnancy
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 adult patients.
Overdosage:
Overdosage overdosage will not ordinarily cause acute problems. if diclofenac sodium ophthalmic solution is accidentally ingested, fluids should be taken to dilute the medication.
Description:
Description diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. diclofenac sodium is designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of c 14 h 10 cl 2 no 2 na. the structural formula of diclofenac sodium is: diclofenac sodium ophthalmic solution, 0.1% is available as a sterile solution which contains diclofenac sodium 0.1% (1 mg/ml). inactive ingredients: polyoxyl 35 castor oil, boric acid, tromethamine, sorbic acid (2 mg/ml), edetate disodium (1 mg/ml), and purified water. diclofenac sodium is a faintly yellow-white to light-beige, slightly hygroscopic crystalline powder. it is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1n hydrochloric acid. its molecular weight is 318.14. diclofenac sodium ophthalmic solution, 0.1% is an iso-osmotic solution with an osmolality of about 300 mosmol/1000 g, buffered at approximately ph 7.2. diclofenac sodium ophthalmic solution, 0.1% has a faint characteristic odor of castor oil. chemical
Clinical Pharmacology:
Clinical pharmacology pharmacodynamics diclofenac sodium is one of a series of phenylacetic acids that has demonstrated anti-inflammatory and analgesic properties in pharmacological studies. it is thought to inhibit the enzyme cyclooxygenase, which is essential in the biosynthesis of prostaglandins. animal studies prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. in studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. pharmacokinetics results from a bioavailability study established that plasma levels of diclofenac following ocular instillation of two drops of diclofenac sodium ophthalmic solution, 0.1% to each eye were below the limit of quantification (10 ng/ml) over a 4-hour period. this study suggests that limited, if any, systemic absorption occurs with
Read more... diclofenac sodium ophthalmic solution, 0.1%. clinical trials postoperative anti-inflammatory effects in two double-masked, controlled, efficacy studies of postoperative inflammation, a total of 206 cataract patients were treated with diclofenac sodium ophthalmic solution, 0.1% and 103 patients were treated with vehicle placebo. diclofenac sodium ophthalmic solution, 0.1% was favored over vehicle placebo over a 2-week period for the clinical assessments of inflammation as measured by anterior chamber cells and flare. in double-masked, controlled studies of corneal refractive surgery (radial keratotomy (rk) and laser photorefractive keratectomy (prk)) patients were treated with diclofenac sodium ophthalmic solution, 0.1% and/or vehicle placebo. the efficacy of diclofenac sodium ophthalmic solution given before and shortly after surgery was favored over vehicle placebo during the 6-hour period following surgery for the clinical assessments of pain and photophobia. patients were permitted to use a hydrogel soft contact lens with diclofenac sodium ophthalmic solution for up to three days after prk.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility long-term carcinogenicity studies in rats given diclofenac sodium ophthalmic solution in oral doses up to 2 mg/kg/day (approximately 500 times the human topical ophthalmic dose) revealed no significant increases in tumor incidence. a 2-year carcinogenicity study conducted in mice employing oral diclofenac sodium ophthalmic solution up to 2 mg/kg/day did not reveal any oncogenic potential. diclofenac sodium ophthalmic solution did not show mutagenic potential in various mutagenicity studies including the ames test. diclofenac sodium ophthalmic solution administered to male and female rats at 4 mg/kg/day (approximately 1000 times the human topical ophthalmic dose) did not affect fertility.
How Supplied:
How supplied diclofenac sodium ophthalmic solution, 0.1% (1 mg/ml) sterile solution is supplied in a low density polyethylene (ldpe) white drop-tainer* bottle with a natural ldpe dropper tip and a gray polypropylene closure in the following sizes: 5 ml fill in 8 ml container ndc 68071-1653-5 *drop-tainer is a registered trademark of alcon research, llc. storage conditions store at 20° to 25°c (68° to 77°f), excursions permitted to 15° to 30°c (59° to 86°f). protect from light. dispense in original, unopened container only.
Information for Patients:
Information for patients except for the use of a bandage hydrogel soft contact lens during the first 3 days following refractive surgery, diclofenac sodium ophthalmic solution should not be used by patients currently wearing soft contact lenses due to adverse events that have occurred in other circumstances.
Package Label Principal Display Panel:
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