Alocril
Nedocromil Sodium
Allergan, Inc.
Human Prescription Drug
NDC 0023-8842Alocril also known as Nedocromil Sodium is a human prescription drug labeled by 'Allergan, Inc.'. National Drug Code (NDC) number for Alocril is 0023-8842. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Alocril drug includes Nedocromil Sodium - 20 mg/mL . The currest status of Alocril drug is Active.
Drug Information:
| Drug NDC: | 0023-8842 |
| 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: | Alocril |
| 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: | Nedocromil Sodium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Allergan, Inc. |
| 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: | NEDOCROMIL SODIUM - 20 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: | 03 Feb, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | NDA021009 |
| 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: | Allergan, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 897292
897294
|
| 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. |
| UPC: | 0300238842053
|
| UPC stands for Universal Product Code. |
| UNII: | ET8IF4KS1T
|
| 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: | Decreased Histamine Release [PE]
Mast Cell Stabilizer [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 |
|---|
| 0023-8842-05 | 1 BOTTLE, DROPPER in 1 CARTON (0023-8842-05) / 5 mL in 1 BOTTLE, DROPPER | 03 Feb, 2000 | 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:
Alocril nedocromil sodium nedocromil sodium nedocromil edetate disodium water sodium chloride benzalkonium chloride
Indications and Usage:
Indications and usage alocril ® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.
Dosage and Administration:
Dosage and administration the recommended dosage is one or two drops in each eye twice a day. alocril ® ophthalmic solution should be used at regular intervals. treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.
Contraindications:
Contraindications alocril ® ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.
Adverse Reactions:
Adverse reactions the most frequently reported adverse experience was headache (~40%). ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10 â 30% of patients. other events occurring between 1 â 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis. some of these events were similar to the underlying ocular disease being studied.
Use in Pregnancy:
Pregnancy teratogenic effects reproduction studies performed in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, alocril ® ophthalmic solution should be used during pregnancy only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in children below the age of 3 years have not been established.
Geriatric Use:
Geriatric use no overall differences in safety or effectiveness have been observed between elderly and younger patients.
Description:
Description alocril ® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use. nedocromil sodium is represented by the following structural formula: chemical n ame: 4 h -pyrano[3,2-g]quinoline-2,8-dicarboxylic acid, 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-, disodium salt. each ml contains: active: nedocromil sodium 20 mg/ml (2%); preservative: benzalkonium chloride 0.01%; inactives : edetate disodium 0.05%, purified water, and sodium chloride 0.5%. it has a ph range of 4.0 to 5.5 and an osmolality range of 270 to 330 mosm/kg. nedocromil sodium is represented by the following structural formula:
Clinical Pharmacology:
Clinical pharmacology nedocromil sodium is a mast cell stabilizer. nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. decreased chemotaxis and decreased activation of eosinophils have also been demonstrated. in vitro studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages. pharmacokinetics and bioavailability nedocromil sodium exhibits low systemic absorption. when administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose was systemically absorbed following multiple dosing. absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. it is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, and impairment of fertility a two-year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 400 times the maximum recommended human daily ocular dose on a mg/kg basis) in wistar rats showed no carcinogenic potential. nedocromil sodium showed no mutagenic potential in the ames salmonella/microsome plate assay, mitotic gene conversion in saccharomyces cerevisiae , mouse lymphoma forward mutation and mouse micronucleus assays. reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose).
How Supplied:
How supplied alocril ® (nedocromil sodium ophthalmic solution) 2% is supplied sterile in opaque white ldpe plastic bottles with dropper tips and white high impact polystyrene (hips) caps as follows: 5 ml in 10 ml bottle ndc 0023-8842-05 allergan pharmacist figure 1 figure 2 figure 3 figure 4 figure 5 allergan storage: store at 2ºâ25º c (36ºâ77º f). rx only revised: 0 6 /2018 distributed by: allergan usa, inc. madison, nj 07940 © 2018 allergan. all rights reserved. all trademarks are the property of their respective owners. v1.0uspi8842 information for the patient alocril ® (nedocromil sodium ophthalmic solution) 2% sterile it is important to use alocril ® ophthalmic solution regularly, as directed by your physician. 1. thoroughly wash your hands. 2. remove safety seal (figure 1). 3. remove cap (figure 2). 4. sit or stand comfortably, with your head tilted back (figure 3). 5. open eyes, look up, and draw the lower lid of your eye down gently with your i
Read more...ndex finger (figure 4). 6. hold the alocril ® bottle upside down. place tip as close as possible to the lower eyelid without touching the tip to the eye, and gently squeeze out the prescribed number of drops (figure 5). 7. do not touch the eye or eyelid with the bottle tip. 8. blink a few times to make sure the eye is covered with the solution. 9. close your eye and remove any excess solution with a clean tissue. 10. repeat process in the other eye. special tips 1. avoid placing alocril ® ophthalmic solution directly on the cornea (the area just over the pupil), because it is especially sensitive. you will find the administration of eye drops more comfortable if you place the drops just inside the lower eyelid as shown in figure 5 on the previous page. 2. to avoid contamination of the solution, do not touch dropper tip to the eye, fingers, or any other surface. replace bottle cap after use. it is recommended that any remaining contents be discarded after treatment period prescribed by your physician. 3. store at 2ºâ25º c (36ºâ77º f). store in original carton. 4. keep bottle tightly closed and out of the reach of children. 5. do not use with any other ocular medication unless directed by your physician. do not wear contact lenses during treatment with alocril ® ophthalmic solution. figure 1 figure 2 figure 3 figure 4 figure 5 distributed by: allergan usa, inc. madison, nj 07940 © 2018 allergan. all rights reserved. all trademarks are the property of their respective owners. v1.0ppi8842
Information for Patients:
Information for patients patients should be advised to follow the patient instructions listed on the information for patients sheet. users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis. patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Package Label Principal Display Panel:
Principal display panel ndc 0023-8842-05 alocril ® (nedocromil sodium ophthalmic solution) 2% sterile for topical application in the eye 5 ml principal display panel ndc 0023-8842-05 alocril® (nedocromil sodium ophthalmic solution) 2% sterile for topical application in the eye 5 ml