Natacyn
Natamycin
Eyevance Pharmaceuticals, Llc
Human Prescription Drug
NDC 71776-005Natacyn also known as Natamycin is a human prescription drug labeled by 'Eyevance Pharmaceuticals, Llc'. National Drug Code (NDC) number for Natacyn is 71776-005. This drug is available in dosage form of Suspension/ Drops. The names of the active, medicinal ingredients in Natacyn drug includes Natamycin - 50 mg/mL . The currest status of Natacyn drug is Active.
Drug Information:
| Drug NDC: | 71776-005 |
| 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: | Natacyn |
| 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: | Natamycin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Eyevance Pharmaceuticals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suspension/ 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: | NATAMYCIN - 50 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: | 12 Jun, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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: | NDA050514 |
| 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: | Eyevance Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 204451
207100
|
| 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. |
| NUI: | N0000175936
M0017172
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 8O0C852CPO
|
| 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 EPC: | Polyene Antimicrobial [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Polyenes [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Polyene Antimicrobial [EPC]
Polyenes [CS]
|
| 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 |
|---|
| 71776-005-15 | 1 BOTTLE, GLASS in 1 CARTON (71776-005-15) / 15 mL in 1 BOTTLE, GLASS | 12 Jun, 2021 | 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:
Natacyn natamycin sodium hydroxide hydrochloric acid water benzalkonium chloride natamycin natamycin
Indications and Usage:
Indications and usage: natacyn ® (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including fusarium solani keratitis. as in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. whenever possible the in vitro activity of natamycin against the responsible fungus should be determined. the effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established.
General Precautions:
Precautions: general. for topical ophthalmic use only â not for injection. failure of improvement of keratitis following 7-10 days of administration of the drug suggests that the infection may be caused by a microorganism not susceptible to natamycin. continuation of therapy should be based on clinical re-evaluation and additional laboratory studies. adherence of the suspension to areas of epithelial ulceration or retention of the suspension in the fornices occurs regularly. use only if the container is undamaged.
Dosage and Administration:
Dosage and administration: shake well before using. the preferred initial dosage in fungal keratitis is one drop of natacyn ® (natamycin ophthalmic suspension) 5% instilled in the conjunctival sac at hourly or two-hourly intervals. the frequency of application can usually be reduced to one drop 6 to 8 times daily after the first 3 to 4 days. therapy should generally be continued for 14 to 21 days or until there is resolution of active fungal keratitis. in many cases, it may be helpful to reduce the dosage gradually at 4 to 7 day intervals to assure that the replicating organism has been eliminated. less frequent initial dosage (4 to 6 daily applications) may be sufficient in fungal blepharitis and conjunctivitis.
Contraindications:
Contraindications: natacyn ® (natamycin ophthalmic suspension) 5% is contraindicated in individuals with a history of hypersensitivity to any of its components.
Adverse Reactions:
Adverse reactions: the following events have been identified during post-marketing use of natacyn ® (natamycin ophthalmic suspension) 5% in clinical practice. because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. the events, which have been chosen for inclusion due to their seriousness, frequency of reporting, possible causal connection to natacyn ® (natamycin ophthalmic suspension) 5%, or a combination of these factors include: allergic reaction, change in vision, chest pain, corneal opacity, dyspnea, eye discomfort, eye edema, eye hyperemia, eye irritation, eye pain, foreign body sensation, parethesia, and tearing.
Use in Pregnancy:
Pregnancy: animal reproduction studies have not been conducted with natamycin. it is also not known whether natamycin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. natacyn ® (natamycin ophthalmic suspension) 5% should be given to a pregnant woman only if clearly needed.
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.
Description:
Description: natacyn ® (natamycin ophthalmic suspension) 5% is a sterile, antifungal drug for topical ophthalmic administration. each ml of natacyn ® (natamycin ophthalmic suspension) contains: active: natamycin 5% (50 mg). preservative: benzalkonium chloride 0.02%. inactive: sodium hydroxide and/or hydrochloric acid (neutralized to adjust the ph), purified water. the active ingredient is represented by the chemical structure: established name: natamycin molecular formula: c 33 h 47 no 13 molecular weight: 665.73 g/mol chemical name: stereoisomer of 22-[(3-amino-3,6-dideoxy- β-d-mannopyranosyl)oxy]-1,3,26- trihydroxy-12- methyl-10-oxo-6,11,28- trioxatricyclo[22.3.1.05,7] octacosa-8,14,16,18,20-pentaene-25- carboxylic acid. other: pimaricin the ph range is 5.0-7.5. chemical
Clinical Pharmacology:
Clinical pharmacology: natamycin is a tetraene polyene antibiotic derived from streptomyces natalensis . it possesses in vitro activity against a variety of yeast and filamentous fungi, including candida, aspergillus, cephalosporium, fusarium and penicillium . the mechanism of action appears to be through binding of the molecule to the sterol moiety of the fungal cell membrane. the polyenesterol complex alters the permeability of the membrane to produce depletion of essential cellular constituents. although the activity against fungi is dose-related, natamycin is predominantly fungicidal. natamycin is not effective in vitro against gram-positive or gram-negative bacteria. topical administration appears to produce effective concentrations of natamycin within the corneal stroma but not in intraocular fluid. systemic absorption should not be expected following topical administration of natacyn ® (natamycin ophthalmic suspension) 5%. as with other polyene antibiotics, absorption from th
Read more...e gastrointestinal tract is very poor. studies in rabbits receiving topical natamycin revealed no measurable compound in the aqueous humor or sera, but the sensitivity of the measurement was no greater than 2 mg/ml.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility: there have been no long term studies done using natamycin in animals to evaluate carcinogenesis, mutagenesis, or impairment of fertility.
How Supplied:
How supplied: natacyn ® (natamycin ophthalmic suspension) 5% is a 15 ml fill packaged in a 15 ml amber glass bottle with a black closure. a flint glass dropper with a red plastic closure and a black rubber bulb are packaged separately in a clear plastic blister with tyvek backing. 15 ml ndc 71776-005-15 storage: store between 2°c to 24°c (36°f-75°f). do not freeze . avoid exposure to light and excessive heat. rx only distributed by: eyevance pharmceuticals, llc fort worth, texas 76134 revised: 05/2020
Information for Patients:
Information for patients: do not touch dropper tip to any surface, as this may contaminate the suspension. patients should be advised not to wear contact lenses if they have signs and symptoms of fungal blepharitis, conjunctivitis, and keratitis.
Package Label Principal Display Panel:
Image description image description