Ery

Erythromycin


Padagis Israel Pharmaceuticals Ltd
Human Prescription Drug
NDC 45802-962
Ery also known as Erythromycin is a human prescription drug labeled by 'Padagis Israel Pharmaceuticals Ltd'. National Drug Code (NDC) number for Ery is 45802-962. This drug is available in dosage form of Swab. The names of the active, medicinal ingredients in Ery drug includes Erythromycin - 20 mg/mL . The currest status of Ery drug is Active.

Drug Information:

Drug NDC: 45802-962
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: Ery
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: Erythromycin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Padagis Israel Pharmaceuticals Ltd
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Swab
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:ERYTHROMYCIN - 20 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
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: 07 Jul, 2008
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 17 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: ANDA064126
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:Padagis Israel Pharmaceuticals Ltd
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:797452
798133
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:0345802962720
UPC stands for Universal Product Code.
NUI:N0000009982
N0000175877
N0000175935
M0028311
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:63937KV33D
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:Macrolide [EPC]
Macrolide 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 PE:Decreased Sebaceous Gland Activity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Macrolides [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:Decreased Sebaceous Gland Activity [PE]
Macrolide Antimicrobial [EPC]
Macrolide [EPC]
Macrolides [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
45802-962-7260 APPLICATOR in 1 JAR (45802-962-72) / .8 mL in 1 APPLICATOR07 Jul, 2008N/ANo
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:

Ery erythromycin erythromycin erythromycin alcohol propylene glycol citric acid monohydrate

Indications and Usage:

Indications and usage ery 2% pads are indicated for the topical treatment of acne vulgaris.

Warnings:

Warnings pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. studies indicate that a toxin produced by clostridium difficile is one primary cause of “antibiotic-associated colitis”. after the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. in moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against c. difficile colitis.

General Precautions:

General - for topical use only; not for ophthalmic use. concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. the use of antibiotic agents may be associated with the overgrowth of antibiotic-resistant organisms. if this occurs, discontinue use and take appropriate measures. avoid contact with eyes and all mucous membranes.

Dosage and Administration:

Dosage and administration the ery 2% pads should be rubbed over the affected area twice a day (morning and evening) after skin is thoroughly washed with warm water and soap and patted dry. acne lesions on the face, neck, shoulders, chest, and back may be treated in this manner. additional pledgets may be used, if needed. each pledget should be used once and discarded. wash hands after application. close jar tightly after each use. drying and peeling may be controlled by reducing the frequency of applications.

Contraindications:

Contraindications ery 2% pads are contraindicated in those individuals who have shown hypersensitivity to any of its components.

Adverse Reactions:

Adverse reactions the following local adverse reactions have been reported occasionally: peeling, dryness, itching, erythema, and oiliness. irritation of the eyes and tenderness of the skin have also been reported with topical use of erythromycin. generalized urticarial reactions, possibly related to the use of erythromycin, which required systemic steroid therapy have been reported.

Use in Pregnancy:

Pregnancy: teratogenic effects: pregnancy category b - there was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% diet) prior to and during mating, during gestation and through weaning of two successive litters. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low.

Pediatric Use:

Pediatric use - safety and effectiveness of this product in pediatric patients have not been established.

Description:

Description ery 2% pads contain erythromycin, usp for topical dermatologic use. erythromycin is a macrolide antibiotic produced from a strain of saccaropolyspora erythraea (formerly streptomyces erythreus ). it is a base and readily forms salts with acids. chemically, erythromycin is c 37 h 67 no 13 . it has the following structural formula: the chemical name for erythromycin is (3 r *,4 s *,5 s *,6 r *,7 r *,9 r *,11 r *,12 r *,13 s *,14 r *)-4-[(2,6-dideoxy-3- c -methyl-3- o -methyl-α-l- ribo -hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-d- xylo -hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. erythromycin has the molecular weight of 733.94. it is a white or slightly yellow, crystalline powder, slightly soluble in water, soluble in alcohol, in chloroform, and in ether. it is odorless or practically odorless. it has a ph range between 8.0 and 10.5 in a methanol and water solution prepared by diluting 1 volume of a methanol solution, containing 40 mg per ml, with 19 volumes of water. each ml of expressible liquid contains 20 mg erythromycin in a base of dehydrated alcohol, propylene glycol and citric acid to adjust ph. each pledget is filled to contain 0.8 ml of erythromycin topical solution 2%. chemical structure

Clinical Pharmacology:

Clinical pharmacology the exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug. microbiology erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50s ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-rna and inhibiting polypeptide synthesis. antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol, and clindamycin.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility - no animal studies have been performed to evaluate the carcinogenic and mutagenic potential or effects on fertility of topical erythromycin. however, long-term (2-year) oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. there was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.

How Supplied:

How supplied ery 2% pads are available as follows: a plastic jar containing 60 pledgets (ndc 45802- 962 -72) each pledget is filled to contain 0.8 ml of erythromycin topical solution 2%.

Information for Patients:

Information for patients - patients using ery 2% pads should receive the following information and instructions: 1. this medication is to be used as directed by the physician. it is for external use only. avoid contact with the eyes, nose, mouth, and all mucous membranes. 2. this medication should not be used for any disorder other than that for which it was prescribed. 3. patients should not use any other topical acne medication unless otherwise directed by their physician. 4. patients should report to their physician any signs of local adverse reactions.

Package Label Principal Display Panel:

Principal display panel rx only ery 2% pads (erythromycin pledgets usp, 2%) for external use avoid contact with eyes 60 pledgets the following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. label serialization-template.jpg


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