Gentamicin Sulfate
Padagis Israel Pharmaceuticals Ltd
Human Prescription Drug
NDC 45802-056Gentamicin Sulfate is a human prescription drug labeled by 'Padagis Israel Pharmaceuticals Ltd'. National Drug Code (NDC) number for Gentamicin Sulfate is 45802-056. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Gentamicin Sulfate drug includes Gentamicin Sulfate - 1 mg/g . The currest status of Gentamicin Sulfate drug is Active.
Drug Information:
| Drug NDC: | 45802-056 |
| 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: | Gentamicin Sulfate |
| 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: | Gentamicin Sulfate |
| 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: | Cream |
| 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: | GENTAMICIN SULFATE - 1 mg/g
|
| 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: | 23 Aug, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | ANDA062307 |
| 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: | 197735
|
| 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: | 8X7386QRLV
|
| 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: | Aminoglycoside Antibacterial [EPC]
Aminoglycosides [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 |
|---|
| 45802-056-11 | 1 TUBE in 1 CARTON (45802-056-11) / 30 g in 1 TUBE | 23 Aug, 2006 | N/A | No |
| 45802-056-35 | 1 TUBE in 1 CARTON (45802-056-35) / 15 g in 1 TUBE | 05 Dec, 2006 | 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:
Gentamicin sulfate gentamicin sulfate gentamicin sulfate gentamicin isopropyl myristate propylene glycol propylene glycol monopalmitostearate polysorbate 40 water sorbitol stearic acid methylparaben butylparaben
Indications and Usage:
Indications and usage primary skin infections: impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. secondary skin infections: infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial superinfections of fungal or viral infections. please note: gentamicin sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. it is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. patients sensitive
Read more...to neomycin can be treated with gentamicin sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. gentamicin sulfate cream usp, 0.1% is recommended for wet, oozing primary infections, and greasy, secondary infections, such as pustular acne or infected seborrheic dermatitis. gentamicin sulfate ointment helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. if a water-washable preparation is desired, the cream is preferable. gentamicin sulfate cream usp, 0.1% has been used successfully in infants over one year of age, as well as in adults and children.
Dosage and Administration:
Dosage and administration a small amount of gentamicin sulfate cream usp, 0.1% should be applied gently to lesions three or four times a day. the area treated may be covered with a gauze dressing if desired. in impetigo contagiosa, the crusts should be removed before application of gentamicin sulfate cream usp, 0.1% to permit maximum contact between the antibiotic and the infection. care should be exercised to avoid further contamination of the infected skin. infected stasis ulcers have responded well to gentamicin sulfate under gelatin packing.
Contraindications:
Contraindications this drug product is contraindicated in individuals with a history of sensitivity to any of its components.
Adverse Reactions:
Adverse reactions in patients with dermatoses treated with gentamicin sulfate, irritation (erythema and pruritus) that did not usually require discontinuance of treatment has been reported in a small percentage of cases. there was no evidence of irritation or sensitization, however, in any of these patients patch-tested subsequently with gentamicin sulfate on normal skin. possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of gentamicin sulfate followed by exposure to ultraviolet radiation.
Description:
Description gentamicin sulfate cream usp, 0.1% is a wide spectrum antibiotic preparation for topical administration. each gram of gentamicin sulfate cream usp, 0.1% contains gentamicin sulfate usp equivalent to 1 mg of gentamicin base in a cream base of isopropyl myristate, propylene glycol, propylene glycol monostearate, polysorbate 40, purified water, sorbitol solution, and stearic acid, with methylparaben and butylparaben as preservatives.
Clinical Pharmacology:
Clinical pharmacology gentamicin sulfate is a wide spectrum antibiotic that provides highly effective topical treatment in primary and secondary bacterial infections of the skin. gentamicin sulfate cream usp, 0.1% may clear infections that have not responded to other topical antibiotic agents. in primary skin infections such as impetigo contagiosa, treatment three or four times daily with gentamicin sulfate cream usp, 0.1% usually clears the lesions promptly. in secondary skin infections, gentamicin sulfate cream usp, 0.1% aids in the treatment of the underlying dermatosis by controlling the infection. bacteria susceptible to the action of gentamicin sulfate include sensitive strains of streptococci (group a beta-hemolytic, alpha-hemolytic), staphylococcus aureus (coagulase positive, coagulase negative, and some penicillinase-producing strains), and the gram-negative bacteria, pseudomonas aeruginosa, aerobacter aerogenes, escherichia coli, proteus vulgaris and klebsiella pneumoniae .
How Supplied:
How supplied gentamicin sulfate cream usp, 0.1% is available as follows: 15 g tube (ndc 45802- 056 -35) 30 g tube (ndc 45802- 056 -11)
Package Label Principal Display Panel:
Principal display panel - 15 g cream carton rx only ndc 45802- 056 -35 gentamicin sulfate cream usp, 0.1% net wt 15 g 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. 1a5rc-gentamicin-sulfate-cream.jpg serialization-template.jpg