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| Product NDC Code | 45802-056 | ||||||
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| Drug Name | Gentamicin sulfate |
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| Type | Generic | ||||||
| Pharm Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 197735 | ||||||
| Application Number | ANDA062307 | ||||||
| Labeler Name | Padagis Israel Pharmaceuticals Ltd | ||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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 .
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS This drug product is contraindicated in individuals with a history of sensitivity to any of its components.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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 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.
Spl product data elements
Usually a list of ingredients in a drug product.Gentamicin Sulfate Gentamicin Sulfate GENTAMICIN SULFATE GENTAMICIN ISOPROPYL MYRISTATE PROPYLENE GLYCOL PROPYLENE GLYCOL MONOPALMITOSTEARATE POLYSORBATE 40 WATER SORBITOL STEARIC ACID METHYLPARABEN BUTYLPARABEN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.For Dermatologic Use Only Not For Ophthalmic Use Rx Only
Manufactured By Perrigo Bronx, NY 10457 Distributed By Perrigo Allegan, MI 49010 ● www.perrigo.com Rev. 09-17 :1A500 RC JX1
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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)
Storage and handling
Information about safe storage and handling of the drug product.STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS The use of topical antibiotics occasionally allows overgrowth of nonsusceptible organisms, including fungi. If this occurs, or if irritation, sensitization, or superinfection develops, treatment with Gentamicin Sulfate should be discontinued and appropriate therapy instituted.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API