Gentamicin (topical)

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# Overview
Gentamicin (topical) is a antibacterial and aminoglycoside that is FDA approved for the treatment of primary skin infections like impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum; secondary skin infections like 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.   Common adverse reactions include photosensitivity.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- 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. 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 is recommended for wet, oozing primary infections, and greasy, secondary infections, such as postular acne or infected seborrheic dermatitis. Gentamicin Sulfate Ointment USP, 0.1% helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment USP, 0.1% has been used successfully in infants over one year of age as well as in adults and children.

### Dosing Information
- A small amount of Gentamicin Sulfate Ointment USP, 0.1% should be applied gently to lesions three to 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 Ointment 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Gentamicin (topical) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Gentamicin (topical) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Gentamicin (topical) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Gentamicin (topical) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Gentamicin (topical) in pediatric patients.

# Contraindications
- Gentamicin Sulfate Ointment USP, 0.1% is contraindicated in individuals with a history of sensitivity reactions to any of its components.

# Warnings

### PRECAUTIONS
- 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 Ointment USP, 0.1% should be discontinued and appropriate therapy instituted.

# Adverse Reactions

## Clinical Trials Experience
- 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 on normal skin. Possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of gentamicin followed by exposure to ultraviolet radiation.

## Postmarketing Experience
There is limited information regarding Gentamicin (topical) Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Gentamicin (topical) Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Gentamicin (topical) in women who are pregnant.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Gentamicin (topical) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Gentamicin (topical) during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Gentamicin (topical) in women who are nursing.

### Pediatric Use
There is no FDA guidance on the use of Gentamicin (topical) in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Gentamicin (topical) in geriatric settings.

### Gender
There is no FDA guidance on the use of Gentamicin (topical) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Gentamicin (topical) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Gentamicin (topical) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Gentamicin (topical) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Gentamicin (topical) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Gentamicin (topical) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
There is limited information regarding Gentamicin (topical) Administration in the drug label.

### Monitoring
There is limited information regarding Gentamicin (topical) Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Gentamicin (topical) and IV administrations.

# Overdosage
There is limited information regarding Gentamicin (topical) overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action
There is limited information regarding Gentamicin (topical) Mechanism of Action in the drug label.

## Structure
- Gentamicin Sulfate Ointment USP, 0.1% is a wide spectrum antibiotic preparation for topical administration. Each gram of Gentamicin Sulfate Ointment USP, 0.1% contains Gentamicin Sulfate USP equivalent to 1 mg of gentamicin base in a base of light mineral oil and white petrolatum, with 0.5 mg methylparaben and 0.1 mg propylparaben as preservatives.

## Pharmacodynamics

### CLINICAL PHARMACOLOGY
- Gentamicin Sulfate is a wide spectrum antibiotic that provides highly effective topical treatment in primary and secondary bacterial infections of the skin. This product may clear infections that have not responded to other topical antibiotic agents. In impetigo contagiosa and other primary skin infections, treatment with a small amount of Gentamicin Sulfate Ointment three to four times daily usually clears the lesions promptly. In secondary skin infections, the product facilitates 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, Aerobacteraerogens, Escherichia coli, Proteus vulgaris and Klebsiellapneumoniae.

## Pharmacokinetics
There is limited information regarding Gentamicin (topical) Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Gentamicin (topical) Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Gentamicin (topical) Clinical Studies in the drug label.

# How Supplied
Gentamicin Sulfate Ointment USP, 0.1% is available as follows:
15 g tube (NDC 45802-046-35)
30 g tube (NDC 45802-046-11)

## Storage
- Store at 20-25 C (68-77 F)

# Images

## Drug Images

## Package and Label Display Panel
Rx Only
Gentamicin Sulfate Ointment USP, 0.1%
NET WT 15 g

# Patient Counseling Information
There is limited information regarding Gentamicin (topical) Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Gentamicin (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- Garamycin
- Gentacidin
- Gentafair
- Gentak
- Gentasol

# Look-Alike Drug Names
gentamicin - gentian violet

# Drug Shortage Status

# Price