Gentamicin (ophthalmic)

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# Overview
Gentamicin (ophthalmic) is a antibacterial and aminoglycoside that is FDA approved for the treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens..   Common adverse reactions include ocular burning, irritation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

### Dosing Information
- Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.

## Off-Label Use and Dosage (Adult)

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

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

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Gentamicin (ophthalmic) 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 (ophthalmic) in pediatric patients.

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

# Contraindications
- Gentamicin sulfate ophthalmic solution, USP is contraindicated in patients with known hypersensitivity to any of its components.

# Warnings
- NOT FOR INJECTION INTO THE EYE.
- Gentamicin sulfate ophthalmic solution, USP is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

### PRECAUTIONS
- Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
- If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.

# Adverse Reactions

## Clinical Trials Experience
- Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.
- The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.
- Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.

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

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

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Gentamicin (ophthalmic) in women who are pregnant.

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

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

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

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

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

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

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

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

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

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

# Administration and Monitoring

### Administration
- Ophthalmic solution

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

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

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

# Pharmacology

## Mechanism of Action
- Gentamicin is an aminoglycoside antibiotic, inhibiting microbial protein synthesis in susceptible pathogens

## Structure
- Gentamicin sulfate ophthalmic solution, USP is a sterile, topical anti-infective agent for ophthalmic use.
- Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:

## Pharmacodynamics
- Gentamicin sulfate is active in vitro against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

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

## Nonclinical Toxicology
- There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.

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

# How Supplied
There is limited information regarding Gentamicin (ophthalmic) How Supplied in the drug label.

## Storage
There is limited information regarding Gentamicin (ophthalmic) Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel
PACIFIC 
PHARMA
NDC 60758-188-05
GENTAMICIN 
SULFATE 
-phthalmic 
solution, USP 
5 mL
sterile
Rx only

# Patient Counseling Information
- To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.

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

# Brand Names
- Ocu-Mycin
- Genoptic
- Genoptic S.O.P.

# Look-Alike Drug Names
There is limited information regarding Gentamicin (ophthalmic) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price