Neomycin (topical)

Neomycin (topical)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Neomycin (topical) is an anti- bacterial agent, anti- infective agent that is FDA approved for the treatment of hepatic encephalopathy, preoperative preparation of bowel for procedure, prophylaxis for infection of skin,in minor cuts, scrapes, and burns. Common adverse reactions include diarrhea, nausea, vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hepatic encephalopathy

• Dosing Information

• 4 to 12 g/day ORALLY in divided doses for 5 to 6 days, maximum 12 g/day; do not use longer than 2 wks.

Infection of skin, In minor cuts, scrapes, and burns; Prophylaxis

• Dosing Information

• Apply small amount TOPICALLY to affected area not more than 2 to 3 times daily; may be covered with a sterile bandage.

Preparation of bowel for procedure, Preoperative; Adjunct

• Dosing Information

• 1 g ORALLY 19, 18, and 9 hrs prior to surgery in combination with recommended bowel preparation regimen which includes erythromycin.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Neomycin (topical) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Infection of skin, In minor cuts, scrapes, and burns; Prophylaxis

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Neomycin (topical) in pediatric patients.

Contraindications

There is limited information regarding Neomycin (topical) Contraindications in the drug label.

Warnings

• Warnings: For external use only. Do not use: if you are allergic to any of the ingredients, in the eyes, over large areas of the body. Ask a doctor before use if you have: large puncture wounds, animal bites, serious burns.

• Stop use and ask a doctor if: you need to use longer than one week, condition persists or gets worse, symptoms persist for more than one week or clear up and occur again within a few days, rash or other allergic reaction develops.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Neomycin (topical) Clinical Trials Experience in the drug label.

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Neomycin (topical) in women who are pregnant.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

• There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Neomycin (topical) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Neomycin (topical) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Neomycin (topical) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Neomycin (topical) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Neomycin (topical) with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

There is no FDA guidance on the use of Neomycin (topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Neomycin (topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Neomycin (topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Neomycin (topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Adults and children over 2 years of age or older: Clean the affected area. Apply contents of packet to surface of affected area 2 times daily. Gently rub in. Children under 2 years of age: Ask a doctor.

Monitoring

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

IV Compatibility

There is limited information regarding IV Compatibility of Neomycin (topical) in the drug label.

Overdosage

There is limited information regarding Neomycin (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

Structure

File:Neomycin (topical)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Neomycin (topical) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Neomycin (topical) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Neomycin (topical) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Neomycin (topical) in the drug label.

How Supplied

Storage

There is limited information regarding Neomycin (topical) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

Neo-Fradin

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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