Neomycin (topical)

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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.

• 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.

• Dosing Information

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

• Dosing Information

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

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

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

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

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

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

• 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.

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

• 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.

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

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

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.

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

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

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

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

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

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

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

Neo-Fradin

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