Neosporin topical

Aminoglycoside antibiotic.a

Administration

Topical Administration

Apply ointment or cream topically to cleansed area.a

May cover affected area with a sterile bandage following use of ointments or creams.a

Do not apply to the eye.c d

Do not apply over large areas of the body.c d

Bladder Irrigation

Intended for continuous irrigation of the lumen of an intact urinary bladder in patients with indwelling catheters; use under constant supervision by a clinician.b

Administer via a 3-way catheter.b

Important that the irrigation is continuous; the inflow should not be interrupted for more than a few minutes.b

Neomycin sulfate and polymyxin B sulfate solution for irrigation is not for injection.b

Add 1 mL of commercially available urogenital solution containing 57 mg of neomycin sulfate and 200,000 units of polymyxin B sulfate to 1 L of 0.9% sodium chloride solution.b

1 L every 24 hours (approximately 40 mL/hour).b Adjust the inflow rate to 2 L every 24 hours if the patient’s urine output exceeds 2 L/day.b

Dosage

Available as neomycin sulfate; dosage expressed in terms of the salt or the base.b c d

Pediatric Patients

Children ≥2 years of age: Apply amount equal to the surface area of a fingertip to the affected area 1–3 times daily.c d

Adults

Apply amount equal to the surface area of a fingertip to the affected area 1–3 times daily.c d

1 L of a solution containing 57 mg of neomycin sulfate and 200,000 units of polymyxin B sulfate in 0.9% sodium chloride solution every 24 hours.b Adjust the inflow rate to 2 L every 24 hours if the patient’s urine output exceeds 2 L/day.b Administer for ≤10 days.b

Prescribing Limits

Pediatric Patients

Maximum 1 week of use unless directed by a physician.b c

Adults

Maximum 1 week of use unless directed by a physician.b c

Maximum 10 days.b

Contraindications

• Known hypersensitivity to neomycin or any ingredient in the formulation.b c d

• Bladder irrigation: History of hypersensitivity or serious toxic reaction to an aminoglycoside.b

Warnings/Precautions

Warnings

For bladder irrigation only.b

Do not use if systemic absorption possible.b

Topical application to open wounds, burns, and granulation surfaces associated with substantial systemic absorption and risk of toxicity.b (See Toxicity under Cautions.)

Irrigation of an intact urinary bladder for ≤10 days is not expected to result in clinically important systemic absorption.b Absorption of neomycin from denuded bladder surface reported.b

Avoid in patients with defects in the bladder mucosa or bladder wall (e.g., vesical rupture); do not use in conjunction with operative procedures on the bladder wall.b Systemic absorption possible; risk of toxicity.b

Safety and efficacy in patients with recent lower urinary tract surgery not established.b

Sensitivity Reactions

Topical neomycin is a contact sensitizer, especially when used for prolonged periods.a Contact dermatitis, burning, erythema, rash, and urticaria reported following topical application.a

If irritation or hypersensitivity occurs, discontinue use and consult a clinician.a

Patch testing (e.g., 20% neomycin sulfate in petrolatum) may be useful in diagnosing allergic contact dermatitis to the drug.a

Anaphylactoid reactions reported rarely with topical application.a

Major Toxicities

Ototoxicity, nephrotoxicity, and neuromuscular blockade reported following topical application of neomycin, especially in patients undergoing peritoneal instillation, irrigation of wounds or surgical sites, or those receiving treatment for skin ulcers, granulating wounds, burns, or extensive areas of denuded skin.a Death reported rarely.a (See Appropriate Use of Neomycin Sulfate and Polymyxin B Sulfate Solution for Irrigation under Cautions.)

Application to large areas of abraded skin in infants with diaper rash could result in substantial absorption, especially since the diaper may act as an occlusive dressing.a

Use with caution for treatment of extensive burns, trophic ulceration, or other extensive dermatological condition where rapid absorption of the drug is possible.a

Risk of toxicity highest in patients with renal impairment, infants, dehydrated individuals, geriatric individuals, and patients receiving high doses for prolonged periods.b

General Precautions

Overgrowth of nonsusceptible organisms, particularly fungi, may occur; institute appropriate therapy if superinfection occurs.a b

When neosporin is used in fixed-combination with other drugs, observe the cautions and precautions of the other drugs.b c d

Corticosteroids in topical anti-infective combination preparations may mask the clinical signs of bacterial, fungal, or viral infections, or may suppress hypersensitivity reactions to the antibiotics or other ingredients in the formulations; weigh benefits against risks.a

Specific Populations

Category C.e

Bladder irrigation: Category D.b

Clinically unimportant amounts of neomycin may distribute into breast milk.e

Bladder irrigation: Safety and efficacy not established in pediatric patients.b

Ointments/creams for self-medication: Suitable for children ≥2 years of age.c d

Risk of toxicity increased in infants.b (See Toxicity under Cautions.)

Bladder irrigation: Risk of toxicity increased in geriatric patients.b (See Toxicity under Cautions.)

Bladder irrigation: Risk of toxicity increased in patients with renal impairment.b (See Toxicity under Cautions.)

Common Adverse Effects

Local or systemic hypersensitivity reactions, irritation of the urinary bladder mucosa.b

Absorption

Bioavailability

Not absorbed to any appreciable extent from intact skin.a Readily absorbed through denuded or abraded areas of skin or skin that has lost the keratin layer (i.e., wounds, burns, ulcers).a Rapidly absorbed from the peritoneum, draining sinuses, wounds, or surgical sites.a

Plasma Concentrations

Plasma concentrations following topical application to open wounds, burns, or granulating surfaces comparable to, or higher than, those achieved following oral or parenteral administration (parenteral preparation no longer commercially available in the US).b