Neosporin (Polymyxin B / Neomycin)

NEOSPORIN® Preparations

Glaxo Wellcome

Polymyxin B – Neomycin Compound


Indications And Clinical Uses: Cream: Infection in dermatologic disorders particularly where the lesions are moist or weeping. Prophylactically, against bacterial contamination in burns, skin grafts, incisions and other clean lesions. For abrasions, minor cuts and wounds, the cream may prevent infection and permit normal healing.

Irrigating Solution: To be diluted and used as a continuous irrigant or rinse for short-term use in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod bacteremia associated with the use of indwelling catheters.

Ointment: For all lesions which are infected or likely to become infected by bacteria.

Sterile Ophthalmic Ointment: Infections of eyes and external ear.

Eye and Ear Solution: For prophylaxis and treatment of eye and ear infections.

Contra-Indications: Hypersensitivity to any of the components.

The presence of preexisting nerve deafness is a contraindication to the use of any topical aminoglycoside in circumstances where significant systemic absorption could occur.

Neosporin cream and Neosporin ointment should not be used in the eyes or in the external ear canal if the eardrum is perforated.

A possibility of increased neomycin absorption exists in neonates and infants, thus Neosporin is not recommended for use in neonates, and should be used at reduced dosages in infants.

Manufacturers’ Warnings In Clinical States: In neonates and infants, absorption by immature skin may be enhanced. Immaturity of renal function may predispose these patients to decreased elimination and increased blood levels.

Irrigating Solution: Prophylactic bladder care with Neosporin irrigant should not be given where there is a possibility of systemic absorption. Neosporin should not be used for irrigation other than for the urinary bladder. Systemic absorption after topical application of neomycin to open wounds, burns and granulating surfaces is significant and serum concentrations comparable to and often higher than those attained following oral and parenteral therapy have been reported. Absorption of neomycin from the denuded bladder surface has been reported.

However, the likelihood of toxicity following topical irrigation of the intact urinary bladder with Neosporin is low since no appreciable amounts of these antibiotics enter the systemic circulation by this route if irrigation does not exceed 10 days.

Neosporin irrigant is intended for continuous prophylactic irrigation of the lumen of the intact urinary bladder of patients with indwelling catheters. Patients should be under constant supervision by a physician. Irrigation should be avoided in patients with defects in the bladder mucosa or bladder wall, such as vesical rupture, or in association with operative procedures on the bladder wall, because of the risk of toxicity due to systemic absorption following diffusion into absorptive tissues and spaces. When absorbed, neomycin and polymyxin B are nephrotoxic antibiotics, and the nephrotoxic potentials are additive. In addition, both antibiotics, when absorbed, are neurotoxins: neomycin can destroy fibers of the acoustic nerve causing permanent bilateral deafness; neomycin and polymyxin B are additive in their neuromuscular blocking effects, not only in terms of potency and duration but also in terms of characteristics of the blocks produced.

Eye and Ear Solution: The manifestations of sensitization to neomycin are usually itching, reddening and edema of the conjunctiva and eyelid. It may be manifest simply as a failure to heal. During long-term use of neomycin-containing products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. These symptoms subside quickly on withdrawing the medication. Neomycin-containing applications should be avoided for the patient thereafter.

Precautions: Articles in current medical literature indicate an increase in the incidence of allergies to neomycin in patients with stasis ulcers or eczema. The possibility of an allergic reaction to neomycin should be borne in mind. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.

Because of the potential hazard of nephrotoxicity and ototoxicity due to neomycin, care should be exercised when treating extensive burns, trophic ulceration and other extensive conditions where absorption of neomycin is possible.

After a maximal course, treatment should not be repeated for at least 3 months.

Pregnancy and Lactation: There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy and lactation. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of fetal toxicity, thus use of Neosporin is not recommended in pregnancy and lactation.

Children: Dosage in children should be reduced in proportion to body weight.

Geriatrics: No specific information is available regarding the use of Neosporin in the elderly; however, the maximum dosage should be reduced in cases where a decrease in renal function may exist.

Irrigating Solution: Care should be taken to prevent reflux of the solution up the ureters, since the concentration of neomycin may cause renal toxicity. Ototoxicity, nephrotoxicity, and neuromuscular blockade may occur if the components of the preparation are systemically absorbed (see Warnings). Absorption of neomycin from the denuded bladder surface has been reported. Patients with impaired renal function, infants, dehydrated patients, elderly patients, and patients receiving high doses of prolonged treatment are especially at risk for the development of the toxicity.

The safety and effectiveness of the preparation for use in the care of patients with recent lower urinary tract surgery have not been established.

Urine specimens should be collected during prophylactic bladder care for urinalysis, culture, and susceptibility testing. Positive culture suggest the presence of organisms which are resistant to the bladder rinse antibiotics.

Eye and Ear Solution: Should not be given subconjunctivally or intraocularly, nor should it be used for the irrigation of fistulous tracts in or about the eye or its socket. Treatment should be continued until at least 48 hours after the eye has apparently recovered. In patients with perforated ear drums or long-standing otitis media, treatment should be restricted to 10 days.

Adverse Reactions: Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see Warnings). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In 1 clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2 175 (0.09%) individuals in the general population. In another study the incidence was found to be approximately 1%.

Irrigating Solution: Irritation of the urinary bladder mucosa has been reported.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Gastric lavage.

Dosage And Administration: Cream: Apply a small quantity 2 to 5 times daily, as required, rub in gently if condition permits.

Irrigating Solution: For use with 3-way catheters or with other catheter systems permitting continuous irrigation of bladder. Under sterile conditions add 1 mL to 1 000 mL bottle of isotonic saline solution. Connect this bottle to inflow lumen of the three way catheter which has been inserted with aseptic precautions. Outflow lumen is connected via sterile disposable plastic hose, to a sterile disposable collection bag. In-flow rate, for most patients, should be adjusted to a slow drip to deliver about 1 000 mL every 24 hours. If the patient’s urine output exceeds 2 L/day, it is recommended that the in-flow rate should be adjusted to deliver 2 000 mL of the solution in a 24-hour period.

Ointment: Apply 2 to 5 times daily over the affected area. Cover with dressing or leave exposed. Do not use in the eyes.

Sterile Ophthalmic Ointment: Apply 2 to 5 times daily over the affected area. Cover with dressing or leave exposed.

Eye and Ear Solution: The suggested dose is 1 or 2 drops in the affected eye or ear, 2 to 4 times a day, or more frequently as required.

Children and Infants: Neosporin is suitable for use in children at the same dose as adults, but the doses should be reduced for use in infants. Neosporin is not recommended for use in neonates (see Warnings).

Availability And Storage: Cream: Each g contains: polymyxin B sulfate 10 000 units, neomycin sulfate (equiv. to 3.5 mg neomycin base) 5 mg, gramicidin 250 g in a white vanishing cream base, pH approximately 5.0. Nonmedicinal ingredients: emulsifying wax, methylparaben, mineral oil, poloxamer, propylene glycol, purified water and white petrolatum. Tubes of 15 g. Store at 15 to 25°C.

Irrigating Solution: Each mL of sterile, aqueous solution contains: neomycin (as sulfate, 57 mg) 40 mg, polymyxin B (as sulfate) 200 000 units. Nonmedicinal ingredients: methylparaben and water for injection in 20 mL vials. Not for injection. Ampuls of 1 mL. Vials of 20 mL. Store at 2 to 8°C.

Ointment: Each g contains: polymyxin B sulfate 5 000 units, zinc bacitracin 400 units and neomycin sulfate 5 mg, in a low melting point petrolatum base. Tubes of 15 and 30 g. Store at 15 to 25°C.

Sterile Ophthalmic Ointment: Each g contains: polymyxin B sulfate 10 000 units, zinc bacitracin 400 units and neomycin sulfate 5 mg, in a low melting point petrolatum base. Tubes of 3.5 g. Store at 15 to 25°C.

Eye and Ear Solution: Each mL contains: polymyxin B sulfate 10 000 units, 2.5 mg neomycin sulfate, 25 g gramicidin. Nonmedicinal ingredients: alcohol, benzalkonium chloride, poloxamer, propylene glycol and water for injection. Plastic dropper bottles of 10 mL. Store at 15 to 25°C.

NEOSPORIN® Preparations Glaxo Wellcome Polymyxin B – Neomycin Compound Antibiotic

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