Neosporin Information
Neosporin (Neomycin) Description
Neosporin (Neomycin) OPHTHALMIC OINTMENT (neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment) is a sterile antimicrobial ointment for ophthalmic use. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units, and white petrolatum, q.s.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 µg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:
Polymyxin B sulfate is the sulfate salt of polymyxin B and B, which are produced by the growth of (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:
Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the group of var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula is:
Neosporin (Neomycin) Clinical Pharmacology
A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin.
Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.
Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.
Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis.
Neosporin (Neomycin) Indications And Usage
Neosporin (Neomycin) Ophthalmic Ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
Neosporin (Neomycin) Contraindications
Neosporin (Neomycin) Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.
Neosporin (Neomycin)
Neosporin (Neomycin) Precautions
As with other antibiotic preparations, prolonged use of Neosporin (Neomycin) Ophthalmic Ointment may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.
Bacterial resistance to Neosporin (Neomycin) Ophthalmic Ointment may also develop. If purulent discharge, inflammation, or pain become aggravated, the patient should discontinue use of the medication and consult a physician.
There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see ).
Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.
Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see ).
If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.
Keep tightly closed when not in use. Keep out of reach of children.
Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 µg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.
Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.
Neosporin (Neomycin) Adverse Reactions
Adverse reactions have occurred with the anti-infective components of Neosporin (Neomycin) Ophthalmic Ointment. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see ). More serious hypersensivity reactions, including anaphylaxis, have been reported rarely.
Local irritation on instillation has also been reported.
Neosporin (Neomycin) Dosage And Administration
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
Neosporin (Neomycin) How Supplied
Tube of 1/8 oz (3.5 g) with ophthalmic tip (NDC 0081-0732-86).
Manufactured by:
Burroughs Wellcome Inc.
Kirkland; Que., Canada H9H 4J4 for
BURROUGHS WELLCOME CO.
Research Triangle Park, NC 27709
