Neomycin sulfate, polymyxin b sulfate and gramicidin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]
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Overview
Neomycin sulfate, polymyxin b sulfate and gramicidin is an antiseptic that is FDA approved for the treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Common adverse reactions include itching, swelling, and conjunctival erythema.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- NEOSPORIN Ophthalmic Solution 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.
- Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Neomycin sulfate, polymyxin b sulfate and gramicidin in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Neomycin sulfate, polymyxin b sulfate and gramicidin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Neomycin sulfate, polymyxin b sulfate and gramicidin in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Neomycin sulfate, polymyxin b sulfate and gramicidin in pediatric patients.
Contraindications
- NEOSPORIN Ophthalmic Solution is contraindicated in individuals who have shown hypersensitivity to any of its components.
Warnings
- NOT FOR INJECTION INTO THE EYE. NEOSPORIN Ophthalmic Solution should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally.
- Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Application of products containing these ingredients should be avoided for the patient thereafter.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin Clinical Trials Experience in the drug label.
Postmarketing Experience
- Adverse reactions have occurred with the anti-infective components of NEOSPORIN Ophthalmic Solution. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema. More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.
- Local irritation on instillation has also been reported.
Drug Interactions
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
- Pregnancy Category C. Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin B sulfate, or gramicidin. It is also not known whether NEOSPORIN Ophthalmic Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NEOSPORIN Ophthalmic Solution should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Neomycin sulfate, polymyxin b sulfate and gramicidin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Neomycin sulfate, polymyxin b sulfate and gramicidin during labor and delivery.
Nursing Mothers
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NEOSPORIN Ophthalmic Solution is administered to a nursing woman.
Pediatric Use
There is no FDA guidance on the use of Neomycin sulfate, polymyxin b sulfate and gramicidin in pediatric settings.
Geriatic Use
- Clinical studies of NEOSPORIN® Ophthalmic Solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Gender
There is no FDA guidance on the use of Neomycin sulfate, polymyxin b sulfate and gramicidin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Neomycin sulfate, polymyxin b sulfate and gramicidin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Neomycin sulfate, polymyxin b sulfate and gramicidin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Neomycin sulfate, polymyxin b sulfate and gramicidin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Neomycin sulfate, polymyxin b sulfate and gramicidin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Neomycin sulfate, polymyxin b sulfate and gramicidin in patients who are immunocompromised.
Administration and Monitoring
Administration
Monitoring
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Neomycin sulfate, polymyxin b sulfate and gramicidin and IV administrations.
Overdosage
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin Pharmacology in the drug label.
Mechanism of Action
- A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin.
- 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.
- Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane.
- Neomycin sulfate, polymyxin B sulfate, and gramicidin together are considered active against the following microorganisms: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.
Structure
- Neosporin Ophthalmic Solution (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution) is a sterile antimicrobial solution for ophthalmic use. Each mL contains: neomycin sulfate equivalent to 1.75 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and gramicidin 0.025 mg. The vehicle contains alcohol 0.5%, thimerosal 0.001% (added as a preservative), and the inactive ingredients propylene glycol, polyoxyethylene polyoxypropylene compound, sodium chloride, and Water for Injection.
- Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae 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:
This image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin Clinical Studies in the drug label.
How Supplied
- Drop Dose® of 10 mL (plastic dispenser bottle) (NDC 61570-045-10).
Storage
- Store at 15° to 25°C (59° to 77°F) and protect from light.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Neomycin sulfate, polymyxin b sulfate and gramicidin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- NEOSPORIN ®[1]
Look-Alike Drug Names
There is limited information regarding Neomycin sulfate, polymyxin b sulfate and gramicidin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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