Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone
FDA Drug Information • Also known as: Neomycin And Polymyxin B Sulfates And Hydrocortisone
- Brand Names
- Neomycin And Polymyxin B Sulfates And Hydrocortisone
- Drug Class
- Corticosteroid [EPC]
- Route
- AURICULAR (OTIC)
- Dosage Form
- SUSPENSION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is a sterile antimicrobial and anti-inflammatory suspension for ophthalmic use. Each mL contains: Actives: neomycin sulfate (equivalent to 3.5 mg neomycin base), polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). Preservative: thimerosal 0.001%. Inactives: cetyl alcohol, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, propylene glycol, sulfuric acid (to adjust pH) 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. Streptomycetacae). It has a potency equivalent to not less than 600 μg of neomycin standard per mg, calculated on an anhydrous basis. Its structural formula are: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) Polymyxin B sulfate is the sulfate salt of Polymyxin, B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg calculated on an anhydrous basis. Its structural formula are: Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20 dione, is an anti-inflammatory hormone. Its structural formula is: neomycin polymyxin name hydrocortisone-chemical
What Is Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone Used For?
INDICATIONS AND USAGE Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye [see Clinical Pharmacology: Microbiology ]. The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus , Escherichia coli , Haemophilus influenzae , Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa . The product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae .
Dosage and Administration
DOSAGE AND ADMINISTRATION One or two drops in the affected eye every 3 or 4 hours, depending on the severity of the condition. The suspension may be used more frequently if necessary. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. The exact incidence is not known. Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling, and conjunctival erythema [see Warnings ]. More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used. Local irritation on instillation has also been reported. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings and Precautions
WARNINGS NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension should never be directly introduced into the anterior chamber of the eye. Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution. 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 [see Precautions: General ] .
Contraindications
CONTRAINDICATIONS Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.
Pregnancy and Breastfeeding
Pregnancy Teratogenic Effects Pregnancy Category C. Corticosteroids have been found to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 -18 of gestation and in mice when applied topically at a concentration of 15% on days 10 -13 of gestation. There are no adequate and well-controlled studies in pregnant women. Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
How Supplied
HOW SUPPLIED Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a bottle containing 7.5 mL. NDC 61314-641-75 SHAKE WELL BEFORE USING. Store at 20° to 25°C (68° to 77°F).
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.