Neomycin and Polymyxin B Sulfates and Dexamethasone 1 mg/g
Neomycin and Polymyxin B Sulfates and Dexamethasone · OINTMENT · A-S Medication Solutions
Neomycin and Polymyxin B Sulfates and Dexamethasone is a ointment containing neomycin and polymyxin b sulfates and dexamethasone at 1 mg/g, taken ophthalmic. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Neomycin and Polymyxin B Sulfates and Dexamethasone
- Generic Name
- Neomycin and Polymyxin B Sulfates and Dexamethasone
- NDC Code (Product)
50090-4435- Manufacturer
- A-S Medication Solutions
- Strength
- 1 mg/g
- Dosage Form
- OINTMENT
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA050065
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 02/21/1996
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid 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. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa . This product does not provide adequate coverage against: Serratia marcescens and Streptococci, inc…
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply a small amount into the conjunctival sac(s) up to three or four times daily. How to Apply neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment: 1. Tilt your head back. 2. Place a finger on your cheek just under your eye and gently pull down until a “V” pocket is formed between your eyeball and your lower lid. 3. Place a small amount (about 1/2 inch) of neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment in the “V” pocket. Do not let the tip of the tube touch your eye. 4. Look downward before closing your eye. Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
Warnings
WARNINGS NOT FOR INJECTION. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of steroid medication in the treatment of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. Prolonged use may result in 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 acute purulent conditions or parasitic infections of the eye, steroids may mask infection or enhance existing infection. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. If this product is used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. IOP should be checked frequently. The use of steroids after cataract surgery may delay healing and increase the incidence of …
Contraindications
CONTRAINDICATIONS Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is also contraindicated in individuals with known or suspected hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)
Adverse Reactions
ADVERSE REACTIONS Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. The reactions due to the steroid component are: elevation of 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 steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. Secondary bacterial ocular infection following suppression of host r…
Frequently Asked Questions
What is Neomycin and Polymyxin B Sulfates and Dexamethasone used for?
Neomycin and Polymyxin B Sulfates and Dexamethasone contains Neomycin and Polymyxin B Sulfates and Dexamethasone. It is a ointment taken ophthalmic. Consult your doctor for specific uses.
Is Neomycin and Polymyxin B Sulfates and Dexamethasone a controlled substance?
Neomycin and Polymyxin B Sulfates and Dexamethasone is not classified as a controlled substance by the DEA.
What is the generic name for Neomycin and Polymyxin B Sulfates and Dexamethasone?
The generic name for Neomycin and Polymyxin B Sulfates and Dexamethasone is Neomycin and Polymyxin B Sulfates and Dexamethasone. There are 1 other brand versions of Neomycin and Polymyxin B Sulfates and Dexamethasone.
What is the NDC code for Neomycin and Polymyxin B Sulfates and Dexamethasone 1 mg/g?
The NDC (National Drug Code) for Neomycin and Polymyxin B Sulfates and Dexamethasone 1 mg/g is 50090-4435, listed by A-S Medication Solutions.