Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is supplied in a plastic squeeze bottle with a controlled drop tip and a natural cap in the following size: NDC 24208-790-62 - 10 mL Storage: Store between 15°C to 25°C (59°F to 77°F). PROTECT FROM LIGHT. Keep out of reach of children.; PRINCIPAL DISPLAY PANEL NDC 24208-790-62 Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP (Sterile) FOR TOPICAL APPLICATION IN THE EYE (eye image) Rx only 10 mL BAUSCH + LOMB 9536803 AB03409 carton
- HOW SUPPLIED Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is supplied in a plastic squeeze bottle with a controlled drop tip and a natural cap in the following size: NDC 24208-790-62 - 10 mL Storage: Store between 15°C to 25°C (59°F to 77°F). PROTECT FROM LIGHT. Keep out of reach of children.
- PRINCIPAL DISPLAY PANEL NDC 24208-790-62 Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP (Sterile) FOR TOPICAL APPLICATION IN THE EYE (eye image) Rx only 10 mL BAUSCH + LOMB 9536803 AB03409 carton
Overview
Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is a sterile antimicrobial solution for ophthalmic use. Each mL contains: Actives: neomycin sulfate, (equivalent to 1.75 mg neomycin base), polymyxin B sulfate equal to 10,000 polymyxin B units, gramicidin, 0.025 mg; Inactives: sodium chloride, alcohol (0.5%), Poloxamer 188, propylene glycol, purified water. Hydrochloric acid and/or ammonium hydroxide may be added to adjust pH (4.7-6.0). Preservative: thimerosal 0.001%. 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 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formulae are: Polymyxin B Sulfate is the sulfate salt of polymyxin B 1 and B 2 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 milligram, calculated on an anhydrous basis. The structural formulae are: Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillus brevis Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are: Neomycin Sulfate (structural formula) Polymyxin B Sulfate (structural formula) Gramicidin (structural formula)
Indications & Usage
Neomycin and polymyxin B sulfates and gramicidin 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.
Dosage & Administration
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. donot
Warnings & Precautions
WARNINGS NOT FOR INJECTION INTO THE EYE. This product 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. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS : Error! Hyperlink reference not valid. ).
Contraindications
This product is contraindicated in those persons who have shown hypersensitivity to any of its components.
Adverse Reactions
Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic reactions including itching, swelling, and conjunctival erythema (see WARNINGS ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. Local irritation on instillation has also been reported. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
Storage: Store between 15°C to 25°C (59°F to 77°F). PROTECT FROM LIGHT. Keep out of reach of children.
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