Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Gentamicin Sulfate Ophthalmic Solution is supplied sterile, in a natural LDPE plastic bottle with a natural LDPE dropper tip and a white polypropylene cap as follows: NDC 61314-633-05 - 5mL filled in 8mL bottle. STORAGE Store at controlled room temperature 15° to 25°C (59° to 77°F). Protect from light and store away from heat.; PRINCIPAL DISPLAY PANEL NDC 61314-633-05 Gentamicin Sulfate Ophthalmic Solution, USP 0.3% Equivalent to 3 mg Gentamicin per mL Rx Only STERILE 5 mL SANDOZ gentamicincarton
- HOW SUPPLIED Gentamicin Sulfate Ophthalmic Solution is supplied sterile, in a natural LDPE plastic bottle with a natural LDPE dropper tip and a white polypropylene cap as follows: NDC 61314-633-05 - 5mL filled in 8mL bottle. STORAGE Store at controlled room temperature 15° to 25°C (59° to 77°F). Protect from light and store away from heat.
- PRINCIPAL DISPLAY PANEL NDC 61314-633-05 Gentamicin Sulfate Ophthalmic Solution, USP 0.3% Equivalent to 3 mg Gentamicin per mL Rx Only STERILE 5 mL SANDOZ gentamicincarton
Overview
Gentamicin Sulfate is a water-soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to approximately pH 7 for ophthalmic use. Gentamicin is obtained from cultures of Micromonospora purpurea . It is a mixture of the sulfate salts of gentamicin C 1 , C 2 , and C 1A . All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as white powder and is soluble in water and insoluble in alcohol. The structure is as follows: Established name: Gentamicin Sulfate Chemical name: 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine. Ingredients: Each mL contains: Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin). Preservative: Benzalkonium Chloride 0.1 mg (0.01%). Inactives: Dibasic Sodium Phosphate Anhydrous, Sodium Chloride, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH), Tyloxapol and Purified Water. chemicalstructure
Indications & Usage
Gentamicin Sulfate Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
Dosage & Administration
Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops once every hour.
Warnings & Precautions
WARNINGS NOT FOR INJECTION INTO THE EYE. Gentamicin Sulfate Ophthalmic Solution is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
Contraindications
Gentamicin Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.
Adverse Reactions
Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations. The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia. Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura, and hallucinations. 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.
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