Generic Name: gentamicin sulfate
Dosage Form: ophthalmic solution
Gentamicin Sulfate
Ophthalmic Solution USP
DESCRIPTION
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 C1, C2, and C1A. 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: Sodium Chloride, Dried Sodium Phosphate, Tyloxapol, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Purified Water. DM - 00
CLINICAL PHARMACOLOGY
Microbiology: Gentamicin sulfate is active in vitro against many 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.
INDICATIONS AND 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.
CONTRAINDICATIONS
Gentamicin Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.
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.
PRECAUTIONS
General
Prolonged use of topical antibiotics may give rise to overgrowth of non-susceptible organisms including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician. If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation, and appropriate therapy should be instituted.
Information for Patients
To avoid contamination, do not touch tip of container to the eye, eyelid, or any surface.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.
Pregnancy
Pregnancy Category C. Gentamicin has been shown to depress body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric Use
Safety and effectiveness in neonates have not been established.
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.
DOSAGE AND 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.
HOW SUPPLIED
Gentamicin Sulfate Ophthalmic Solution: 5 mL in plastic DROP-TAINER® dispenser. NDC 61314-633-05
STORAGE: Protect from light and store away from heat. Store at controlled room temperature 15°-30°C (59°-86°F).
Rx Only
340166-0300
Dist. by:
FALCON Pharmaceuticals, Ltd.
Fort Worth, Texas 76134 USA
Mfd. by:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA
Revised: March 2000
PRINCIPAL DISPLAY PANEL
NDC 61314-633-05 Rx Only
FALCON PHARMACEUTICALS®
Gentamicin
Sulfate
Ophthalmic
Solution USP
Equivalent to
3 mg Gentamicin
per mL
5 mL STERILE
AFFILIATE OF
ALCON LABORATORIES, INC.
QUALITY RX
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA062196 | 04/05/1996 | |
| Labeler - Falcon Pharmaceuticals, Ltd. (874345820) |
| Registrant - Alcon Laboratories, Inc. (008018525) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Alcon Laboratories, Inc. | 008018525 | MANUFACTURE | |
More Gentamicin Ophthalmic Solution resources
- Gentamicin Ophthalmic Solution Use in Pregnancy & Breastfeeding
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