NDC | 61919-106-05, 61919-918-05 |
Set ID | 51a411a0-2671-4c1c-bf25-e29b32efed0c |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | DIRECT RX |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | ANDA062452 |
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DESCRIPTION
Gentamicin sulfate is a water-soluble antibiotic of the aminoglycoside group.
Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution for ophthalmic use.
Each mL contains:
Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base)
Preservative: Benzalkonium Chloride
Inactives: Disodium Phosphate, Monosodium Phosphate, and Sodium Chloride. The pH range is from 6.8 to 7.3.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 a white powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:
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CLINICAL PHARMACOLOGY SECTION
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.
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INDICATIONS & USAGE SECTION
Gentamicin sulfate ophthalmic solution, USP 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 SECTION
- WARNINGS SECTION
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PRECAUTIONS SECTION
General
Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, 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
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ADVERSE REACTIONS SECTION
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 & ADMINISTRATION SECTION
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HOW SUPPLIED SECTION
Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows:
5 mL in 10 mL bottle – NDC 60758-188-05
Storage: Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above).
Revised: 08/2013
© 2013 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® mark owned by Allergan, Inc.
Made in the U.S.A.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GENTAMICIN SULFATE
gentamicin sulfate solution/ dropsProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-918(NDC:17478-283) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-918-05 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064163 03/19/2019 GENTAMICIN SULFATE
gentamicin sulfate solution/ dropsProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-106(NDC:60758-188) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) POLYVINYL ALCOHOL (UNII: 532B59J990) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-106-05 5 mL in 1 CARTON; Type 0: Not a Combination Product 05/07/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062452 01/01/2014 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 relabel(61919-918, 61919-106)