GENTAMICIN SULFATE- gentamicin sulfate solution 
REMEDYREPACK INC.

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Gentamicin Sulfate

Ophthalmic Solution USP

Sterile

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 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:

 chemicalstructure

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.                        

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°-25°C (59°-77°F).

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.

*DROP-TAINER is a registered trademark of Alcon Research, Ltd.

Rx Only

9011648-0315

Manufactured by

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for

Sandoz Inc.

Princeton, NJ 08540

Rev. April 2015

DRUG: Gentamicin Sulfate

GENERIC: Gentamicin Sulfate

DOSAGE: SOLUTION

ADMINSTRATION: OPHTHALMIC

NDC: 70518-1323-0

PACKAGING: 5 mL in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • GENTAMICIN SULFATE 3mg in 1mL

INACTIVE INGREDIENT(S):

  • BENZALKONIUM CHLORIDE
  • HYDROCHLORIC ACID
  • SODIUM HYDROXIDE
  • TYLOXAPOL
  • SODIUM CHLORIDE
  • SODIUM PHOSPHATE
  • WATER

Remedy_Label

GENTAMICIN SULFATE 
gentamicin sulfate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70518-1323(NDC:61314-633)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TYLOXAPOL (UNII: Y27PUL9H56)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-1323-05 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/26/201803/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06219607/26/201803/11/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2021
 
REMEDYREPACK INC.