GENTAMICIN SULFATE solution/ drops

Gentamicin Sulfate by

Drug Labeling and Warnings

Gentamicin Sulfate by is a Prescription medication manufactured, distributed, or labeled by Akorn, Inc. , Akorn Operating Company LLC, Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx only

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:

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 Sterile 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 Sterile 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 nonsusceptible 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

Gentamicin Sulfate sterile ophthalmic solution; 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 - Sterile, 5-mL plastic dropper bottle, box of one. (NDC: 17478-826-05)

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Avoid exposure to excessive heat.

PREMIERProRx®
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

PremierProRx® is a registered trademark of Premier Inc., used under license.

PGK00N
Rev. 10/15

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 17478-826-05

Gentamicin

Sulfate Ophthalmic

Solution, USP

0.3%

(equivalent to 3 mg

gentamicin per mL)

Rx only Sterile 5 mL

Premier Logo

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 17478-826-05

Gentamicin

Sulfate

Ophthalmic

Solution, USP

0.3%

(equivalent to 3 mg

gentamicin per mL)

Sterile

Rx only 5 mL

Premier Logo

INGREDIENTS AND APPEARANCE

GENTAMICIN SULFATE 
gentamicin sulfate solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 17478-826
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, Dibasic, Anhydrous (UNII: 22ADO53M6F)
Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)
Sodium Chloride (UNII: 451W47IQ8X)
Benzalkonium Chloride (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17478-826-05	1 in 1 CARTON	03/11/2013
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA064163	03/11/2013

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(17478-826) , ANALYSIS(17478-826) , STERILIZE(17478-826) , PACK(17478-826) , LABEL(17478-826)