GENTAMICIN SULFATE solution/ drops

Gentamicin Sulfate by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Gentamicin Sulfate Ophthalmic Solution
Sterile
ANADA 200-576, Approved by FDA
Veterinary
For Use in Dogs and Cats

DESCRIPTION:

Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group active against a wide variety of pathogenic gram-negative and gram-positive bacteria.

Gentamicin Sulfate Ophthalmic Solution is a sterile aqueous solution for use in the eye. Each mL contains: Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base). Inactives: 2.9 mg Disodium Phosphate, 0.1 mg Monosodium Phosphate, and 7.40 mg Sodium Chloride. The pH range is from 6.8 to 7.3. Preservative: 0.1 mg Benzalkonium Chloride as preservative.

CHEMISTRY:

Gentamicin is an aminoglycoside antibiotic mixture derived from Micromonospora purpurea of the Actinomycetes group. It is a powder, white to buff in color, readily soluble in water, and heat stable.

ACTION:

Gentamicin sulfate, a broad spectrum antibiotic, is a highly effective topical treatment in primary and secondary bacterial infections of the eye and surrounding tissues. Gentamicin is bactericidal in vitro against a wide variety of gram-positive and gram-negative bacteria. Concentrations of gentamicin sulfate required to inhibit growth of gram-positive and gram-negative clinical and laboratory strains of bacteria tested were less than those of neomycin in most instances.1,2 Gentamicin is active against most gram-negative bacteria including Pseudomonas aeruginosa, indole positive and negative Proteus species, Escherichia coli, Klebsiella sp. and Enterobacter sp. Gentamicin is also active against strains of gram-positive bacteria including Staphylococcus species and Streptococcus species.

INDICATIONS:

Gentamicin Sulfate Ophthalmic Solution is indicated for topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats.

DOSAGE AND ADMINISTRATION:

Gentamicin Sulfate Ophthalmic Solution-1 or 2 drops instilled into the conjunctival sac 2 to 4 times a day.

PRECAUTIONS:

Antibiotic susceptibility of infecting organisms should be determined prior to the use of these preparations. Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms such as fungi. Should this occur or if irritation or hypersensitivity to any component develops, discontinue use of the preparation and institute appropriate therapy.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

HOW SUPPLIED:

Gentamicin Sulfate Ophthalmic Solution is supplied in a white low density polyethylene plastic squeeze bottle with a white controlled dropper tip and a white polypropylene cap in the following sizes:

NDC: 59399-101-05 5 mL; box of one

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

REFERENCES:

1. Weinstein MJ, Leudemann GM, Oden EM, Wagman GH. Gentamicin, a new broad spectrum antibiotic complex. Antimicrob Agents and Chemother. 1963:1-7.
2. Black J, et al. Pharmacology of Gentamicin: a new broad spectrum antibiotic. Antimicrob Agents and Chemother. 1964:138-147.

AKORN
Animal Health
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
VTGKO0N
Rev. 07/16

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 59399-101-05

Gentamicin Sulfate

Ophthalmic Solution

Veterinary

Caution: Federal law restricts this drug

to use by or on the order of a

licensed veterinarian.

ANADA 200-576, Approved by FDA

Sterile 5 mL

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 59399-101-05

Akorn Animal Health Logo

Gentamicin

Sulfate

Ophthalmic

Solution

Veterinary

Caution: Federal law restricts

this drug to use by or on the

order of a licensed veterinarian.

ANADA 200-576, Approved

by FDA

Sterile

5 mL

INGREDIENTS AND APPEARANCE

GENTAMICIN SULFATE 
gentamicin sulfate solution/ drops

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 59399-101
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: 59399-101-05	1 in 1 CARTON
1		5 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200576	01/30/2015

Labeler - Akorn Animal Health, Inc. (078876357)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL