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Gentamicin Sulfate Ophthalmic SolutionUSP,0.3%Sterile | Gentamicin Sulfate [Akorn, Inc. ] | BioPortfolio

12:42 EST 27th January 2019 | BioPortfolio

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Rx only

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 C, C, and C. 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:

Microbiology: Gentamicin sulfate is active in vitro against many strains of the following microorganisms:

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:

Gentamicin Sulfate Sterile Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

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.

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.

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.

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.

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.

PGK00NRev. 10/15

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 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

Manufacturer

Akorn, Inc.

Active Ingredients

Source

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