Gentocin Ophthalmic Solution (Canada)

This page contains information on Gentocin Ophthalmic Solution for veterinary use.
The information provided typically includes the following:
  • Gentocin Ophthalmic Solution Indications
  • Warnings and cautions for Gentocin Ophthalmic Solution
  • Direction and dosage information for Gentocin Ophthalmic Solution

Gentocin Ophthalmic Solution

This treatment applies to the following species:

Sterile Opthalmic Solution

Manufacturer: Schering-Plough

DIN 00241636

Veterinary Use Only

Gentamicin is an aminoglycoside antibiotic derived from some Micromonospora species of the Actinomyces genus. It is supplied as a sulfate salt and the powder is white, water soluble and thermostable.

Composition

Gentocin Ophthalmic Solution is a sterile antibiotic aqueous solution for ophthalmic use in veterinary practice.

Each millilitre of buffered aqueous solution (pH 7) contains: 3 mg (0.3%) gentamicin (as sulfate USP), 2.9 mg disodium phosphate, 0.1 mg monosodium phosphate, 7.4 mg sodium chloride, 0.05 mg benzalkonium chloride as preservative, purified water q.s.

Action

Gentamicin sulfate is a broad spectrum aminoglycoside antibiotic which is effective in the treatment of primary and secondary, simple or mixed bacterial infections of the conjunctiva, cornea and eyelids. Gentamicin is a bactericidal antibiotic which inhibits normal protein synthesis in susceptible bacteria.

Among the gram-negative bacteria susceptible in vitro are Pseudomonas aeruginosa, Proteus, Escherichia coli, Klebsiella pneumoniae, Aerobacter aerogenes, Neisseria, Serratia marcescens and certain Salmonella and Shigella species. Among the gram-positive bacteria, in vitro sensitivity has been shown for Staphylococcus species (including penicillin and methicillin resistant strains) and betahemolytic streptococci which are sensitive to gentamicin.1

Among the gram-negative bacteria susceptible in vivo (human and animal) are species of Pseudomonas, Proteus, Escherichia, Klebsiella, Aerobacter and Neisseria. Among the gram-positive bacteria, in vivo (human and animal) sensitivity has been shown for species of Staphylococcus and Streptococcus.

Topical gentamicin preparations have been shown to be effective in vivo for the treatment of various bacterial infections in the animal and in the human.2,3,4

Gentocin Ophthalmic Solution Indications And Clinical Uses

Gentocin Ophthalmic Solution is indicated for the treatment of external bacterial infections of the eye and surrounding tissues such as conjunctiva, cornea and eyelids of dogs and cats. Such bacterial infections, caused by organisms sensitive to gentamicin, include conjunctivitis, keratitis, keratoconjunctivitis, and superficial corneal ulcers of bacterial origin.

Contraindications

Hypersensitivity to gentamicin or any of the components of the solution is a contraindication.

Adverse Reactions

Eye medications may sting briefly on application and a transient stinging sensation, usually expressed as some form of resentment by the animal, following topical application of the drug, has been noted in a few instances.

Pharmacology

It has been shown that gentamicin administered topically is capable of penetrating both the normal and inflammed eye.5 Any amount of gentamicin absorbed in the circulatory system is excreted unchanged in the urine by glomerular filtration.

Toxicology

Various ocular toxicity studies have shown no special irritation arising from the gentamicin of Gentocin Ophthalmic Solution.

The LD50 values for gentamicin are as follows:

Mice I.V.

75 mg/kg

Mice S.C.

584 mg/kg

Mice Oral

9050 mg/kg

Gentocin Ophthalmic Solution Dosage And Administration

The topical application of Gentocin Ophthalmic Solution should be adapted to the specific needs of each individual case.

One or two drops of the solution may be instilled into the conjunctival sac three or four times a day (and less often at night) until a favourable response is obtained. Thereafter, the dosage may be reduced gradually. This is important in chronic conditions. A transient stinging sensation common to many ophthalmic preparations may sometimes occur but usually does not require cessation of the treatment.

Ocular re-examinations should be made at frequent intervals, particularly during long-term therapy.

Dosage Forms

Gentocin Ophthalmic Solution is packaged in 5 mL squeeze dropper plastic bottle. Store between 2° and 25°C.

Bibliography

1. Finland, M., Gentamicin: Antibacterial Activity, Clinical Pharmacology and Clinical Applications, Medical Times, Vol. 97, No. 12, pp. 161-74, Dec. '69.

2. Magnuson, R., Gentamicin Sulfate in External Eye Conditions, J.A.M.A., Vol. 199, pp. 427-8, Feb. 6 '67.

3. Miller, G.K., Clinical Evaluation of Gentamicin in Bacterial Infections of the Canine and Feline Eye, Vet. Med. Small Anim. Clin., Vol. 66, pp. 492-95, May '71.

4. Magnuson, R., et al, Clinical and Bacteriologic Evaluation of Gentamicin Ophthalmic Preparations, Amer. J. Ophthal., Vol. 70, pp. 734-38, Nov. '70.

5. Furgiuele, F.P., Ocular Penetration and Tolerance of Gentamicin, Am. J. Ophthal., pp. 421-6, Sept. '67.

® Registered trademark of Schering-Plough Canada Inc.

© Copyright Schering-Plough Canada Inc.

Assignment of original copyright by Schering Corporation.

Schering-Plough Animal Health (Schering-Plough Canada Inc.), Pointe-Claire, Québec H9R 1B4

HCAN094247INR

71-465235 E

Nac No.

12080492
SCHERING-PLOUGH ANIMAL HEALTH
Division of Schering Canada Inc.

3535 TRANS CANADA HWY., POINTE CLAIRE, QC, H9R 1B4
Telephone:   800-605-2584
Telephone Orders:  
Quebec:   FRENCH: 800-361-2431 or 514-426-7340
Telephone:   ENGLISH: 800-361-6550 or 514-426-7344
Atlantic Provinces & Ontario:   800-361-6550
Fax Orders:   888-428-7400 or 514-428-7400
Telephone Orders:  
Manitoba/Saskatchewan/Alberta/British Columbia:   800-661-3134 or 403-236-7363
Fax Orders:   403-236-5196
Every effort has been made to ensure the accuracy of the Gentocin Ophthalmic Solution information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Gentocin Ophthalmic Solution product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-12-03

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