Gentocin Sterile Ophthalmic Solution (Canada)

Sterile Ophthalmic Solution

Manufacturer: Merck Animal Health

DIN 00241636

VETERINARY USE ONLY

Description

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. Gentocin ophthalmic solution is a sterile antibiotic aqueous solution for ophthalmic use in veterinary practice. Ingredients: Each mL contains: Medicinal ingredient: Gentamicin (as sulfate USP) 3 mg. Non-medicinal ingredients: disodium phosphate 2.9 mg, monosodium phosphate 0.1 mg, sodium chloride 7.4 mg, purified water q.s. Preservative: benzalkonium chloride 0.05 mg.

Gentocin Sterile Ophthalmic Solution Indications

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.

Gentocin Sterile 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.

Contraindications

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

Warning

Keep out of reach of children

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.

Clinical 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.

Microbiology

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

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

Storage

Store between 2° and 25°C.

How Supplied

Gentocin ophthalmic solution is packaged in 5 mL squeeze dropper plastic bottle.

References

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.

INTERVET CANADA CORP., KIRKLAND, QUÉBEC

H9H 4M7, 1-888-306-0069

Rev.13NOV2009

Nac No.

12080495