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Gentocin Durafilm (Canada)

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

Gentocin Durafilm

This treatment applies to the following species:
Manufacturer: Merck Animal Health

DIN 00256536

Gentamicin sulfate and betamethasone acetate ophthalmic solution, USP

VETERINARY USE ONLY

STERILE

Description

GENTOCIN® DURAFILM® is a sterile antibiotic anti-inflammatory glucocorticoid colloidal aqueous solution for ophthalmic use in veterinary practice.

Each milliliter of buffered aqueous solution contains: 3 mg gentamicin (as sulphate) and 1 mg betamethasone acetate as active ingredients and 0.1 mg benzalkonium chloride as preservative.

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

Betamethasone is a potent synthetic glucocorticoid. It is 9-α-Fluoro-11β, 17, 21-trihydroxy-16β-methylpregna-1, 4-diene-3, 20 dione.

Therapeutic classification: antibiotic-glucocorticoid

Gentocin Durafilm Indications

GENTOCIN DURAFILM is indicated for the treatment of inflammation and of external bacterial infections of the eye in dogs.

Dosage and Administration

The application of GENTOCIN DURAFILM should be adapted to the specific needs of each individual case.

A maximum of two drops of the solution may be instilled into the conjunctival sac of each eye up to four times a day for a maximum duration of 14 days.

Contraindications

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

GENTOCIN DURAFILM is also contraindicated where there is deep ulceration without vascularization, in the initial treatment of corneal ulcers and in all conditions of fungal and viral origin. Viral, fungal diseases and tuberculosis may all be enhanced by the glucocorticoids and in such cases appropriate therapy should be instituted.

Cautions: The antibiotic sensitivity of the infective organism should be determined before use. The use of this drug is not indicated in cases of non-susceptible bacteria. In deep-seated infections or when there is a systemic infection, specific systemic antimicrobial therapy should be considered. Systemic effects of the glucocorticoid betamethasone may occur.

Glucocorticoids can affect the regulation of diabetes mellitus. Use of glucocorticoids, depending on dose, duration and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal.

Topical glucocorticoids may cause increased intra-ocular pressure. In human medicine, in diseases that cause thinning of the cornea, perforation of the latter has been known to occur with topical steroids.

Safety has not been established in dogs less than 5 months of age or in breeding, pregnant or lactating animals.

Warnings

Keep out of reach of children.

Adverse Reactions

A transient stinging sensation common to many ophthalmic preparations may occur but usually does not require cessation of the treatment. If the condition being treated worsens or irritation occurs, contact a veterinarian immediately.

Other information:

Pharmacology

GENTOCIN DURAFILM incorporates polyoxyl 40 stearate and polyoxyethylated vegetable oil to provide a colloidal dispersion of the active ingredients. This colloidal solution covers the conjunctival surface with a clear, quickly spreading film and ensures the prolonged contact of the therapeutic components with all accessible structures.

GENTOCIN DURAFILM provides the antibacterial properties of gentamicin sulphate with the anti-inflammatory action of betamethasone acetate.

Gentamicin sulphate is a broad spectrum aminoglycoside antibiotic which is effective in the treatment of primary and secondary infections of the eye and surrounding tissue. 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 and Neisseria. Among the gram-positive bacteria, in vitro sensitivity has been shown for Staphylococcus species and some Streptococci.

Betamethasone produces the hormonal and metabolic effects common to glucocorticoid steroids. Studies in man show the glucocorticoid activity of betamethasone to be 10 to 15 times greater than prednisone. As such, betamethasone helps control excessive tissue inflammatory reactions to infections, allergens and trauma. The corticoids control the inflammatory and exudate phases of eye conditions, particularly those affecting the anterior chamber and external structures of the eye. However, they do not curtail the growth of causative organisms. Betamethasone therapy may reduce the damaging sequelae in certain eye diseases and injuries as well as scarring and vascularization, and appears to alter the usual tissue response to injury. In initial acute phases of inflammation, local application of betamethasone provides prompt, symptomatic relief, accomplishing temporary control of the exudative phase, whether of bacterial, allergic, or traumatic origin. Betamethasone also inhibits fibroblast formation during tissue repair.

It has been shown that gentamicin administered topically is capable of penetrating both the normal and inflamed eye. Any amount of gentamicin absorbed in the circulatory system is excreted unchanged in the urine by glomerular filtration. Any absorbed betamethasone, like other glucocorticoids, undergoes extensive molecular transformation and is practically entirely excreted in the urine within 72 hours.

Animal Safety: GENTOCIN DURAFILM was administered for 14 consecutive days to healthy Beagle dogs at a dose of 2 drops/eye 4 times daily (1X maximum daily dose; 8 dogs), 4 drops/eye 4 times daily (2X maximum daily dose; 8 dogs), and 6 drops/eye (3X maximum daily dose; 8 dogs). Eight dogs received 6 drops of sterile saline/eye 4 times daily (0X). A mild serous ocular discharge was observed in GENTOCIN DURAFILM-treated dogs in a dose-related manner, which resolved uneventfully within a few hours of dosing. Mild bilateral scleral redness was seen in the 2X and 3X groups between Days 4-8 which spontaneously resolved without any complications or sequelae. Polyuria, a commonly observed side effect associated with corticosteroid therapy in dogs, was also identified in the study. Polyuria was evident in 1 of 8 dogs in the 3X group on Day 2. Likewise, polyuria was evident in a dose proportional manner in all three treatment groups after 14 days of dosing. Only 3 of 8 dogs had polyuria in the 1X group. In contrast, 7 of 8 and 8 of 8 animals from the 2X and 3X groups respectively had polyuria. Dogs administered GENTOCIN DURAFILM had increased food consumption compared to dogs in the control group. Changes in hematology parameters included neutrophilia, lymphopenia and eosinopenia. These changes are attributed to the glucocorticoid. A reduced reticulocyte count was observed in the GENTOCIN DURAFILM treated dogs and attributed to the gentamicin component of the drug. Alanine aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase were increased after 14 days of administration of GENTOCIN DURAFILM. The increase is attributed to steroid therapy and due to enzyme induction. GENTOCIN DURAFILM administration also resulted in an increase in triglyceride, albumin, globulin, and total protein levels. Creatine kinase concentration decreased. The serum chemistry changes are consistent with dogs treated with glucocorticoids.

Storage

Store between 2° and 25°C.

How Supplied

GENTOCIN DURAFILM is packaged in 10 ml squeeze dropper white plastic bottle with a 5 ml fill.

Rev. August 3, 2015

INTERVET CANADA CORP., subsidiary of Merck & Co., Inc., 16750, route Transcanadienne, KIRKLAND QUÉBEC.

H9H 4M7, 1-866-683-7838

® Intervet Canada Corp.

CPN: 1208048.4

MERCK ANIMAL HEALTH
Intervet Canada Corp.

16750 ROUTE TRANSCANADIENNE, KIRKLAND, QC, H9H 4M7
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Website:   www.merck-animal-health.ca
Every effort has been made to ensure the accuracy of the Gentocin Durafilm information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2016 North American Compendiums. Updated: 2016-10-31

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