Cortavance Topical Spray Solution (Canada)

Company: Virbac

Hydrocortisone Aceponate Topical Spray Solution

VETERINARY USE ONLY

DIN 02376482

Description

CORTAVANCE^® Topical Spray is formulated with the active ingredient hydrocortisone aceponate, 0.584 mg/mL in a suitable solvent, propylene glycol methyl ether for dermatologic use in dogs. Hydrocortisone aceponate is a dermocorticoid with a potent intrinsic glucocorticoid activity.

Cortavance Topical Spray Solution Indications

CORTAVANCE^® Topical Spray is indicated for the symptomatic treatment of inflammatory and pruritic skin conditions in dogs.

THERAPEUTIC CLASSIFICATION: Glucocorticoid.

ACTION: Hydrocortisone aceponate belongs to the diester class of glucocorticoids. Diesters are highly lipophilic substances of low plasma availability that effectively and rapidly penetrate the skin to accumulate at the site of inflammation without significant systemic absorption. Once inside the skin, the diesters are locally bioactivated to deliver targeted anti-inflammatory activity. In laboratory animals, hydrocortisone aceponate is eliminated like endogenous cortisol, through the urine and feces.

Dosage and Administration

Before administration, remove the cap and screw the pump spray on the bottle. The product is applied by activating the pump. Spray from a distance of about 10 cm above the area of skin to be treated. The recommended dose is 1.52 µg of hydrocortisone aceponate per cm² of skin surface. This dose can be achieved with 2 pump spray activations over a 10 cm x 10 cm square surface area of skin. The spray microdroplets are designed to disperse through the coat to penetrate the skin so no shaving is required (except with extra long hair coat). Leave treated area to dry. Presented as a volatile spray, this product does not require any massage. Care should be taken to avoid spraying in the eyes of the dog. Repeat treatment once daily for 7 consecutive days. If no improvement is seen within 7 days, treatment should be re-evaluated by the veterinarian.

Contraindications

Do not use on cutaneous ulcers.

CAUTIONS: Total body surface treated with CORTAVANCE^® Topical Spray should not exceed a surface corresponding to, for example, two flanks from the spine to mammary chains including the shoulders and thighs (1/3 of dog’s body). Avoid spraying in the eyes of the dog. In the case of concurrent microbial, fungal infections and flea infestations, dogs should receive appropriate treatment. If a favourable response does not occur promptly, treatment should be discontinued until the infection has been adequately controlled. Not for use in animals with hyperadrenocorticism (Cushing’s Disease). Since glucocorticoids are known to slow growth, use in young animals (under 7 months of age) is not recommended. Not for use in breeding, pregnant or lactating animals, as the safety of CORTAVANCE^® Topical Spray has not been established. As with all glucocorticoids, the use of this product may adversely affect the Hypothalamic Pituitary Adrenal axis (HPA axis). Do not exceed the recommended dose or duration of treatment. Not for use in sick or debilitated animals. It is not recommended to apply other topical preparations simultaneously on the same lesion.

Warnings

Keep out of reach of children. In case of accidental contact with skin, it is recommended to wash thoroughly with water. Wash hands after use. Avoid contact with eyes. In case of accidental eye contact, rinse with abundant quantities of water. In case of eye irritation, seek medical advice.

Avoid inhalation of CORTAVANCE^® Topical Spray.

In case of accidental ingestion, seek medical advice immediately and show the labelling to the physician.

Spray in a well-ventilated area. Flammable. Do not spray on naked flame or any incandescent material.

Adverse Reactions

Although not all adverse reactions are reported, the following adverse reaction information is based on voluntary post-approval drug experience reporting. It is generally recognized that this method of reporting results in significant under-reporting of adverse drug reactions. It should be noted that suspected ADRs listed here reflect reporting and not causality. Transient local reactions at the application site (erythema and/or pruritus) can occur in very rare cases (less than 1 in 10,000 animals).

SAFETY AND EFFICACY STUDY INFORMATION: The safety of CORTAVANCE^® Topical Spray in dogs was demonstrated in two studies using 1X, 3X and 5X the therapeutic dose for 14 consecutive days in young dogs. Dogs with 3X and 5X the recommended dose for twice the recommended duration of treatment resulted in a reduced capacity for production of cortisol that was reversible within 7 to 9 weeks after the end of treatment. No adverse effects were seen during the clinical studies. Clinical efficacy of CORTAVANCE^® Topical Spray has been demonstrated in a multi-site, controlled clinical field trial in dogs under normal conditions of use. In this study, 105 dogs (54 dogs treated with CORTAVANCE^® Topical Spray; 51 dogs as positive control) representing 33 breeds were diagnosed with the following Skin Dermatoses:

At day 7 (the day after last treatment), 50% (27/54) had recovered, 42.6% (24/54) had improvement in skin lesions and 7.4% (4/54) had no improvement. After 7 days of treatment, CORTAVANCE^® Topical Spray had significantly reduced pruritus scores and skin lesion scores.

Storage

Store below 25°C. Do not freeze. Keep container closed when not in use and protected from light and humidity. Use within 6 months after opening.

How Supplied

CORTAVANCE^® Spray is available in a 31 mL or 76 mL plastic container equipped with a spray pump.

Imported/Distributed in Canada by: Virbac Canada, Inc., 231, Shearson Crescent, Suite 209, Cambridge (Ontario) N1T 1J5. 1-800-338-3659

Rev date: 2022/01

CORTAVANCE is a registered trademark of Virbac S. A.

© 2022 Virbac Corporation. All Rights Reserved.

11607 - 11608

84176501

CPN: 1177065.2