Hydrocortisone aceponate 0.584 mg/ml

Cutaneous spray, solution.

Target species
Dogs

Indications for use
For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.

Contra-indications
Do not use on cutaneous ulcers.

Special warnings for each target species
Total body surface treated should not exceed a surface corresponding for example to a treatment of two flanks from the spine to the mammary chains including the shoulders and the thighs. Otherwise, use only according to the risk-benefit assessment and subject the dog to regular clinical evaluations.

Special precautions for use in animals
In the case of concurrent microbial disease or parasitic infestation, the dog should receive appropriate treatment for such conditions. In the absence of specific information, the use in animals suffering from Cushing’s syndrome shall be based on the risk-benefit assessment. Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age) shall be based on the risk-benefit assessment and subject to regular clinical evaluations.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental skin contact, 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. In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to the physician.
Spray preferably in a well ventilated area.
Flammable. Do not spray on naked flame or any incandescent material. Do not smoke while handling the veterinary medicinal product.

Use during pregnancy or lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for teratogenic, foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs.
Use only according to the risk-benefit assessment by the responsible veterinarian.

Interactions<br /> In the absence of information, it is recommended not to apply other topical preparations simultaneously on the same lesions.
Amounts to be administered and administration route
Cutaneous use.
Before administration, screw the pump spray on the bottle.
The veterinary medicinal product is then applied by activating the pump spray, from a distance of about 10 cm from the area to be treated.
The recommended dosage is 1.52 µg of hydrocortisone aceponate/cm2 of affected skin per day. This dosage can be achieved with two pump spray activations over the surface to be treated equivalent to a square of 10 cm x 10 cm. Repeat the treatment daily for 7 consecutive days.
Care should be taken to avoid spraying into the eyes of the animal.
Presented as a volatile spray, this veterinary medicinal product does not require any massage.
In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the veterinary medicinal product to the risk-benefit assessment.
If signs fail to improve within 7 days, treatment should be re-evaluated by the veterinarian.

Overdose
After topical application on the skin at the recommended therapeutic dosage and twice the recommended duration of treatment and up to a body surface area corresponding to the two flanks, from the spine to the mammary chains including the shoulder and the thighs, no systemic effects are observed.
Tolerance studies using 3 and 5 times the recommended dosage for twice the recommended duration of treatment resulted in a reduced capacity for production of cortisol, that is fully reversible within 7 to 9 weeks after the end of treatment

Withdrawal periods
Not alicable

Pharmacodynamic properties The veterinary medicinal product contains the active substance hydrocortisone aceponate.
Hydrocortisone aceponate (HCA) is a dermocorticoid with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to a quick improvement of skin lesions observed in case of inflammatory and pruritic dermatosis.

Pharmacokinetic properties HCA belongs to the diesters class of the glucocorticosteroids.
The diesters are lipophilic components ensuring an enhanced penetration into the skin associated to a low plasma availability. HCA thus accumulates in the dog’s skin allowing local efficacy at low dosage. The diesters are transformed inside the skin structures. This transformation is responsible for the potency of the therapeutic class. In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
Topical application of diesters results in high therapeutic index: high local activity with reduced systemic secondary effects.

Excipients
Propylene glycol methyl ether

Major incompatibilities
None known.

Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 6 months.

Special precautions for storage
None

Immediate packaging

Box containing a polyethylene terephtalate (PET) bottle filled with 76 ml of solution, closed with an aluminium screw cap and a pump spray.

Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

POM-V