Isaderm Gel (Canada)

Company: Dechra

DIN 02427850

Active Ingredients

Fusidic acid (as fusidic acid hemihydrate) 0.5% w/w

Betamethasone (as betamethasone valerate) 0.1% w/w

Topical antibiotic/Corticosteroid

For veterinary use only

Description

Isaderm is a white translucent carbomer gel. Each gram of Isaderm contains 5 mg of fusidic acid (as hemihydrate, Ph. Eur.) and 1 mg of betamethasone (as betamethasone 17-valerate, Ph. Eur.). Non-medicinal ingredients include: methyl parahydroxybenzoate and propyl parahydroxybenzoate as preservative, carbomer (carbopol 974), polysorbate 80, dimethicone, sodium hydroxide, and purified water.

Pharmacology

Fusidic acid, the active antibacterial component of Isaderm, exerts its antibacterial action by interfering with bacterial protein synthesis. Fusidic acid exhibits in vitro activity against a number of Gram-positive and Gram-negative cocci.

Almost all strains of Staphylococci, including penicillinase producing strains, demonstrate in vitro sensitivity to fusidic acid. Fusidic acid is highly effective against Staph. intermedius which plays a pivotal role in complicating surface pyoderma in dogs.

Betamethasone 17-valerate is a corticosteroid that possesses anti-inflammatory and anti-pruritic properties.

Indication: Isaderm gel is indicated for the topical treatment of surface pyoderma in the dog such as acute moist dermatitis (i.e. hot spots) and intertrigo (skin fold dermatitis).

Dosage and Administration

Apply Isaderm to the affected area twice daily for 5 to 7 days. Apply sufficiently to affected area and massage gently into skin. If there is no response to treatment within 3 days or if the condition deteriorates, then the diagnosis should be re-evaluated.

Warnings

Human risks: Betamethasone 17-valerate can be absorbed percutaneously and may cause temporary suppression of adrenal function. Wash your hands thoroughly after applying the gel to your dog.

Corticosteroids may produce irreversible effects in the skin; they can be absorbed and may have harmful effects, especially with frequent and extensive contact or in pregnancy. Avoid getting the gel into your eyes, since it may cause stinging. If this should happen wash with water.

Keep Isaderm out of the reach of children.

Isaderm Gel Caution

Prolonged treatment or treatment of large surface areas should be avoided. Discontinue use if hypersensitivity develops to the product.

Contraindications

Isaderm gel is contraindicated for use in the following situations: in animals with hypersensitivity to any of the components of the gel; in pregnant bitches as corticosteroids may cause abortion or early parturition; for the treatment of deep pyoderma for which corticosteroids are contraindicated; where fungal infection is present; and in the presence of corneal ulceration.

Adverse effects: Topically applied steroids may cause local thinning of the skin.

Experimentally it has been demonstrated that corticosteroids, especially at high doses, may delay wound healing.

The immunosuppressant actions of corticosteroids may weaken resistance to or exacerbate existing infections. In the presence of viral infections, steroids may worsen or hasten the progression of the disease. Extensive percutaneous absorption may cause temporary suppression of the hypothalamo-pituitreal-adrenal axis. Following cessation of treatment, symptoms of adrenal insufficiency can arise and this may render the animal unable to deal adequately with stressful situations.

Adverse systemic reactions, including gastrointestinal ulceration, have been observed following oral ingestion of some topical corticosteroid preparations.

Storage

Store below 25°C. Do not refrigerate or freeze.

Do not use after expiry date.

How Supplied

15 g and 30 g tubes.

Information for the customer: Complete the full treatment course as prescribed by your veterinarian. Do not use Isaderm on other skin conditions unless prescribed by your veterinarian. Should the skin condition occur again at a later date, do not use the gel without consulting your veterinarian.

Isaderm was prescribed for your dog only, and it should not be used on other dogs.

If you forget to use Isaderm at any time, use it as soon as you remember, then continue use as before. If your dog’s skin condition has not started to improve after 3 days of treatment or if the condition gets worse, consult your veterinarian. Avoid getting the gel into your own or your dog’s eyes, since it may cause stinging. If it gets into the eyes then bathe them with water. Although Isaderm is a fast-drying gel, the dog should be prevented from licking the treated area. It may be helpful to apply the gel immediately before feeding or before taking the dog for a walk in order to distract the dog’s attention.

Wash your hands thoroughly after applying the gel to your dog. Steroids can be absorbed and may have harmful effects, especially with frequent and extensive contact or in pregnancy.

Dechra Veterinary Products A/S, Mekuvej 9, DK-7171 Uldum, Denmark

Imported and distributed by: Dechra Veterinary Products Inc., 1 Holiday Avenue, East Tower, Suite 345, Pointe-Claire, Quebec, Canada, H9R 5N3

F1047

CPN: 1786008.0