Dermisolone® Tablets

Oral tablet.

Antiallergic – Steroidal anti-inflammatory.

Dogs and cats.

Each tablet contains:
Prednisolone base………………. 20 mg
Excipients c.s.p……… 1 tablet

It is indicated as an aid in the treatment of non-infectious inflammatory disorders, nonseptic arthropathies and in the treatment of allergic dermatitis; in chronic inflammatory bowel disease and as an immunosuppressant in tumor states.

Oral administration.

• Anti-inflammatory and anti-allergic therapy: 0.5 to 1 mg/kg in dogs and 1 to 2 mg/kg in cats, every 12 to 24 hours for 3 to 5 days.
  In case of prolonged treatments, it is recommended to reduce to the lowest effective dose and give in the alternate day regimen in the morning for dogs, and in the afternoon in cats (to respect the circadian rhythm).
• As an immunosuppressant : 2.2 to 3.3 mg/kg body weight, every 24 hours, for two days in a row and then 2 – 4 mg/kg every 48 hours. Assess the duration of treatment based on symptom severity and remission.
• Chronic inflammatory bowel disease: 1 – 2 mg/kg body weight daily for 2 to 4 weeks.

• As an anti-inflammatory and anti-allergic:
  Dogs: 1/4 – 1/2 tablet/10 kg weight every 12 to 24 hours for 3 to 5 days.
  Cats: 1/4 – 1/2 tablet/5 kg weight every 12 to 24 hours for 3 to 5 days.
  As an immunosuppressant: 1 – 1 1/2 tablets/10 kg body weight, every 24 hours, for two consecutive days and then 1 – 2 tablets/10 kg every 48 hours. Assess the duration of treatment based on symptom severity and remission.
• Chronic inflammatory bowel disease:
  1/2 – 1 tablet/10 kg body weight per day for 2 to 4 weeks in the treatment of chronic inflammatory bowel disease.

• Do not use in patients with systemic fungal infections or viral infections.
• Systemic therapy with prednisolone is contraindicated in animals with peptic ulcer, corneal ulcer, and Cushing’s syndrome.
• Do not administer to pregnant animals.
• Do not use in animals that are hypersensitive to some of the ingredients of this product.

• The therapeutic use of prednisolone is unlikely to cause glucocorticoid-associated metabolic effects. A delayed effect on wound healing has not been described, however, such a possibility should be considered when used in surgery.
• Prolonged treatment shows an increase in the incidence of osteoporosis, especially in older dogs. It is not recommended for use during the recovery phase of a bone fracture.
• The most common side effects are polyuria, polydipsia and polyphagia; and are preferably associated with anti-inflammatory doses.
• For immunosuppressive doses and extensive treatments, adverse reactions are more likely and potentially more pronounced. These effects, observed on rare occasions, manifest as symptoms of hyperadrenocorticism (Cushing’s syndrome): dull and dry coat, weight gain, panting, vomiting, diarrhea, hepatomegaly with the consequent alteration of the concentration of liver enzymes in the serum, pancreatitis, gastrointestinal ulceration (particularly when used with NSAIDs), lipidemias, alteration of insulin requirements, activation or intensification of diabetes mellitus, muscle wasting and changes in behavior (depression, lethargy, vices).

It is recommended to avoid concomitant administration of Prednisolone with:

• Amphotericin B or caliuretic diuretics (furosemide, thiazides), as hypokalemia may occur. Digitalis may increase the possibility of toxicity if hypokalemia occurs.
• Phenytoin, Phenobarbital and Rifampicin, because they can increase the metabolism of corticosteroids.
• Cyclosporine, because blood levels of both drugs can be increased with mutual inhibition of hepatic metabolism.
• With ulcerogenic drugs (e.g., nonsteroidal anti-inflammatory drugs) as the risk of gastrointestinal ulceration may be increased.
• Cyclophosphamide, as corticosteroids can inhibit hepatic chemotherapy metabolism.
• Patients treated with corticosteroids at immunosuppressive doses should generally not receive live attenuated vaccines, because viral replication may be enhanced.
• Insulin requirements may be increased in patients receiving glucocorticoids.

• In case of prolonged treatments with Prednisolone, a higher protein intake should be provided to keep the animal in a positive nitrogen balance.
• A delayed effect on wound healing has not been described, however, such a possibility should be considered when used in surgery.
• Prolonged glucocorticoid therapy may suppress adrenocortical activity, so discontinuation of adrenocortical activity should be performed in a graduated manner to ensure the gradual return of ACTH and endogenous corticosteroid functions.
• Administer with caution in animals with diabetes, osteoporosis, or recovering from bone fracture, predisposition to thrombophlebitis, hypertension, congestive heart failure, renal failure, or active tuberculosis.
• The anti-inflammatory effects can mask signs of infection.
• Administer with caution in growing animals as it may cause retardation.
• Administer with caution in animals with hepatic impairment.
• Prednisolone passes into milk and may induce negative effects in infants, but only if the mother receives high doses for long periods.
• Keep out of reach of children and pets.

Wash your hands after administering the product.

• Dispose of unused product residues in their original packaging.
• Do not dispose of the empty container or with product residues in rivers, lakes or natural water streams.
• Dispose of waste of this product with caution along with household waste.
• Contact the manufacturing company or companies specialized in waste disposal, to receive recommendations on the disposal of expired or unused products.

Store at a temperature between 15 and 30°C, away from light.

Sale by prescription to the Veterinary Doctor.

VETERINARY USE

Box with 10 tablets.

Chile: Reg. SAG N° 1745
Bolivia: Reg. SENASAG PUV-F-N° 005507/13
Costa Rica: Reg. No. MV-7365
Rep. Dominican: Reg. No. 12566

Laboratorio Drag Pharma Chile Invetec S.A. Lautaro N° 300 • Quilicura • Santiago • Chile