Anupco


ANCOSOLONE

Oral tablets

COMPOSITION

Prednisolonum 5 mg/20 mg – Lactosum monohydricum – Amylum solani – Polyvidonum-á Silica colloidalis anhydrica – Talcum – Magnesii stearas – Aqua purificata – q.s. pro compresso uno

PHARMACOLOGICAL PROPERTIES

Prednisolone isá a synthetic glucocorticosteroid, with two main pharmacological activities:

1) action on the carbohydrate, protein and fat metabolism with stimulation of the gluconeogenesis in the liver, resulting in increased glycogen storage in the liver and hyperglycemia.

2) an anti-inflammatory action (including anti-allergic and immunosuppressive action).

When administered orally, prednisolone is almost completely absorbed. Following metabolism in the liver, it is mainly conjugated with glucuronic acid and excreted with the urine. Only a small fraction (▒ 10%) is excreted unchanged.

INDICATIONS

ANCOSOLONE tablets are indicated for symptomatic treatment of inflammatory, allergic and immunopathologic conditions in dogs. They can be used in control of pruritis and skin lesions associated with dermatologic disorders (eg. parasitic dermatitis and flea allergy, atopic dermatitis, contact dermatitis, lick dermatitis, pyotraumatic dermatitis, seborrhoea, auto-immune disease: pemphigus-pemphigoid complex, systemic lupus erythematosus) and otitis externa; in musculoskeletal disorders (e.g. non-erosive polyarthritis and myositis) and some chronic neurological disorders (e.g. meningitis-arteritis, meningomyelitis).

CONTRA-INDICATIONS

Diabetes mellitas, renal insufficiency, Cushingoid syndrome, viral infections and gastro-intestinal ulcers are absolute contra-indications. Caution should be taken in case an infection is present or suspected and, if necessary, an appropriate antimicrobial, antiparasitic or antimycotic treatment should be given. Caution should be taken when used in animals with congestive heart insufficiency, hypertensia, osteoporosis, predisposition to thrombophlebitis, liver disease and hypoalbuminemia.

DOSAGE AND MODE OF ADMINISTRATION

ANCOSOLONE tablets are orally administered. The dosage schedule given underneath should be interpreted only as an initial guideline. It may be necessary to adjust the doses according to the individual clinical situation.

Initial dose: 1 mg prednisolone/ kg b.w./ day or 1 tablet per 5 kg b.w. divided over 2 equal administrations per day for 3-7 days (range 0.5-2mg/ kg b.w./ day).

Tapering: 1 mg prednisolone/ kg b.w./ day or 1 tablet per 5 kg b.w. every morning for 1 week. Then reduce the dose by half each 5-7 days.

Maintenance: Change to alternate-day therapy: 1 mg predn./ kg b.w. or 1 tablet per 5 kg b.w. given on alternate mornings. Then reduce the dose by half until a minimum dose is reached. Satisfactory control of clinical symptoms can be obtained in most cases of chronically affected dogs with 0.25-0.5 mg predn./ kg b.w. or 1/2 to 1 tablet per 10 kg b.w. every other morning.

UNDESIRABLE EFFECTS

Undesirable effects are linked to the pharmacological actions of prednisolone on carbohydrate, protein and lipid metabolism, water-electrolyte balance, host defence mechanisms, and endocrine functions. In general the frequency and severity of side effects are dose-related and depend on the frequency of administration, the duration of therapy and on the individual sensitivity of the animal. Although side-effects may occur after short-term administration, they mostly occur with long-term therapies (symptoms of iatrogenic hyperadrenocorticism, Cushing’s syndrome) and/ or abrupt cessation of therapy (symptoms of iatrogenic hypoadrenocorticism). Gradual cessation of therapy is usually followed by complete recovery.

SPECIAL PRECAUTIONS FOR USE AND WARNINGS

Whenever possible, ethiologic therapies always should be applied. Prolonged prednisolone therapy should be tapered progressively to the lowest possible level. For maintenance therapy, alternate-day therapy is recommended, as this minimizes the suppression of the hypothalamic-pituitary-adrenal axis and drug-related side effects.

PACK SIZE

Plastic container with 30 or 60 tablets.

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