Y.S.P. PREDNISOLONE Tablet

For the treatment of bronchial asthma, allergic disease, rheumatoid arthritis, rheumatosis, Still’s disease, rheumatoid myocarditis, psoriasis, osteoarthritis, rheumatic myelitis, gouty arthritis, acute and chronic gout and other inflammatory skin disease.

Dosage and Administration

- Diseases of connective tissue:

Rheumatoid arthritis: Initially 5mg daily, given as a single dose in the morning or on alternate days: the dosage regimen is adjusted to individual patient response. In the absence of adequate improvement, steroid dose may be raised by 1mg increments, at intervals of a few weeks, up to a maximum of 10mg daily.

Rheumatic carditis: Corticosteroids are indicated in patients who fail to respond to salicylates or cannot tolerate them in high doses. The dose usually is 1mg/kg/day given in a single or divided doses for 7-10 days, thereafter reduced by 2.5mg daily every 5-7 days.

- Asthma and other respiratory diseases:

Prednisolone 5-10mg orally as a single daily dose or in divided doses. Larger doses may be required temporarily during exacerbations. (For other cases, the initial adult dosage of Prednisolone may range from 5-60mg daily, depending on the disease being treated, and is usually administered in 2-4 divided doses. The dose may be decreased by a half to 1 tablet every 2-3 days interval for maintenance after an improvement is seen. The dosage may be adjusted according to symptoms and age. To be dispensed on physician’s prescription.)

In patient with systemic fungal infections and those who have shown hypersensitivity to any component of this product.

The prolonged therapy may result in suppression of pituitary adrenal function and the principal complications resulting from prolonged therapy with Prednisolone are fluid and electrolyte disturbances, hyperglycemia and glycosuria;

increased susceptibility to infections, including tuberculosis;

peptic ulcers which may bleed or perforate;

osteoporosis;

a characteristic myopathy;

behavioral disturbances;

posterior subcapsular cataracts;

arrest of growth;

Cushing’s habitus, consisting of “moon face”, “buffalo hump”, enlargement of supraclavicular fat pads, “central obesity”, striae, ecchymoses, acne and hirsutism.

See the package insert about the details below:

- Anticonvulsant drugs (Barbiturates, Phenytoin)

- Rifampicin

- Cyclosporine

- Corticosteroids

- NSAIDs

- Antacids

- Insulin

The use of Prednisolone in pregnancy, nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards, to the mother and embryo or fetus.

The adverse effects of Prednisolone are nearly always due to its use in excess of normal physiological requirement. They should be treated symptomatically, where possible, the dosage being reduced or the drug slowly withdrawn.

Prednisolone may mask some signs of infections and new infections may appear during its use. There may be decreased resistance and inability to localize infection when Prednisolone is used.

Because of possibility of fluid retention, care must be taken when corticosteroids are administered to patients with congestive heart failure.

Corticosteroids may worsen diabetes mellitus, osteoporosis, hypertension, glaucoma and epilepsy. Care should be taken when there is a history of severe affective disorders (esp. severe history of steroid psychosis), previous steroid myopathy or peptic ulceration.

1. Prednisolone can decrease or prevent tissue responses to inflammatory processes, thereby reducing development of symptoms of inflammation without affecting the underlying cause. Prednisolone inhibits accumulation of inflammatory cells including macrophages and leukocytes at sites of inflammation. It also inhibits phagocytosis, lysosomal enzyme release, and synthesis and/or release of several chemical mediators of inflammatory.

2. Prednisolone is readily absorbed from the gastrointestinal tract and already exists in a metabolically active form, biological half-life is about 60 minutes.

3. Peak plasma concentration obtained 1-2 hours after oral administration. It has a usual plasma half-life of 2-3 hours and is excreted in the urine as free and conjugated metabolites. Prednisolone crosses the placenta and small amounts are excreted in breast milk.