Prednicort 8Mg

WARNINGS & PRECAUTIONS

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Corticosteroids may mask some signs of infection and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi or viruses. Average and large doses of hydrocortisone or cortisone may cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. While on corticosteroid therapy, patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high doses, because of possible hazards of neurological complications and lack of antibody response. The use of PREDNICORT in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate ant tuberculous regiment. If corticosteroids are indicated in patients with talent tubercu10SiS or tuberculin reactivity, Close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Osteoporosis is a common but infrequently recognized adverse effect associated with Longterm use of large doses of glucocorticoid.

ADVERSE REACTIONS

Fluid and electrolyte disturbances: sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis and hypertension. Musculoskeletal: muscle weakness, steroid myopathy, osteoporosis, vertebral compression fractures, aseptic necrosis, and pathologic fractures. Gastrointestinal: peptic ulceration with possible perforation and hemorrhage, gastric hemorrhage, perforation of the bowel, pancreatitis, abdominal distention and ulcerative esophagitis. Increases in alanine transaminase (ALT, SGPT), aspartate transaminase, (AST, SGOT) and alkaline phosphatase have been Observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation. Dermatologic: impaired wound healing, thin fragile skin, petechiae and ecchymosis, facial erythema, and increased sweating. Neurological: increased intracranial pressure, pseudotumor cerebri, psychic derangements, and seizures. Endocrine: development of Cushingoid state, suppression of pituitary-adrenal axis, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress as in trauma, surgery or illness, menstrual irregularities, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics, suppression of growth in children. Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.

PT Otto Pharmaceutical Industries