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Prednisolone Tablet

Brand and Other Names: ORAPRED
Mechanism of Action:

Prednisolone is a synthetic adrenocortical steroid drug with predominantly glucocorticoid properties. Some of these properties reproduce the physiological actions of endogenous glucocorticosteroids, but others do not necessarily reflect any of the adrenal hormones' normal functions; they are seen only after administration of large therapeutic doses of the drug. The pharmacological effects of prednisolone which are due to its glucocorticoid properties include: promotion of gluconeogenesis; increased deposition of glycogen in the liver; inhibition of the utilization of glucose; anti-insulin activity; increased catabolism of protein; increased lipolysis; stimulation of fat synthesis and storage; increased glomerular filtration rate and resulting increase in urinary excretion of urate (creatinine excretion remains unchanged); and increased calcium excretion. Depressed production of eosinophils and lymphocytes occurs, but erythropoiesis and production of polymorphonuclear leukocytes are stimulated. Inflammatory processes (edema, fibrin deposition, capillary dilatation, migration of leukocytes and phagocytosis) and the later stages of wound healing (capillary proliferation, deposition of collagen, cicatrization) are inhibited. Prednisolone can stimulate secretion of various components of gastric juice.Suppression of the production of corticotropin may lead to suppression of endogenous corticosteroids. Prednisolone has slight mineralocorticoid activity, whereby entry of sodium into cells and loss of intracellular potassium is stimulated. This is particularly evident in the kidney, where rapid ion exchange leads to sodium retention and hypertension.

Indications:

Orapred ODT is a corticosteroid indicated

  • as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation
  • for the treatment of certain endocrine conditions
  • for palliation of certain neoplastic conditions
Route: Oral
Dose:

Individualize dosing based on disease severity and patient response:

  • Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of prednisolone sodium phosphate)
  • Maintenance Dose: Use lowest dosage that will maintain an adequate clinical response (2
  • Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy
  • Take with food to avoid gastrointestinal (GI) irritation 
Adverse Reactions:

Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.

Contraindication:

Hypersensitivity to prednisolone or any components of this product. 

Warnings and Precautions:

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and hyperglycemia: Monitor patients for these conditions with chronic use. Taper doses gradually for withdrawal after chronic use.

Immunosuppression and Increased Risk of Infection: Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection. Signs and symptoms of infection may be masked.

Elevated blood pressure, salt and water retention and hypokalemia: Monitor blood pressure and sodium, potassium serum levels. 

GI perforation: increased risk in patients with certain GI disorders. Signs and symptoms may be masked. 

Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. Existing conditions may be aggravated. 

Decrease in bone density: Monitor bone density in patients receiving long term corticosteroid therapy.

Ophthalmic effects: May include cataracts, infections and glaucoma. Monitor intraocular pressure if corticosteroid therapy is continued for more than 6 weeks. 

Live or live attenuated vaccines: Do not administer to patients receiving immunosuppressive doses of
 orticosteroids.

Negative effects on growth and development: Monitor pediatric patients on long-term corticosteroid therapy. 

Embryo-Fetal Toxicity: Can cause fetal harm with first trimester use. Advise patients of potential harm to the fetus. 

See package insert for full prescribing information.