ORAPRED ODT

Absorption: Oral administration of single doses of 30 mg prednisolone base equivalent of Orapred ODT, and Pediapred Solution to 21 adult volunteers yielded comparable pharmacokinetic data: Table 1. Comparison of Mean Pharmacokinetic Parameters (%CV) in Healthy Volunteers Following a Single Dose of 30 mg Orapred ODT and Pediapred Solution, Dose Administered under fasting conditions. AUC 0- ∞ (ng∙hr/mL) C max (ng∙hr/mL) Mean values of 21 normal volunteers (30 mg prednisolone base equivalent) (± S....

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. Allergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture fol...

Orapred ODT is contraindicated in patients who are hypersensitive to corticosteroids such as prednisolone or any components of this product. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. Hypersensitivity to prednisolone or any components of this product. ( 4 )

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. ( 5.1 ) 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. ( 5.2 ) Elevated blood pressure, salt and water retention a...

7 DRUG INTERACTIONS Aminoglutethimide: Aminoglutethimide may lead to loss of corticosteroid-induced adrenal suppression. Amphotericin B: There have been cases reported in which concomitant use of Amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see also Potassium depleting agents). Anticholinesterase agents: Concomitant use of anticholinesterase a...