Generic Name and Formulations:
Prednisolone (as sodium phosphate) 10mg, 15mg, 30mg; orally-disintegrating tabs; grape flavor.
Company:
Concordia Pharmaceuticals Inc.
Indications for ORAPRED ODT:
Steroid-responsive disorders.
Adult:
See full labeling. Tabs: swallow whole or dissolve on tongue; do not break or use partial tabs. Initially 5–60mg/day.
Children:
See full labeling. Tabs: swallow whole or dissolve on tongue; do not break or use partial tabs. Initially 0.14–2mg/kg per day in 3–4 divided doses.
Contraindications:
Systemic mycoses. Live vaccinations. Cerebral malaria.
Warnings/Precautions:
Tuberculosis. Latent infection (esp. amebiasis). Hypo- or hyperthyroidism. Cirrhosis. Ocular herpes simplex, optic neuritis: not recommended. Avoid exposure to chickenpox or measles; consider prophylactic passive immune therapy if exposure occurs. Renal insufficiency. Ulcerative colitis if perforation pending. Diverticulitis. Peptic ulcer. Hypertension. CHF. Osteoporosis. Diabetes. Supplement with additional steroids in physiologic stress. Avoid abrupt cessation. Alternate, intermittent or single-daily doses at 8AM minimize adrenal suppression. Monitor weight, growth, fluid and electrolyte balance, and intraocular pressure. Emotional instability. Psychotic tendencies. Pregnancy (Cat.C). Nursing mothers.
Interactions:
Effects may be decreased by hepatic enzyme inducers (eg, barbiturates, hydantoins, rifampin). May be potentiated by ketoconazole estrogens. Acute myopathy with neuromuscular blockers. Avoid aspirin. Cyclosporine: both drugs potentiated and seizures reported. Monitor warfarin, antidiabetic agents. Avoid anticholinesterases. Monitor if given with potassium-depleting agents, digoxin.
See Also:
ORAPRED
Pharmacological Class:
Glucocorticoid.
Adverse Reactions:
HPA axis suppression, masks infection, increased susceptibility to infection, glaucoma, cataracts, secondary infections, hypokalemia, hypocalcemia, hypernatremia, hypertension, psychic disorders, myopathy, osteoporosis, peptic ulcer, dermal atrophy, increased intracranial pressure, carbohydrate intolerance.
How Supplied:
Soln—237mL; Tabs—48