Known hypersensitivity to prednisone or any excipients in the formulation
WARNINGS AND PRECAUTIONS
Corticosteroids can cause 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
RAYOS may increase susceptibility to new infection and increase risk of exacerbation, dissemination or reactivation of latent infection. RAYOS may mask signs
and symptoms of infection. The rate of infectious complications increases with increasing doses of corticosteroids
Corticosteroids can cause elevated blood pressure, salt and water retention and hypokalemia. Monitor blood pressure and sodium, potassium serum levels.
RAYOS should be used with caution in patients with a history of recent myocardial infarction, congestive heart failure, hypertension or renal insufficiency
There is an increased risk of gastrointestinal (GI) perforation in patients with certain GI disorders. RAYOS may mask signs and symptoms of GI perforation
Corticosteroid use may be associated with behavioral and mood disturbances, including euphoria, insomnia, mood swings, personality changes, severe
depression and psychosis. Existing conditions may be aggravated
Corticosteroid use may lead to inhibition of bone growth in children and adolescents and the development of osteoporosis at any age. Give special consideration
to patients at increased risk of osteoporosis (eg, postmenopausal women) before initiating corticosteroid therapy, and bone density should be monitored in patients on long-term corticosteroid therapy
Prolonged use of corticosteroids may result in cataracts, infections and glaucoma. Monitor intraocular pressure if corticosteroid therapy is continued for more
than 6 weeks
Do not administer live or attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids
Long‐term use of corticosteroids can have negative effects on growth and development in children. Monitor pediatric patients on long‐term corticosteroid therapy
Fetal harm can occur with first trimester use of corticosteroids. Apprise women of potential harm to the fetus
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
INDICATIONS AND USAGE
RAYOS 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
For a complete list of indications for RAYOS, please see the full Prescribing Information.
For further information on RAYOS, please see full Prescribing Information at www.RAYOSrx.com/PI.
© 2012 Horizon Pharma
RAYOS is a registered trademark of Horizon Pharma.
All rights reserved. October 2013.