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Indications and usage:
Prednisone in a pharmaceutical form of corticosteroid tablets is indicated:
as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervoussystem, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation
for the treatment of certain endocrine conditions
for palliation of certain neoplastic conditions
Dosage and administration:
Individualize dosing based on disease severity and patient response. The timing of administration should take into account the delayed-release pharmacokinetics and the disease or condition being treated:
Initial dose: prednisone 5 mg administered once per day. Patients currently on immediate-release prednisone, prednisolone, or methylprednisolone should be switched to prednisone at an equivalent dose based on relative potency.
Maintenance dose: use lowest dosage that will maintain an adequate clinical response.
Discontinuation: withdraw gradually if discontinuing long-term or high-dose therapy.
Prednisone should be taken daily with food.
This medication should be swallowed whole and not broken, divided, or chewed.
The effects of accidental ingestion of large quantities of prednisone over a very short period of time have not been reported, but prolonged use of the drug can produce mental symptoms, moon face, abnormal fat deposits, fluid retention, excessive appetite, weight gain, hypertrichosis, acne, striae, ecchymosis, increased sweating, pigmentation, dry scaly skin, thinning scalp hair, increased blood pressure, tachycardia, thrombophlebitis, decreased resistance to infection, negative nitrogen balance with delayed bone and wound healing, headache, weakness, menstrual disorders, accentuated menopausal symptoms, neuropathy, fractures, osteoporosis, peptic ulcer, decreased glucose tolerance, hypokalemia, and adrenal insufficiency.Hepatomegaly and abdominal distention have been observed in children.
Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy the dosage of prednisone may be reduced only temporarily, or alternate day treatment may be introduced.
Dosage forms and strengths:
Prednisone 1 mg, 2 mg, 5 mg, 10 mg, 20 mg, 40 mg tablets for oral use.
Known hypersensitivity to prednisone or any excipients in the formulation.
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.
Infections: 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.
Decreases 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 corticosteroids.
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 patientsofpotential harm to the fetus.
Adverse reactions, side effects:
Common adverse reactions for prednisone and other corticosteroids include fluid retention, alteration in glucose tolerance, elevation in bl ood pressure, behavioraland mood changes, increased appetite and weight gain.
To report suspected side effects of prednisone contact your local FDA.
Anticoagulant agents: prednisone may enhance or diminish anticoagulant effects.
Antidiabetic agents: may increase blood glucose concentrations. Dose adjustments of antidiabetic agents may be required.
CYP 3A4 inducers and inhibitors: may, respectively, increase or decrease clearance of corticosteroids, necessitating dose adjustment.
Cyclosporine: increase in activity of both, cyclosporine and corticosteroid when administered concurrently. Convulsions have been reported with concurrent use.
NSAIDs including aspirin and salicylates: Increased risk of gastrointestinal side effects.
Patient counseling information:
Patients should be informed of the following information before initiating therapy with prednisone and periodically during the course of ongoing therapy.
Patients should be warned not to discontinue the use of prednisone abruptly or without medical supervision, to advise any medical attendants that they are taking it, and to seek medical advice at once should they develop fever or other signs of infection. Patients should be told to take prednisone exactly as prescribed, followthe instructions on the prescription label, and not stop taking this medication without first checking with their healthcare providers, as there may be a need for gradual dose reduction.
Patients should discuss with their physician if they have had recent or ongoing infections or if they have recently received a vaccine.
Persons who are on immunosuppressant doses of corticosteroidsshould be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
There are a number of medicines that can interact with prednisone. Patients should inform their healthcare provider of all the medicines they are taking, including over-the-counter and prescription medicines (such as phenytoin, diuretics, digitalis or digoxin, rifampin, amphotericin B, cyclosporine, insulin or diabetes medicines, ketoconazole, estrogens including birth control pills and hormone replacement therapy, blood thinners such as warfarin, aspirin or other NSAIDS, barbiturates), dietary supplements, and herbal products. If patients are taking any of these drugs, alternate therapy, dosage adjustment, and/or special test may be needed during the treatment.
For missed doses, patients should be told to take the missed dose as soon as they remember. If it is almost time for the next dose, the missed dose should be skipped and the medicine taken at thenext regularly schedule time. Patients should not take an extra dose to make up for the missed dose.
Patients should be told to take prednisone with food. Patients should be advised not to break, divide, or chew this medicine.
Patients should be advised of common adverse reactions that could occur with prednisone use to include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy.
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