>10%:

Central nervous system: Insomnia, nervousness

Gastrointestinal: Increased appetite, indigestion

1% to 10%:

Dermatologic: Hirsutism

Endocrine & metabolic: Diabetes mellitus, glucose intolerance, hyperglycemia

Neuromuscular & skeletal: Arthralgia

Ocular: Cataracts, glaucoma

Respiratory: Epistaxis

<1%: Edema, hypertension, vertigo, seizure, psychoses, pseudotumor cerebri, headache, mood swings, delirium, hallucinations, euphoria, acne, skin atrophy, bruising, hyperpigmentation, Cushing's syndrome, pituitary-adrenal axis suppression, growth suppression, glucose intolerance, hypokalemia, alkalosis, amenorrhea, sodium and water retention, hyperglycemia, peptic ulcer, nausea, vomiting, abdominal distention, ulcerative esophagitis, pancreatitis, muscle weakness, osteoporosis, fractures, muscle wasting, hypersensitivity reactions

Decreased effect:

Barbiturates, phenytoin, rifampin decrease corticosteroid effectiveness

Decreases salicylates

Decreases vaccines

Decreases toxoids effectiveness

Increased effect/toxicity: NSAIDs: Concurrent use of prednisone may increase the risk of GI ulceration

Ethanol: Avoid ethanol (may increase gastric mucosal irritation)

Food: Prednisone interferes with calcium absorption, Limit caffeine.

Herb/Nutraceutical: St John's wort may decrease prednisone levels. Avoid cat's claw, echinacea (have immunostimulant properties).

Protein binding (concentration dependent): 65% to 91%

Metabolism: Hepatically converted from prednisone (inactive) to prednisolone (active); may be impaired with hepatic dysfunction

Half-life elimination: Normal renal function: 2.5-3.5 hours

See Prednisolone monograph for complete information.

Children:

Anti-inflammatory or immunosuppressive dose: 0.05-2 mg/kg/day divided 1-4 times/day

Acute asthma: 1-2 mg/kg/day in divided doses 1-2 times/day for 3-5 days

Alternatively (for 3- to 5-day "burst"):

<1 year: 10 mg every 12 hours

1-4 years: 20 mg every 12 hours

5-13 years: 30 mg every 12 hours

>13 years: 40 mg every 12 hours

Asthma long-term therapy (alternative dosing by age):

<1 year: 10 mg every other day

1-4 years: 20 mg every other day

5-13 years: 30 mg every other day

>13 years: 40 mg every other day

Nephrotic syndrome:

Initial (first 3 episodes): 2 mg/kg/day or 60 mg/m²/day (maximum: 80 mg/day) in divided doses 3-4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1-1.5 mg/kg/dose or 40 mg/m²/dose given every other day for 4 weeks

Maintenance dose (long-term maintenance dose for frequent relapses): 0.5-1 mg/kg/dose given every other day for 3-6 months

Children and Adults: Physiologic replacement: 4-5 mg/m²/day

Children 5 years and Adults: Asthma:

Moderate persistent: Inhaled corticosteroid (medium dose) or inhaled corticosteroid (low-medium dose) with a long-acting bronchodilator

Severe persistent: Inhaled corticosteroid (high dose) and corticosteroid tablets or syrup long term: 2 mg/kg/day, generally not to exceed 60 mg/day

Adults:

Immunosuppression/chemotherapy adjunct: Range: 5-60 mg/day in divided doses 1-4 times/day

Allergic reaction (contact dermatitis):

Day 1: 30 mg divided as 10 mg before breakfast, 5 mg at lunch, 5 mg at dinner, 10 mg at bedtime

Day 2: 5 mg at breakfast, 5 mg at lunch, 5 mg at dinner, 10 mg at bedtime

Day 3: 5 mg 4 times/day (with meals and at bedtime)

Day 4: 5 mg 3 times/day (breakfast, lunch, bedtime)

Day 5: 5 mg 2 times/day (breakfast, bedtime)

Day 6: 5 mg before breakfast

Pneumocystis carinii pneumonia (PCP):

40 mg twice daily for 5 days followed by

40 mg once daily for 5 days followed by

20 mg once daily for 11 days or until antimicrobial regimen is completed

Thyrotoxicosis: Oral: 60 mg/day

Chemotherapy (refer to individual protocols): Oral: Range: 20 mg/day to 100 mg/m²/day

Rheumatoid arthritis: Oral: Use lowest possible daily dose (often 7.5 mg/day)

Idiopathic thrombocytopenia purpura (ITP): Oral: 60 mg daily for 4-6 weeks, gradually tapered over several weeks

Systemic lupus erythematosus (SLE): Oral:

Acute: 1-2 mg/kg/day in 2-3 divided doses

Maintenance: Reduce to lowest possible dose, usually <1 mg/kg/day as single dose (morning)

Elderly: Use the lowest effective dose

Dosing adjustment in hepatic impairment: Prednisone is inactive and must be metabolized by the liver to prednisolone. This conversion may be impaired in patients with liver disease, however, prednisolone levels are observed to be higher in patients with severe liver failure than in normal patients. Therefore, compensation for the inadequate conversion of prednisone to prednisolone occurs.

Dosing adjustment in hyperthyroidism: Prednisone dose may need to be increased to achieve adequate therapeutic effects

Hemodialysis: Supplemental dose is not necessary

Peritoneal dialysis: Supplemental dose is not necessary

Neuromuscular Effects: ICU-acquired paresis was recently studied in 5 ICUs (3 medical and 2 surgical ICUs) at 4 French hospitals. All ICU patients without pre-existing neuromuscular disease admitted from March 1999 through June 2000 were evaluated (De Jonghe B, 2002). Each patient had to be mechanically ventilated for 7 days and was screened daily for awakening. The first day the patient was considered awake was Study Day 1. Patients with severe muscle weakness on Study Day 7 were considered to have ICU-acquired paresis. Among the 95 patients who were evaluable, about 25% developed ICU-acquired paresis. Independent predictors included: female gender, the number of days with 2 organ dysfunction, and administration of corticosteroids. Further studies may be required to verify and characterize the association between the development of ICU-acquired paresis and use of corticosteroids. Concurrent use of a corticosteroid and muscle relaxant appear to increase the risk of certain ICU myopathies; avoid or administer the corticosteroid at the lowest dose possible.

Adrenal Insufficiency: Patients will often have steroid-induced adverse effects on glucose tolerance and lipid profiles. When discontinuing steroid therapy in patients on long-term steroid supplementation, it is important that the steroid therapy be discontinued gradually. Abrupt withdrawal may result in adrenal insufficiency with hypotension and hyperkalemia. Patients on long-term steroid supplementation will require higher corticosteroid doses when subject to stress (ie, trauma, surgery, severe infection). Guidelines for glucocorticoid replacement during various surgical procedures has been published (Salem M, 1994, Coursin DB, 2002).

Septic Shock: A recent randomized, double-blind, placebo controlled trial assessed whether low dose corticosteroid administration could improve 28-day survival in patients with septic shock and relative adrenal insufficiency. Relative adrenal insufficiency was defined as an inappropriate response to corticotropin administration (increase of serum cortisol of 9 mcg/dL from baseline). Cortisol levels were drawn immediately before corticotropin administration and 30 to 60 minutes afterwards. Three hundred adult septic shock patients requiring mechanical ventilation and vasopressor support were randomized to either hydrocortisone (50 mg IVP every 6 hours) and fludrocortisone (50 mcg tablet daily via nasogastric tube) or matching placebos for 7 days. In patients who did not appropriately respond to corticotropin (nonresponders), there were significantly fewer deaths in the active treatment group. Vasopressor therapy was withdrawn more frequently in this subset of the active treatment group. Adverse events were similar in both groups. Patients who lack adrenal reserve and thus have relative adrenal insufficiency during the stress of septic shock may benefit from physiologic steroid replacement. However, there was a trend for increased mortality in patients who responded to the corticotropin test (increase serum cortisol >9 mcg/dL from baseline). These patients may not benefit from physiologic steroid replacement. Further study is required to better characterize the patient populations who may benefit.

Oral and intravenous steroid therapy in patients with heart failure should be administered cautiously with special attention given to signs and symptoms of fluid retention.

Solution, oral: 1 mg/mL (5 mL, 120 mL, 500 mL) [contains alcohol 5%, sodium benzoate; vanilla flavor]

Solution, oral concentrate (Prednisone Intensol™): 5 mg/mL (30 mL) [contains alcohol 30%]

Tablet: 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 50 mg

Sterapred®: 5 mg [supplied as 21 tablet 6-day unit-dose package or 48 tablet 12-day unit-dose package]

Sterapred® DS: 10 mg [supplied as 21 tablet 6-day unit-dose package or 48 tablet 12-day unit-dose package]

Boot AM, Nauta J, Hokken-Koelega AC, et al, "Renal Transplantation and Osteoporosis,"Arch Dis Child, 1995, 72(6):502-6.

Bowman H and Lennard TW, "Immunosuppressive Drugs,"Br J Hosp Med, 1992, 48(9):570-3.

Frey BM and Frey FJ, "Clinical Pharmacokinetics of Prednisone and Prednisolone,"Clin Pharmacokinet, 1990, 19(2):126-46.

Grotz WH, Mundinger FA, Gugel B, et al, "Bone Mineral Density After Kidney Transplantation: A Cross-Sectional Study in 190-Graft Recipients Up to 20 Years After Transplantation,"Transplantation, 1995, 59(7):982-6.

Gutin PH, "Corticosteroid Therapy in Patients With Brain Tumors,"Natl Cancer Inst Monogr, 1977, 46:151-6.

Kimberly RP, "Glucocorticoids,"Curr Opin Rheumatol, 1994, 6(3):273-80.

Lowenthal RM and Jestrimski KW, "Corticosteroid Drugs: Their Role in Oncological Practice,"Med J Aust, 1986, 144(2):81-5.

Murphy CM, Coonce SL, and Simon PA, "Treatment of Asthma in Children,"Clin Pharm, 1991, 10(9):685-703.

Report of a Workshop by the British Association for Paediatric Nephrology and Research Unit, Royal College of Physicians, "Consensus Statement on Management and Audit Potential for Steroid Responsive Nephrotic Syndrome,"Arch Dis Child, 1994, 70(2):151-7.

Verbeek PR and Geerts WH, "Nontapering Versus Tapering Prednisone in Acute Exacerbations of Asthma: A Pilot Trial,"J Emerg Med, 1995, 13(5):715-9.

Wolkowitz OM, "Long-Lasting Behavioral Changes Following Prednisone Withdrawal,"JAMA, 1989, 261(12):1731-2.