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PredniSONE


Pronunciation

 (PRED ni sone)


U.S. Brand Names

 Prednisone Intensol™; Sterapred®; Sterapred® DS


Synonyms

 Deltacortisone; Deltadehydrocortisone


Generic Available

 Yes


Canadian Brand Names

 Apo-Prednisone®; Winpred™


Use

 Treatment of a variety of diseases including adrenocortical insufficiency, hypercalcemia, rheumatic, and collagen disorders; dermatologic, ocular, respiratory, gastrointestinal, and neoplastic diseases; organ transplantation and a variety of diseases including those of hematologic, allergic, inflammatory, and autoimmune in origin; not available in injectable form, prednisolone must be used


Use - Dental

 Treatment of a variety of oral diseases of allergic, inflammatory, or autoimmune origin


Use - Unlabeled/Investigational

 Investigational: Prevention of postherpetic neuralgia and relief of acute pain in the early stages


Pregnancy Risk Factor

 B


Pregnancy Implications

 Crosses the placenta. Immunosuppression reported in 1 infant exposed to high-dose prednisone plus azathioprine throughout gestation. One report of congenital cataracts. Available evidence suggests safe use during pregnancy.


Lactation

 Enters breast milk/compatible


Contraindications

 Hypersensitivity to prednisone or any component of the formulation; serious infections, except tuberculous meningitis; systemic fungal infections; varicella


Warnings/Precautions

 Withdraw therapy with gradual tapering of dose, may retard bone growth. Use with caution in patients with hypothyroidism, cirrhosis, CHF, ulcerative colitis, thromboembolic disorders, and patients at increased risk for peptic ulcer disease. Corticosteroids should be used with caution in patients with diabetes, hypertension, osteoporosis, glaucoma, cataracts, or tuberculosis. Use caution in hepatic impairment. Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in the elderly, in the smallest possible dose, and for the shortest possible time.


Adverse Reactions

>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


Overdosage/Toxicology

 When consumed in high doses for prolonged periods, systemic hypercorticism and adrenal suppression may occur. In those cases, discontinuation of the corticosteroid should be done judiciously.


Drug Interactions

 Substrate of CYP3A4 (minor); Induces CYP2C19 (weak), 3A4 (weak)

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/Nutrition/Herb Interactions

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).


Mechanism of Action

 Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; suppresses the immune system by reducing activity and volume of the lymphatic system; suppresses adrenal function at high doses. Antitumor effects may be related to inhibition of glucose transport, phosphorylation, or induction of cell death in immature lymphocytes. Antiemetic effects are thought to occur due to blockade of cerebral innervation of the emetic center via inhibition of prostaglandin synthesis.


Pharmacodynamics/Kinetics

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.


Dosage

 Oral: Dose depends upon condition being treated and response of patient; dosage for infants and children should be based on severity of the disease and response of the patient rather than on strict adherence to dosage indicated by age, weight, or body surface area. Consider alternate day therapy for long-term therapy. Discontinuation of long-term therapy requires gradual withdrawal by tapering the dose.

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/m 2 /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/m 2 /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/m 2 /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/m 2 /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


Administration

 Administer with meals to decrease gastrointestinal upset


Monitoring Parameters

 Blood pressure, blood glucose, electrolytes


Test Interactions

 Response to skin tests


Dietary Considerations

 Should be taken after meals or with food or milk; increase dietary intake of pyridoxine, vitamin C, vitamin D, folate, calcium, and phosphorus.


Patient Education

 Take exactly as directed. Do not take more than prescribed dose and do not discontinue abruptly; consult prescriber. Take with or after meals. Take once-a-day dose with food in the morning. Avoid alcohol. Limit intake of caffeine or stimulants. Maintain adequate nutrition; consult prescriber for possibility of special dietary recommendations. If you have diabetes, monitor serum glucose closely and notify prescriber of changes; this medication can alter hypoglycemic requirements. Notify prescriber if you are experiencing higher than normal levels of stress; medication may need adjustment. Periodic ophthalmic examinations will be necessary with long-term use. You will be susceptible to infection (avoid crowds and exposure to infection). You may experience insomnia or nervousness; use caution when driving or engaging in tasks requiring alertness until response to drug is known. Report weakness, change in menstrual pattern, vision changes, signs of hyperglycemia, signs of infection (eg, fever, chills, mouth sores, perianal itching, vaginal discharge), other persistent side effects, or worsening of condition.


Nursing Implications

 Withdraw therapy with gradual tapering of dose


Additional Information

 Tapering of corticosteroids after a short course of therapy (<7-10 days) is generally not required unless the disease/inflammatory process is slow to respond. Tapering after prolonged exposure is dependent upon the individual patient, duration of corticosteroid treatments, and size of steroid dose. Recovery of the HPA axis may require several months. Subtle but important HPA axis suppression may be present for as long as several months after a course of as few as 10-14 days duration. Testing of HPA axis (cosyntropin) may be required, and signs/symptoms of adrenal insufficiency should be monitored in patients with a history of use.


Anesthesia and Critical Care Concerns/Other Considerations

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.


Cardiovascular Considerations

 Long-term steroid therapy is associated with fluid retention and hypertension. Glucocorticoid agents have some mineralocorticoid activity with consequent hemodynamic effects. Patients will often have steroid-induced adverse effects on glucose tolerance and lipid profiles. In 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.

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.


Dental Health: Effects on Dental Treatment

 No significant effects or complications reported


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 No information available to require special precautions


Mental Health: Effects on Mental Status

 Nervousness and insomnia are common; may rarely cause delirium, mood swings, euphoria, and hallucinations


Mental Health: Effects on Psychiatric Treatment

 Barbiturates and carbamazepine may decrease corticosteroid effectiveness


Oncology: Emetic Potential

 Very low (<10%)


Oncology: Vesicant

 No


Dosage Forms

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]


References

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.


International Brand Names

 Apo-Prednisone® (CA, NZ); Bersen® (CL); Cortancyl® (FR); Cortiprex® (CL); Cutason® (DE); Dacortin® (ES); Decortin® (DE, HR); Decortisyl® (IE); Dehydrocortison® (BG); Deltacortene® (IT); Deltasone® (BD, NZ); Deltison® (SE); Encorton® (PL); Meticorten® (AR, BR, CL, CR, DO, EC, GT, HN, MX, PA, PT, SV); Panafcort® (AU); Pehacort® (ID); Predeltin® (ZA); Predicorten® (BR); Prednicort® (BE, LU); Prednidib® (MX); Prednisona Alonga® (ES); Prednisona® (BR, CL); Prednison acsis® (DE); Prednisona L.CH.® (CL); Prednison-Armedica® (RO); Prednison® (CZ, FI); Prednison Dak® (DK); Prednisone® (CY, IL, ZA); Prednison Galen® (DE); Prednison Galepharm® (CH); Prednison Hexal® (DE); Prednison-ratiopharm® (DE); Prednison Streuli® (CH); Predni Tablinen® (DE); Prednitone® (IL); Predson® (BR); Pronison® (YU); Rectodelt® (DE); Sone® (AU); Uniao Prednisona® (BR); Winpred™ (CA)


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