|
|
|
Pronunciation |
|
(PRED
ni
sone) |
|
|
U.S. Brand
Names |
|
Deltasone®; Liquid Pred®;
Meticorten®; Orasone®; Prednicen-M® |
|
|
Generic
Available |
|
Yes |
|
|
Canadian Brand
Names |
|
Apo®-Prednisone; Jaa-Prednisone®;
Novo-Prednisone; Wimpred |
|
|
Synonyms |
|
Deltacortisone; Deltadehydrocortisone |
|
|
Pharmacological Index |
|
Corticosteroid, Oral |
|
|
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 |
|
|
Pregnancy Risk
Factor |
|
B |
|
|
Pregnancy/Breast-Feeding
Implications |
|
Clinical effects on the fetus: 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.
Breast-feeding/lactation: Crosses into breast milk. No data on clinical
effects on the infant. American Academy of Pediatrics considers
compatible with breast-feeding. |
|
|
Contraindications |
|
Serious infections, except septic shock or tuberculous meningitis; systemic
fungal infections; hypersensitivity to prednisone or any component;
varicella |
|
|
Warnings/Precautions |
|
Withdraw therapy with gradual tapering of dose, may retard bone growth; use
with caution in patients with hypothyroidism, cirrhosis, hypertension,
congestive heart failure, ulcerative colitis, thromboembolic disorders, and
patients at increased risk for peptic ulcer disease. 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
Ocular: Cataracts, glaucoma
Neuromuscular & skeletal: Arthralgia
Respiratory: Epistaxis
<1%: Edema, hypertension, vertigo, seizures, 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 excessive quantities for prolonged periods, systemic
hypercorticism and adrenal suppression may occur; in those cases,
discontinuation and withdrawal of the corticosteroid should be done
judiciously. |
|
|
Drug
Interactions |
|
CYP3A3/4 enzyme substrate
Barbiturates, phenytoin, rifampin decrease corticosteroid effectiveness
Decreases salicylates
Decreases vaccines
Decreases toxoids effectiveness |
|
|
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 |
|
Refer to Prednisolone monograph for complete pharmacokinetic information
Prednisone is inactive and must be metabolized to prednisolone which may be
impaired in patients with impaired liver function
Half-life: Normal renal function: 2.5-3.5 hours |
|
|
Usual 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.
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
Adults: 5-60 mg/day in divided doses 1-4 times/day
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 |
|
|
Dietary
Considerations |
|
Should be taken after meals or with food or milk; limit caffeine; increase
dietary intake of pyridoxine, vitamin C, vitamin D, folate, calcium, and
phosphorus |
|
|
Monitoring
Parameters |
|
Blood pressure, blood glucose, electrolytes |
|
|
Test
Interactions |
|
Response to skin tests |
|
|
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 |
|
|
Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
|
No information available to require special precautions |
|
|
Dental Health:
Effects on Dental Treatment |
|
No effects or complications reported |
|
|
Patient
Information |
|
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. Limit intake of caffeine or
stimulants. Maintain adequate nutrition; consult prescriber for possibility of
special dietary recommendations. If diabetic, 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 or infected persons or persons with contagious diseases.
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 |
|
|
Dosage Forms |
|
Solution, oral: Concentrate (30% alcohol): 5 mg/mL (30 mL); Nonconcentrate
(5% alcohol): 5 mg/5 mL (5 mL, 500 mL)
Syrup: 5 mg/5 mL (120 mL, 240 mL)
Tablet: 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 50 mg |
|
|
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. |
|
Copyright © 1978-2000 Lexi-Comp Inc. All Rights Reserved
| |