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PrednisoLONE Drug Information Provided by Lexi-Comp

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Medication Safety Issues

Sound-alike/look-alike issues:

PrednisoLONE may be confused with predniSONE

Pediapred® may be confused with Pediazole®

Prelone® may be confused with Prozac®

Pronunciation

(pred NISS oh lone)

U.S. Brand Names

  • Econopred® Plus [DSC]
  • Millipred™
  • Omnipred™
  • Orapred ODT®
  • Orapred®
  • Pediapred®
  • Pred Forte®
  • Pred Mild®
  • Prelone®
  • Veripred™ 20

Index Terms

  • Deltahydrocortisone
  • Metacortandralone
  • Prednisolone Acetate
  • Prednisolone Acetate, Ophthalmic
  • Prednisolone Sodium Phosphate
  • Prednisolone Sodium Phosphate, Ophthalmic

Generic Available

Yes

Canadian Brand Names

  • Diopred®
  • Hydeltra T.B.A.®
  • Inflamase® Mild
  • Novo-Prednisolone
  • Ophtho-Tate®
  • Pediapred®
  • Pred Forte®
  • Pred Mild®
  • Sab-Prenase

Pharmacologic Category

  • Corticosteroid, Ophthalmic
  • Corticosteroid, Systemic

Pharmacologic Category Synonyms

  • Ophthalmic Corticosteroid
  • Steroid, Ophthalmic
  • Steroid, Systemic
  • Systemic Corticosteroid

Use: Labeled Indications

Treatment of palpebral and bulbar conjunctivitis; corneal injury from chemical, radiation, thermal burns, or foreign body penetration; endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, and gastrointestinal diseases; resolution of acute exacerbations of multiple sclerosis; management of fulminating or disseminated tuberculosis and trichinosis; acute or chronic solid organ rejection

Use: Dental

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

Pregnancy Risk Factor

C

Pregnancy Considerations

Ophthalmic prednisolone was shown to be teratogenic in animal studies and adverse events have been observed with corticosteroids in animal reproduction studies. Prednisolone crosses the placenta; prior to reaching the fetus, prednisolone is converted by placental enzymes to prednisone. As a result, the amount of prednisolone reaching the fetus is ~8-10 times lower than the maternal serum concentration (healthy women at term; similar results observed with preterm pregnancies complicated by HELLP syndrome). Some studies have shown an association between first trimester corticosteroid use and oral clefts; adverse events in the fetus/neonate have been noted in case reports following large doses of systemic corticosteroids during pregnancy. Women exposed to prednisolone during pregnancy for the treatment of an autoimmune disease may contact the OTIS Autoimmune Diseases Study at 877-311-8972.

Lactation

Enters breast milk/use caution (AAP rates “compatible”)

Breast-Feeding Considerations

Prednisolone is excreted into breast milk with peak concentrations occurring ~1 hour after the maternal dose. The milk/plasma ratio was found to be 0.2 with doses ?30 mg/day and 0.1 with doses <30 mg/day. Following a maternal dose of prednisolone 80 mg/day, a breast-feeding infant would ingest <0.1% of the dose.

Contraindications

Hypersensitivity to prednisolone or any component of the formulation; acute superficial herpes simplex keratitis; live or attenuated virus vaccines (with immunosuppressive doses of corticosteroids); systemic fungal infections; varicella

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections) or prolong or exacerbate viral infections. Exposure to chickenpox should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria or viral hepatitis. Use with caution in patients with tuberculosis.

• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.

• Myopathy: Acute myopathy has been reported with high dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatine kinase; recovery may be delayed.

• Ocular effects: Prolonged use of corticosteroids may result in glaucoma; damage to the optic nerve (not indicated for treatment of optic neuritis), defects in visual acuity and fields of vision, and posterior subcapsular cataract formation may occur. Use following cataract surgery may delay healing or increase the incidence of bleb formation.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Pre-existing psychiatric conditions may be exacerbated by corticosteroid use.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with HF; long-term use has been associated with fluid retention and hypertension.

• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, peptic ulcer, ulcerative colitis) due to perforation risk.

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.

• Myocardial infarction (MI): Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

Special populations:

• Elderly: Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in the elderly in the smallest possible effective dose for the shortest duration.

• Pediatrics: May affect growth velocity; growth should be routinely monitored in pediatric patients.

Other warnings/precautions:

• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.

Adverse Reactions

Frequency not defined.

Ophthalmic formulation:

Endocrine & metabolic: Hypercorticoidism (rare)

Ocular: Conjunctival hyperemia, conjunctivitis, corneal ulcers, delayed wound healing, glaucoma, intraocular pressure increased, keratitis, loss of accommodation, optic nerve damage, mydriasis, posterior subcapsular cataract formation, ptosis, secondary ocular infection

Oral formulation:

Cardiovascular: Cardiomyopathy, CHF, edema, facial edema, hypertension

Central nervous system: Convulsions, headache, insomnia, malaise, nervousness, pseudotumor cerebri, psychic disorders, vertigo

Dermatologic: Bruising, facial erythema, hirsutism, petechiae, skin test reaction suppression, thin fragile skin, urticaria

Endocrine & metabolic: Carbohydrate tolerance decreased, Cushing's syndrome, diabetes mellitus, growth suppression, hyperglycemia, hypernatremia, hypokalemia, hypokalemic alkalosis, menstrual irregularities, negative nitrogen balance, pituitary adrenal axis suppression

Gastrointestinal: Abdominal distention, increased appetite, indigestion, nausea, pancreatitis, peptic ulcer, ulcerative esophagitis, weight gain

Hepatic: LFTs increased (usually reversible)

Neuromuscular & skeletal: Arthralgia, aseptic necrosis (humeral/femoral heads), fractures, muscle mass decreased, muscle weakness, osteoporosis, steroid myopathy, tendon rupture, weakness

Ocular: Cataracts, exophthalmus, eyelid edema, glaucoma, intraocular pressure increased, irritation

Respiratory: Epistaxis

Miscellaneous: Diaphoresis increased, impaired wound healing

Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Inhibits CYP3A4 (weak)

Drug Interactions

Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy

Aminoglutethimide: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy

Antacids: May decrease the bioavailability of Corticosteroids (Oral). Risk D: Consider therapy modification

Antidiabetic Agents: Corticosteroids (Systemic) may diminish the hypoglycemic effect of Antidiabetic Agents. In some instances, corticosteroid-mediated HPA axis suppression has led to episodes of acute adrenal crisis, which may manifest as enhanced hypoglycemia, particularly in the setting of insulin or other antidiabetic agent use. Risk C: Monitor therapy

Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Risk D: Consider therapy modification

Barbiturates: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Risk C: Monitor therapy

Calcitriol: Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol. Risk C: Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): May decrease the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

CycloSPORINE: Corticosteroids (Systemic) may increase the serum concentration of CycloSPORINE. CycloSPORINE may increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Fluconazole: May decrease the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Risk D: Consider therapy modification

Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Risk C: Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification

Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Macrolide Antibiotics: May decrease the metabolism of Corticosteroids (Systemic). Exceptions: Azithromycin; Dirithromycin [Off Market]; Spiramycin. Risk D: Consider therapy modification

Mitotane: May decrease the serum concentration of Corticosteroids (Systemic). Risk D: Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination

Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Risk D: Consider therapy modification

NSAID (COX-2 Inhibitor): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (COX-2 Inhibitor). Risk C: Monitor therapy

NSAID (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (Nonselective). Risk C: Monitor therapy

Primidone: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Quinolone Antibiotics: May enhance the adverse/toxic effect of Corticosteroids (Systemic). Risk of tendon-related side effects, including tendonitis and rupture, may be enhanced. Risk C: Monitor therapy

Rifamycin Derivatives: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor therapy

Thiazide Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide Diuretics. Risk C: Monitor therapy

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin. Risk C: Monitor therapy

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may increase gastric mucosal irritation).

Food: Prednisolone interferes with calcium absorption. Limit caffeine.

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

Storage

Store Orapred ODT® at 20°C to 25°C (68°F to 77°F) in blister pack. Protect from moisture.

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

Pharmacodynamics/Kinetics

Duration: 18-36 hours

Protein binding (concentration dependent): 65% to 91%; decreased in elderly

Metabolism: Primarily hepatic, but also metabolized in most tissues, to inactive compounds

Half-life elimination: 3.6 hours; End-stage renal disease: 3-5 hours

Excretion: Primarily urine (as glucuronides, sulfates, and unconjugated metabolites)

Dosage

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. Oral dosage expressed in terms of prednisolone base. Consider alternate day therapy for long-term therapy. Discontinuation of long-term therapy requires gradual withdrawal by tapering the dose. Patients undergoing unusual stress while receiving corticosteroids, should receive increased doses prior to, during, and after the stressful situation.

Children: Oral:

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

Anti-inflammatory or immunosuppressive dose: 0.1-2 mg/kg/day in divided doses 1-4 times/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 (long-term maintenance dose for frequent relapses): 0.5-1 mg/kg/dose given every other day for 3-6 months

Adults: Oral:

Usual range: 5-60 mg/day

Multiple sclerosis: 200 mg/day for 1 week followed by 80 mg every other day for 1 month

Rheumatoid arthritis: Initial: 5-7.5 mg/day; adjust dose as necessary

Ophthalmic suspension/solution: Conjunctivitis, corneal injury: Children and Adults: Instill 1-2 drops into conjunctival sac every hour during day, every 2 hours at night until favorable response is obtained, then use 1 drop every 4 hours.

Elderly: Use lowest effective dose

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

Hemodialysis: Slightly dialyzable (5% to 20%); administer dose posthemodialysis

Peritoneal dialysis: Supplemental dose is not necessary

Dosage: Combination Regimens

Lymphoma, Hodgkin's:

LOPP

MOPP

Dental Usual Dosing

Anti-inflammatory or immunosuppressive dose: Oral:

Children: 0.1-2 mg/kg/day in divided doses 1-4 times/day

Adults: Usual range: 5-60 mg/day

Administration: Oral

Administer oral formulation with food or milk to decrease GI effects.

Orapred ODT®: Do not break or use partial tablet. Remove tablet from blister pack just prior to use. May swallow whole or allow to dissolve on tongue.

Monitoring Parameters

Blood pressure; blood glucose, electrolytes; intraocular pressure (use >6 weeks); bone mineral density

Test Interactions

Response to skin tests

Dietary Considerations

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

Patient Education

Take exactly as directed; do not increase dose or discontinue abruptly without consulting prescriber. Avoid alcohol. Limit intake of caffeine or stimulants. Prescriber may recommend increased dietary vitamins, minerals, or iron. If you have diabetes, monitor glucose levels closely (antidiabetic medication may need to be adjusted). Inform prescriber if you are experiencing greater-than-normal levels of stress (medication may need adjustment). Some forms of this medication may cause GI upset (oral medication should be taken with meals to reduce GI upset; small frequent meals and frequent mouth care may reduce GI upset). You may be more susceptible to infection (avoid crowds and exposure to infection). Report promptly excessive nervousness or sleep disturbances; any signs of infection (sore throat, unhealed injuries); excessive growth of body hair or loss of skin color; vision changes; excessive or sudden weight gain (>3 lb/week); swelling of face or extremities; respiratory difficulty; muscle weakness; change in color of stools (black or tarry) or persistent abdominal pain; or worsening of condition or failure to improve. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Ophthalmic: For ophthalmic use only. Wash hands before using. Tilt head back and look upward. Put drops of suspension inside lower eyelid. Close eye and roll eyeball in all directions. Do not blink for 1/2 minute. Apply gentle pressure to inner corner of eye for 30 seconds. Do not use any other eye preparation for at least 10 minutes. Do not let tip of applicator touch eye; do not contaminate tip of applicator (may cause eye infection, eye damage, or vision loss). Do not share medication with anyone else. Wear sunglasses when in sunlight; you may be more sensitive to bright light. Inform prescriber if condition worsens or fails to improve or if you experience eye pain, disturbances of vision, or other adverse eye response.

Geriatric Considerations

Useful in patients with inability to activate prednisone (liver 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. For long-term use, monitor bone mineral density and institute fracture prevention strategies.

Anesthesia and Critical Care Concerns/Other Considerations

Evidence-Based Information:

Neuromuscular Effects: ICU-acquired paresis was recently studied in five ICUs (three medical and two surgical ICUs) at four French hospitals. All ICU patients without pre-existing neuromuscular disease admitted from March 1999 through June 2000 were evaluated (de Jonghe, 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 evaluated, 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 appears 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 (eg, trauma, surgery, severe infection). Guidelines for glucocorticoid replacement during various surgical procedures have been published (Coursin, 2002; Salem, 1994).

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.

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

Key adverse event(s) related to dental treatment: Ulcerative esophagitis.

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

Nursing: Physical Assessment/Monitoring

Assess other medications patient may be taking for effectiveness and interactions. Assess results of laboratory tests, therapeutic effectiveness, and adverse effects according to indications for therapy, dose, route, and duration of therapy. With systemic administration, patients with diabetes should monitor glucose levels closely. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report. When used for long-term therapy (>10-14 days), do not discontinue abruptly; decrease dosage incrementally.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, ophthalmic, as sodium phosphate: 1% (5 mL, 10 mL, 15 mL) [contains benzalkonium chloride]

Solution, oral, as base: 15 mg/5 mL (240 mL, 480 mL)

Solution, oral, as sodium phosphate: Prednisolone base 5 mg/5 mL (120 mL, 240 mL); prednisolone base 15 mg/5 mL (240 mL)

Millipred™: Prednisolone base 10 mg/5 mL (237 mL) [dye free; grape flavor]

Orapred®: Prednisolone base 15 mg/5 mL (20 mL, 240 mL) [dye free; contains ethanol 2%, sodium benzoate; grape flavor]

Pediapred®: Prednisolone base 5 mg/5 mL (120 mL) [dye free; raspberry flavor]

Veripred™ 20: Prednisolone base 20 mg/5 mL (237 mL) [dye free, ethanol free; grape flavor]

Suspension, ophthalmic, as acetate: 1% (5 mL, 10 mL, 15 mL)

Econopred® Plus [DSC], Omnipred™: 1% (5 mL, 10 mL) [contains benzalkonium chloride]

Pred Forte®: 1% (1 mL, 5 mL, 10 mL, 15 mL) [contains benzalkonium chloride and sodium bisulfite]

Pred Mild®: 0.12% (5 mL, 10 mL) [contains benzalkonium chloride and sodium bisulfite]

Syrup, as base: 5 mg/5 mL (120 mL); 15 mg/5 mL (5 mL [DSC], 240 mL, 480 mL)

Prelone®: 15 mg/5 mL (240 mL, 480 mL) [contains ethanol 5%, benzoic acid, propylene glycol; wild cherry flavor]

Tablet, as base: 5 mg

Tablet, orally disintegrating, as sodium phosphate [strength expressed as base]:

Orapred ODT®: 10 mg, 15 mg, 30 mg [grape flavor]

Pricing: U.S. (www.drugstore.com)

Solution (Pediapred)

6.7 mg/5 mL (120): $50.87

Solution (PrednisoLONE Sodium Phosphate)

1% (5): $19.99

1% (10): $23.99

1% (15): $29.99

5 mg/5 mL (118): $26.99

15 mg/5 mL (237): $65.34

Suspension (Econopred Plus)

1% (5): $40.99

1% (10): $57.99

Suspension (Omnipred)

1% (10): $67.18

Suspension (Pred Forte)

1% (5): $34.32

1% (10): $62.93

1% (15): $90.41

Suspension (Pred Mild)

0.12% (10): $39.99

Suspension (PrednisoLONE Acetate)

1% (5): $15.99

1% (10): $20.99

1% (15): $33.99

Syrup (PrednisoLONE)

15 mg/5 mL (240): $70.90

Tablet, orally-disintegrating (Orapred ODT)

15 mg (48): $257.22

References

Abraham E and Evans T, “Corticosteroids and Septic Shock [editorial],” JAMA, 2002, 288(7):886-7.

Annane D, Sebille V, Charpentier C, et al, “Effect of Treatment With Low Doses of Hydrocortisone and Fludrocortisone on Mortality in Patients With Septic Shock,” JAMA, 2002, 288(7):862-71.

Beitins IZ, Bayard F, Ances IG, et al, “The Transplacental Passage of Prednisone and Prednisolone in Pregnancy Near Term,” J Pediatr, 1972, 81(5):936-45.

Cooper MS and Stewart PM, “Corticosteroid Insufficiency in Acutely Ill Patients,” N Engl J Med, 2003, 348(8):727-34.

Coursin DB and Wood KE, “Corticosteroid Supplementation for Adrenal Insufficiency,” JAMA, 2002, 287(2):236-40.

de Jonghe B, Sharshar T, Lefaucheur JP, et al, “Paresis Acquired in the Intensive Care Unit. A Prospective Multicenter Study,” JAMA, 2002, 288(22):2859-67.

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

Frey FJ, "Kinetics and Dynamics of Prednisolone," Endocr Rev, 1987, 8(4):453-73.

Gambertoglio JG, Amend WJ Jr and Benet LZ, "Pharmacokinetics and Bioavailability of Prednisone and Prednisolone in Healthy Volunteers and Patients: A Review," J Pharmacokinet Biopharm, 1980, 8(1):1-52.

Gamsu HR, Mullinger BM, Donnai P, et al, “Antenatal Administration of Betamethasone to Prevent Respiratory Distress Syndrome in Preterm Infants: Report of a UK Multicentre Trial,” Br J Obstet Gynaecol, 1989, 96(4):401-10.

Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,” J Natl Cancer Inst, 2002, 94(22):1712-8.

Hotchkiss RS and Karl IE, “The Pathophysiology and Treatment of Sepsis,” N Engl J Med, 2003, 348(2):138-50.

Lawrence RA, “Corticosteroid Effect on Lactation,” JAMA, 1991, 265(18):2409.

Liggins GC and Howie RN, “A Controlled Trial of Antepartum Glucocorticoid Treatment of Respiratory Distress Syndrome in Premature Infants,” Pediatrics, 1972, 50:515-25.

McGee S and Hirschmann J, “Use of Corticosteroids in Treating Infectious Diseases,” Arch Intern Med, 2008, 168(10):1034-46.

Ost L, Wettrell G, Björkhem I, et al, “Prednisolone Excretion in Human Milk,” J Pediatr, 1985, 106(6):1008-11.

Ostensen M, “Optimisation of Antirheumatic Drug Treatment in Pregnancy,” Clin Pharmacokinet, 1994, 27(6):486-503.

Pradat P, Robert-Gnansia E, Di Tanna GL, et al, “First Trimester Exposure to Corticosteroids and Oral Clefts,” Birth Defects Res A Clin Mol Teratol, 2003, 67(12):968-70.

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.

Salem M, Tainsh RE Jr, Bromberg J, et al, “Perioperative Glucocorticoid Coverage. A Reassessment 42 Years After Emergence of a Problem,” Ann Surg, 1994, 219(4):416-25.

van Runnard Heimel PJ, Schobben AF, Huisjes AJ, et al, “The Transplacental Passage of Prednisolone in Pregnancies Complicated by Early-Onset HELLP Syndrome,” Placenta, 2005, 26(10):842-5.

International Brand Names

  • Adelcort (GR)
  • Aprednislon (AT)
  • Caberdelta (IT)
  • Cortisolone (IT)
  • Dacortin H (ES)
  • Decortin H (BG, PL)
  • Delcortol (DK)
  • Delta Phorical (BB, BM, BS, BZ, GY, JM, SR, TT)
  • Deltacortril (LU, PK)
  • Deltidrosol (IT)
  • Domucortone (IT)
  • Econopred Plus (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, IL, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SG, SL, SN, SY, TN, TZ, UG, YE, ZA, ZM, ZW)
  • Encortolon (PL)
  • Fenicort (PL)
  • Fisopred (MX)
  • Hydrocortancyl (FR)
  • Inflanefran (DE)
  • Klismacort (HU)
  • Linola P (PL)
  • Linola-H N (CZ)
  • Liquipred (FR)
  • Meticortelon (HR)
  • Meticortelone (IT, MX)
  • Normonsona (ES)
  • Optilon (KP)
  • Pred Forte (BE, BR, CN, GB, HK, IE, IL, KP, MY, NL, NZ, PH, TH, TW, ZA)
  • Pred Mild (BR, CN, HK, MY, NZ, PH, TH, ZA)
  • Pred Un (MX)
  • Pred-NF (MX)
  • Predartrina (IT)
  • Predmet (IN)
  • Predmix Oral Solution (AU)
  • Prednefrin (CO, PE)
  • Prednefrin Forte (EC, PE)
  • Prednefrin SF (MX)
  • Predni-Ophtal (DE)
  • Prednicortelone (LU)
  • Prednisolon (FI, HU, NO)
  • Prednisolon Galepharm (CH)
  • Prednisolon Streuli[Tab.] (CH)
  • Prednisolon ”Dak” (DK)
  • Prednisolon ”DuraScan” (DK)
  • Prednisolone Ratiopharm (LU)
  • Prednisolonum (PL)
  • Predon (MY)
  • Predsol-Forte (DO, HN)
  • Prezolon (GR)
  • Redipred (AU)
  • Scherisolona (UY)
  • Solupred (FR)
  • Sophipren Ofteno (CR, DO, GT, HN, MX, NI, PA, SV)
  • Spiricort (CH)
  • Ultracortenol (AR, PY, SE, TW)
  • Vistapred (PH)

Lexi-Comp.com

Last full review/revision July 2009

Content last modified July 2009

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