Pronunciation:

(pred NISS oh lone)

U.S. Brand Names:

Synonyms:

Generic Available:

Canadian Brand Names:

Use:

Use - Dental:

Pregnancy Risk Factor:

Lactation:

Contraindications:

Warnings/Precautions:

Adverse Reactions:

>10%:

Central nervous system: Insomnia, nervousness

Gastrointestinal: Increased appetite, indigestion

1% to 10%:

Dermatologic: Hirsutism

Endocrine & metabolic: Diabetes mellitus

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:

Drug Interactions:

Decreased effect:

Barbiturates, phenytoin, rifampin decrease corticosteroid effectiveness

Decreases salicylates

Decreases vaccines

Decreases toxoids effectiveness

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).

Mechanism of Action:

Pharmacodynamics/Kinetics:

Duration: 18-36 hours

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

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:

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

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

Ophthalmic suspension/solution: 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

Administration:

Monitoring Parameters:

Test Interactions:

Dietary Considerations:

Patient Education:

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.

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:

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:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Dosage Forms:

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

AK-Pred®: 1% (5 mL, 15 mL) [contains benzalkonium chloride]

Inflamase® Forte: 1% (5 mL, 10 mL, 15 mL) [contains benzalkonium chloride]

Inflamase® Mild: 0.125% (5 mL, 10 mL) [contains benzalkonium chloride]

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

Bubbli-Pred™: Prednisolone base 5 mg/5 mL (120 mL) [bubble gum flavor]

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

Pediapred®: 6.7 mg/5 mL (120 mL) [equivalent to prednisolone base 5 mg/5 mL; dye free; raspberry flavor]

Suspension, ophthalmic, as acetate: 1% (5 mL, 10 mL, 15 mL) [contains benzalkonium chloride]

Econopred® Plus: 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 (240 mL, 480 mL)

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

Tablet, as base: 5 mg

International Brand Names: