prednisolone (Pediapred, FloPred, Orapred, Orapred ODT, Millipred, Millipred DP, Prelone Syrup, Veripred 20)

Dosing and uses of Pediapred, Orapred (prednisolone)

• Adult
• Pediatric

 

Adult dosage forms and strengths

oral solution

• 5mg/5mL
• 10mg/5mL
• 15mg/5mL
• 20mg/5mL
• 25mg/5mL

tablet

• 5mg

tablet, dose pack

• 5mg (6 days [21 tabs])
• 5mg (12 days [48 tabs])

tablet, orally disintegrating

• 10mg
• 15mg
• 30mg

 

Rheumatoid Arthritis

5-7.5 mg PO qDay

 

Multiple Sclerosis

200 mg/day PO for 1 week, then 80 mg PO every other day for 1 month

 

Acute Exacerbation of COPD (Off-label)

30-40 mg PO qDay for 10-14 days

 

Bells Palsy (Off-label)

60 mg PO qDay for 5 days; then taper down by 10 mg daily for 5 days for total duration time of 10 days

 

Pediatric dosage forms and strengths

oral solution

• 5mg/5mL
• 10mg/5mL
• 15mg/5mL
• 20mg/5mL
• 25mg/5mL

tablet

• 5mg

tablet, dose pack

• 5mg (6 days [21 tabs])
• 5mg (12 days [48 tabs])

tablet, orally disintegrating

• 10mg
• 15mg
• 30mg

 

Inflammation

0.1-2 mg/kg/day PO in single daily dose or divided q6-12hr; not to exceed 80 mg/day

 

Acute Asthma

1-2 mg/kg/day in single daily dose or divided q12hr for 3-5 days

 

Nephrotic Syndrome

First 4 weeks: 60 mg/m²/day or 2 mg/kg/day PO divided q8hr until urine is protein free for 3 consecutive days; not to exceed 28 days; dose not to exceed 80 mg/day

Subsequent 4 weeks: 40 mg/m² or 1-1.5 mg/kg PO every other day; not to exceed 80 mg/day

Maintenance in frequent relapses: 0.5-1 mg/kg/dose PO every other day for 3-6 months

Treatment may have to be individualized

 

Pediapred, Orapred (prednisolone) adverse (side) effects

Frequency not defined

Acne

Adrenal suppression

Delayed wound healing

Diabetes mellitus

GI perforation

Glucose intolerance

Hepatomegaly

Hypokalemic alkalosis

Increased transaminases

Insomnia

Menstrual irregularity

Myopathy

Neuritis

Osteoporosis

Peptic ulcer

Perianal pruritus

Pituitary adrenal axis suppression

Pseudotumor cerebri (on withdrawal)

Psychosis

Seizure

Ulcerative esophagitis

Urticaria

Vertigo

Weight gain

 

Warnings

Contraindications

Documented hypersensitivity

Systemic fungal infection, varicella, superficial herpes simplex keratitis

Receipt of live or attenuated live vaccine; Advisory Committee on Immunization Practices (ACIP) and American Academy of Family Physicians (AAFP) state that administration of live virus vaccines usually is not contraindicated in patients receiving corticosteroid therapy as short-term (<2 weeks) treatment, in low-to-moderate dosages, as long-term alternate-day treatment with short-acting preparations, or in maintenance of physiologic dosages (replacement therapy)

 

Cautions

Use with caution in cirrhosis, diabetes, ocular herpes simplex, hypertension, diverticulitis, following myocardial infarction, thyroid disease, seizure disorders, hypothyroidism, myasthenia gravis, hepatic impairment, peptic ulcer disease, osteoporosis, ulcerative colitis, psychotic tendencies, untreated systemic infections, renal insufficiency, pregnancy

Thromboembolic disorders or myopathy may occur

Delayed wound healing is possible

Patients receiving corticosteroids should avoid chickenpox or measles-infected persons if unvaccinated

Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored)

Some suggestion (not fully substantiated) of slightly increased cleft palate risk if corticosteroids are used in pregnancy

Parenteral forms (prednisolone sodium phosphate) have been discontinued

Suppression of hypothalamic-pituitary-adrenal axis may occur particularly in patients receiving high doses for prolonged periods or in young children; discontinuation of therapy should be done through slow taper

Posterior subcapular cataract formation associated with prolonged use of corticosteroids

Prolonged use of corticosteroids may increase risk of secondary infections

Increase in intraocular pressure associated with prolonged use of corticosteroids

Long-term use associated with fluid retention and hypertension

Development of Kaposi's sarcoma associated with prolonged corticosteroid use

Acute myopathy associated with high dose of corticosteroids

Corticosteroid use may cause psychiatric disturbances

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Excreted in breast milk; use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Pediapred, Orapred (prednisolone)

Mechanism of action

Glucocorticosteroid; elicits mild mineralocorticoid activity and moderate anti-inflammatory effects; controls or prevents inflammation by controlling rate of protein synthesis, suppressing migration of polymorphonuclear leukocytes (PMNs) and fibroblasts, reversing capillary permeability, and stabilizing lysosomes at cellular leveL

 

Absorption

Duration: 18-36 hr

Peak plasma time: 5 min (IV); 1 hr (PO)

 

Distribution

Protein bound: 65-91% (lower in elderly)

Vd: 0.22-0.7 L/kg

 

Metabolism

Extensively metabolized in liver

 

Elimination

Half-life: 3.6 hr (normal renal function); 3-5 hr (end-stage renal disease)

Dialyzable: Hemodialysis, no

Renal clearance: 9.5 mL/min

Excretion: Urine (mainly)