Orapred Solution is a dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of Orapred contains 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base) in a palatable, aqueous vehicle.
Orapred Solution is indicated in the following conditions:
- Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.
- Rheumatic Disorders
As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren's syndrome, relapsing polychondritis, and certain cases of vasculitis.
- Dermatologic Diseases
Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides.
- Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.
- Ophthalmic Diseases
Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia.
- Respiratory Diseases
Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under "Allergic States"), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia.
- Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia.
- Neoplastic Diseases
For the treatment of acute leukemia and aggressive lymphomas in adults and children.
- Edematous States
To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia.
- Gastrointestinal Diseases
To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis.
- Nervous System
Acute exacerbations of multiple sclerosis.
Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).
Published Studies Related to Orapred (Prednisolone)
Intravenous immunoglobulin versus intravenous methylprednisolone for chronic
inflammatory demyelinating polyradiculoneuropathy: a randomised controlled trial. 
intravenous methylprednisolone... INTERPRETATION: Treatment of CIDP with IVIg for 6 months was less frequently
Efficacy of methylprednisolone in preventing lung injury following pulmonary
pulmonary thromboendarterectomy... CONCLUSIONS: Perioperative methylprednisolone does not reduce the incidence of
Short-course of prednisolone in solitary cysticercus granuloma: a randomized, double-blind, placebo-controlled trial. [2011.10]
PURPOSE: To determine the effect of administration of a short course of prednisolone on seizure and radiologic outcome in patients with solitary cysticercus granuloma (SCG). METHODS: One hundred forty-eight subjects presenting with new-onset seizures (<15 days duration) and with SCG demonstrated on imaging studies were randomly allocated to either treatment with prednisolone (40-60 mg/day for 2 weeks) or placebo in addition to standard antiepileptic drug therapy.
A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery. [2011.10]
PURPOSE: To compare the effects of 2 corticosteroids on corneal thickness and visual acuity after cataract surgery. DESIGN: Multicenter, randomized, contralateral-eye, double-masked trial... CONCLUSIONS: In this high-dose pulsed-therapy regimen, difluprednate reduced inflammation more effectively than prednisolone acetate, resulting in more rapid return of vision. Difluprednate was superior at protecting the cornea and reducing macular thickening after cataract surgery. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Prednisolone and budesonide for short- and long-term treatment of microscopic colitis: systematic review and meta-analysis. [2011.10]
BACKGROUND & AIMS: The incidence of microscopic colitis and its disease burden are increasing, yet there is limited systematic information addressing the use of conventional corticosteroids and budesonide in microscopic colitis. We performed a systematic review and meta-analysis on the short- and long-term efficacy of corticosteroids in treatment of microscopic colitis... CONCLUSIONS: Both short- and long-term treatment with budesonide is effective and well-tolerated for microscopic colitis. However, the rate of symptom relapse once budesonide is discontinued is high. Further studies are needed to determine optimal treatment duration, dose, and withdrawal procedure. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
Clinical Trials Related to Orapred (Prednisolone)
Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone [Recruiting]
Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS) [Recruiting]
Patients with an acute exacerbation of Relapsing-Remitting Multiple Sclerosis or with
Clinically Isolated Syndrome receive either one single infusion of Nanocort or three daily
infusions of SoluMedrol. Main objective is to assess the occurrence of new
gadolinium-enhanced T1-weighted lesions at week 8 vs week 1 after treatment.
Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE) [Recruiting]
Hypothesis: A reason for repeated disappointing outcomes of clinical trials testing targeted
immune biologics for lupus may be the heterogeneity of the disease, exacerbated by the
variable effects on immune homeostasis of the background medications that must be continued,
in most study designs, in these flare-prone patients.
Purpose of Study: This study will purposefully study a population equivalent to the placebo
group of typical trials in SLE. Patients will enter the trial in mild-moderate flare, be
treated with depomedrol, and background treatments will be withdrawn. Biomarkers at entry on
various medications will be compared to biomarkers after steroid efficacy with background
medications withdrawn. Depomedrol usually slowly wears off over one to three months.
Patients will be closely observed, with serial biomarkers drawn at monthly intervals or,
immediately at the time of a new flare. Those patients who do develop new flares during the
course of the next year (maximal participation time) will donate blood samples for
biomarkers (flaring on tapering or absent depomedrol effect) and will then be immediately
treated as deemed appropriate, exiting the study. The study will end when 50 patients have
met this endpoint. A control population of matched, healthy individuals will donate blood
once for the same biomarker studies.
Prednisolone and Acupuncture in Bell's Palsy: a Randomised, Placebo-controlled, Multicentre Trial in China [Recruiting]
The aim of this study is to compare the effects of prednisolone and staging acupuncture in
the recovery of the affected facial nerve, and to verify that whether in combination with
staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large
number of patients.
Methylprednisolone N Acetylcysteine in Hepatic Resections [Recruiting]
This is a prospective double-blind randomized phase II clinical trial, with two groups of
intervention (one with administration of N-acetylcysteine and the other with administration
of methylprednisolone), and one group of placebo. The purpose of this study is to
investigate the role of N-acetylcysteine and Methylprednisolone in the modulation of warm
ischemia of the liver during hepatic resection. In fact to avoid massive blood loss in liver
surgery, continuous or intermittent vascular clamping of the hepatic hilum ('Pringle
maneuver') is generally used with good results. However, as a consequence, ischemia and
subsequent reperfusion result in complex metabolic, immunological, and microvascular
changes, which together might contribute to hepatocellular damage and dysfunction. This
phenomenon, known as ischemia-reperfusion (IR) injury of the liver, is a complex multi-path
process leading to the activation of some inflammatory pathways. Any patient candidate to
liver resection will be enrolled in the study based on the aforementioned criteria. The
primary objective of the study is to assess the real efficacy of Methylprednisolone and
N-acetylcysteine in reducing the secondary damage from ischemia reperfusion injury in liver
resection and in reducing inflammatory response. Secondary objective of the study is whether
the reduction of ischemia-reperfusion injury results in: lower incidence of postoperative
liver failure, improvement of postoperative liver function, and reduction of blood
components transfusions. The randomization will be done the day before the operation. The
drugs will be prepared in a blind fashion by the hospital pharmacy. The hospital pharmacy
will provide to each patient a drip to make bolus of about an hour before the start of the
liver resection and a syringe pump for an infusion of approximately 6 hours. If the patient
is enrolled and randomized in the placebo arm, he/she will receive 250 ml of glucose 5%
plus the infusion of 100 ml of glucose 5% If the patient is randomized in the
Methylprednisolone arm, he/she will receive a dose of 500 mg in 250 ml of glucose 5% plus
100 mg of glucose 5%. If the patient is randomized in the N-acetylcysteine arm, he/she will
receive a dose of 150 mg/kg in 250 ml of glucose 5% plus N-acetylcysteine 50 mg/kg in 100 ml
glucose 5%. Systematic sampling of liver function tests will be done the day before the
operation, at the end of the operation, as well as in postoperative day 1, 3, 5 and 7.
Page last updated: 2013-02-10