Orapred (Prednisolone Sodium Phosphate) - Summary

ORAPRED SUMMARY

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:

1. 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.
2. 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.
3. Dermatologic Diseases
   Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides.
4. 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.
5. Ophthalmic Diseases
   Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia.
6. 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.
7. Hematologic Disorders
   Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia.
8. Neoplastic Diseases
   For the treatment of acute leukemia and aggressive lymphomas in adults and children.
9. 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.
10. Gastrointestinal Diseases
    To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis.
11. Nervous System
    Acute exacerbations of multiple sclerosis.
12. Miscellaneous
    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).

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NEWS HIGHLIGHTS

Published Studies Related to Orapred (Prednisolone)

Intravenous immunoglobulin versus intravenous methylprednisolone for chronic inflammatory demyelinating polyradiculoneuropathy: a randomised controlled trial. [2012]
intravenous methylprednisolone... INTERPRETATION: Treatment of CIDP with IVIg for 6 months was less frequently

Efficacy of methylprednisolone in preventing lung injury following pulmonary thromboendarterectomy. [2012]
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 &#38; 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.

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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.

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