Phosphate, USP, Oral Solution
6.7 mg / 5 mL
Prednisolone Sodium Phosphate, USP, Oral Solution is a dye free, colorless to light straw colored, bubblegum flavored solution. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate, USP, Oral Solution contains 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) in a palatable, aqueous vehicle. Prednisolone Sodium Phosphate, USP, Oral Solution also contains dibasic sodium phosphate, edetate disodium, methylparaben, purified water, sodium biphosphate, sorbitol, and bubblegum flavor. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane.
Prednisolone Sodium Phosphate, USP, Oral Solution is indicated in the following conditions:
1. 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.
2. Dermatologic Diseases
Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome);exfoliative erythroderma; mycosis fungoides.
3. 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.
4. 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.
5. Gastrointestinal Diseases
To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis.
6. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults;selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia.
7. Neoplastic Diseases
For the treatment of acute leukemia and aggressive lymphomas in adults and children.
8. Nervous System
Acute exacerbations of multiple sclerosis.
9. Ophthalmic Diseases
Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia.
10. 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.
11. 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.
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 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 Prednisolone
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge Model [Active, not recruiting]
The purpose of the study is to determine whether prednisolone acetate 1% ophthalmic
suspension is effective in preventing signs and symptoms of allergic conjunctivitis in
comparison with prednisolone acetate 0. 12% ophthalmic suspension, loteprednol etabonate 0. 2%
ophthalmic suspension and placebo in a modified conjunctival allergen challenge (CAC) model.
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte [Completed]
Scandinavian Bell's Palsy Study [Completed]
The main objective of this study is to study the effects of prednisolone and valaciclovir,
with equal importance, compared to placebo for the treatment of Bell´s palsy. The combination
of prednisolone and valaciclovir will also be studied.
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.
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]
Reports of Suspected Prednisolone Side Effects
Pneumocystis Jiroveci Pneumonia (98),
Respiratory Failure (94),
Herpes Zoster (89),
Infection (86), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 8 ratings/reviews, Prednisolone has an overall score of 6.50. The effectiveness score is 8.50 and the side effect score is 6.75. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Prednisolone review by 26 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || SLE (Lupus), Rheumatoid Arthritis|
|Dosage & duration:|| || 10mg to 5mg taken once daily (morning) for the period of 8 weeks|
|Other conditions:|| || Degenerative bone, joint and disc disease|
|Other drugs taken:|| || Ortho Tri Cyclen Lo|
|Benefits:|| || Severe pain in entire body was gone, and I mean GONE. I felt like I was a little kid again, able to do anything. I also had increased energy.|
|Side effects:|| || Slight weight gain. |
|Comments:|| || I take this medicine on and off, usually for a duration of about two months on a very low dosage. |
Prednisolone review by 52 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || lupus-like systemic autoimmune condition|
|Dosage & duration:|| || 30mg max / 7.5 mg min so far taken daily for the period of 3 years, ongoing|
|Other conditions:|| || underactive thyroid|
|Other drugs taken:|| || levo-thyroxine, lansoprazole when dose above 12.5mg to protect stomach|
|Benefits:|| || keeps me alive during flare-ups! (They incl pericarditis & pleural effusions, ie inflammation of the lining around the heart and lungs – involving LOTS of fluid for which there isn't space, leading to heart failure and breathlessness - nice...) I can more or less live a normal life, apart from at the start of a flare (and spending hours researching online!).|
|Side effects:|| || rampant hunger at high dose (above 25mg) - but, with discipline (and vanity!) have managed to keep my weight within 4lbs of my prior weight; SLIGHT rounding of face (I'm lucky!); bodily skin thinning, particularly evident on my shins (I use Nivea CoQ10 firming lotion - fab – all over, 2x daily, and am about to start taking Qsilica to see if it'll help); most importantly...slight bone density loss when tested 20 mths ago (next DEXA scan is later this month) but as well as exercising, I take daily organic calcium, magnesium, L-Lysine (amino acid), boron, zinc, 2 gms slow release vit C, marine collagen, plus am trying to eat an alkaline diet to keep body at neutral pH (see SaveOurBones online - I have no affiliation!).|
|Comments:|| || For good reasons (not typical lupus, plus 'you know your body best'), my Doc and Consultant basically leave me to decide my dosage! After 3 years I have learnt that when I have the 1st definite signs of a flare-up (pericarditis symptom, ie pressure in neck when bending over), I need to put the dose up to 30mg straight away - from trial and error, anything less just doesn't work, ie putting dose up to e.g. 15mg, then 20mg, then 25mg gives the flare-up more time to really get hold of me! Am trying to decide whether to take 'steroid-sparing' drug Azathioprine as well...v hard decision as it's a serious immune suppressant and has scary side-effects. Hey ho! (Once tried 35mg for a couple of days when 30mg wasn't quite sorting it, and got tingly lips - checked online and thought it could be a sign of calcium deficiency; called Doc, he agreed (!) so went back down to 30mg and was fine.)|
Prednisolone review by 33 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || r/a|
|Dosage & duration:|| || 60mg taken daily for the period of weeks|
|Other conditions:|| || none|
|Other drugs taken:|| || methatrex|
|Benefits:|| || first cople week felt great swelling down no pain fulll of energy wanted to go jogging |
|Side effects:|| || big fat face,body ectdepressed mood swings up and down dont want to go out the house gained about a stone only been on it for 4 weeks some and pain swelling back feeling ill and night swets and spots over face and body feeling iritabill and can not think straght could go on |
|Comments:|| || start on 60mg second week 50mg third week 40 forth week 30 and had anough|
Page last updated: 2013-02-10