Prednisolone (Prednisolone Sodium Phosphate) - Summary

PREDNISOLONE SUMMARY

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.

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).

See all Prednisolone indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Prednisolone

Effect of timing and route of methylprednisolone administration during pediatric cardiac surgical procedures. [2015]
cardiopulmonary bypass (CPB) prime... CONCLUSIONS: Methylprednisolone administration at anesthesia induction was

Combined oral prednisolone and heparin versus heparin: the effect on peripheral NK cells and clinical outcome in patients with unexplained recurrent miscarriage. A double-blind placebo randomized controlled trial. [2014]
CONCLUSION: The addition of prednisolone to heparin and low dose aspirin might be

A comparison of the effects of methylprednisolone and tenoxicam on pain, edema, and trismus after impacted lower third molar extraction. [2014]
CONCLUSIONS: Preoperative administration of 80 mg methylprednisolone achieves

Effects of long-acting bronchodilators and prednisolone on inspiratory lung function parameters in stable COPD. [2014]
dyspnea (visual analog scale (VAS)) and clinical COPD questionnaire (CCQ)... CONCLUSIONS: After a single dose of long-acting bronchodilator salmeterol,

Efficiency of bupivacaine versus lidocaine and methylprednisolone versus placebo to reduce postoperative pain and swelling after surgical removal of mandibular third molars: a randomized, double-blinded, crossover clinical trial. [2013]
swelling after surgical removal of mandibular third molars... CONCLUSIONS: Bupivacaine combined with methylprednisolone reduced the

more studies >>

Clinical Trials Related to Prednisolone

Prednisolone Priming Study in Patients With Chronic Hepatitis B [Recruiting]
Study purpose: To investigate whether ALT rebound following corticosteroid priming enhances response to telbivudine therapy. Efficacy assessments: The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without prednisolone priming. Data analysis: A summary table will be presented as frequency tables for categorical variables as number, and percentage, whereas descriptive tables for continuous variables as number, mean ± SD and median (minimum, maximum). All statistical assessments will be two-sided and evaluated at significance level of 0. 05. Continuous variables will be analyzed using t-test, or ANOVA, and categorical variables will be analyzed using chi-square or Fisher's exact test. A non-parametric method, Wilcoxon rank-sum or sign-rank tests will be conducted for continuous, and categorical variables if data is far from normal distribution.

Biomarkers of Prednisolone Treatment (P05888) [Completed]
Primary objective:

- To identify a biomarker or biomarker-set for the adverse metabolic effects of various

doses of prednisolone treatment. Secondary objectives:

- To describe the PK of prednisolone and PD of a series of biomarkers.

- To identify biomarkers that reflect side effects of prednisolone.

- To elucidate part of the mechanisms by which prednisolone induces metabolic changes.

The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia [Completed]
A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may be as effective as 6 months-therapy.

A Comparison of Three Different Formulations of Prednisolone Acetate 1% [Completed]

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte [Completed]
The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1. 0% and tobramycin 0. 3% ophthalmic suspension compared to PredForte (prednisolone acetate 1. 0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.

more trials >>

Reports of Suspected Prednisolone Side Effects

Pyrexia (183),  Pneumonia (170),  Neutropenia (123),  Sepsis (119),  Anaemia (106),  Pneumocystis Jiroveci Pneumonia (98),  Respiratory Failure (94),  Hallucination (91),  Herpes Zoster (89),  Infection (86), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Prednisolone review by 26 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
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
		Reported Results
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
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
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
		Reported Results
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
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		r/a
Dosage & duration:		60mg taken daily for the period of weeks
Other conditions:		none
Other drugs taken:		methatrex
		Reported Results
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