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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. 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 multi-forme (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).


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NEWS HIGHLIGHTS

Published Studies Related to Orapred (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 Orapred (Prednisolone)

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

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.

Preoperative Methylprednisolone in Endovascular Aortic Repair [Completed]

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.

more trials >>


Page last updated: 2015-08-10

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