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Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions:
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with:
- Atopic dermatitis
- Drug hypersensitivity reactions
- Seasonal or perennial allergic rhinitis
- Serum sickness
- Bullous dermatitis herpetiformis
- Contact dermatitis
- Exfoliative erythroderma
- Mycosis fungoides
- Severe erythema multiforme (Stevens-Johnson syndrome)
- Congenital adrenal hyperplasia
- Hypercalcemia of malignancy
- Nonsuppurative thyroiditis
- Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorricoids where applicable.
During acute episodes in:
- Acquired (autoimmune) hemolytic anemia
- Diamond-Blackfan anemia
- Idiopathic thrombocytopenic purpura in adults
- Pure red cell aplasia
- Secondary thrombocytopenia in adults
For the treatment of:
- Acute leukemia
- Aggressive lymphomas
Nervous System Conditions
- Acute exacerbations of multiple sclerosis
- Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury
- Sympathetic ophthalmia
- Uveitis and ocular inflammatory conditions unresponsive to topical corricosteroids
Conditions Related to Organ Transplantation
- Acute or chronic solid organ rejection
- Acute exacerbations of chronic obstructive pulmonary disease (COPD)
- Allergic bronchopulmonary aspergillosis
- Aspiration pneumonitis
- Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy
- Hypersensitivity pneumonitis
- Idiopathic bronchiolitis obliterans with organizing pneumonia
- Idiopathic eosinophilic pneumonias
- Idiopathic pulmonary fibrosis Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics
- Symptomatic sarcoidosis
- As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in:
- Acute gouty arthritis
- During an exacerbation or as maintenance therapy in selected cases of:
- Ankylosing spondylitis
- Dermatomyositis /polymyositis
- Polymyalgia rheumatica/temporal arteritis
- Psoriatic arthritis
- Relapsing polychondritis
- Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy)
- Sjogren's syndrome
- Systemic lupus erythematosus
Specific Infectious Diseases
DOSAGE AND ADMINISTRATION
Dosage of Orapred ODT (prednisolone sodium phosphate) should be individualized according to the severity of the disease and the response of the patient. For pediatric patients, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.
Do not break or use partial Orapred ODT (prednisolone sodium phosphate) tablets. Use an appropriate formulation of prednisolone if indicated dose cannot be obtained using Orapred ODT. This may become important in the treatment of conditions that require tapering doses that cannot be adequately accommodated by Orapred ODT (prednisolone sodium phosphate) , e.g., tapering the dose below 10 mg.
The initial dose of Orapred ODT (prednisolone sodium phosphate) may vary from 10 to 60 mg (prednisolone base) per day, depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time, there is a lack of satisfactory clinical response, Orapred should be discontinued and the patient placed on other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Orapred ODT (prednisolone sodium phosphate) for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Orapred ODT (prednisolone sodium phosphate) are packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The blister pack should then be peeled open, and the orally disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without the assistance of water. Orally disintegrating tablet dosage forms are friable and are not intended to be cut, split, or broken.
In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for one month have been shown to be effective.
In pediatric patients, the initial dose of Orapred may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m2bsa/day).
The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m2/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m2/day.
The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone or methylprednisolone in children whose asthma is uncontrolled by inhaled corricosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses.
It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.
Blood pressure, body weight, routine laboratory studies, including serum potassium and fasting blood glucose, should be obtained at regular intervals during prolonged therapy. Appropriate diagnostic studies should be performed in patients with known or suspected peptic ulcer disease and in patients at risk for reactivation of latent tuberculosis infections.
Corticosteroid Comparison Chart
For the purpose of comparison, one 10 mg Orapred ODT tablet (13.4 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorricoids:
|Betamethasone 1.75 mg||Paramethasone 4 mg|
|Cortisone 50 mg||Prednisolone 10 mg|
|Dexamethasone 1.75 mg||Prednisone lOmg|
|Hydrocortisone 40 mg||Triamcinolone 8 mg|
|Methylprednisolone 8 mg|
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
Dosage Forms And Strengths
Orally disintegrating tablets:
- 10 mg prednisolone (as 13.4 mg prednisolone sodium phosphate)
- 15 mg prednisolone (as 20.2 mg prednisolone sodium phosphate)
- 30 mg prednisolone (as 40.3 mg prednisolone sodium phosphate)
Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) 13.4 mg prednisolone sodium phosphate (equivalent to 10 mg prednisolone base) are white, flat faced, bevelled tablet, debossed with ORA on one side and 10 on the other. Supplied as:
- NDC 59630-700-48: 48 tablets per carton. Each carton has 8 cards containing 6 tablets.
Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) 20.2 mg prednisolone sodium phosphate (equivalent to 15 mg prednisolone base) are white, flat faced, bevelled tablet, debossed with ORA on one side and 15 on the other. Supplied as:
- NDC 59630-701-48: 48 tablets per carton. Each carton has 8 cards containing 6 tablets.
Orapred ODT: (prednisolone sodium phosphate orally disintegrating tablets) 40.3 mg prednisolone sodium phosphate (equivalent to 30 mg prednisolone base) are white, flat faced, beveled tablets, debossed with ORA on one side and 30 on the other. Supplied as:
- NDC 59630-702-48: 48 tablets per carton. Each carton has 8 cards containing 6 tablets.
Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP controlled Room Temperature]. Protect from moisture.
Do not break or use partial Orapred ODT (prednisolone sodium phosphate) tablets. Keep out of the reach of children.
Manufactured for: Shionogi Pharma, Inc. Atlanta, GA 30328. Manufactured by: CIMA® LABS INC., Eden Prairie, MN 55344. Revised 07/2010
Last reviewed on RxList: 8/20/2010
This monograph has been modified to include the generic and brand name in many instances.
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