Drugplain

Orapred ODT 30 mg/1

prednisolone sodium phosphate · TABLET, ORALLY DISINTEGRATING · Advanz Pharma (US) Corp.

No Recall History
Plain English

Orapred ODT is a tablet, orally disintegrating containing prednisolone sodium phosphate at 30 mg/1, taken oral. Manufactured by Advanz Pharma (US) Corp..

Key Facts

Brand Name
Orapred ODT
Generic Name
prednisolone sodium phosphate
NDC Code (Product)
59212-702
Manufacturer
Advanz Pharma (US) Corp.
Strength
30 mg/1
Dosage Form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Marketing Status
Application #
NDA021959
Marketing Start
06/01/2006

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective193 reports
off label use171 reports
pyrexia166 reports
condition aggravated154 reports
treatment failure153 reports
vomiting149 reports
fatigue126 reports
pneumonia126 reports
headache125 reports
pain119 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions: Orapred ODT is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation ( 1 ) for the treatment of certain endocrine conditions ( 1 ) for palliation of certain neoplastic conditions ( 1 ) 1.1 Allergic 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 1.2 Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) 1.3 Endocrine Conditions Congenital adrenal hyperplasia Hypercalcemia of malignancy Nonsuppurative thyroiditis Primary or secondary adrenocortical insuf…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Individualize dosing based on disease severity and patient response: Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of prednisolone sodium phosphate) ( 2 ) Maintenance Dose: Use lowest dosage that will maintain an adequate clinical response ( 2 ) Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy ( 2 ) Take with food to avoid gastrointestinal (GI) irritation ( 2 ) DO NOT BREAK OR USE PARTIAL ORAPRED ODT TABLETS. USE AN APPROPRIATE FORMULATION OF PREDNISOLONE IF INDICATED DOSE CANNOT BE OBTAINED USING ORAPRED ODT. ( 2 ) 2.1 Recommended Dosing Dosage of Orapred ODT 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 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 Or…

Contraindications

4 CONTRAINDICATIONS Orapred ODT is contraindicated in patients who are hypersensitive to corticosteroids such as prednisolone or any components of this product. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. Hypersensitivity to prednisolone or any components of this product. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Aminoglutethimide: Aminoglutethimide may lead to loss of corticosteroid-induced adrenal suppression. Amphotericin B: There have been cases reported in which concomitant use of Amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see also Potassium depleting agents). Anticholinesterase agents: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. Anticoagulant agents: Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetic Agents: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs: Serum concentrations of isoniazid may be decreased. CYP 3A4 inducers (e.g. barbiturates, phenytoin, carbamazepine, and rifampin): Drugs …

Adverse Reactions

6 ADVERSE REACTIONS Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain. Allergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or hypo-pigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria Endocrine: Abnormal fat deposits, decreased carbohydrate tolerance, development of Cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabet…

Frequently Asked Questions

What is Orapred ODT used for?

Orapred ODT contains prednisolone sodium phosphate. It is a tablet, orally disintegrating taken oral. Consult your doctor for specific uses.

Is Orapred ODT a controlled substance?

Orapred ODT is not classified as a controlled substance by the DEA.

What is the generic name for Orapred ODT?

The generic name for Orapred ODT is prednisolone sodium phosphate. There are 10 other brand versions of prednisolone sodium phosphate.

What is the NDC code for Orapred ODT 30 mg/1?

The NDC (National Drug Code) for Orapred ODT 30 mg/1 is 59212-702, listed by Advanz Pharma (US) Corp..

Product NDC

59212-702

Package NDC

59212-702-12

Other Orapred ODT Dosages

Other Prednisolone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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