prednisolone sodium phosphate ODT 15 mg/1

prednisolone sodium phosphate · TABLET, ORALLY DISINTEGRATING · Ingenus Pharmaceuticals, LLC

No Recall History

Plain English

prednisolone sodium phosphate ODT is a tablet, orally disintegrating containing prednisolone sodium phosphate at 15 mg/1, taken oral. Manufactured by Ingenus Pharmaceuticals, LLC.

Key Facts

Brand Name: prednisolone sodium phosphate ODT
Generic Name: prednisolone sodium phosphate
NDC Code (Product): 50742-384
Manufacturer: Ingenus Pharmaceuticals, LLC
Strength: 15 mg/1
Dosage Form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Marketing Status
Application #: NDA021959
Marketing Start: 09/15/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective181 reports

off label use159 reports

treatment failure152 reports

pyrexia145 reports

condition aggravated132 reports

pain118 reports

rheumatoid arthritis118 reports

vomiting118 reports

hypersensitivity114 reports

fatigue110 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS & USAGE Prednisolone sodium phosphate orally disintegrating tablets are indicated in the treatment of the following diseases or conditions: Prednisolone sodium phosphate orally disintegrating tablet 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 sec…

Dosage & Administration

2 DOSAGE & 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 PREDNISOLONE SODIUM PHOSPHATE ORALLY DISINTEGRATING TABLETS. USE AN APPROPRIATE FORMULATION OF PREDNISOLONE IF INDICATED DOSE CANNOT BE OBTAINED USING PREDNISOLONE SODIUM PHOSPHATE ORALLY DISINTEGRATING TABLETS. 2.1 Recommended Dosing Dosage of Prednisolone Sodium Phosphate Orally Disintegrating Tablets 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 Prednisolone Sodium Phosphate Orally Disintegrating Tablets. Use an appropriate formulation of prednisolone if indicated dose cannot …

Contraindications

4 CONTRAINDICATIONS Prednisolone sodium phosphate orally disintegrating tablets are 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.

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) :…

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 di…

Frequently Asked Questions

What is prednisolone sodium phosphate ODT used for?

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

Is prednisolone sodium phosphate ODT a controlled substance?

prednisolone sodium phosphate ODT is not classified as a controlled substance by the DEA.

What is the generic name for prednisolone sodium phosphate ODT?

The generic name for prednisolone sodium phosphate ODT is prednisolone sodium phosphate. There are 12 other brand versions of prednisolone sodium phosphate.

What is the NDC code for prednisolone sodium phosphate ODT 15 mg/1?

The NDC (National Drug Code) for prednisolone sodium phosphate ODT 15 mg/1 is 50742-384, listed by Ingenus Pharmaceuticals, LLC.

Product NDC

50742-384

Package NDC

50742-384-12

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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