Prednisolone Sodium Phosphate Oral Solution 25 mg/5mL

Prednisolone Sodium Phosphate · SOLUTION · BioComp Pharma, Inc.

3 Recalls on Record

Plain English

Prednisolone Sodium Phosphate Oral Solution is a solution containing prednisolone sodium phosphate at 25 mg/5mL, taken oral. Manufactured by BioComp Pharma, Inc..

Key Facts

Brand Name: Prednisolone Sodium Phosphate Oral Solution
Generic Name: Prednisolone Sodium Phosphate
NDC Code (Product): 44523-182
Manufacturer: BioComp Pharma, Inc.
Strength: 25 mg/5mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: ANDA091396
Marketing Start: 10/28/2019

Recall History

3 Recalls on Record

Class III06/05/2020

Akorn, Inc.

Discoloration: Out of Specification (OOS) result for APHA Color Test.

TerminatedVoluntary: Firm initiated

Class II07/24/2018

Morton Grove Pharmaceuticals, Inc.

Defective Container: Tamper Evident foil seal not completely intact.

TerminatedVoluntary: Firm initiated

Class II09/23/2019

Morton Grove Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective180 reports

off label use159 reports

treatment failure152 reports

pyrexia146 reports

condition aggravated132 reports

vomiting119 reports

pain118 reports

rheumatoid arthritis118 reports

hypersensitivity114 reports

fatigue110 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) 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 nephritic 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; nonsuppura…

Dosage & Administration

DOSAGE AND ADMINISTRATION The initial dosage of prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) may vary from 1 mL to 12 mL (5 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, prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) 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 which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in …

Warnings

WARNINGS General: In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection: Corticosteroids, including prednisolone sodium phosphate oral solution, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: • Reduce resistance to new infections • Exacerbate existing infections • Increase the risk of disseminated infections • Increase the risk of reactivation or exacerbation of latent infections • Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider prednisolone sodium phosphate oral solution withdrawal or dosage reduction as needed. Tuberculosis: If prednisolone sodium phosphate oral solution is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of…

Contraindications

CONTRAINDICATIONS Systemic fungal infections. Hypersensitivity to the drug or any of its components.

Adverse Reactions

ADVERSE REACTIONS (listed alphabetically under each subsection) Cardiovascular: Hypertrophic cardiomyopathy in premature infants. Dermatologic: Facial erythema; increased sweating; impaired wound healing; may suppress reactions to skin tests; petechiae and ecchymoses; thin fragile skin; urticaria; edema. Endocrine: Decreased carbohydrate tolerance; development of cushingoid state; hirsutism; increased requirements for insulin or oral hypoglycemic agents in diabetic patients; manifestations of latent diabetes mellitus; menstrual irregularities; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; suppression of growth in children. Fluid and Electrolyte Disturbances : Congestive heart failure in susceptible patients; fluid retention; hypertension; hypokalemic alkalosis; potassium loss; sodium retention. Gastrointestinal: Abdominal distention; elevation in serum liver enzyme levels (usually reversible upon discontinuation); pancreatitis; peptic ulcer with possible perforation and hemorrhage; ulcerative esophagitis. Metabolic: Negative nitrogen balance due to protein catabolism. Musculoskeletal: Aseptic necrosis of …

Frequently Asked Questions

What is Prednisolone Sodium Phosphate Oral Solution used for?

Prednisolone Sodium Phosphate Oral Solution contains Prednisolone Sodium Phosphate. It is a solution taken oral. Consult your doctor for specific uses.

Is Prednisolone Sodium Phosphate Oral Solution a controlled substance?

Prednisolone Sodium Phosphate Oral Solution is not classified as a controlled substance by the DEA.

What is the generic name for Prednisolone Sodium Phosphate Oral Solution?

The generic name for Prednisolone Sodium Phosphate Oral Solution is Prednisolone Sodium Phosphate. There are 11 other brand versions of Prednisolone Sodium Phosphate.

What is the NDC code for Prednisolone Sodium Phosphate Oral Solution 25 mg/5mL?

The NDC (National Drug Code) for Prednisolone Sodium Phosphate Oral Solution 25 mg/5mL is 44523-182, listed by BioComp Pharma, Inc..

Product NDC

44523-182

Package NDC

44523-182-08

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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