Prednisolone Sodium Phosphate 10 mg/5mL
Prednisolone Sodium Phosphate · SOLUTION · Edenbridge Pharmaceuticals LLC.
Prednisolone Sodium Phosphate is a solution containing prednisolone sodium phosphate at 10 mg/5mL, taken oral. Manufactured by Edenbridge Pharmaceuticals LLC..
Key Facts
- Brand Name
- Prednisolone Sodium Phosphate
- Generic Name
- Prednisolone Sodium Phosphate
- NDC Code (Product)
42799-812- Manufacturer
- Edenbridge Pharmaceuticals LLC.
- Strength
- 10 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203559
- Marketing Start
- 11/11/2011
Recall History
Akorn, Inc.
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Morton Grove Pharmaceuticals, Inc.
Defective Container: Tamper Evident foil seal not completely intact.
Imprimis NJOF, LLC
Subpotent Drug
Morton Grove Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Mylan Pharmaceuticals Inc.
CGMP Deviations
US Compounding Inc
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Mylan Pharmaceuticals Inc.
CGMP Deviations
Mylan Pharmaceuticals Inc.
CGMP Deviations
Oregon Compounding Centers, Inc. dba Creative Compounds
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Prednisolone Sodium Phosphate Oral Solution (15 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 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; nonsuppura…
Dosage & Administration
DOSAGE AND ADMINISTRATION The initial dosage of Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL) may vary from 1.67 mL to 20 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 (15 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 …
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. Cardio-renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infections (General) Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. There may be decreased resistance and inability to localize infection when cortic…
Contraindications
CONTRAINDICATIONS Systemic fungal infections. Hypersensitivity to the drug or any of its components.
Drug Interactions
Drug Interactions Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of prednisolone and require that the dosage of Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL) be increased. Increased activity of both cyclosporin and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Estrogens may decrease the hepatic metabolism of certain corticosteroids thereby increasing their effect. Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60% leading to an increased risk of corticosteroid side effects. Coadministration 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. Concomitant use of aspirin (or other non-steroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with …
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 f…
Frequently Asked Questions
What is Prednisolone Sodium Phosphate used for?
Prednisolone Sodium Phosphate contains Prednisolone Sodium Phosphate. It is a solution taken oral. Consult your doctor for specific uses.
Is Prednisolone Sodium Phosphate a controlled substance?
Prednisolone Sodium Phosphate is not classified as a controlled substance by the DEA.
What is the generic name for Prednisolone Sodium Phosphate?
The generic name for Prednisolone Sodium Phosphate is Prednisolone Sodium Phosphate. There are 3 other brand versions of Prednisolone Sodium Phosphate.
What is the NDC code for Prednisolone Sodium Phosphate 10 mg/5mL?
The NDC (National Drug Code) for Prednisolone Sodium Phosphate 10 mg/5mL is 42799-812, listed by Edenbridge Pharmaceuticals LLC..
Other Prednisolone Sodium Phosphate Dosages
- Prednisolone Sodium Phosphate15 mg/5mL67296-2134
- Prednisolone Sodium Phosphate15 mg/5mL68788-4046
- Prednisolone Sodium Phosphate15 mg/5mL0121-4759
- Prednisolone Sodium Phosphate15 mg/5mL17856-0815
- Prednisolone Sodium Phosphate10 mg/5mL0121-0773
- Prednisolone Sodium Phosphate20 mg/5mL0121-0777
- Prednisolone Sodium Phosphate15 mg/5mL42799-815
- Prednisolone Sodium Phosphate25 mg/5mL42799-816
- Prednisolone Sodium Phosphate15 mg/5mL50090-1582
Other Prednisolone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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