Important Safety Information

INDICATION AND USAGE

Prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) is indicated in 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. See full Prescribing Information for additional Indications and Usage.

Important Safety Information

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

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. See full Prescribing Information for additional Warnings including: Cardio-renal, Endocrine, Infections (General), Infections (Viral), Ophthalmic, Special Pathogens, and Tuberculosis.

PRECAUTIONS: Pediatric Use Precautions: The efficacy and safety of prednisolone in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month of age). However, some of these conclusions and other indications for pediatric use of corticosteroid, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. See full Prescribing Information for additional Pediatric Use and other Precautions.

ADVERSE REACTIONS: The adverse effects of prednisolone in pediatric patients are similar to those in adults. Please see full Prescribing Information for additional information on Adverse Reactions listed alphabetically: Cardiovascular, Dermatologic, Endocrine, Fluid and Electrolyte Disturbances, Gastrointestinal, Metabolic, Musculoskeletal, Neurological, Ophthalmic, and Other (increased appetite; malaise; nausea; weight gain).



 

When it’s asthma and allergy season

 

Less volume for your pediatric patients*

Administration

* 40% less volume than the 15 mg/5 mL for equivalent dose based on difference in strength*

*Please see Dosage and Administration in full Prescribing Information because 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.
 

Flavor

* Grape flavor

 

 

 

Dosing chart




INDICATION AND USAGE

Prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) is indicated in 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. See full Prescribing Information for additional Indications and Usage.

Important Safety Information

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

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. See full Prescribing Information for additional Warnings including: Cardio-renal, Endocrine, Infections (General), Infections (Viral), Ophthalmic, Special Pathogens, and Tuberculosis.

PRECAUTIONS: Pediatric Use Precautions: The efficacy and safety of prednisolone in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month of age). However, some of these conclusions and other indications for pediatric use of corticosteroid, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. See full Prescribing Information for additional Pediatric Use and other Precautions.

ADVERSE REACTIONS: The adverse effects of prednisolone in pediatric patients are similar to those in adults. Please see full Prescribing Information for additional information on Adverse Reactions listed alphabetically: Cardiovascular, Dermatologic, Endocrine, Fluid and Electrolyte Disturbances, Gastrointestinal, Metabolic, Musculoskeletal, Neurological, Ophthalmic, and Other (increased appetite; malaise; nausea; weight gain).

* Provided in 3 or 4 divided doses. Please see Dosage and Administration in full Prescribing Information because 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.
In pediatric patients, the initial dose of prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in 3 or 4 divided doses (4 to 60 mg/m2bsa/day).
 

 

 

 

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