PEDIAPRED Oral solution (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Royal Pharmaceuticals

Λέξεις κλειδιά

68791-104

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1. Description

PEDIAPRED (prednisolone sodium phosphate) Oral Solution is a dye free, colorless to light straw colored, raspberry flavored solution. Each 5 mL (teaspoonful) of PEDIAPRED contains 6.7 mg prednisolone sodium ...

2. Clinical Pharmacology

Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily ...

3. Indications and Usage

PEDIAPRED 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 ...

4. Contraindications

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

5. 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 ...

6. Precautions

Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with hypertension, ...

6.1. General

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual. Since complications of treatment ...

6.2. Information for Patients

Patients should be warned not to discontinue the use of PEDIAPRED (prednisolone sodium phosphate) Oral Solution abruptly or without medical supervision, to advise any medical attendants that they are taking ...

6.4. 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 PEDIAPRED ...

6.7. Pregnancy

Teratogenic Effects Pregnancy Category C. Prednisolone has been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which prednisolone has ...

6.9. Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised ...

6.10. Pediatric Use

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 ...

6.11. Geriatric Use

Clinical studies of PEDIAPRED did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with ...

7. Adverse Reactions

Cardiovascular: Hypertrophic cardiomyopathy in premature infants. Dermatologic: Facial erythema; increased sweating; impaired wound healing; may suppress reactions to skin tests; petechiae ...

9. Overdosage

The effects of accidental ingestion of large quantities of prednisolone over a very short period of time have not been reported, but prolonged use of the drug can produce mental symptoms, moon face, abnormal ...

10. Dosage and Administration

The initial dosage of PEDIAPRED may vary from 5 mL to 60 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 ...

11. How Supplied

PEDIAPRED (prednisolone sodium phosphate) Oral Solution is a colorless to light straw-colored, raspberry flavored solution containing 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) per 5 ...

12. Storage and Handling

Store at 4°-25°C (39°-77°F). May be refrigerated. Keep tightly closed and out of the reach of children.