Prednisolone Sodium Phosphate (Page 3 of 3)

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 fat deposits, fluid retention, excessive appetite, weight gain, hypertrichosis, acne, striae, ecchymosis, increased sweating, pigmentation, dry scaly skin, thinning scalp hair, increased blood pressure, tachycardia, thrombophlebitis, decreased resistance to infection, negative nitrogen balance with delayed bone and wound healing, headache, weakness, menstrual disorders, accentuated menopausal symptoms, neuropathy, fractures, osteoporosis, peptic ulcer, decreased glucose tolerance, hypokalemia, and adrenal insufficiency. Hepatomegaly and abdominal distention have been observed in children.

Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy the dosage of prednisolone may be reduced only temporarily, or alternate day treatment may be introduced.

DOSAGE AND ADMINISTRATION

The initial dose of prednisolone sodium phosphate oral solution, (15 mg prednisolone base) 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 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 regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of prednisolone sodium phosphate oral solution for a period of time consistent with the patient’s condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4 to 8 mg dexamethasone every other day for one month have been shown to be effective.

In pediatric patients, the initial dose of prednisolone sodium phosphate oral solution may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m2bsa/day).

The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m2/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m2/day.

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone or methylprednisolone in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1–2 mg/kg/day in single or divided doses. It is further recommended that short course, or “burst” therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.

For the purpose of comparison, 5 mL of prednisolone sodium phosphate oral solution (20.2 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids:

Cortisone , 75
Triamcinolone , 12
Hydrocortisone , 60
Paramethasone , 6
Prednisolone , 15
Betamethasone , 2 . 25
Prednisone , 15
Dexamethasone , 2 . 25
Methylprednisolone , 12

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

HOW SUPPLIED

Prednisolone Sodium Phosphate Oral Solution is a clear, grape flavored solution, containing 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base) per 5 mL (teaspoonful).

Available as: 8 fl oz (237 mL) PET bottles (NDC 60432-212-08).

Dispense in tight, light-resistant glass or PET plastic containers as defined in USP.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Keep tightly closed and out of the reach of children.

Product No.: 8212

Manufactured For: Wockhardt USA, LLC., Parsippany, NJ 07054

Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

A50-8212-08

REV. 07-18

PRINCIPAL DISPLAY PANEL mL Bottle Label

MGP

NDC 60432-212-08

PrednisoLONE

Sodium Phosphate

Oral Solution,

15 mg/5 mL*

DYE-FREE

*Each 5 mL (teaspoonful) contains 20.2 mg

prednisolone sodium phosphate (equivalent

to 15 mg prednisolone base) in a palatable

solution. Contains alcohol 1.8%.

Rx Only

NET: 8 fl oz (237 mL)

Prednisolone Label
(click image for full-size original)

Prednisolone Label

PREDNISOLONE SODIUM PHOSPHATE
prednisolone sodium phosphate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-212
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE) PREDNISOLONE 15 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM PHOSPHATE, DIBASIC
SODIUM PHOSPHATE, MONOBASIC
SODIUM BENZOATE
GLYCERIN
ALCOHOL
SORBITOL
SUCROSE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60432-212-08 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076895 10/04/2004
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)
Establishment
Name Address ID/FEI Operations
Morton Grove Pharmaceuticals, Inc. 801897505 ANALYSIS (60432-212), LABEL (60432-212), MANUFACTURE (60432-212), PACK (60432-212)
Establishment
Name Address ID/FEI Operations
Crystal Pharma S.A.U. 563371111 API MANUFACTURE (60432-212)

Revised: 09/2021 Morton Grove Pharmaceuticals, Inc.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.