of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).
DIRECTIONS FOR USING THE ACT-O-VIAL SYSTEM
1. Press down on plastic activator to force diluent into the lower compartment.
2. Gently agitate to effect solution.
3. Remove plastic tab covering center of stopper.
4. Sterilize top of stopper with a suitable germicide.
5. Insert needle squarely through center of stopper until tip is just visible. Invert vial and withdraw dose.
Storage Conditions
Protect from light.
Store unreconstituted product at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Store solution at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Use solution within 48 hours after mixing.
How Supplied
SOLU-MEDROL Sterile Powder is available in the following packages:
40 mg Act-O-Vial System (Single-Dose Vial)
1 mL NDC 00009-0113-12
25 x 1 mL MDC 0009-0113-19
125 mg Act-O-Vial System (Single-Dose Vial)
25 x 2 mL NDC 0009-0190-16
500 mg Act-O-Vial System (Single-Dose Vial)
4 mL NDC 0009-0765-02
1 gram Act-O-Vial System (Single-Dose Vial)
8 mL NDC 0009-3389-01
500 mg (Multi-Dose Vial)
8 mL NDC 0009-0758-01
1 gram (Multi-Dose Vial)
16 mL NDC 0009-0698-01
2 gram Vial with Diluent
NDC 00009-0796-01
References
1Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050-1.
2Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63.
Rx only
Pharmacia and Upjohn Company
A subsidiary of PHarmacia Corporation
Kalamazoo, Michigan 49001, USA
Revised October 2001
Sample Outer Label
SOLU-MEDROL
methylprednisolone sodium succinate injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52584-113(00009-0113)
Route of Administration INTRAMUSCULAR,INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylprednisolone Sodium Succinate(Methylprednisolone) Methylprednisolone Sodium Succinate 40mg in1mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
NDC Package Description Multilevel Packaging
1 52584-113-12 1VIALIn1BAG contains a VIAL, SINGLE-DOSE
1 1mLIn1VIAL, SINGLE-DOSE This package is contained within the BAG(52584-113-12)
Marketng Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011856 09/01/2010
Labeler -General Injectables & Vaccines, Inc(108250663)
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