When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, SOLU-MEDROL Sterile Powder is indicated for intravenous or intramuscular use in the following conditions:

Primary or secondary adrenocortical insufficiency (hydro-cortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance) Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used) Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful Shock unresponsive to conventional therapy if adrenocor-tical insufficiency exists or is suspected Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:

Severe acute and chronic allergic and inflammatory processes involving the eye, such as:

To tide the patient over a critical period of the disease in:

Ulcerative colitis (systemic therapy)

Regional enteritis (systemic therapy)

Acquired (autoimmune) hemolytic anemia

Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)

Secondary thrombocytopenia in adults

Erythroblastopenia (RBC anemia)

Congenital (erythroid) hypoplastic anemia

For palliative management of:

Leukemias and lymphomas in adults

Acute leukemia of childhood

To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus

Acute exacerbations of multiple sclerosis

Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy

Trichinosis with neurologic or myocardial involvement

When high dose therapy is desired, the recommended dose of SOLU-MEDROL Sterile Powder is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours.

In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized; usually not beyond 48 to 72 hours.

Although adverse effects associated with high dose short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.

In other indications initial dosage will vary from 10 to 40 mg of methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given intravenously over a period of several minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition. Corticoid therapy is an adjunct to, and not replacement for conventional therapy.

Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be less than 0.5 mg per kg every 24 hours.

Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.

SOLU-MEDROL may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection. To administer by intravenous (or intramuscular) injection, prepare solution as directed. The desired dose may be administered intravenously over a period of several minutes. If desired, the medication may be administered in diluted solutions by adding Water for Injection or other suitable diluent to the Act-O-Vial and withdrawing the indicated dose.

To prepare solutions for intravenous infusion, first prepare the solution for injection as directed. This solution may then be added to indicated amounts of 5% dextrose in water, isotonic saline solution or 5% dextrose in isotonic saline solution.

In treatment of acute exacerbations of multiple sclerosis, daily doses 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 pred-nisolone).

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. Invertvial and withdraw dose.

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.

SOLU-MEDROL Sterile Powder is available in the following packages:

1 mL NDC 0009-0113-12

25x1 mL NDC 0009-0113-19

25x2 mL NDC 0009-0190-16

4 mL NDC 0009-0765-02

8 mL NDC 0009-3389-01

8 mL NDC 0009-0758-01

16 mL NDC 0009-0698-01

¹ Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050-1.

² Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6): 954-63.

Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation Kalamazoo, Michigan 49001, USA, Revised October 2001

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