Solu Medrol ® – Methylprednisolone

Methylprednisolone (Solu Medrol ®)

Usual Diluents

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]

Stability / Miscellaneous

Label: Do not Refrigerate.
May be given IM, IVpush, or IVPB.

High dose: 30 mg/kg over 30 minutes (may repeat q4-6h) in a 48hr period.

Asthma: 2 mg/ kg q4 -6h until severe symptoms controlled, then reduce dose.

Management of severe ulcerative colitis:  16 to 20 mg IV every eight hours.

MS acute exacerbation: 500 mg once daily x 5 days.

PCP: 40 to 60 mg every 6 hours or pulse dosing: 250 to 1000mg once daily x 3 to 5 days.

Spinal cord injury: 30 mg/kg (over 15 to 30 minutes) then 5.4 mg/ kg/ hr x 23 hours. (higher doses possible).

Medrol dose pack: (4mg tab # 21): Day#1: 2 tabs before breakfast, 1 tab after lunch & dinner, and 2 tabs at bedtime. (Total=6 tabs) If received later in the day, may take all 6 tablets at once or in divided doses. Day#2: 1 tab before breakfast, 1 tab after lunch & dinner, and 2 tablets at bedtime. Day#3: Same as day#2 except 1 tab at bedtime. Day#4: 1 tab before breakfast, after lunch and at bedtime. Day#5: 1 tab after breakfast and at bedtime. Day#6: 1 tab after breakfast.

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INDICATIONS AND USAGE
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, A-Methapred sterile powder is indicated for intravenous or intramuscular use in the following conditions:

Endocrine Disorders
• Primary or secondary adrenocortical insufficiency (hydrocortisone 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 adrenocortical insufficiency exists or is suspected
• Congenital adrenal hyperplasia
• Hypercalcemia associated with cancer
• Nonsuppurative thyroiditis

Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
• Post-traumatic osteoarthritis
• Synovitis of osteoarthritis
• Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
• Acute and subacute bursitis
• Epicondylitis
• Acute nonspecific tenosynovitis
• Acute gouty arthritis
• Psoriatic arthritis
• Ankylosing spondylitis

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

Dermatologic Diseases
• Pemphigus
• Severe erythema multi-forme (Stevens-Johnson syndrome)
• Exfoliative dermatitis
• Bullous dermatitis herpetiformis
• Severe seborrheic dermatitis
• Severe psoriasis
• Mycosis fungoides

Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:
• Bronchial asthma
• Contact dermatitis
• Atopic dermatitis
• Serum sickness
• Seasonal or perennial allergic rhinitis
• Drug hypersensitivity reactions
• Urticarial transfusion reactions
• Acute noninfectious laryngeal edema (epinephrine is the drug of first choice)

Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye, such as:
• Herpes zoster ophthalmicus
• Iritis, iridocyclitis
• Chorioretinitis
• Diffuse posterior uveitis and choroiditis
• Optic neuritis
• Sympathetic ophthalmia
• Anterior segment inflammation
• Allergic conjunctivitis
• Allergic corneal marginal ulcers
• Keratitis

Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
• Ulcerative colitis (systemic therapy)
• Regional enteritis (systemic therapy)

Respiratory Diseases
• Symptomatic sarcoidosis
• Berylliosis
• Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
• Loeffler’s syndrome not manageable by other means
• Aspiration pneumonitis

Hematologic Disorders
• 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
Neoplastic Diseases

For palliative management of:
• Leukemias and lymphomas in adults
• Acute leukemia of childhood

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

Nervous System
• Acute exacerbations of multiple sclerosis

Miscellaneous
• Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
• Trichinosis with neurologic or myocardial involvement

DOSAGE AND ADMINISTRATION
When high dose therapy is desired, the recommended dose of A-Methapred 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/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.

A-Methapred 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.

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.

Multiple Sclerosis
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 prednisolone).

Directions for Reconstitution
1.Remove protective cap.
2.Cleanse stopper with suitable germicide.
3.Aseptically add 1 mL Bacteriostatic Water for Injection, USP (with benzyl alcohol) for the 40 mg vial or 2 mL Bacteriostatic Water for Injection, USP (with benzyl alcohol) for the 125 mg vial.
4.Agitate to effect solution.
5.Invert vial. Insert needle through target area of stopper until tip is just visible. Withdraw dose.

STORAGE CONDITIONS
Protect from light.

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

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

Use solution within 48 hours after mixing.

HOW SUPPLIED
A-Methapred sterile powder is available in the following packages:

List Container Concentration
3217 Single-Dose Vial 40 mg/vial
3218 Single-Dose Vial 125 mg/vial

Rev: October, 2005
©Hospira 2005EN-1059
HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Source: [package insert]