Please scroll to see the Indication below.

Important Safety Information

DEPO-MEDROL Sterile Aqueous Suspension is contraindicated in patients with known hypersensitivity to the product and its constituents. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. DEPO-MEDROL Sterile Aqueous Suspension is contraindicated for intrathecal administration. It is also contraindicated in premature infants because of a risk of fatal gasping syndrome, in systemic fungal infections.

DEPO-MEDROL is available in two formulations: DEPO-MEDROL benzyl alcohol and DEPO-MEDROL Myristyl-gamma-picolinium-chloride (MGPC). Multidose use of DEPO-MEDROL benzyl alcohol from a single vial requires strict aseptic technique to avoid contamination. This product contains benzyl alcohol which is potentially toxic when administered locally to neural tissues. DEPO-MEDROL MGPC (single-dose vials) is not suitable for multi-dose use. Following administration of the desired dose, any remaining suspension should be discarded.

Corticosteroids may mask some signs of infection, and new infections may appear during their use, especially in patients with immune deficiency. Repeated intra-articular administration may result in instability of the joint. Injection of DEPO-MEDROL may result in dermal and/or subdermal changes forming depressions in the skin at the injection site. Prolonged use of corticosteroids may produce ocular damage. Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. As with all corticosteroids, DEPO-MEDROL has been associated with allergic dermatitis, erythema, and tendon rupture. Hyperglycemia, osteoporosis, psychiatric disorders, myopathy, and growth arrest may also occur.

Indication

A. For Intramuscular Administration

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, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows:

1. 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:

• Congenital adrenal hyperplasia
• Hypercalcemia associated with cancer
• Nonsuppurative thyroiditis

2. Rheumatic Disorders

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

• Post-traumatic osteoarthritis
• Epicondylitis
• Synovitis of osteoarthritis
• Acute nonspecific tenosynovitis
• Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
• Acute gouty arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Acute and subacute bursitis

3. Collagen Diseases

During an exacerbation or as maintenance therapy in selected cases of:

• Systemic lupus erythematosus
• Acute rheumatic carditis
• Systemic dermatomyositis (polymyositis)

4. Dermatologic Diseases

• Pemphigus
• Bullous dermatitis herpetiformis
• Severe erythema multiforme (Stevens-Johnson syndrome)
• Severe seborrheic dermatitis
• Severe psoriasis
• Exfoliative dermatitis
• Mycosis fungoides

5. Allergic States

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

• Bronchial asthma
• Drug hypersensitivity reactions
• Contact dermatitis
• Urticarial transfusion reactions
• Atopic dermatitis
• Acute noninfectious laryngeal edema (epinephrine is the drug of first choice)
• Serum sickness
• Seasonal or perennial allergic rhinitis

6. Ophthalmic Diseases

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

• Herpes zoster ophthalmicus
• Sympathetic ophthalmia
• Iritis, iridocyclitis
• Anterior segment inflammation
• Chorioretinitis
• Allergic conjunctivitis
• Diffuse posterior uveitis and choroiditis
• Allergic corneal marginal ulcers
• Optic neuritis
• Keratitis

7. Gastrointestinal Diseases

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

• Ulcerative colitis (systemic therapy)
• Regional enteritis (systemic therapy)

8. Respiratory Diseases

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

9. Hematologic Disorders

• Acquired (autoimmune) hemolytic anemia
• Erythroblastopenia (RBC anemia)
• Secondary thrombocytopenia in adults
• Congenital (erythroid) hypoplastic anemia

10. Neoplastic Diseases

For palliative management of:

• Leukemias and lymphomas in adults
• Acute leukemia of childhood

11. 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

12. Nervous System

Acute exacerbations of multiple sclerosis

13. Miscellaneous

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

B. For Intrasynovial Or Soft Tissue Administration

DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

• Synovitis of osteoarthritis
• Epicondylitis
• Rheumatoid arthritis
• Acute nonspecific tenosynovitis
• Acute and subacute bursitis
• Post-traumatic osteoarthritis
• Acute gouty arthritis

C. For Intralesional Administration

DEPO-MEDROL is indicated for intralesional use in the following conditions:

• Keloids
• Localized hypertrophic, infiltrated, inflammatory lesions of:
  • Lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis)
  • Discoid lupus erythematosus
  • Necrobiosis lipoidica diabeticorum
  • Alopecia areata

DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).

Please see full prescribing information.

DEPO-MEDROL^® (methylprednisolone acetate injectable suspension, USP)

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