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
• 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

3. Collagen Diseases

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

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

4. Dermatologic Diseases

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

5. 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)

6. 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

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

9. Hematologic Disorders

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

(See WARNINGS)

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

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).

Because of possible physical incompatibilities, DEPO-MEDROL Sterile Aqueous Suspension should not be diluted or mixed with other solutions.

Administration for Local Effect

Therapy with DEPO-MEDROL does not obviate the need for the conventional measures usually employed. Although this method of treatment will ameliorate symptoms, it is in no sense a cure and the hormone has no effect on the cause of the inflammation.

1. Rheumatoid and Osteoarthritis. The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. In chronic cases, injections may be repeated at intervals ranging from one to five or more weeks depending upon the degree of relief obtained from the initial injection. The doses in the following table are given as a general guide:

Procedure: It is recommended that the anatomy of the joint involved be reviewed before attempting intra-articular injection. In order to obtain the full anti-inflammatory effect it is important that the injection be made into the synovial space. Employing the same sterile technique as for a lumbar puncture, a sterile 20 to 24 gauge needle (on a dry syringe) is quickly inserted into the synovial cavity. Procaine infiltration is elective. The aspiration of only a few drops of joint fluid proves the joint space has been entered by the needle. The injection site for each joint is determined by that location where the synovial cavity is most superficial and most free of large vessels and nerves. With the needle in place, the aspirating syringe is removed and replaced by a second syringe containing the desired amount of DEPO-MEDROL. The plunger is then pulled outward slightly to aspirate synovial fluid and to make sure the needle is still in the synovial space. After injection, the joint is moved gently a few times to aid mixing of the synovial fluid and the suspension. The site is covered with a small sterile dressing.

Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal, and hip joints. Since difficulty is not infrequently encountered in entering the hip joint, precautions should be taken to avoid any large blood vessels in the area. Joints not suitable for injection are those that are anatomically inaccessible such as the spinal joints and those like the sacroiliac joints that are devoid of synovial space. Treatment failures are most frequently the result of failure to enter the joint space. Little or no benefit follows injection into surrounding tissue. If failures occur when injections into the synovial spaces are certain, as determined by aspiration of fluid, repeated injections are usually futile. Local therapy does not alter the underlying disease process, and whenever possible comprehensive therapy including physiotherapy and orthopedic correction should be employed.

Following intra-articular steroid therapy, care should be taken to avoid overuse of joints in which symptomatic benefit has been obtained. Negligence in this matter may permit an increase in joint deterioration that will more than offset the beneficial effects of the steroid.

Unstable joints should not be injected. Repeated intra-articular injection may in some cases result in instability of the joint. X-ray follow-up is suggested in selected cases to detect deterioration.

If a local anesthetic is used prior to injection of DEPO-MEDROL, the anesthetic package insert should be read carefully and all the precautions observed.

2. Bursitis. The area around the injection site is prepared in a sterile way and a wheal at the site made with 1 percent procaine hydrochloride solution. A 20 to 24 gauge needle attached to a dry syringe is inserted into the bursa and the fluid aspirated. The needle is left in place and the aspirating syringe changed for a small syringe containing the desired dose. After injection, the needle is withdrawn and a small dressing applied.

3. Miscellaneous: Ganglion, Tendinitis, Epicondylitis. In the treatment of conditions such as tendinitis or tenosynovitis, care should be taken, following application of a suitable antiseptic to the overlying skin, to inject the suspension into the tendon sheath rather than into the substance of the tendon. The tendon may be readily palpated when placed on a stretch. When treating conditions such as epicondylitis, the area of greatest tenderness should be outlined carefully and the suspension infiltrated into the area. For ganglia of the tendon sheaths, the suspension is injected directly into the cyst. In many cases, a single injection causes a marked decrease in the size of the cystic tumor and may effect disappearance. The usual sterile precautions should be observed, of course, with each injection.

The dose in the treatment of the various conditions of the tendinous or bursal structures listed above varies with the condition being treated and ranges from 4 to 30 mg. In recurrent or chronic conditions, repeated injections may be necessary.

4. Injections for Local Effect in Dermatologic Conditions. Following cleansing with an appropriate antiseptic such as 70% alcohol, 20 to 60 mg of the suspension is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40 mg by repeated local injections in the case of large lesions. Care should be taken to avoid injection of sufficient material to cause blanching since this may be followed by a small slough. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection.

When multidose vials are used, special care to prevent contamination of the contents is essential. (See WARNINGS.)

Administration for Systemic Effect.

The intramuscular dosage will vary with the condition being treated. When employed as a temporary substitute for oral therapy, a single injection during each 24-hour period of a dose of the suspension equal to the total daily oral dose of MEDROL® Tablets (methylprednisolone) is usually sufficient. When a prolonged effect is desired, the weekly dose may be calculated by multiplying the daily oral dose by 7 and given as a single intramuscular injection.

Dosage must be individualized according to the severity of the disease and response of the patient. For infants and children, the recommended dosage will have to be reduced, but dosage should be governed by the severity of the condition rather than by strict adherence to the ratio indicated by age or body weight.

Hormone therapy is an adjunct to, and not a replacement for, conventional therapy. Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. The severity, prognosis and expected duration of the disease and the reaction of the patient to medication are primary factors in determining dosage. 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.

In patients with the adrenogenital syndrome, a single intramuscular injection of 40 mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single dose of 80 to 120 mg. In chronic contact dermatitis repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80 mg may be adequate to control the condition.

Following intramuscular administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks. Similarly in patients with allergic rhinitis (hay fever) an intramuscular dose of 80 to 120 mg may be followed by relief of coryzal symptoms within six hours persisting for several days to three weeks.

If signs of stress are associated with the condition being treated, the dosage of the suspension should be increased. If a rapid hormonal effect of maximum intensity is required, the intravenous administration of highly soluble methylprednisolone sodium succinate is indicated.

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).

DEPO-MEDROL Sterile Aqueous Suspension is available in the following strengths and package sizes:

20 mg per mL

5 mL multidose vials NDC 0009-0274-01

40 mg per mL

5 mL multidose vials NDC 0009-0280-02
25 x 5 mL multidose vials NDC 0009-0280-51
10 mL multidose vials NDC 0009-0280-03
25 x 10 mL multidose vials NDC 0009-0280-52

80 mg per mL

5 mL multidose vials NDC 0009-0306-02
25 x 5 mL multidose vials NDC 0009-0306-12

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Distributed by Pharmacia and Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised July 2006.

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