Generic Name
MethylPREDNISolone Acetate
Brand Names
Depo-Medrol, Medroloan, Medroloan SUIK, Dyural
FDA approval date: May 28, 1959
Classification: Corticosteroid
Form: Injection, Kit
What is Depo-Medrol (MethylPREDNISolone Acetate)?
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 Methylprednisolone Acetate Injectable Suspension is indicated as follows: A llergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. De rmatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme . E ndocrine Disorders : Primary or secondary adrenocortical insufficiency , congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. G astrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hem atologic Disorders : Acquired hemolytic anemia, congenital hypoplastic anemia , pure red cell aplasia, select cases of secondary thrombocytopenia. M iscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of leukemias and lymphomas. Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. O phthalmic Diseases : Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Re nal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Re spiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. R heumatic Disorders : As adjunctive therapy for short-term administration in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis . For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. FOR INTRA-ARTICULAR OR SOFT TISSUE ADMINISTRATION Methylprednisolone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. FOR INTRALESIONAL ADMINISTRATION Methylprednisolone Acetate Injectable Suspension is indicated for intralesional use in alopecia areata, discoid lupus erythematosus, keloids, localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus , and psoriatic plaques, necrobiosis lipoidica diabeticorum. Methylprednisolone Acetate Injectable Suspension also may be useful in cystic tumors of an aponeurosis or tendon .
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Brand Information
Depo-Medrol (methylprednisolone acetate)
1DESCRIPTION
DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL, 40 mg/mL, 80 mg/mL.
Each mL of these preparations contains:
Sodium Chloride was added to adjust tonicity.
When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.
The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0).
The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular weight is 416.51. The structural formula is represented below:
DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water.
2CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids.
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt retaining properties, are used in replacement therapy in adrenocortical deficiency states. Their synthetic analogs are used primarily for their anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune response to diverse stimuli.
3CONTRAINDICATIONS
DEPO-MEDROL 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. Reports of severe medical events have been associated with this route of administration.
DEPO-MEDROL is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see
DEPO-MEDROL is contraindicated in systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions (see
4ADVERSE REACTIONS
The following adverse reactions have been reported with DEPO-MEDROL or other corticosteroids:
Allergic reactions: Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema.
Blood and lymphatic system disorders: Leukocytosis.
Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.
Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.
Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.
Gastrointestinal: Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible subsequent perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.
Metabolic: Negative nitrogen balance due to protein catabolism.
Musculoskeletal: Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intralesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, post injection flare (following intra-articular, soft tissue, and tendon sheath injections), steroid myopathy, tendon rupture, vertebral compression fractures.
Neurologic/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.
Ophthalmic: Exophthalmoses, glaucoma, increased intraocular pressure, posterior subcapsular cataracts.
Vascular: Flushing.
Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, injection site infections following non-sterile administration (see WARNINGS), malaise, moon face, weight gain.
5OVERDOSAGE
Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.
6DOSAGE AND ADMINISTRATION
Because of possible physical incompatibilities, DEPO-MEDROL Sterile Aqueous Suspension should not be diluted or mixed with other solutions.
The initial dosage of parenterally administered DEPO-MEDROL will vary from 4 to 120 mg, depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.
It Should Be Emphasized that Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation, it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
6.1A. 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.
6.1.1Rheumatoid Arthritis 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:
6.1.1.1Procedure:
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.
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.
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.
6.1.2Bursitis:
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.
6.1.3Miscellaneous: 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.
6.1.4Injections for Local Effect in Dermatologic Conditions:
Following cleansing with an appropriate antiseptic such as 70% alcohol, 20 to 60 mg 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
6.2B. 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
In pediatric patients, the initial dose of methylprednisolone may vary depending upon the specific disease entity being treated. The range of initial doses is 0.11 to 1.6 mg/kg/day. Dosage must be individualized according to the severity of the disease and response of the patient.
In patients with the
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.
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.
For the purpose of comparison, the following is the equivalent milligram dose of the various glucocorticoids:
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
7HOW SUPPLIED
DEPO-MEDROL Sterile Aqueous Suspension is available in the following strengths and package sizes:
8PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Label
5 mL Multidose Vial
NDC 0009-0274-01
NDC 0009-0274-01
Depo-Medrol
(methylPREDNISolone acetate
injectable suspension, USP)
(methylPREDNISolone acetate
injectable suspension, USP)
100 mg/5 mL
(20 mg/mL)
Rx only
Rx only
9PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Carton
5 mL
Multidose Vial
Multidose Vial
NDC 0009-0274-01
Depo-Medrol
(methylPREDNISolone
acetate injectable
suspension, USP)
(methylPREDNISolone
acetate injectable
suspension, USP)
100 mg/5 mL
(20 mg/mL)
For intramuscular,
NOT for IV use
Contains Benzyl Alcohol
as a Preservative
as a Preservative
Rx only
Pfizer Injectables
10PRINCIPAL DISPLAY PANEL - 200 mg/5 mL Vial Label
5 mL Multidose Vial
NDC 0009-0280-02
NDC 0009-0280-02
Depo-Medrol
(methylPREDNISolone acetate
injectable suspension, USP)
(methylPREDNISolone acetate
injectable suspension, USP)
200 mg/5 mL
(40 mg/mL)
(40 mg/mL)
Rx only
11PRINCIPAL DISPLAY PANEL - 200 mg/5 mL Vial Package
25—5 mL Multidose Vials
NDC 0009-0280-51
Depo-Medrol®
(methylPREDNISolone acetate injectable suspension, USP)
(methylPREDNISolone acetate injectable suspension, USP)
200 mg/5 mL
(40 mg/mL)
(40 mg/mL)
For intramuscular, intrasynovial and soft tissue injection only
Pfizer Injectables
Rx only
12PRINCIPAL DISPLAY PANEL - 400 mg/5 mL Vial Label
5 mL Multidose Vial
NDC 0009-0306-02
NDC 0009-0306-02
Depo-Medrol
(methylPREDNISolone acetate
injectable suspension, USP)
(methylPREDNISolone acetate
injectable suspension, USP)
400 mg/5 mL
(80 mg/mL)
(80 mg/mL)
Rx only
13PRINCIPAL DISPLAY PANEL - 400 mg/5 mL Vial Carton
5 mL
Multidose Vial
Multidose Vial
NDC 0009-0306-02
Depo-Medrol
(methylPREDNISolone
acetate injectable
suspension, USP)
(methylPREDNISolone
acetate injectable
suspension, USP)
400 mg/5 mL
(80 mg/mL)
(80 mg/mL)
For intramuscular,
NOT for IV use
Contains Benzyl Alcohol
as a Preservative
as a Preservative
Rx only
Pfizer Injectables
