Depo-medrol
Depo-medrol Medication Information:
Depo-medrol medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.
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Depo-medrol 20 mg/mL
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Depo-medrol 40 mg/mL
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Depo-medrol 80 mg/mL
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Pharmacology
Depo-Medrol is a sterile aqueous suspension of the synthetic glucocorticoid methylprednisolone acetate. It has a strong and prolonged anti-inflammatory, immunosuppressive and anti-allergic activity. Depo-Medrol can be administered i.m. for a prolonged systemic activity, as well as in situ for a local treatment. The prolonged activity of Depo-Medrol is explained by the slow release of the active substance.
Indications
I.M.: 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 i.m. use of methylprednisolone is indicated as follows:
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). 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 multiforme (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, optic neuritis, drug hypersensitivity reactions, 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, Löeffler's syndrome not manageable by other means, aspiration pneumonitis.
Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, 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.
Central 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.
Intra-Synovial or Soft Tissue Administration (including periarticular and intrabursal): See Warnings . 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.
Intralesional Administration: 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.
May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
Precautions
Drug Interactions
The pharmacokinetic interactions listed below are potentially clinically important. Mutual inhibition of metabolism occurs with concurrent use of cyclosporine and methylprednisolone, therefore it is possible that adverse events associated with the individual use of either drug may be more apt to occur. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine.
Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of methylprednisolone and may require increase in methylprednisolone dose to achieve the desired response.
Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and thus decrease its clearance. Therefore the dose of methylprednisolone should be titrated to avoid steroid toxicity.
Methylprednisolone may increase the clearance of chronic high dose ASA. This could lead to a decrease in salicylate serum levels or increase the risk of salicylate toxicity when methylprednisolone is withdrawn. ASA should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.
The effect of methylprednisolone on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids. Therefore coagulation indices should be monitored to maintain the desired anticoagulant effect.
Supplied
80 mg
Each mL of sterile suspension contains: methylprednisolone acetate 80 mg. Nonmedicinal ingredients: myristyl gamma picolinium chloride (MGPC), polyethylene glycol and sodium chloride to adjust the tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Vials of 1 mL, cartons of 5.
The pH of the finished product remains within the USP specified range i.e., 3.5 to 7.0. Store at room temperature between 15 and 30°C. Protect from freezing.
20 mg
Each mL of sterile suspension contains: methylprednisolone acetate 20 mg. Nonmedicinal ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polyethylene glycol, polysorbate 80, sodium chloride to adjust tonicity and benzyl alcohol as a preservative. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Vials of 5 mL, cartons of 1.
40 mg
Each mL of sterile suspension contains: methylprednisolone acetate 40 mg. Nonmedicinal ingredients: myristyl gamma picolinium chloride (MGPC), polyethylene glycol and sodium chloride to adjust the tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Vials of 1 mL, cartons of 10.
Single Use Vials
Multidose Vials
Contraindications
Intrathecal administration. I.V. administration. Systemic fungal infections. Known hypersensitivity to the product and its constituents.
Warnings
Lactation
See Pregnancy.
Pregnancy
Some animal studies have shown that corticosteroids, when administered to the mother at high doses, may cause fetal malformations. Adequate human reproductive studies have not been done with corticosteroids. Therefore, the use of this drug in pregnancy, nursing mothers, or women of childbearing potential requires that the benefits of the drug be carefully weighed against the potential risk to the mother and embryo or fetus. Since there is inadequate evidence of safety in human pregnancy, this drug should be used in pregnancy only if clearly needed.
Corticosteroids readily cross the placenta. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency. There are no known effects of corticosteroids on labor and delivery. Corticosteroids are excreted in breast milk.
Adverse Effects
Immune System
masking infections, latent infections becoming active, opportunistic infections, hypersensitivity reactions including anaphylaxis, may suppress reactions to skin tests.
The following additional adverse reactions are related to parenteral corticosteroid therapy: rare instances of blindness associated with intralesional therapy around the face and head, anaphylactic reaction or allergic reactions, hyperpigmentation or hypopigmentation, s.c. and cutaneous atrophy, sterile abscess, postinjection flare—following intra-synovial use, Charcot-like arthropathy. Injection site infections can occur following nonsterile technique.
Endocrine
menstrual irregularities, development of Cushingoid state, suppression of growth in children, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetes, suppression of pituitary-adrenal axis.
Gastrointestinal
peptic ulcer with possible subsequent perforation and hemorrhage, pancreatitis, gastric hemorrhage, esophagitis, perforation of the bowel.
Increases in ALT, AST and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.
Musculoskeletal
muscle weakness, steroid myopathy, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, tendon rupture—particularly of the Achilles tendon.
Dermatologic
impaired wound healing, thin fragile skin, petechiae and ecchymoses.
Metabolic
negative nitrogen balance due to protein catabolism.
Neurological
increased intracranial pressure (pseudotumor cerebri), psychic derangements, seizures.
Ophthalmic
posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.
Overdose
Symptoms
There is no clinical syndrome of acute overdosage with methylprednisolone. Repeated frequent doses (daily or several times/week) over a protracted period may result in a Cushingoid state.
Dosage
Because of possible physical incompatibilities, methylprednisolone should not be diluted or mixed with other solutions. Parenteral suspensions should be inspected visually for foreign particulate matter and discoloration prior to administration whenever drug product and container permit.
Administration for Local Effect: Therapy with methylprednisolone 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.
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 1 to 5 or more weeks depending upon the degree of relief obtained from the initial injection. The doses in Table 1 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 methylprednisolone. The plunger is then pulled outward slightly to aspirate synovial fluid and to make sure the needle is still in the synovial space. After the 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.
Table 1: Depo-Medrol
Dosage—Rheumatoid and Osteoarthritis
| Size of Joint | Examples | Range of Dosage |
|---|---|---|
| Large | knees ankles shoulders | 20 to 80 mg |
| Medium | elbows wrists | 10 to 40 mg |
| Small | metacarpophalangeal interphalangeal sternoclavicular acromioclavicular | 4 to 10 mg |
Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal, and hip joints. Since difficulty is occasionally 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 the injection of methylprednisolone, the anesthetic package insert should be read carefully and all the precautions observed.
Bursitis: The area around the injection site is prepared in a sterile way and a wheal at the site made with 1% procaine HCl 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.
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.
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 i.m. dosage will vary with the condition being treated. 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 i.m. 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, 2-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 gastrointestinal x-rays are desirable in patients with an ulcer history or significant dyspepsia.
In patients with the adrenogenital syndrome, a single i.m. injection of 40 mg every 2 weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly i.m. 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 methylprednisolone administered i.m. at weekly intervals for 1 to 4 weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following i.m. 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 i.m. administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to 2 weeks. Similarly in patients with allergic rhinitis (hay fever) an i.m. dose of 80 to 120 mg may be followed by relief of coryzal symptoms within 6 hours persisting for several days to 3 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 i.v. 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).
