Important Safety Information and Indications for Solu-Medrol and Depo-Medrol
Solu-Medrol®
(methylprednisolone sodium succinate for injection, USP)
Solu-Medrol Sterile Powder is contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
The Solu-Medrol 40 mg presentation includes lactose monohydrate produced from cow's milk. This presentation is therefore contraindicated in patients with a known or suspected hypersensitivity to cow's milk or its components or other dairy products because it may contain trace amounts of milk ingredients.
Solu-Medrol is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration.
Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
Formulations preserved with benzyl alcohol are contraindicated for use in premature infants. These formulations are potentially toxic when administered locally to neural tissue.
Serious neurological events, some resulting in death, have been reported with epidural injection of corticosteroids.
Injection of Solu-Medrol may result in dermal and/or subdermal changes, forming depressions in the skin at the injection site.
Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.
In patients receiving the 40 mg presentation of Solu-Medrol during the treatment for acute allergic conditions and where these symptoms worsen or any new allergic symptoms occur, consideration should be given to the potential for hypersensitivity reactions to cow's milk ingredients. If appropriate, administration of Solu-Medrol should be stopped, and the patient's condition should be treated accordingly. Alternative treatments, including the use of corticosteroid formulations that do not contain ingredients produced from cow's milk, should be considered for acute allergy management, where appropriate.
Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy who are subjected to any unusual stress before, during, or after the stressful situation.
High doses of systemic corticosteroids including Solu-Medrol should not be used for the treatment of traumatic brain injury.
Corticosteroids can cause elevation of blood pressure, salt and water retention, and increase excretion of potassium.
Therapy with corticosteroids should be used with great caution in patients with a recent myocardial infarction.
Corticosteroids can produce hypothalamic-pituitary adrenal axis suppression with the potential for glucocorticosteroid insufficiency after treatment withdrawal. Corticosteroids can also cause Cushing’s syndrome and hyperglycemia.
Rarely, high doses of cyclically pulsed intravenous methylprednisolone can induce a toxic form of acute hepatitis.
Patients on corticosteroids are more susceptible to infections than healthy patients. Infections may be mild, but can be severe and at times fatal. Corticosteroids may mask some signs of current infection. Do not use intra-articularly, intrabursally, or for intratendinous administration for local effect in the presence of acute local infection.
A study failed to establish the efficacy of methylprednisolone sodium succinate in the treatment of sepsis syndrome and septic shock and suggested that certain patients may have a higher risk of mortality.
Corticosteroids may exacerbate systemic fungal infections and should not be used in the presence of such infections unless needed to control drug reactions.
Latent disease may be activated or there may be an exacerbation of intercurrent infections caused by certain pathogens. Consult the full Prescribing Information for these pathogens and restrictions.
Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered; however, the response to such vaccines cannot be predicted.
Chicken pox and measles can have a more serious or fatal course in pediatric and adult patients on corticosteroids.
Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. Corticosteroids should not be used in active ocular herpes simplex.
The lowest possible dose of corticosteroid should be used to control the condition under treatment. When dosage reduction is possible, the reduction should be gradual.
Use with caution in patients with congestive heart failure, hypertension, renal insufficiency, active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses and nonspecific ulcerative colitis. Corticosteroids decrease bone formation and increase bone resorption. An acute myopathy has been observed with high doses of corticosteroids. Psychic derangements may appear when corticosteroids are used.
Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. Amphotericin B injection and potassium-depleting agents may produce hypokalemia, cardiac enlargement and congestive heart failure. Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance. Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. Coadministration with warfarin usually results in inhibition of response to warfarin. Dosage adjustments of antidiabetic agents may be required. Serum isoniazid concentrations may be decreased. Cholestyramine may increase corticosteroid clearance. When used concurrently with cyclosporine, convulsions have been reported. Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens may decrease the hepatic metabolism of certain corticosteroids. Drugs which induce cytochrome P450 3A4 enzyme activity may enhance the metabolism of corticosteroids. Drugs which inhibit cytochrome P450 3A4 have the potential to increase the plasma concentrations of corticosteroids. Ketoconazole can significantly decrease the metabolism of certain corticosteroids. Concomitant use of aspirin or other nonsteroidal anti-inflammatory agents increases the risk of gastrointestinal side effects.
Corticosteroids may suppress reactions to skin tests. Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines.
Corticosteroids should only be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Benzyl alcohol can cross the placenta.
Adverse effects of corticosteroids in pediatric patients are similar to those in adults.
Dose selection for elderly patients should be cautious due to greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy.
The following adverse reactions have been reported with Solu-Medrol or other corticosteroids:
Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, and angioedema. Leukocytosis. Bradycardia, cardiac arrest, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, and vasculitis. Acne, allergic dermatitis, burning or tingling, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses, petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, thin fragile skin, thinning scalp hair, and urticaria.
Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents, manifestations of latent diabetes mellitus, menstrual abnormalities, secondary adrenocortical and pituitary unresponsiveness, and suppression of growth in pediatric patients. Fluid retention, hypokalemic alkalosis, potassium loss and sodium retention. Abdominal distension, bowel/bladder dysfunction, elevation in serum liver enzyme levels, hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer, perforation of small and large intestine, and ulcerative esophagitis. Negative nitrogen balance. Aseptic necrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare, steroid myopathy, tendon rupture, and vertebral compression fractures. Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, and vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia and sensory disturbances. Exophthalmos, glaucoma, increased ocular pressure, rare instances of blindness. Abnormal fat deposits, hiccups, increased or decreased motility and number of spermatozoa, injection site infections, malaise, moon face and weight gain.
Allergic states - severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment.
Dermatologic diseases - bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders - primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.
Gastrointestinal diseases - regional enteritis (systemic therapy) and ulcerative colitis.
Hematologic disorders - acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia.
Miscellaneous - trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Neoplastic diseases - palliative management of leukemias and lymphomas.
Nervous System - acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy.
Ophthalmic diseases - sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases - to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory disease - berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders - adjunctive therapy for short-term administration in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus
Depo-Medrol® (methylprednisolone acetate injectable suspension, USP) - Not For Intravenous Use
ISI and Indications Statement Developed by Mary Baker, Pharm.D.
February 13, 2018
Indications
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 is indicated as follows (see Full Prescribing Information for a complete list of indications):
Allergic States: Severe allergic conditions intractable to adequate trials of conventional treatment
Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome)
Endocrine Disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis
Gastrointestinal Diseases: Regional enteritis and ulcerative colitis
Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, select cases of secondary thrombocytopenia
Miscellaneous: Certain trichinosis and tuberculous infections
Neoplastic Diseases: Palliative management of leukemias and lymphomas
Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with brain tumor or craniotomy
Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids
Renal Diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or lupus erythematosus
Respiratory Diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis
Rheumatic Disorders: Adjunctive therapy for short-term administration in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis; dermatomyositis; polymyositis; and systemic lupus erythematosus
For intra-articular or soft tissue administration, DEPO-MEDROL is indicated as adjunctive therapy short-term in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.
For intralesional use, DEPO-MEDROL is indicated 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. DEPO-MEDROL may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
Important Safety Information
DEPO-MEDROL Multi-Dose Vials contain benzyl alcohol as a preservative and should not be used in neonates.
DEPO-MEDROL is contraindicated in patients with known hypersensitivity to the product and its constituents, for idiopathic thrombocytopenic purpura, for intrathecal administration and for systemic fungal infections except when administered as an intra-articular injection for localized joint conditions.
Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without the use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.
Systemic corticosteroids including DEPO-MEDROL should not be used for the treatment of traumatic brain injury. Corticosteroids can cause elevation of blood pressure, salt, and water retention, and increased excretion of potassium and calcium. Therapy with corticosteroids should be used with great caution in patients with a recent myocardial infarction. Corticosteroids can reverse hypothalamic-pituitary-adrenal axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.
Injection of DEPO-MEDROL may result in dermal and/or subdermal changes forming depressions in the skin at the injection site. Injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy.
Persons who are on corticosteroids are more susceptible to infections than are healthy individuals. These infections may be mild, but can be severe and at times fatal. Corticosteroids may mask some signs of current infection. Do not use intra-articularly, intrabursally, or for intratendinous administration for local effect in the presence of acute infection. Latent disease may be activated or there may be an exacerbation of intercurrent infections. The use of corticosteroids in active tuberculosis should be restricted to certain cases. Please see full Prescribing Information for a list of pathogens and restrictions.
Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted.
Chicken pox and measles can have a more serious or even fatal course in patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure.
Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. It is not recommended in the treatment of optic neuritis and should not be used in active ocular herpes simplex.
The lowest possible dose of corticosteroid should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual.
Corticosteroids should be used with caution in patients with congestive heart failure, renal insufficiency, active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of perforation. Corticosteroids decrease bone formation and increase bone resorption. An acute myopathy has been observed with the use of high doses of corticosteroids. Psychic derangements may appear when corticosteroids are used.
Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. Amphotericin B and other potassium-depleting agents may produce hypokalemia, cardiac enlargement, and congestive heart failure. Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance. Anticholinesterase agents may produce severe weakness in patients with myasthenia gravis. Coadministration with warfarin usually results in inhibition of response to warfarin. Dosage adjustments of antidiabetic agents may be required. Serum concentrations of isoniazid may be decreased. Convulsions have been reported with cyclosporine. Patients on digitalis glycosides may be at risk of arrhythmias due to hypokalemia. Estrogens, including oral contraceptives and ketoconazole, may decrease the metabolism of certain corticosteroids. Drugs which induce cytochrome P450 3A4 enzyme activity may enhance the metabolism of corticosteroids. Drugs which inhibit cytochrome P450 3A4 have the potential to result in increased plasma concentrations of corticosteroids. Concomitant use of aspirin or other nonsteroidal anti-inflammatory agents and corticosteroids increases the risk of gastrointestinal side effects.
DEPO-MEDROL should not be diluted or mixed with other solutions because of possible physical incompatibilities.
Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Steroids may increase or decrease motility and number of spermatozoa.
The linear growth of pediatric patients treated with corticosteroids should be monitored, and potential growth effects of prolonged treatment should be weighed against clinical benefits.
The following adverse reactions have been reported with DEPO-MEDROL or other corticosteroids:
Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, and angioedema. Leukocytosis. 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, pulmonary embolism, syncope, tachycardia, thromboembolism, thrombophlebitis, and vasculitis. 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 reaction to skin tests, thin fragile skin, thinning scalp hair, and urticaria. Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness. Abdominal distention, bowel/bladder dysfunction, elevation in serum liver enzyme levels, hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer, perforation of the small and large intestine and ulcerative esophagitis. Negative nitrogen balance. Aseptic necrosis of femoral and humeral heads, calcinosis, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare, steroid myopathy, tendon rupture, and vertebral compression fractures. Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, and vertigo. Exophthalmoses and increased intracranial pressure. Abnormal fat deposits, hiccups, injection site infections, malaise, moon face, and weight gain. Arachnoiditis, meningitis, sensory disturbances, and rhinitis.
Adapted from USPI Depo-Medrol LAB-0159-11.0 Revised February 2017 and LAB-0160-11.0 Revised January 2017
Please see full Prescribing Information
