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, A-METHAPRED (methylprednisolone sodium succinate) is indicated for intravenous or intramuscular use in the following conditions:Endocrine disorders:a.
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).b.
Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used).c.
Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.d.
Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.e.
Congenital adrenal hyperplasia.f.
Hypercalcemia associated with cancer.g.Nonsuppurative thyroiditis.Rheumatic disorders— As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:a.Post-traumatic osteoarthritis.b.Synovitis of osteoarthritis.c.Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).d.
Acute and subacute bursitis.e.
Acute nonspecific tenosynovitis.g.
Acute gouty arthritis.h.
Ankylosing spondylitis.Collagen diseases— During an exacerbation or as maintenance therapy in selected cases of:a.
Systemic lupus erythematosus.b.
Systemic dermatomyositis (polymyositis).c.
Acute rheumatic carditis.Dermatologic diseases:a.
Pemphigus.b.Severe erythema multiforme (Stevens-Johnson syndrome).c.
Bullous dermatitis herpetiformis.e.
Severe seborrheic dermatitis.f.
Mycosis fungoides.Allergic states— Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:a.Bronchial asthma.b.Contact dermatitis.c.Atopic dermatitis.d.Serum sickness.e.Seasonal or perennial allergic rhinitis.f.
Drug hypersensitivity reactions.g.
Urticarial transfusion reactions.h.
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:a.
Herpes zoster ophthalmicus.b.
Diffuse posterior uveitis and choroiditis.e.
Anterior segment inflammation.h.
Allergic corneal marginal ulcers.j.
Keratitis.Gastrointestinal diseases— To tide the patient over a critical period of disease in:a.
Ulcerative colitis — (Systemic therapy).b.
Regional enteritis — (Systemic therapy).Respiratory diseases:a.
Fulminating or disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculous chemotherapy.d.
Loeffler’s syndrome not manageable by other means.e.
Aspiration pneumonitis.Hematologic disorders:a.
Acquired (autoimmune) hemolytic anemia.b.
Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated).c.
Secondary thrombocytopenia in adults.d.
Erythroblastopenia (RBC anemia).e.
Congenital (erythroid) hypoplastic anemia.Neoplastic diseases— For palliative management of:a.Leukemias and lymphomas in adults.b.
Acute leukemia of childhood.Edematous state— To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.Nervous system:a.
Acute exacerbations of multiple sclerosis.Miscellaneous:a.
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.b.Trichinosis with neurologic and myocardial involvement.
The use of methylprednisolone sodium succinate for injection is contraindicated in premature infants because benzyl alcohol, a preservative contained in Bacteriostatic Water for Injection used to reconstitute this product, has been reported to be associated with fatal “Gasping Syndrome” in premature infants.Methylprednisolone sodium succinate for injection is also contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals.
Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids.
In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known.
The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.
If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.
If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated.
(See the respective package inserts for complete VZIG and IG prescribing information).
If chickenpox develops, treatment with antiviral agents may be considered.In patients on corticosteroid therapy subjected to any unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.Corticosteroids may mask some signs of infection, and new infections may appear during their use.
There may be decreased resistance and inability to localize infection when corticosteroids are used.A study has failed to establish the efficacy of methylprednisolone sodium succinate in the treatment of sepsis syndrome and septic shock.
The study also suggests that treatment of these conditions with methylprednisolone may increase the risk of mortality in certain patients (i.e., patients with elevated serum creatinine levels or patients who develop secondary infections after methylprednisolone).Prolonged 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 fungi or viruses.Usage in PregnancySince adequate human reproduction studies have not been done with corticosteroids the use of these drugs in pregnancy, nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.
Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses.
Dietary salt restriction and potassium supplementation may be necessary.
All corticosteroids increase calcium excretion.
While on corticosteroid therapy patients should not be vaccinated against smallpox.
Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.The use of A-METHAPRED (methylprednisolone sodium succinate) in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with appropriate antituberculous regimen.If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur.During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.Because rare instances of anaphylactic (e.g., bronchospasm) reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.There are reports of cardiac arrhythmias and/or circulatory collapse and/or cardiac arrest following the rapid administration of large IV doses of methylprednisolone sodium succinate (greater than 500 mg administered over a period of less than 10 minutes). Bradycardia has been reported during or after the administration of large doses of methylprednisolone sodium succinate and may be unrelated to the speed or duration of the infusion.