s of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. gastrointestinal diseases to tide the patient over a critical period of the disease in 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 for the 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 diseases berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) 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.

n preterm infants, associated with exposure to excessive amounts of benzyl alcohol. the amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. the amount of benzyl alcohol at which toxicity may occur is not known. if the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see precautions , pediatric use). injection of solu-medrol may result in dermal and/or subdermal changes forming depressions in the skin at the injection site. in order to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections. injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy. rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see adverse reactions ). 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 (see contraindications) . 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, and after the stressful situation. results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an intravenous corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. high doses of systemic corticosteroids, including solu-medrol, should not be used for the treatment of traumatic brain injury. cardio-renal average and large doses of corticosteroids 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. literature reports suggest an apparent association between the use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. endocrine hypothalamic-pituitary adrenal (hpa) axis suppression, cushing's syndrome, and hyperglycemia. monitor patients for these conditions with chronic use. corticosteroids can produce reversible hpa axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. this type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. drug-induced liver injury rarely, high doses of cyclically pulsed intravenous methylprednisolone (usually for the treatment of exacerbations of multiple sclerosis at doses of 1 gram/day) can induce a toxic form of acute hepatitis. the time to onset of this form of steroid-induced liver injury can be several weeks or longer. resolution has been observed after discontinuation of treatment. however, serious liver injury can occur, sometimes resulting in acute liver failure and death. discontinue intravenous methylprednisolone if toxic hepatitis occurs. since recurrence has occurred after re-challenge, avoid use of high dose intravenous methylprednisolone in patients with a history of toxic hepatitis caused by methylprednisolone. infections general patients who are on corticosteroids are more susceptible to infections than are healthy individuals. there may be decreased resistance and inability to localize infection when corticosteroids are used. infections with any pathogen (viral, bacterial, fungal, protozoan, or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents. these infections may be mild, but can be severe and at times fatal. with increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. corticosteroids may also 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 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 sodium succinate 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 sodium succinate). fungal infections corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions. there have been cases reported in which concomitant use of amphotericin b and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see contraindications and precautions , drug interactions, amphotericin b injection and potassium-depleting agents). special pathogens latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by amoeba, candida, cryptococcus, mycobacterium, nocardia, pneumocystis, toxoplasma. it is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea. similarly, corticosteroids should be used with great care in patients with known or suspected strongyloides (threadworm) infestation. in such patients, corticosteroid-induced immunosuppression may lead to strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. corticosteroids should not be used in cerebral malaria. there is currently no evidence of benefit from steroids in this condition. tuberculosis the use of corticosteroids 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. vaccination 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 can not be predicted. immunization procedures may be undertaken in patients receiving corticosteroids as replacement therapy, e.g., for addison's disease. viral infections chicken pox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. in pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. the contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. if exposed to chicken pox, prophylaxis with varicella zoster immune globulin (vzig) may be indicated. if exposed to measles, prophylaxis with immunoglobulin (ig) may be indicated. (see the respective package inserts for complete vzig and ig prescribing information.) if chicken pox develops, treatment with antiviral agents should be considered. neurologic reports of severe medical events have been associated with the intrathecal route of administration (see adverse reactions , gastrointestinal and neurologic/psychiatric). ophthalmic 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. the use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. corticosteroids should be used cautiously in patients with ocular herpes simplex because of corneal perforation. corticosteroids should not be used in active ocular herpes simplex.

rrest following the rapid administration of large intravenous doses of solu-medrol (greater than 0.5 gram 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 infusion. when high dose therapy is desired, the recommended dose of solu-medrol sterile powder is 30 mg/kg administered intravenously over at least 30 minutes. this dose may be repeated every 4 to 6 hours for 48 hours. in general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized; usually not beyond 48 to 72 hours. in other indications, initial dosage will vary from 10 to 40 mg of methylprednisolone depending on the specific disease entity being treated. however, in certain overwhelming, acute, life-threatening situations, administrations 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. solu-medrol may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection. to administer by intravenous (or intramuscular) injection, prepare solution as directed. the desired dose may be administered intravenously over a period of several minutes. if desired, the medication may be administered in diluted solutions by adding water for injection or other suitable diluent (see below) to the act-o-vial and withdrawing the indicated dose. to prepare solutions for intravenous infusion, first prepare the solution for injection as directed. this solution may then be added to indicated amounts of 5% dextrose in water, isotonic saline solution, or 5% dextrose in isotonic saline solution. in pediatric patients, the initial dose of methylprednisolone may vary depending on the specific disease entity being treated. the range of initial doses is 0.11 to 1.6 mg/kg/day in three or four divided doses (3.2 to 48 mg/m2bsa/day). the national heart, lung, and blood institute (nhlbi) recommended dosing for systemic prednisone, prednisolone, or methylprednisolone in pediatric patients whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1–2 mg/kg/day in single or divided doses. it is further recommended that short course, or "burst" therapy, be continued until the patient achieves a peak expiratory flow rate of 80% of his or her personal best or until symptoms resolve. this usually requires 3 to 10 days of treatment, although it can take longer. there is no evidence that tapering the dose after improvement will prevent a relapse. dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. it should not be less than 0.5 mg per kg every 24 hours. dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. 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 treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective (see precautions , neurologic-psychiatric). for the purpose of comparison, the following is the equivalent milligram dosage 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. directions for using the act-o-vial system press down on plastic activator to force diluent into the lower compartment. gently agitate to effect solution. remove plastic tab covering center of stopper. sterilize top of stopper with a suitable germicide. insert needle squarely through center of stopper until tip is just visible. invert vial and withdraw dose. dosage dosage i

o 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 perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis. hepatobiliary: hepatitis (see warnings , drug-induced liver injury). metabolic: negative nitrogen balance due to protein catabolism. musculoskeletal: aseptic necrosis of femoral and humeral heads, charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), 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. arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration (see warnings , neurologic). ophthalmic: exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections. 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.

activity. following the intravenous injection of methylprednisolone sodium succinate, demonstrable effects are evident within one hour and persist for a variable period. excretion of the administered dose is nearly complete within 12 hours. thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. this preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection.