ortical insufficiency exists or is suspected congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer • 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 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 and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis keratitis allergic corneal marginal ulcers • 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 loeffler’s syndrome not manageable by other means aspiration pneumonitis • hematologic disorders acquired (autoimmune) hemolytic anemia idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated) 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 • miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement • diagnostic testing of adrenocortical hyperfunction • cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy. by intra-articular or soft tissue injection 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 by intralesional injection 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)

to amphotericin b. moreover, there have been cases reported in which concomitant use of amphotericin b and hydrocortisone was followed by cardiac enlargement and congestive failure. 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. drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and 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. if the patient is receiving steroids already, dosage may have to be increased. since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. 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. moreover, corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false negative results. in cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding. corticosteroids may activate latent amebiasis. therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. 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. 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. administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. if inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained. however, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for addison’s disease. 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. the use of dexamethasone sodium phosphate 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 an 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. literature reports suggest an apparent association between 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. serious neurologic adverse reactions with epidural administration 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 use of fluoroscopy. the safety and effectiveness of epidural administration of corticosteroids has not been established, and corticosteroids are not approved for this use. pregnancy teratogenic effects: pregnancy category c– since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighed against the possible 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. corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.

se being treated. in less severe diseases doses lower than 0.5 mg may suffice, while in severe diseases doses higher than 9 mg may be required. the initial dosage should be maintained or adjusted until the patient’s response is satisfactory. if a satisfactory clinical response does not occur after a reasonable period of time, discontinue dexamethasone sodium phosphate injection and transfer the patient to other therapy. after a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response. patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). during stress it may be necessary to increase dosage temporarily. if the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually. when the intravenous route of administration is used, dosage usually should be the same as the oral dosage. in certain overwhelming, acute, life-threatening situations, however, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. the slower rate of absorption by intramuscular administration should be recognized. shock there is a tendency in current medical practice to use high (pharmacologic) doses of corticosteroids for the treatment of unresponsive shock. the following dosages of dexamethasone sodium phosphate injection have been suggested by various authors: author dosage cavanagh 1 3 mg/kg of body weight per 24 hours by constant intravenous infusion after an initial intravenous injection of 20 mg dietzman 2 2 to 6 mg/kg of body weight as a single intravenous injection frank 3 40 mg initially followed by repeat intravenous injection every 4 to 6 hours while shock persists oaks 4 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists schumer 5 1 mg/kg of body weight as a single intravenous injection administration of high dose corticosteroid therapy should be continued only until the patient’s condition has stabilized and usually not longer than 48 to 72 hours. although adverse reactions associated with high dose, short term corticosteroid therapy are uncommon, peptic ulceration may occur. cerebral edema dexamethasone sodium phosphate injection is generally administered initially in a dosage of 10 mg intravenously followed by four mg every six hours intramuscularly until the symptoms of cerebral edema subside. response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. for palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with two mg two or three times a day may be effective. acute allergic disorders in acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested: dexamethasone sodium phosphate injection, 4 mg per ml: first day , 1 or 2 ml (4 or 8 mg), intramuscularly. dexamethasone tablets, 0.75 mg: second and third days, 4 tablets in two divided doses each day; fourth day, 2 tablets in two divided doses; fifth and sixth days, 1 tablet each day; seventh day, no treatment; eighth day, follow-up visit. this schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases. intra-articular, intralesional and soft tissue injection intra-articular, intralesional, and soft tissue injections are generally employed when the affected joints or areas are limited to one or two sites. dosage and frequency of injection varies depending on the condition and the site of injection. the usual dose is from 0.2 to 6 mg. the frequency usually ranges from once every three to five days to once every two to three weeks. frequent intra-articular injection may result in damage to joint tissues. some of the usual single doses are: site of injection amount of dexamethasone phosphate (mg) large joints (e.g., knee) 2 to 4 small joints (e.g., interphalangeal, temporomandibular) 0.8 to 1 bursae 2 to 3 tendon sheaths 0.4 to 1 soft tissue infiltration 2 to 6 ganglia 1 to 2 dexamethasone sodium phosphate injection is particularly recommended for use in conjunction with one of the less soluble, longer-acting steroids for intra-articular and soft tissue injection. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

s should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

th papilledema (pseudotumor cerebri) usually after treatment vertigo headache psychic disturbances endocrine: menstrual irregularities development of cushingoid state suppression of growth in children secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness decreased carbohydrate tolerance manifestations of latent diabetes mellitus increased requirements for insulin or oral hypoglycemic agents in diabetics hirsutism ophthalmic: posterior subcapsular cataracts increased intraocular pressure glaucoma exophthalmos metabolic: negative nitrogen balance due to protein catabolism cardiovascular: myocardial rupture following recent myocardial infarction (see warnings ) other: anaphylactoid or hypersensitivity reactions thromboembolism weight gain increased appetite nausea malaise hiccups the following additional adverse reactions are related to parenteral corticosteroid therapy: rare instances of blindness associated with intralesional therapy around the face and head hyperpigmentation or hypopigmentation subcutaneous and cutaneous atrophy sterile abscess post-injection flare (following intra-articular use) charcot-like arthropathy to report suspected adverse reactions, contact fresenius kabi usa, llc at 1-800-551-7176 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.