DEXAMETHASONE SODIUM PHOSPHATE Label

m mm DESCRIPTION: 5 Dermatologic Diseases component of this product, including sulfites (see observation is necessary as reactivation of the dispatients should be observed closely for developDexamethasone sodium phosphate is a waterPemphigus WARNINGS). ease may occur. During prolonged corticosteroid therment of hypokalemia. soluble inorganic ester of dexamethasone. It occurs Severe erythema multiforme (Stevensapy, these patients should receive chemoprophyIntra-articular injection of a corticosteroid may WARNINGS: as a white or slightly yellow crystalline powder, is Johnson syndrome) Because rare instances of anaphylactoid reactions laxis. produce systemic as well as local effects. odorless or has a slight odor of alcohol, is exceedExfoliative dermatitis Literature reports suggest an apparent associaAppropriate examination of any joint fluid preshave occurred in patients receiving parenteral ingly hygroscopic and is freely soluble in water. Bullous dermatitis herpetiformis tion between use of corticosteroids and left venent is necessary to exclude a septic process. corticosteroid therapy, appropriate precautionary Dexamethasone sodium phosphate is an adrenoSevere seborrheic dermatitis tricular free wall rupture after a recent myocardial A marked increase in pain accompanied by local measures should be taken prior to administration, infarction; therefore, therapy with corticosteroids swelling, further restriction of joint motion, fever, cortical steroid anti-inflammatory drug. Severe psoriasis especially when the patient has a history of allergy Chemically, dexamethasone sodium phosphate is Mycosis fungoides should be used with great caution in these patients. and malaise is suggestive of septic arthritis. If this to any drug. Anaphylactoid and hypersensitivity 9-Fluoro-11b,17,21-trihydroxy-16 a-methylpregna-1, 5 Allergic States reactions have been reported for dexamethasone Serious Neurologic Adverse Reactions complication occurs and the diagnosis of sepsis is 4-diene-3,20-dione 21-(dihydrogen phosphate) confirmed, appropriate antimicrobial therapy should sodium phosphate (see ADVERSE REACTIONS). Control of severe or incapacitating allergic with Epidural Administration disodium salt and has the following structural formula: be instituted. conditions intractable to adequate trials of Dexamethasone sodium phosphate injection Serious neurologic events, some resulting in death, Injection of a steroid into an infected site is to conventional treatment in: contains sodium bisulfite, a sulfite that may cause have been reported with epidural injection of be avoided. Bronchial asthma allergic-type reactions including anaphylactic sympcorticosteroids. Specific events reported include, but Corticosteroids should not be injected into Contact dermatitis toms and life-threatening or less severe asthmatic are not limited to, spinal cord infarction, paraplegia, unstable joints. Atopic dermatitis episodes in certain susceptible people. The overquadriplegia, cortical blindness, and stroke. These Patients should be impressed strongly with the Serum sickness all prevalence of sulfite sensitivity in the general serious neurologic events have been reported with importance of not overusing joints in which sympSeasonal or perennial allergic rhinitis population is unknown and probably low. Sulfite and without use of fluoroscopy. The safety and tomatic benefit has been obtained as long as the Drug hypersensitivity reactions sensitivity is seen more frequently in asthmatic than effectiveness of epidural administration or cortico­ inflammatory process remains active. Urticarial transfusion reactions in non-asthmatic people. steroids has not been established, and corticosteFrequent intra-articular injection may result in Corticosteroids may exacerbate systemic fungal Acute noninfectious laryngeal edema (epinephroids are not approved for this use. damage to joint tissues. infections and therefore, should not be used in the rine is the drug of first choice) The slower rate of absorption by intramuscular presence of such infections unless they are needed Pregnancy 5 Ophthalmic Diseases administration should be recognized. to control drug reactions due to amphotericin B. Teratogenic Effects: Pregnancy Category C– C 22 H 28 FNa 2 O 8 P M.W. 516.41 Severe acute and chronic allergic and inflamMoreover, there have been cases reported in which Since adequate human reproduction studies have Information for Patients matory processes involving the eye, such as: concomitant use of amphotericin B and hydrocornot been done with corticosteroids, use of these Persons who are on immunosuppressant doses of Dexamethasone Sodium Phosphate Injection, Herpes zoster ophthalmicus tisone was followed by cardiac enlargement and drugs in pregnancy or in women of childbearing corticosteroids should be warned to avoid exposure USP is a sterile solution of dexamethasone sodium Iritis, iridocyclitis congestive failure. potential requires that the anticipated benefits be to chickenpox or measles. Patients should also be phosphate in water for injection for intravenous Chorioretinitis In patients on corticosteroid therapy subjected weighed against the possible hazards to the mother advised that if they are exposed, medical advice (IV), intramuscular (IM), intra-articular, soft-tissue Diffuse posterior uveitis and choroiditis to any unusual stress, increased dosage of rapidly and embryo or fetus. Infants born of mothers who should be sought without delay. or intralesional use. Optic neuritis acting corticosteroids before, during, and after the have received substantial doses of corticosteroids Each mL contains dexamethasone sodium phosSympathetic ophthalmia stressful situation is indicated. during pregnancy should be carefully observed for ADVERSE REACTIONS: phate equivalent to dexamethasone phosphate Anterior segment inflammation signs of hypoadrenalism. Fluid and electrolyte disturbances: Drug-induced secondary adrenocortical insuf­ 4 mg or dexamethasone 3.33 mg; benzyl alcohol Allergic conjunctivitis ficiency may result from too rapid withdrawal of Corticosteroids appear in breast milk and could Sodium retention 10 mg added as preservative; sodium citrate dihyKeratitis Fluid retention corticosteroids and may be minimized by gradual suppress growth, interfere with endogenous cor­ drate 11 mg; sodium sulfite 1 mg as an antioxidant; Allergic corneal marginal ulcers ticosteroid production, or cause other unwanted Congestive heart failure in susceptible patients reduction of dosage. This type of relative insufWater for Injection q.s. Citric acid and/or sodium 5 Gastrointestinal Diseases ficiency may persist for months after discontinuaeffects. Mothers taking pharmacologic doses of Potassium loss hydroxide may have been added for pH adjustTo tide the patient over a critical period of the tion of therapy; therefore, in any situation of stress corticosteroids should be advised not to nurse. Hypokalemic alkalosis ment (7.0 to 8.5). Air in the container is displaced Hypertension disease in: occurring during that period, hormone therapy by nitrogen. Ulcerative colitis (Systemic therapy) should be reinstituted. If the patient is receiving PRECAUTIONS: Musculoskeletal: CLINICAL PHARMACOLOGY: Regional enteritis (Systemic therapy) steroids already, dosage may have to be increased. This product, like many other steroid formulations, Muscle weakness Dexamethasone sodium phosphate has a rapid 5 Respiratory Diseases Since mineralocorticoid secretion may be impaired, is sensitive to heat. Therefore, it should not be autoSteroid myopathy onset but short duration of action when compared salt and/or a mineralocorticoid should be adminisclaved when it is desirable to sterilize the exterior Loss of muscle mass Symptomatic sarcoidosis with less soluble preparations. Because of this, it is tered concurrently. of the vial. Osteoporosis Berylliosis suitable for the treatment of acute disorders responCorticosteroids may mask some signs of infecFollowing prolonged therapy, withdrawal of corPathologic fracture of long bones Fulminating or disseminated pulmonary tuber­ sive to adrenocortical steroid therapy. tion, and new infections may appear during their ticosteroids may result in symptoms of the corticoVertebral compression fractures culosis when used concurrently with approNaturally occurring glucocorticoids (hydrocortiuse. There may be decreased resistance and steroid withdrawal syndrome including fever, Aseptic necrosis of femoral and humeral heads priate antituberculous chemotherapy Loeffler’s sone and cortisone), which also have salt-retaining inability to localize infection when corticosteroids myalgia, arthralgia, and malaise. This may occur Tendon rupture syndrome not manageable by other means properties, are used as replacement therapy in are used. Moreover, corticosteroids may affect the in patients even without evidence of adrenal insufAspiration pneumonitis Gastrointestinal: adrenocortical deficiency states. Their synthetic nitroblue-tetrazolium test for bacterial infection and ficiency. There is an enhanced effect of corticosteroids in Peptic ulcer with possible subsequent perforation analogs, including dexamethasone, are primarily 5 Hematologic Disorders produce false negative results.