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Basic Drug Info
Drug Name:Dexamethasone Sodium Phosphate
Manufacturer:Baxter Healthcare Corporation
Other Info:



Clinical Trials:


Indications and Usage
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)Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used)Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtfulShock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspectedCongenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer
Adrenal cortical hypofunction -- The inability of the adrenal gland to produce adequate amounts of cortisol.

Adrenal gland hypofunction -- abnormally diminished activity of the adrenal gland.

Malignant Neoplasms -- A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread through the bloodstream and lymphatic system to other parts of the body.

Primary malignant neoplasm --

Contraindications
Systemic fungal infections (see WARNINGS regarding amphotericin B).Hypersensitivity to any component of this product, including sulfites (see WARNINGS).
Systemic mycosis --

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Because rare instances of anaphylactoid 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.

Anaphylactoid and hypersensitivity reactions have been reported for Dexamethasone Sodium Phosphate Injection (see ADVERSE REACTIONS).Dexamethasone Sodium Phosphate Injection contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.

The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.

Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.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 due 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 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 infections 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 in 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 unknown.

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 pool intramuscular immune globulin (IG) may be indicated.

(See the respective package inserts for VZIG and IG for complete prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.The use of Dexamethasone Sodium Phosphate Injection 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 antituberculosis 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.
Branded Drugs
The following US Branded drugs contain Dexamethasone Sodium Phosphate


DEXACORT -- UCB INC

DECADRON -- MERCK AND CO INC

DEXACEN-4 -- CENTRAL PHARMACEUTICALS INC

DEXAMETHASONE -- ABRAXIS PHARMACEUTICAL PRODUCTS

HEXADROL -- ORGANON USA INC

DEXAIR -- PHARMAFAIR INC

MAXIDEX -- ALCON LABORATORIES INC

DECADRON W/ XYLOCAINE -- MERCK AND CO INC

NEODECADRON -- MERCK AND CO INC

NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE -- BAUSCH AND LOMB PHARMACEUTICALS INC

NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE -- ALCON UNIVERSAL LTD

NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE -- PHARMAFAIR INC


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