|
|
| Drug Name: | Dexamethasone Sodium Phosphate |
| Manufacturer: | AMERICAN REGENT, INC. |
| Other Info: | 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 InjectionAmount ofDexamethasone sodiumphosphate(mg) Large Joints(e.g., Knee)2 to 4 Small Joints(e.g., Interphalangeal,Temporomandibular)0.8 to 1 Bursae2 to 3 Tendon Sheaths0.4 to 1 Soft Tissue Infiltration2 to 6 Ganglia1 to 2 Dexamethasone Sodium Phosphate Injection, USP 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. |
| Clinical Trials: | |
By intravenous or intramuscular injection when oral therapy is not feasible:Endocrine disorders 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 doubtful Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancerRheumatic 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 spondylitisCollagen diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Acute rheumatic carditisDermatologic diseases Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Bullous dermatitis herpetiformis Severe seborrheic dermatitis Severe psoriasis Mycosis fungoidesAllergic 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 ulcersGastrointestinal 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 pneumonitisHematologic disorders Acquired (autoimmune) hemolytic anemia Idiopathic thrombocytopenic purpura in adults (I.V.
only: I.M administration is contraindicated) Secondary thrombocytopenia in adults Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplasticanemiaNeoplastic diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhoodEdematous states To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type, or that due to lupus erythematosusMiscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvementDiagnostic testing of adrenocortical hyperfunctionCerebral 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).Systemic fungal infections.
(See WARNINGS regarding amphotericin B)Hypersensitivity to any component of this product, including sulfites (see 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, USP (see ADVERSE REACTIONS).Dexamethasone Sodium Phosphate Injection, USP contains sodium bisulfite, 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 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 Injection, USP 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.
NIH - Clinical Trials