Dexamethasone Sodium Phosphates
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Questions & Answers
Side Effects & Adverse Reactions
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.
Usage in pregnancy. 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.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- 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 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 (I.V. only: I.M administration is contraindicated)
- Secondary thrombocytopenia in adults
- Erythroblastopenia (RBC anemia)
- Congenital (erythroid) hypoplasticanemia
- 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.
- Endocrine disorders
- 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).
History
There is currently no drug history available for this drug.
Other Information
Dexamethasone Sodium Phosphate Injection, USP is a water-soluble inorganic ester of dexamethasone.
It occurs as a yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic, and is freely soluble in water.
Dexamethasone Sodium Phosphate Injection, USP is a synthetic adrenocortical steroid anti-inflammatory drug.
It has the following structural formula:
Dexamethasone Sodium Phosphate Injection, USP C22H28FNa2O8P, has a molecular weight of 516.41 and the chemical name 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate) disodium salt.
Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration.
Each mL of the injection contains the following components:
- Dexamethasone Sodium Phosphate
- (equivalent to 4 mg of Dexamethasone Phosphate)...4.37 mg
- Sodium Sulfite.............................................................1 mg
- Benzyl Alcohol.............................................................10 mg
- Sodium Citrate.............................................................for isotonicity
- Water for Injection........................................................q.s.
- pH adjusted between 7 and 8.5 with Citric Acid and/or Sodium Hydroxide.
Sources
Dexamethasone Sodium Phosphates Manufacturers
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Cardinal Health
![Dexamethasone Sodium Phosphates (Dexamethasone Phosphate) Injection, Solution [Cardinal Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dexamethasone Sodium Phosphates | Cardinal Health
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL -- For intravenous, intramuscular, intra-articular, intralesional, and soft tissue injection.
Dexamethasone Sodium Phosphate Injection, USP can be given directly from the vial, or it can be added to Sodium Chloride Injection or Dextrose Injection and administered by intravenous drip.
Solutions used for intravenous administration or further dilution of this product should be preservative-free when used in the neonate, especially the premature infant.
When it is mixed with an infusion solution, sterile precautions should be observed. Since infusion solutions generally do not contain preservatives, mixtures should be used within 24 hours.
DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.
Intravenous and Intramuscular InjectionThe initial dosage of Dexamethasone sodium phosphate injection varies from 0.5 to 9 mg a day depending on the disease 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, USP 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.
ShockThere 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:
*1. Cavanagh, D.; Singh, K.B.: Endotoxin shock in pregnancy and abortion, in: ``Corticosteroids in the Treatment of Shock′′, Schumer, W.; Nyhus, L.M., Editors, Urbana, University of Illinois Press, 1970, pp.86-96. 2. Dietzman, R.H.; Ersek, R.A.; Bloch, J.M.; Lillehei, R. C.: High-output, low-resistance gram-negative septic shock in man, Angiology 20: 691-700. Dec. 1969. 3. Frank, E.: Clinical observations in shock and management (In: Shields, T.F., ed.: Symposium on current concepts and management of shock), J. Maine Med. Ass. 59: 195-200. Oct. 1968. 4. Oaks, W. W.; Cohen, H.E.: Endotoxin shock in the geriatric patient, Geriat. 22: 120-130. Mar. 1967. 5. Schumer, W.; Nyhus, L.M.: Corticosteroid effect on biochemical parameters of human oligemic shock, Arch. Surg. 100: 405-408. Apr. 1970. Author* Dosage Cavanagh1 3 mg/kg of body weight per 24 hours by constant intravenous infusion after an initial intravenous injection of 20 mg Dietzman2 2 to 6 mg/kg of body weight as a single intravenous injection Frank3 40 mg initially followed by repeat intravenous injection every 4 to 6 hours while shock persists Oaks4 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists Schumer5 1 mg/kg of body weight as a single intravenous injectionAlthough adverse reactions associated with high dose, short term corticosteroid therapy are uncommon, peptic ulceration may occur.
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.
Cerebral EdemaDexamethasone Sodium Phosphate Injection, USP 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 DisordersIn 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, USP, 4 mg/mL: first day, 1 or 2 mL (4 or 8 mg), intramuscularly.
This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.
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.
Intra-articular, Intralesional, and Soft Tissue InjectionIntra-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 sodium
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 2Dexamethasone 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.
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