NDC 67457-421 Dexamethasone Sodium Phosphate

Dexamethasone Sodium Phosphate

NDC Product Code 67457-421

NDC CODE: 67457-421

Proprietary Name: Dexamethasone Sodium Phosphate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dexamethasone Sodium Phosphate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders. It is also used as a test for an adrenal gland disorder (Cushing's syndrome). Dexamethasone belongs to a class of drugs known as corticosteroids. It decreases your immune system's response to various diseases to reduce symptoms such as swelling and allergic-type reactions. This injectable form of dexamethasone is used when a similar drug cannot be taken by mouth or when a very fast response is needed, especially in patients with severe medical conditions. Talk to your doctor about the risks and benefits of dexamethasone, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use.

NDC Code Structure

  • 67457 - Mylan Institutional Llc

NDC 67457-421-30

Package Description: 25 VIAL in 1 CARTON > 30 mL in 1 VIAL (67457-421-00)

Price per Unit: $0.96276 per ML

NDC Product Information

Dexamethasone Sodium Phosphate with NDC 67457-421 is a a human prescription drug product labeled by Mylan Institutional Llc. The generic name of Dexamethasone Sodium Phosphate is dexamethasone sodium phosphate. The product's dosage form is injection, solution and is administered via intra-articular; intralesional; intramuscular; intravenous; soft tissue form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1116927, 1812194 and 309696.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Dexamethasone Sodium Phosphate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intra-articular - Administration within a joint.
  • Intralesional - Administration within or introduced directly into a localized lesion.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Soft Tissue - Administration into any soft tissue.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mylan Institutional Llc
Labeler Code: 67457
FDA Application Number: ANDA040803 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-11-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Dexamethasone Injection

Dexamethasone Injection is pronounced as (dex a meth' a sone)

Why is dexamethasone injection medication prescribed?
Dexamethasone injection is used to treat severe allergic reactions. It is used in the management of certain types of edema (fluid retention and swelling; excess fluid hel...
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Dexamethasone Sodium Phosphate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow, crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The empirical formula is C22H28FNa2O8P and the structural formula is:Dexamethasone sodium phosphate injection, USP is a sterile solution of dexamethasone sodium phosphate, and is supplied in 4 mg/ mL and 10 mg /mL.Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration. Each mL contains: Active: Dexamethasone sodium phosphate 4.4 mg (equivalent to dexamethasone phosphate 4 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL.Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile solution for intravenous or intramuscular use only. Each mL contains: Actives: Dexamethasone sodium phosphate 11 mg (equivalent to dexamethasone phosphate 10 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL.

Clinical Pharmacology

Dexamethasone sodium phosphate injection has a rapid onset but short duration of action when compared with less soluble preparations. Because of this, it is suitable for the treatment of acute disorders responsive to adrenocortical steroid therapy.Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, including dexamethasone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

Indications And Usage

A. By intravenous or intramuscular injection when oral therapy is not feasible:1. 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.2. 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.3. Collagen Diseases:During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosus.Acute rheumatic carditis.4. Dermatologic Diseases:Pemphigus.Severe erythema multiforme. (Stevens-Johnson Syndrome)Exfoliative dermatitis.Bullous dermatitis herpetiformis.Severe seborrheic dermatitis.Severe psoriasis.Mycosis fungoides.5. 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).6. 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.7. Gastrointestinal Diseases:To tide the patient over a critical period of the disease in:Ulcerative colitis (systemic therapy).Regional enteritis (systemic therapy).8. 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.9. 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.10. Neoplastic Diseases:For palliative management of:Leukemias and lymphomas in adults.Acute leukemia of childhood.11. 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.12. Miscellaneous: Tuberculosis meningitis with subarachnoid block or impending block when used concurrently   with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.13.  Diagnostic testing of adrenocortical hyperfunction.14.  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.B. 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.C. 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 WARNINGSregarding amphotericin B)


Serious Neurologic Adverse Reactions with Epidural AdministrationSerious 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. 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).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 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.Patients 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. The risk of developing a disseminated infection varies among individuals and can be related to the dose, route and duration of corticosteroid administration as well as to the underlying disease. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered. If exposed to measles, prophylaxis with immune globulin (IG) may be indicated. (See the respective package inserts for VZIG and IG for complete prescribing information.)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 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 PregnancySince 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.


This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial.Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency.There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation.The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction must be gradual.Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.Aspirin should be used with caution in conjunction with corticosteroids in hypoprothrombinemia.Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess, or other pyogenic infection, also in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Fat embolism has been reported as a possible complication of hypercortisonism.When large doses are given, some authorities advise that antacids be administered between meals to help prevent peptic ulcer. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed.Steroids may increase or decrease motility and number of spermatozoa in some patients.Phenytoin, phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs.False negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies.When corticosteroids are administered concomitantly with potassium depleting diuretics, patients should be observed closely for development of hypokalemia.Intra-articular injection of a corticosteroid may produce systemic as well as local effects. Appropriate examination of any joint fluid present is necessary to exclude a septic process.A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise is suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.Injection of a steroid into an infected site is to be avoided. Corticosteroids should not be injected into unstable joints. Patients should be impressed strongly with the importance of not overusing joints in which symptomatic benefit has been obtained as long as the inflammatory process remains active.Frequent intra-articular injection may result in damage to joint tissues.The slower rate of absorption by intramuscular administration should be recognized.

Information For Patients

Susceptible patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Adverse Reactions

Fluid and electrolyte disturbances:Sodium retentionFluid retentionCongestive heart failure in susceptible patientsPotassium lossHypokalemic alkalosisHypertensionMusculoskeletal:Muscle weaknessSteroid myopathyLoss of muscle massOsteoporosisVertebral compression fracturesAseptic necrosis of femoral and humeral headsTendon rupturePathologic fracture of long bonesGastrointestinal:Peptic ulcer with possible subsequent perforation and hemorrhagePerforation of the small and large bowel; particularly in patients with inflammatory bowel diseasePancreatitisAbdominal distentionUlcerative esophagitisDermatologic:Impaired wound healingThin fragile skinPetechiae and ecchymosesErythemaIncreased sweatingMay suppress reactions to skin testsBurning or tingling especially in the perineal area (after IV injection) other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edemaNeurologic:ConvulsionsIncreased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatmentVertigoHeadachePsychic disturbancesEndocrine:Menstrual irregularitiesDevelopment of cushingoid stateSuppression of growth in childrenSecondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illnessDecreased carbohydrate toleranceManifestations of latent diabetes mellitusIncreased requirements for insulin or oral hypoglycemic agents in diabeticsHirsutismOphthalmic:Posterior subcapsular cataractsIncreased intraocular pressureGlaucomaExophthalmosMetabolic:Negative nitrogen balance due to protein catabolismCardiovascular:Myocardial rupture following recent myocardial infarction. (SeeWARNINGS).Other:Anaphylactoid or hypersensitivity reactionsThromboembolismWeight gainIncreased appetiteNauseaMalaiseHiccupsThe following additional adverse reactions are related to parenteral corticosteroid therapy:Rare instances of blindness associated with intralesional therapy around the face and headHyperpigmentation or hypopigmentationSubcutaneous and cutaneous atrophySterile abscessPost-injection flare (following intra-articular use)Charcot-like arthropathy


Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic.The oral LD50 of dexamethasone in female mice was 6.5 g/kg. The intravenous LD50 of dexamethasone sodium phosphate in female mice was 794 mg/kg.

Dosage And Administration

Dexamethasone sodium phosphate injection, USP 4 mg/mL is for intravenous, intramuscular, intra-articular, intralesional and soft tissue injection.Dexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous or intramuscular use only.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. A. Intravenous and Intramuscular Injection:The 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 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:Author*Dosage Cavanagh13 mg/kg of body weight per 24 hours by constant intravenous infusion after an initial intravenous injection of 20 mgDietzman22 to 6 mg/kg of body weight as a single intravenous injection Frank340 mg initially followed by repeat intravenous injection every 4 to 6 hours while shock persistsOaks440 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persistsSchumer5 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 EdemaDexamethasone 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 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.Dexamethasone sodium phosphate 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.B. Intra-Articular, Intralesional and Soft Tissue Injection:Intra-articular, intralesional and soft tissue injections are generally employed when 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 of DexamethasonePhosphate (mg)Large joints (e.g., Knee)2 to 4Small joints (e.g., Interphalangeal, Temporomandibular)0.8 to 1Bursae2 to 3Tendon sheaths0.4 to 1Soft tissue infiltration2 to 6Ganglia1 to 2Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.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.

How Supplied

Dexamethasone sodium phosphate injection, USP 4 mg/mL is for-intravenous, intramuscular, intra-articular, intralesional and soft tissue administration available as follows:NDC NumberFill volumePack size67457-423-121 mL Single-Dose Vial25’s67457-422-545 mL Multi-Dose Vial25’s67457-421-3030 mL Multi-Dose Vial25’sDexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous and intramuscular injection only available as follows:NDC NumberFill volumePack size67457-420-1010 mL Multi-Dose Vial10’sStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat. Do not autoclave. Protect from freezing.


  • 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.; Lilleher, 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 shocks), 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. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Made in IndiaDECEMBER 2015

Package/Label Display Panel

NDC 67457-420-10Dexamethasone Sodium Phosphate Injection, USP100 mg/10 mL (10 mg/mL*)SterileFor IM or IV use only Rx only10 x10 mL Multi-dose VialsMylan

NDC 67457-421-30Dexamethasone Sodium Phosphate Injection, USP120 mg/30 mL (4 mg/mL*)SterileFor IV, IM, Intra-articular, Soft tissue or Intralesional useRx only25 x30 mL Multi-dose VialsMylan

NDC 67457-422-54Dexamethasone Sodium Phosphate Injection, USP20 mg/5 mL (4 mg/mL*)SterileFor IV, IM, Intra-articular, Soft tissue or Intralesional useRx only25 x5 mL Multi-dose VialsMylan

NDC 67457-423-12Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL*SterileFor IV, IM, Intra-articular, Soft tissue or Intralesional useRx only25 x1 mL Multi-dose VialsMylan

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