Label: DEXAMETHASONE SODIUM PHOSPHATE- dexamethasone phosphate injection, solution 

  • Label RSS
  • NDC Code(s): 0517-4901-25, 0517-4905-25, 0517-4930-25
  • Packager: American Regent, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 05/14

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  • DESCRIPTION

    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:

    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.

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  • CLINICAL PHARMACOLOGY

    Dexamethasone Sodium Phosphate Injection, USP 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.

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  • INDICATIONS AND USAGE

    1. 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 ntituberculous chemotherapy
                            Loeffler's syndrome not manageable by other means 
                            Aspiration pneumonitis

                    9.     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
                            
                    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
                            
    Tuberculous 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).

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  • CONTRAINDICATIONS

    Systemic fungal infections. (See WARNINGS regarding amphotericin B)

    Hypersensitivity to any component of this product, including sulfites (see WARNINGS).

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  • WARNINGS

    Serious Neurologic Adverse Reactions wIth Epidural Administration

    Serious 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, 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.

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  • PRECAUTIONS

    General

    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 cautiously 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 to 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

    Persons 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.

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  • ADVERSE REACTIONS

    Fluid and electrolyte disturbances
        Sodium retention
        Fluid retention
        Congestive heart failure in susceptible patients
        Potassium loss
        Hypokalemic alkalosis
        Hypertension

    Musculoskeletal
        
    Muscle weakness
        Steroid myopathy
        Loss of muscle mass
        Osteoporosis
        Vertebral compression fractures
        Aseptic necrosis of femoral and humeral heads
        Pathologic fracture of long bones
        Tendon rupture

    Gastrointestinal
        
    Peptic ulcer with possible subsequent perforation and hemorrhage
        Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease
        Pancreatitis
        Abdominal distention
        Ulcerative esophagitis

    Dermatologic
        
    Impaired wound healing
        Thin fragile skin
        Petechiae and ecchymoses
        Erythema
        Increased sweating
        May suppress reactions to skin tests
        Burning or tingling, especially in the perineal area (after I.V. injection)
        Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema

    Neurologic
        
    Convulsions
        Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
        Vertigo
        Headache
        Psychic disturbances

    Endocrine
        
    Menstrual irregularities
        Development of cushingoid state
        Suppression of growth in children
        Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness
        Decreased carbohydrate tolerance
        Manifestations of latent diabetes mellitus
        Increased requirements for insulin or oral hypoglycemic agents in diabetics
        Hirsutism

    Ophthalmic
        
    Posterior subcapsular cataracts
        Increased intraocular pressure
        Glaucoma
        Exophthalmos

    Metabolic
        
    Negative nitrogen balance due to protein catabolism

    Cardiovascular
        
    Myocardial rupture following recent myocardial infarction (see WARNINGS).

    Other
        
    Anaphylactoid or hypersensitivity reactions
        Thromboembolism
        Weight gain
        Increased appetite
        Nausea
        Malaise
        Hiccups
        The following additional adverse reactions are related to parenteral corticosteroid therapy:
        Rare instances of blindness associated with intralesional therapy around the face and head
        Hyperpigmentation or hypopigmentation
        Subcutaneous and cutaneous atrophy
        Sterile abscess
        Postinjection flare (following intra-articular use)
        Charcot-like arthropathy

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  • OVERDOSAGE

    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.

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  • DOSAGE AND ADMINISTRATION

    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 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, 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.

    Shock

    There 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 injection

    Although 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 Edema

    Dexamethasone 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 Disorders

    In 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 Injection

    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 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 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.

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  • HOW SUPPLIED

    Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL

     NDC 0517-4901-25  1 mL Single Dose Vial  Boxes of 25
     NDC 0517-4905-25  5 mL Multiple Dose Vial  Boxes of 25
     NDC 0517-4930-25  30 mL Multiple Dose Vial  Boxes of 25

    Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) (See USP Controlled Room Temperature).

    Sensitive to heat - Do not autoclave.

    IN4901
    Rev. 5/14

    AMERICAN
    REGENT, INC.
    SHIRLEY, NY 11967

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  • PRINCIPAL DISPLAY PANEL – 1 mL Label

    NDC 0517-4901-25

    DEXAMETHASONE
    SODIUM PHOSPHATE
    INJECTION, USP

    4 mg/mL (Dexamethasone
    Phosphate Equivalent)

    1 mL SINGLE DOSE VIAL
    FOR IV OR IM USE*

    Rx Only

    AMERICAN REGENT, INC.
    SHIRLEY, NY 11967

    PRINCIPAL DISPLAY PANEL – 1 mL Label
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  • PRINCIPAL DISPLAY PANEL - 1 mL Carton

    NDC 0517-4901-25

    DEXAMETHASONE
    SODIUM PHOSPHATE
    INJECTION, USP

    25 x 1 mL SINGLE DOSE VIALS
    4 mg/mL (Dexamethasone Phosphate Equivalent)

    Rx Only

    FOR INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, SOFT TISSUE
    OR INTRALESIONAL USE
    Each mL contains: Dexamethasone Sodium Phosphate 4.37 mg (equivalent to
    4 mg of Dexamethasone Phosphate), Sodium Sulfite 1 mg, Benzyl Alcohol
    10 mg, Water for Injection q.s.  Sodium Citrate for isotonicity. pH adjusted
    with Citric Acid and/or Sodium Hydroxide. 
    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to
    86°F) (See USP Controlled Room Temperature). Sensitive to heat - Do not autoclave. 
    Directions for Use: See Package Insert.    

    AMERICAN REGENT, INC.
    SHIRLEY, NY  11967

    Rev. 11/05

    NDC 0517-4901-25 DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 25 x 1 mL SINGLE DOSE VIALS 4 mg/mL (Dexamethasone Phosphate Equivalent) Rx Only FOR INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, SOFT TISSUE OR INTRALESIONAL USE Each mL contains: Dexamethasone Sodium Phosphate 4.37 mg (equivalent to 4 mg of Dexamethasone Phosphate), Sodium Sulfite 1 mg, Benzyl Alcohol 10 mg, Water for Injection q.s. Sodium Citrate for isotonicity. pH adjusted with Citric Acid and/or Sodium Hydroxide. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Sensitive to heat - Do not autoclave. Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05
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  • PRINCIPAL DISPLAY PANEL – 5 mL Label

    NDC 0517-4905-25

    DEXAMETHASONE
    SODIUM PHOSPHATE
    INJECTION, USP

    20 mg/5 mL (4mg/mL)
    (Dexamethasone Phosphate Equivalent)

    5 mL MULTIPLE DOSE VIAL
    FOR IV OR IM USE*

    Rx Only

    AMERICAN REGENT, INC.
    SHIRLEY, NY 11967

    PRINCIPAL DISPLAY PANEL – 5mL Label
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  • PRINCIPAL DISPLAY PANEL - 5 mL Carton

    NDC 0517-4905-25

    DEXAMETHASONE
    SODIUM PHOSPHATE
    INJECTION, USP

    25 x 5 mL 
    MULTIPLE DOSE VIALS

    20 mg/5 mL  (4 mg/mL) (Dexamethasone Phosphate Equivalent)

    Rx Only

    FOR INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR,
    SOFT TISSUE OR INTRALESIONAL USE
    Each mL contains: Dexamethasone Sodium Phosphate 4.37 mg (equivalent to 4 mg of
    Dexamethasone Phosphate), Sodium Sulfite 1 mg, Benzyl Alcohol 10 mg, Water for Injection q.s. 
    Sodium Citrate for isotonicity. pH adjusted with Citric Acid and/or Sodium Hydroxide. 
    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP
    Controlled Room Temperature). Sensitive to heat - Do not autoclave. 
    Directions for Use: See Package Insert.    

    AMERICAN REGENT, INC.
    SHIRLEY, NY  11967

    Rev. 5/09

    PRINICPAL DISPLAY PANEL - 5 mL CARTON LABELING
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  • PRINCIPAL DISPLAY PANEL – 30 mL Label

    NDC 0517-4930-25

    DEXAMETHASONE
    SODIUM PHOSPHATE
    INJECTION, USP

    120 mg/30 mL (4 mg/mL)
    (Dexamethasone Phosphate
    Equivalent)

    30 mL MULTIPLE DOSE VIAL
    FOR IV, IM, INTRA-ARTICULAR,
    SOFT TISSUE OR
    INTRALESIONAL USE

    Rx Only

    AMERICAN REGENT, INC.
    SHIRLEY, NY 11967

    PRINCIPAL DISPLAY PANEL – 30 mL Label
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  • INGREDIENTS AND APPEARANCE
    DEXAMETHASONE SODIUM PHOSPHATE 
    dexamethasone sodium phosphate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-4901
    Route of Administration INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXAMETHASONE PHOSPHATE (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 4 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM SULFITE  
    BENZYL ALCOHOL  
    SODIUM CITRATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0517-4901-25 25 in 1 TRAY
    1 1 mL in 1 VIAL, SINGLE-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA087440 09/30/1990
    DEXAMETHASONE SODIUM PHOSPHATE 
    dexamethasone sodium phosphate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-4905
    Route of Administration INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXAMETHASONE PHOSPHATE (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 4 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM SULFITE  
    BENZYL ALCOHOL  
    SODIUM CITRATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0517-4905-25 25 in 1 TRAY
    1 5 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA087440 09/30/1990
    DEXAMETHASONE SODIUM PHOSPHATE 
    dexamethasone sodium phosphate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-4930
    Route of Administration INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXAMETHASONE PHOSPHATE (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 4 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM SULFITE  
    BENZYL ALCOHOL  
    SODIUM CITRATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0517-4930-25 25 in 1 BOX
    1 30 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA087440 09/30/1990
    Labeler - American Regent, Inc. (622781813)
    Establishment
    Name Address ID/FEI Business Operations
    Luitpold Pharmaceuticals, Inc. 002033710 ANALYSIS(0517-4901, 0517-4905, 0517-4930), MANUFACTURE(0517-4901, 0517-4905, 0517-4930), STERILIZE(0517-4901, 0517-4905, 0517-4930)
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