Decadron Phosphate Injection

DECADRON® Phosphate Injection

MSD

Dexamethasone Sodium Phosphate

Corticosteroid

Indications And Clinical Uses: By i.v. or i.m. injection when oral therapy is not feasible:

Adrenocortical Insufficiency: Dexamethasone sodium phosphate injection has predominantly glucocorticoid activity with low mineralocorticoid activity. Therefore, it does not offer complete replacement therapy, and its use must be supplemented with salt and/or desoxycorticosterone. When so supplemented, dexamethasone sodium phosphate injection is indicated in the impairment of all adrenocortical activity, as in Addison’s disease or following bilateral adrenalectomy that requires replacement of both glucocorticoid and mineralocorticoid activity.

Relative Adrenocortical Insufficiency: In the relative adrenocortical insufficiency that may occur following cessation of long-term therapy with suppressive doses of adrenocortical hormones, mineralocorticoid secretion may be unimpaired. Replacement with a hormone that acts predominantly as a glucocorticoid may be sufficient to restore adrenocortical function. When immediate support is mandatory, dexamethasone sodium phosphate injection may be effective within minutes after administration and can be life saving.

Preoperative and postoperative support in patients undergoing bilateral adrenalectomy, or hypophysectomy, or any other surgical procedure when adrenocortical reserve is doubtful, and in postoperative shock unresponsive to conventional therapy.

Nonsuppurative Thyroiditis: By i.v. or i.m. injection when oral therapy is not feasible in thyroid crisis.

Shock: The adjunctive treatment of shock where high (pharmacologic) doses of corticosteroids are needed: e.g., severe shock of hemorrhagic, traumatic, surgical origin. Treatment with dexamethasone sodium phosphate injection is an adjunct to, and not a substitute for, specific or supportive measures that the patient may require, e.g., restoration of circulating blood volume, correction of fluid and electrolyte balance, oxygen, surgical measures and antibiotics.

Rheumatic Disorders: As adjunctive therapy for short-term administration (to support the patient during 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: Initial control of severe 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, anaphylaxis (epinephrine is the drug of first choice).

Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation.

Gastrointestinal Diseases: To support the patient during a critical period of the disease in: ulcerative colitis (systemic therapy), regional enteritis (systemic therapy).

Respiratory Diseases: Ldistffler’s syndrome not manageable by other means, symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculous chemotherapy, 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) hypoplastic anemia.

Neoplastic Disorders: For palliative management of hypercalcemia associated with cancer, 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.

Cerebral Edema: Dexamethasone sodium phosphate injection may be used to treat patients with cerebral edema from various causes: associated with primary or metastatic brain tumors; associated with cerebral vascular accident (acute stroke) excluding intracerebral hemorrhage; associated with neurosurgery; associated with head injury or pseudotumor cerebri.

It may be used also in the preoperative preparation of patients with increased intracranial pressure secondary to brain tumors or for palliation of patients with inoperable or recurrent brain neoplasms.

Use of dexamethasone sodium phosphate injection in cerebral edema is not a substitute for careful neurological evaluation and definitive management such as neurosurgery or other specific therapy.

Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when concurrently accompanied by appropriate antituberculous chemotherapy.

Trichinosis with neurologic or myocardial involvement.

Diagnostic testing of adrenocortical hyperfunction.

Neonatal Respiratory Distress: antenatal prophylaxis.

In combination with ondansetron for the management of nausea and vomiting associated with cisplatin and noncisplatin emetogenic chemotherapy.

By intra-articular or soft tissue injection. As adjunctive therapy for short-term administration (to support patient during 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).

Contra-Indications: Systemic fungal infections (see Precautions re: amphotericin B). Hypersensitivity to sulfites or to any component of this medication.

Administration of live virus vaccines (see Warnings).

Manufacturers’ Warnings In Clinical States: Administration of live virus vaccines 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.

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.

The use of dexamethasone sodium phosphate injection in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate 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.

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. If corticosteroids have to be used in the presence of bacterial infections, appropriate vigorous anti-infective therapy must be instituted.

Corticosteroids may activate latent amebiasis or strongyloidiasis, or exacerbate active disease. Therefore, it is recommended that latent or active amebiasis and strongyloidiasis be ruled out before initiating corticosteroid therapy in any patient at risk of, or with symptoms suggestive of, either conditon.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. 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.

Dexamethasone sodium phosphate injection 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 nonasthmatic people.

Pregnancy: Since human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug 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.

Lactation: 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.

Precautions: Average and large doses of hydrocortisone or cortisone 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.

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, corticosteroid therapy should be reinstituted. If the patient is receiving steroids already, the dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineral corticoid should be administered concurrently.

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.

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.

Corticosteroids may suppress reactions to skin tests.

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 instability or psychotic tendencies may be aggravated by corticosteroids.

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.

Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.

Steroids may increase or decrease motility and number of spermatozoa in some patients.

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 are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.

Local injection of a steroid into an infected site is to be avoided.

Corticosteroids should not be injected into unstable joints.

Overdistention of the joint capsule and deposition of steroid along the needle track should be avoided in intra-articular injection, since this may lead to tissue atrophy.

Frequent intra-articular injection may result in damage to joint tissues.

Injection in the deltoid muscle should be avoided because of high incidence of tissue atrophy.

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.

Children: Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Steroids should be used with caution in: nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomosis; 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.

There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.

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 nonimmune 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 may be related to the dose, route and duration of corticosteroid administration as well as to the underlying disease. Exposed patients should be advised to seek medical advice without delay. If exposed to measles, prophylaxis with i.m. pooled immunoglobulin (IG) may be indicated. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated (see the respective product monographs for IG and VZIG for complete prescribing information). If chickenpox develops, treatment with antiviral agents should be considered.

Drug Interactions: Corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false negative results.

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.

ASA should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

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 the dexamethasone suppression tests which should be interpreted with caution during administration of these drugs.

When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.

False negative results in the dexamethasone suppression test in patients being treated with indomethacin have been reported.

Adverse Reactions: Fluid and electrolyte disturbances: sodium retention; fluid retention; congestive heart failure in susceptible patients; potassium loss; hypokalemic alkalosis; hypertension; hypotension or shock-like reaction.

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.

Neurological: 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 diabetes; hirsutism.

Ophthalmic: posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos; retinopathy of prematurity.

Cardiovascular: myocardial rupture following recent myocardial infarction (see Precautions); hypertrophic cardiomyopathy in low birth weight infants.

Metabolic: negative nitrogen balance due to protein catabolism.

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; s.c. and cutaneous atrophy; sterile abscess; postinjection flare (following intra-articular use); Charcot-like arthropathy.

Symptoms And Treatment Of Overdose: Symptoms: hypertension, edema.

Treatment: Anaphylactic and hypersensitivity reactions may be treated with epinephrine, positive-pressure artificial respiration, and aminophylline. The patient should be kept warm and quiet.

Treatment probably is not indicated for reactions due to chronic overdosage.

Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. There are no specific recommendations for the treatment of overdosage with dexamethasone sodium phosphate injection.

Dosage And Administration: I.V. and I.M. injection: The usual initial dosage of dexamethasone sodium phosphate injection may vary from 0.5 mg to 20 mg/day depending on the specific disease entity being treated. Usually the parenteral dosage ranges are 33 to 50% the oral dose given every 12 hours. However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages have been used. In these circumstances, the slower rate of absorption by i.m. administration should be recognized.

Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

If the drug is to be stopped after it has been given for more than a few days, it is recommended that it be withdrawn gradually rather than stopped abruptly.

In emergencies, the usual dose of dexamethasone sodium phosphate injection by i.v. or i.m. injection is 1 to 5 mL (4 to 20 mg) depending on the severity of the condition. In shock, use only the i.v. route (see also Shock). This dose may be repeated until adequate response is noted.

After initial improvement, single doses of 0.5 to 1 mL ( 2 to 4 mg) repeated as necessary, should be sufficient. The total daily dosage usually need not exceed 20 mL (80 mg) even in severe conditions.

When constant maximal effect is desired, dosage must be repeated at 3- or 4-hour intervals or maintained by slow i.v. drip.

I.V. and i.m. injections are advised in acute illness. When the acute stage has passed, substitute oral steroid therapy as soon as feasible.

Antiemetic Prophylaxis During Emetogenic Chemotherapy: Dexamethasone administered concomitantly with ondansetron has been demonstrated to achieve enhanced efficacy for antiemetic prophylaxis during emetogenic chemotherapy. Various dosing schedules have been used in clinical studies; however, the following is suggested for this combination:

Eight to 20 mg of dexamethasone sodium phosphate injection infused over 5 to 15 minutes just prior to chemotherapy, followed by 4 mg of dexamethasone sodium phosphate orally every 4 to 6 hours, or by 8 mg orally every 8 hours, and tapered in either strength or frequency of administration over 2 to 3 days. In general the total treatment duration for this indication should not exceed 5 days beyond chemotherapy. Alternatively, injectable dexamethasone can be infused i.v. in lieu of an oral formulation of dexamethasone sodium phosphate using various schedules.

For the recommended dosing of ondansetron, see the product monograph for Zofran.

Admixtures containing 8 mg of ondansetron and 20 mg of dexamethasone sodium phosphate in 50 mL of 5% dextrose infusion fluid stored in 50 mL polyvinyl chloride infusion bags, have been shown to be physically and chemically stable for up to 2 days at room temperature or up to 7 days at 2 to 8°C. In addition, these same admixtures have demonstrated compatibility with Continu-Flo administration sets.

Shock (of hemorrhagic, traumatic, surgical origin): The usual dose is 2 to 6 mg/kg body weight given as a single i.v. injection. This may be repeated in 2 to 6 hours, if shock persists. As an alternative, dexamethasone sodium phosphate injection, 2 to 6 mg/kg body weight is given as a single i.v. injection followed immediately by the same dose in an i.v. infusion. Therapy with dexamethasone sodium phosphate injection is an adjunct to, and not a replacement for, conventional therapy (see Precautions).

The doses are large in comparison with the usual recommended doses of dexamethasone injection but they are for emergency use in acute conditions needing high pharmacologic doses. Administration of high dose corticosteroid therapy should be continued only until the patient’s condition has stabilized and usually no longer than 48 to 72 hours.

Cerebral Edema: Associated with primary or metastatic brain tumor, neurosurgery, head injury, pseudotumor cerebri or preoperative preparation of patients with increased intracranial pressure secondary to brain tumor: initially 10 mg (2.5 mL) i.v. followed by 4 mg (1 mL) i.m. every 6 hours until symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours: dosage may be reduced after 2 to 4 days and gradually discontinued over a period of 5 to 7 days.

High doses of dexamethasone phosphate injection are recommended for initiating short-term intensive therapy for acute life-threatening cerebral edema. Following the high loading dose schedule of the first day of therapy, the dose is scaled down over the 7- to 10-day period of intensive therapy and subsequently reduced to zero over the next 7 to 10 days. When maintenance therapy is required this should be changed to oral dexamethasone as soon as possible.

Suggested high dose schedule in cerebral edema: Adults: Initial dose: 50 mg, i.v.; 1st day: 8 mg, i.v. every 2 hours; 2nd day: 8 mg, i.v. every 2 hours; 3rd day: 8 mg, i.v. every 2 hours; 4th day: 4 mg, i.v. every 2 hours; 5th to 8th day: 4 mg, i.v. every 4 hours; thereafter decrease by daily reduction of 4 mg.

Children (35 kg and over): Initial dose: 25 mg, i.v.; 1st day: 4 mg, i.v. every 2 hours; 2nd day: 4 mg, i.v. every 2 hours; 3rd day: 4 mg, i.v. every 2 hours; 4th day: 4 mg, i.v. every 4 hours; 5th to 8th day: 4 mg, i.v. every 6 hours; thereafter decrease by daily reduction of 2 mg.

Children (below 35 kg): Initial dose: 20 mg, i.v.; 1st day: 4 mg, i.v. every 3 hours; 2nd day: 4 mg, i.v. every 3 hours; 3rd day: 4 mg, i.v. every 3 hours; 4th day: 4 mg, i.v. every 6 hours; 5th to 8th day: 2 mg, i.v. every 6 hours; thereafter, decrease by daily reduction of 1 mg.

Palliative management of patients with recurrent or inoperable brain tumors: Maintenance therapy should be individualized with oral or parenteral dexamethasone.

A dosage of 2 mg 2 or 3 times a day may be effective.

Associated with acute stroke (excluding intracerebral hemorrhage): Initially 10 mg (2.5 mL) i.v. followed by 4 mg (1 mL) i.m. every 6 hours for 10 days. The doses should then be tapered to zero on the ensuing 7 days.

The smallest dosage necessary to control cerebral edema should be utilized.

The usual precautions associated with corticosteroid therapy should be kept in mind. Antacids, anticholinergic drugs, and dietary measures to prevent gastrointestinal ulcer or hemorrhage should be considered.

Neonatal Respiratory Distress: Antenatal Prophylaxis: The recommended dosage of dexamethasone phosphate injection is 5 mg (1.25 mL) administered i.m. to the mother every 12 hours for up to a total of 4 doses. Administration should be initiated preferably between 24 hours and 7 days before estimated delivery.

This schedule is designed to provide adequate therapy during acute episodes, with minimizing the risk of overdosage in chronic cases. In some patients, this is all that will be needed to control the condition. Other patients will require further treatment, such as topical steroids, antihistamines, or bronchodilators. A few may require further systemic steroid therapy. By noting the dosage on the day before symptoms reappear in the latter group, the physician can decide more easily on any necessary additional therapy.

When acute exacerbations of asthma are accompanied by signs of infection, concomitant administration of antibiotics is recommended.

Intra-articular, Intralesional and Soft-tissue Injection: Intra-articular, intralesional, and soft-tissue injections generally are employed when affected joints or areas are limited to 1 or 2 sites.

In the treatment of tendon and tendon sheath inflammations, inject into the tendon sheath rather than into the tendon.

In radiculitis, inject about the involved nerve root near its exit from the spine. Do not inject the steroid directly into the nerve. In intercostal neuritis and neuralgia, pass the needle under the inner edge of the rib, letting it ride over one ridge to a second ridge. Inject the steroid under the rib and infiltrate the painful area. Guard against piercing the pleura. Sudden sharp pain during injection may mean the pleura has been penetrated.

In ganglia, inject directly into the cyst cavity after complete evacuation of its contents with a 16-gauge needle. Seal the puncture wound with a compression bandage for several days.

Repeat injections at appropriate intervals. The frequency of injection varies from patient to patient and ranges from once every 3 to 5 days to once every 2 to 3 weeks.

Stability and Storage Recommendations: This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when sterilization of the exterior of the vial is desired. Protect from freezing.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Special Instructions: This preparation can be given directly from the vial without mixing or dilution. If preferred, it can be added to Sodium Chloride Injection, or Dextrose Injection, without loss of potency, and administered by i.v. drip.

When dexamethasone sodium phosphate injection is added to an infusion solution, the mixture must be used within 24 hours since infusion solutions do not contain preservatives.

Solutions used for i.v. administration or further dilution of this product should be used preservative-free in the neonate, especially the premature infant.

The usual aseptic techniques governing injections should be observed.

Availability And Storage: Each mL of clear, colorless sterile solution contains: dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg (equal to 3.33 mg of dexamethasone or roughly about 100 mg of hydrocortisone). Nonmedicinal ingredients: creatinine, sodium citrate, sodium hydroxide (to adjust pH) and water for injection with sodium bisulfite, methylparaben, and propylparaben added as preservatives. Vials of 5 mL. Protect from freezing. Do not autoclave.

DECADRON® Phosphate Injection MSD Dexamethasone Sodium Phosphate Corticosteroid

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