Dexamethasone (injection)

Dexamethasone (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]; Sree Teja Yelamanchili, MBBS [3]

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Overview

Dexamethasone (injection) is an anti-inflammatory agent that is FDA approved for the treatment of endocrine disorders, diagnostic testing of adrenocortical hyperfunction- cushing's syndrome and hyperaldosteronism, cerebral edema, synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, post-traumatic osteoarthritis, keloids, localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus, discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, alopecia areata, and ganglia. Common adverse reactions include hypertension, atrophic condition of skin, finding of impaired skin healing, cushing's syndrome, decreased body growth, risk for infection, abnormal vision, cataract, conjunctival edema, conjunctivitis , dry eye, raised intraocular pressure, vitreous floaters, depression, euphoria, and pulmonary tuberculosis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Allergic condition

• 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)

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.
• In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, a combination of parenteral and oral therapy is recommended. On the first day, give dexamethasone sodium phosphate 4 to 8 mg IM; on the second and third days, 4 tablets (0.75 mg each) orally in 2 divided doses each day; on the fourth day, 2 tablets orally in 2 divided doses; on the fifth and sixth days, 1 tablet orally each day; and on the seventh day no treatment. A follow-up visit is recommended on the eighth day.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Cerebral edema, Associated with brain tumor

• 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.

• Dosing Information

• The dose of dexamethasone for maintenance palliative therapy in patients with recurrent or inoperable brain tumors is 2 mg 2 to 3 times daily.

Collagen disease

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the collagen disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.
• The initial dose of dexamethasone in adult patients ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Cushing's syndrome; Diagnosis

• Dosing Information

• Low-Dose Test for Cushing's Syndrome:
• The dose of dexamethasone for the diagnosis of Cushing's syndrome in adults is 1 mg orally at 11 pm. Blood is drawn for plasma cortisol determinations at 8 am the following morning. Greater accuracy can be achieved by administering dexamethasone 0.5 mg every 6 hours for 48 hours, with 24-hour urine collections for determination of 17-hydroxycorticosteroid excretion.

• High-Dose Test to distinguish Cushing's Syndrome due to pituitary adrenocorticotropic hormone excess from cushing syndrome due to other causes.
• The dose of dexamethasone to be administered for the high-dose test to distinguish Cushing syndrome due to pituitary adrenocorticotropic hormone (ACTH) excess from Cushing syndrome due to other causes is 8 mg orally at 11 pm or midnight, with blood drawn for a serum cortisol level at 8 am the following morning. Alternatively, 2 mg ORALLY every 6 hours for 48 hours may be administered, with either 24-hour urine collections for determination of 17-hydroxycorticosteroid excretion or 24-hour urine collection on day 2 or 3 for urine free cortisol level measurement.

Diabetic macular edema

• Dosing Information

• Recommended dose for diabetic macular edema: 1 implant (0.7 mg) injected intravitreally; may repeat in contralateral eye.

Disorder of endocrine system

• 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

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone in adult patients ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The dose of dexamethasone sodium phosphate for the treatment of shock unresponsive to conventional therapy (if adrenocortical insufficiency exists or is suspected) is 1 to 6 mg/kg as a single IV injection or 20 mg IV followed by 3 mg/kg per 24 hours by continuous IV infusion, or 40 mg IV every 2 to 6 hours while shock persists.

Disorder of eye

• 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

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Disorder of gastrointestinal tract

• To tide the patient over a critical period of the disease in:

• Ulcerative colitis (Systemic therapy)

• Regional enteritis (Systemic therapy)

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Disorder of hematopoietic structure

• Acquired (autoimmune) hemolytic anemia

• Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)

• Secondary thrombocytopenia in adults

• Erythroblastopenia (anemia)

• Congenital (erythroid) hypoplastic anemia

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Disorder of respiratory system

• 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

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Disorder of skin

• Pemphigus

• Severe erythema multiforme (Stevens-Johnson syndrome)

• Exfoliative dermatitis

• Bullous dermatitis herpetiformis

• Severe seborrheic dermatitis

• Severe psoriasis

• Mycosis fungoides

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone in adult patients ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Exacerbation of multiple sclerosis (Acute)

• Dosing Information

• The dose of dexamethasone for the treatment of acute exacerbations of multiple sclerosis is 30 mg orally daily for 1 week followed by 4 to 12 mg every other day for 1 month.

Hypercalcemia of malignancy

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Idiopathic thrombocytopenic purpura

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Inflammatory disorder of musculoskeletal system

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone in adult patients ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Macular retinal edema

• Dosing Information

• Inject 1 implant (0.7 mg) intravitreally into eye. May repeat in the contralateral eye.

Mycosis fungoides

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Neoplastic disease, Palliative management of leukemias and lymphomas

• For palliative management of:

• Leukemias and lymphomas in adults

• Acute leukemia of childhood

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Nephrotic syndrome, Idiopathic or due to lupus erythematosus, without uremia

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Posterior uveitis, Noninfectious

• Dosing Information

• Inject 1 implant (0.7 mg) intravitreally into eye. May repeat in the contralateral eye.

Trichinosis, With neurologic or myocardial involvement

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Tuberculosis of meninges, With subarachnoid block or impending block when used concurrently with antituberculosis therapy; Adjunct

• Dosing Information

• The initial dose of dexamethasone in adult patients ranges from 0.75 to 9 mg orally daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Radiation-induced nausea and vomiting; Treatment and Prophylaxis

Chemotherapy-induced nausea and vomiting; Treatment and Prophylaxis

• Dosing Information

• Combination Therapy: Dexamethasone combined with ondansetron was effective for controlling emesis in patients administered cisplatin. IV dexamethasone 20 mg plus IV ondansetron 8 mg, administered 30 minutes prior to the first course of cisplatin, was significantly more effective than ondansetron with placebo for controlling emesis in 100 cancer patients.

• The use of ondansetron has not been well established in the prevention of delayed nausea and vomiting (N&V) associated with cisplatin chemotherapy. One clinical trial did demonstrate that ondansetron and dexamethasone, started 16 hours after the start of cisplatin therapy, prevented delayed emesis in 69% of patients. The following drug regimen was used: ORAL DEXAMETHASONE - 8 milligrams every 12 hours for 2 days then 4 mg every 12 hours for 2 days; ORAL ONDANSETRON - 8 mg every 8 hours for 2 days. Besides limited efficacy in the prevention of delayed N&V, the 5-HT(3) anti-emetics, in general, exhibit decreased efficacy with subsequent cycles of cisplatin (Rolia, 1996). These factors need to be considered in the overall treatment approach to chemotherapy-induced N&V.
• Ondansetron 8 milligrams (mg) intravenously (IV) plus dexamethasone 20 mg IV, followed by oral ondansetron 8 mg twice daily, was effective in the prevention of nausea and vomiting associated with high-dose cisplatin (greater than 80 mg/square meter (mg/m(2)). During the same study, the 8-mg ondansetron dose was as effective as the 24-mg dose.

Septic shock; Adjunct

• Dosing Information

• IV hydrocortisone is preferred to dexamethasone by the Surviving Sepsis Campaign Guidelines, developed by an international group of experts, for patients with septic shock who inadequately responded to vasopressor support to maintain blood pressure, despite fluid replacement. If dexamethasone is used, then the dose of IV dexamethasone should 12 mg/day or less (the equivalent hydrocortisone dose of 300 mg/day). Oral fludrocortisone 50 mcg/day may be added to the substituted steroid if the substituted steroid has no significant mineralocorticoid activity. Other suggestions include tapering the corticosteroid dose when vasopressors are no longer required.
• In the treatment of shock, several dosing regimens have been suggested. One regimen is 2 to 6 mg/kg as a single IV injection for septic shock. Another regimen is 40 mg IV initially, followed by repeat IV injection every 2 to 6 hours. Other recommendations are 3 mg/kg/day by constant IV infusion after an initial IV bolus of 20 mg and 1 mg/kg IV as a single dose (Shumer & Nyhus, 1970).

Non–Guideline-Supported Use

Complication of prematurity, Single course therapy; Prophylaxis

Postoperative nausea and vomiting; Prophylaxis

• Dexamethasone 10 mg (n=45) and 5 mg (n=45) were equally effective in preventing nausea and vomiting after epidural morphine following total hysterectomy surgery. Dexamethasone 2.5 mg was no better than saline.
• In a dose-ranging study, IV dexamethasone 2.5 mg was the minimum effective dose for preventing postoperative nausea and vomiting after major gynecologic surgery. Significantly fewer patients experienced vomiting after receiving dexamethasone 2.5 mg, 5 mg, or 10 mg versus dexamethasone 1.25 mg or placebo (p less than 0.05). Thirty patients were included in each group.

Sensorineural hearing loss, sudden, refractory

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Allergic condition

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, a combination of parenteral and oral therapy is recommended. On the first day, give dexamethasone sodium phosphate 4 to 8 mg IM; on the second and third days, 4 tablets (0.75 mg each) orally in 2 divided doses each day; on the fourth day, 2 tablets orally in 2 divided doses; on the fifth and sixth days, 1 tablet orally each day; and on the seventh day no treatment. A follow-up visit is recommended on the eighth day.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.
• In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, a combination of parenteral and oral therapy is recommended. On the first day, give dexamethasone sodium phosphate 4 to 8 mg IM; on the second and third days, 4 tablets (0.75 mg each) orally in 2 divided doses each day; on the fourth day, 2 tablets orally in 2 divided doses; on the fifth and sixth days, 1 tablet orally each day; and on the seventh day no treatment. A follow-up visit is recommended on the eighth day.
• Acute Asthma Exacerbations:
• Children with acute asthma exacerbations may receive a single dose of dexamethasone IM. Doses were based on age with children 6 to 12 months old receiving 16 mg, children 13 to 35 months old receiving 24 mg, and children greater than 36 months old receiving 36 mg. Efficacy has been comparable to oral prednisone given over 5 days.

Cerebral edema, Associated with brain tumor

• Dosing Information

• In the treatment of cerebral edema, the recommended dose of dexamethasone sodium phosphate is 10 mg IV initially, followed by 4 mg IM every 6 hours, with clinical response being noted usually within 12 to 24 hours; dosage may be reduced after 2 to 4 days and then gradually tapered over a period of 5 to 7 days. In patients with recurrent or inoperable brain tumors, maintenance therapy with 2 mg 2 or 3 times daily is suggested .
• For cerebral edema, a loading dose of 1 to 2 mg/kg IM, or IV, followed by maintenance doses of 1 to 1.5 mg/kg/day (maximum 16 mg/day) divided every 4 to 6 hours.

Collagen disease

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone in adult patients ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Cushing's syndrome; Diagnosis

Disorder of endocrine system

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.

• For virilizing congenital adrenal hyperplasia, a starting dose of dexamethasone is 0.25 to 0.28 mg/m(2)/day, administered in the morning, preferably as an elixir to allow better dose regulation. The dose should be adjusted to maintain normal rate of growth and adrenal androgen secretion. Undertreatment is evident when 17-ketosteroid secretion rates exceed the normal range for age (1 to 8 years, 0.5 to 2 mg/day; 8 to 12 years, 2.5 to 8 mg/day; 12 to 16 years, 8 to 22 mg/day) and/or when afternoon serum 17-hydroxyprogesterone level exceeds 200 nanograms/mL. Overtreatment is suggested when the growth rate is slowed, the face becomes round, there is an increase in body hair, or body weight increases more than expected for changes in height.

• The initial dose of dexamethasone in adult patients ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Disorder of eye

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.
• The initial dose of dexamethasone sodium phosphate for ophthalmic administration is 1 to 2 drops into conjunctival sac hourly during the day and every 2 hours during the night, then reduce to 1 drop every 4 hours after favorable response is observed. The dose may be further reduced to 1 drop 3 to 4 times daily for symptom control.

Disorder of gastrointestinal tract

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone in adult patients ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Disorder of hematopoietic structure

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Disorder of respiratory system

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Disorder of skin

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The dose of dexamethasone sodium phosphate for intralesional injection ranges from 0.2 to 6 mg. The usual single doses are 2 to 4 mg in large joints, 0.8 to 1 mg in small joints, 2 to 3 mg in bursae, 0.4 to 1 mg in tendon sheaths. The frequency ranges from once every 3 to 5 days to once every 2 to 3 weeks.
• The initial dose of dexamethasone in adult patients ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Exacerbation of multiple sclerosis (Acute)

Hypercalcemia of malignancy

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Inflammatory disorder of musculoskeletal system

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Mycosis fungoides

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Neoplastic disease, Palliative management of leukemias and lymphomas

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Nephrotic syndrome, Idiopathic or due to lupus erythematosus, without uremia

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Trichinosis, With neurologic or myocardial involvement

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Tuberculosis of meninges, With subarachnoid block or impending block when used concurrently with antituberculosis therapy; Adjunct

• Dosing Information

• The initial dose of dexamethasone in pediatric patients ranges from 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m(2)/day) orally in 3 or 4 divided doses daily depending on disease being treated and patient response.
• The initial dose of dexamethasone ranges from 0.5 to 9 mg IV or IM daily depending on the disease being treated. The dose should be individualized based on patient response and then decreased in small increments at appropriate intervals until the lowest dose that maintains a favorable response is reached.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Chemotherapy-induced nausea and vomiting; Treatment and Prophylaxis

Non–Guideline-Supported Use

• Complication of prematurity, Single course therapy; Prophylaxis

• Postoperative nausea and vomiting; Prophylaxis

• Acute lymphoid leukemia

• Respiratory distress syndrome in the newborn

Contraindications

• Systemic fungal infections

• Hypersensitivity to any component of this product, including sulfites.

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.

General

• 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.

• Dexamethasone Sodium Phosphate Injection contains sodium sulfite, 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 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 infections 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.

• 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 unknown. 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 pool intramuscular immune globulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

• 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 antituberculosis 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.

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 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.

Adverse Reactions

Clinical Trials Experience

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 bone 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 IV 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

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Dexamethasone (injection) in the drug label

Drug Interactions

There is limited information regarding Dexamethasone (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• 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.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

• There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dexamethasone (injection) in women who are pregnant.

Labor and Delivery

• There is no FDA guidance on use of Dexamethasone (injection) during labor and delivery.

Nursing Mothers

• 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.

Pediatric Use

• There is no FDA guidance on the use of Dexamethasone (injection) with respect to pediatric patients.

Geriatic Use

• There is no FDA guidance on the use of Dexamethasone (injection) with respect to geriatric patients.

Gender

• There is no FDA guidance on the use of Dexamethasone (injection) with respect to specific gender populations.

Race

• There is no FDA guidance on the use of Dexamethasone (injection) with respect to specific racial populations.

Renal Impairment

• There is no FDA guidance on the use of Dexamethasone (injection) in patients with renal impairment.

Hepatic Impairment

• There is no FDA guidance on the use of Dexamethasone (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

• There is no FDA guidance on the use of Dexamethasone (injection) in women of reproductive potentials and males.

Immunocompromised Patients

• There is no FDA guidance one the use of Dexamethasone (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Dexamethasone Sodium Phosphate Injection, 4 mg/mL-For intravenous, intramuscular, intra-articular, intralesional and soft tissue injection.

• Dexamethasone Sodium Phosphate Injection, 10 mg/mL-For intravenous and intramuscular injection only.

• Dexamethasone Sodium Phosphate Injection 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 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:

• 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 EDEMA

• Dexamethasone 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 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, 4 mg/mL -First day, 1 or 2 mL (4 or 8 mg) intramuscularly.

• 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.

• This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.

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:

• Dexamethasone Sodium Phosphate Injection 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.

Monitoring

• There is limited information regarding Monitoring of Dexamethasone (injection) in the drug label.

IV Compatibility

• There is limited information regarding IV Compatibility of Dexamethasone (injection) in the drug label.

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.

Pharmacology

Mechanism of Action

Structure

• 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 molecular formula is: C22H28FNa2O8P and the structural formula is:

• Dexamethasone Sodium Phosphate Injection is a sterile solution of dexamethasone sodium phosphate for intravenous and intramuscular use. The 4 mg/mL strength may also be used for intra-articular, intralesional and soft tissue administration.

• Each mL of Dexamethasone Sodium Phosphate Injection 4 mg/mL contains dexamethasone sodium phosphate, equivalent to 4 mg dexamethasone phosphate or 3.33 mg dexamethasone. Inactive ingredients per mL: 1 mg sodium sulfite anhydrous, 19.4 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol (preservative) in Water for Injection.

• Each mL of Dexamethasone Sodium Phosphate Injection 10 mg/mL contains dexamethasone sodium phosphate, equivalent to 10 mg dexamethasone phosphate or 8.33 mg dexamethasone. Inactive ingredients per mL: 1.5 mg sodium sulfite anhydrous, 16.5 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol (preservative) in Water for Injection.

• The pH of both concentrations is 7.0-8.5; sodium hydroxide and/or citric acid used, if needed, for pH adjustment. Sealed under nitrogen.

Pharmacodynamics

• There is limited information regarding Pharmacodynamics of Dexamethasone (injection) in the drug label.

Pharmacokinetics

• 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.

Nonclinical Toxicology

• There is limited information regarding Nonclinical Toxicology of Dexamethasone (injection) in the drug label.

Clinical Studies

• There is limited information regarding Clinical Studies of Dexamethasone (injection) in the drug label.

How Supplied

• Dexamethasone Sodium Phosphate Injection, USP is available in the following package:

• 10 mg/mL
• 1 mL vials packaged in 25s (NDC 0641-0367-25)

Storage

• Protect from light: Keep covered in carton until time of use. Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Avoid freezing. Do not use if solution is hazy or has a precipitate. Do not autoclave.

• To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• For Product Inquiry call 1-877-845-0689.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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.

Precautions with Alcohol

• Alcohol-Dexamethasone (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Decadron, Dexamethasone Intensol, DexPak, Maxidex, DexPak Jr, Dekpak 13 Day Taperpak, Baycadron Elixer, Ozurdex.

Look-Alike Drug Names

There is limited information regarding Dexamethasone (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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