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Dexamethasone (Systemic)

Pronunciation

(deks a METH a sone)

Index Terms

  • Decadron
  • Dexamethasone Sod Phosphate
  • Dexamethasone Sodium Phosphate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Concentrate, Oral:

Dexamethasone Intensol: 1 mg/mL (30 mL) [contains alcohol, usp; unflavored flavor]

Elixir, Oral:

Baycadron: 0.5 mg/5 mL (237 mL [DSC]) [contains alcohol, usp, benzoic acid, fd&c red #40, propylene glycol; raspberry flavor]

Generic: 0.5 mg/5 mL (237 mL)

Kit, Injection, as sodium phosphate:

ReadySharp Dexamethasone: 10 mg/mL [contains benzyl alcohol, sodium sulfite]

Kit, Injection, as sodium phosphate [preservative free]:

Active Injection D: 10 mg/mL

DoubleDex: 10 mg/mL

Solution, Oral:

Generic: 0.5 mg/5 mL (240 mL, 500 mL)

Solution, Injection, as sodium phosphate:

Generic: 4 mg/mL (1 mL); 20 mg/5 mL (5 mL); 120 mg/30 mL (30 mL); 10 mg/mL (1 mL); 100 mg/10 mL (10 mL)

Solution, Injection, as sodium phosphate [preservative free]:

Generic: 4 mg/mL (1 mL); 10 mg/mL (1 mL)

Solution, Intravenous, as sodium phosphate:

Generic: 10 mg/50 mL in NaCl 0.9% (50 mL)

Solution Prefilled Syringe, Intravenous, as sodium phosphate:

Generic: 10 mg/2.5 mL (2.5 mL); 12 mg/3 mL (3 mL [DSC])

Tablet, Oral:

DexPak 10 Day: 1.5 mg [scored; contains fd&c red #40 aluminum lake]

DexPak 13 Day: 1.5 mg [scored; contains fd&c red #40 aluminum lake]

Generic: 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg, 6 mg

Tablet Therapy Pack, Oral:

DexPak 6 Day: 1.5 mg (21 ea) [scored; contains fd&c red #40 aluminum lake]

LoCort 11-Day: 1.5 mg (41 ea) [scored; contains fd&c red #40]

LoCort 7-Day: 1.5 mg (27 ea) [scored; contains fd&c red #40]

Zodex 12-Day: 1.5 MG (49) (49 ea) [scored; contains fd&c red #40]

Zodex 6-Day: 1.5 mg (21 ea) [scored; contains fd&c red #40 aluminum lake]

ZonaCort 11 Day: 1.5 mg (41 ea) [scored; contains fd&c red #40]

ZonaCort 7 Day: 1.5 mg (27 ea) [scored; contains fd&c red #40]

Brand Names: U.S.

  • Active Injection D
  • Baycadron [DSC]
  • Dexamethasone Intensol
  • DexPak 10 Day
  • DexPak 13 Day
  • DexPak 6 Day
  • DoubleDex
  • LoCort 11-Day
  • LoCort 7-Day
  • ReadySharp Dexamethasone
  • Zodex 12-Day
  • Zodex 6-Day
  • ZonaCort 11 Day
  • ZonaCort 7 Day

Pharmacologic Category

  • Anti-inflammatory Agent
  • Antiemetic
  • Corticosteroid, Systemic

Pharmacology

A long acting corticosteroid with minimal sodium-retaining potential. Decreases inflammation by suppression of neutrophil migration, decreased production of inflammatory mediators, and reversal of increased capillary permeability; suppresses normal immune response. Dexamethasone's mechanism of antiemetic activity is unknown.

Absorption

Oral: 61% to 86% (Czock 2005)

Metabolism

Hepatic

Excretion

Urine (~10%) (Duggan 1975; Miyabo 1991)

Onset of Action

Acetate: IV: Rapid

Immune thrombocytopenia: Oral: Initial response: 2 to 14 days; Peak response: 4 to 28 days (Neunert 2011)

Time to Peak

Serum: Oral: 1 to 2 hours (Czock 2005); IM: ~30 to 120 minutes (Egerman 1997; Hochhaus 2001); IV: 5 to 10 minutes (free dexamethasone) (Miyabo 1991; Rohdewald 1987)

Duration of Action

IV: Short

Half-Life Elimination

Extremely low birth-weight infants with BPD: 9.26 ± 3.34 hours (range: 5.85 to 16.1 hours) (Charles 1993)

Children 4 months to 16 years: 4.34 ± 4.14 hours (range: 2.33 to 9.54 hours) (Richter 1983)

Adults: Oral: 4 ± 0.9 hours (Czock 2005); IV: ~1 to 5 hours (Hochhaus 2001; Miyabo 1991; Rohdewald 1987; Toth 1999)

Use: Labeled Indications

Note: Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011], NICE 2014).

Oral, IV or IM injection:

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions; acute noninfectious laryngeal edema, urticarial transfusion reactions (injection only).

Collagen diseases: During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus or acute rheumatic carditis.

Dermatologic diseases: Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; exfoliative erythroderma; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis.

Diagnostic testing: Diagnostic testing of adrenocortical hyperfunction.

Edematous states: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that because of systemic lupus erythematosus.

Endocrine disorders: Primary, secondary, or acute (injection only) adrenocortical insufficiency (hydrocortisone or cortisone is the first choice); preoperatively, and in the event of serious trauma or illness, in adrenal insufficiency or when adrenocortical reserve is doubtful (injection only); shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected (injection only); congenital adrenal hyperplasia; nonsuppurative thyroiditis; hypercalcemia associated with cancer.

GI diseases: To tide the patient over a critical period of the disease in ulcerative colitis or regional enteritis.

Hematologic disorders: Immune thrombocytopenia (formerly known as idiopathic thrombocytopenic purpura) in adults (not IM); secondary thrombocytopenia in adults (select cases); acquired (autoimmune) hemolytic anemia; pure red cell aplasia; congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia).

Neoplastic diseases: Palliative management of leukemias and lymphomas in adults and acute leukemia of childhood.

Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.

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 and iridocyclitis; chorioretinitis; anterior segment inflammation; diffuse posterior uveitis and choroiditis; optic neuritis; sympathetic ophthalmia; temporal arteritis; uveitis; ocular inflammatory conditions unresponsive to topical corticosteroids.

Respiratory diseases: Symptomatic sarcoidosis; Loeffler syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis; idiopathic eosinophilic pneumonias.

Rheumatic disorders: As adjunctive therapy for short-term administration in psoriatic arthritis, rheumatoid arthritis (RA), juvenile RA, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, posttraumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis; treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.

Intraarticular or soft tissue injection: As adjunctive therapy for short-term administration in synovitis of osteoarthritis, RA, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, posttraumatic osteoarthritis

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; cystic tumors of an aponeurosis or tendon (ganglia)

Off Label Uses

Accelerated fetal lung maturation

In a systematic review of available evidence comparing any 2 corticosteroid regimens, no clear advantages of one corticosteroid over another was found. However, dexamethasone, in comparison to betamethasone, may have some additional benefits (eg, less intraventricular hemorrhage) [Brownfoot 2013]. Additional trials may be necessary to further define the role of dexamethasone in this setting.

Based on the American Congress of Obstetricians and Gynecologists (ACOG) practice bulletin for the management of premature rupture of membranes or preterm labor, the antenatal use of corticosteroids (eg, dexamethasone) to accelerate fetal lung maturation is effective and recommended.[ACOG 171 2016], [ACOG 172 2016], [ACOG 677 2016].

Chemotherapy-associated nausea and vomiting, prevention

Based on guidelines from the American Society of Clinical Oncology and the Multinational Association of Supportive Care in Cancer, dexamethasone is recommended as a component of antiemetic regimens for the prevention of nausea and vomiting associated with chemotherapy in adults.

Based on guidelines from the Pediatric Oncology Group of Ontario, dexamethasone is recommended as a component of antiemetic regimens for the prevention of nausea and vomiting associated with chemotherapy in children.

Glucocorticoid remediable aldosteronism, treatment

Based on the Endocrine Society guidelines for the management of primary aldosteronism, dexamethasone is an effective and recommended treatment to lower ACTH levels in patients with glucocorticoid remediable aldosteronism.

Immune thrombocytopenia (primary) (children/adolescents)

The American Society of Hematology 2011 evidence-based practice guidelines for immune thrombocytopenia suggest high-dose dexamethasone may be considered for second-line therapy in pediatrics with primary immune thrombocytopenia (ITP) with significant ongoing bleeding following first-line treatment with immune globulin (IV), Rho(D) immune globulin, or conventional corticosteroid doses [Neunert 2011].

Immune thrombocytopenia, chronic (refractory) (children/adolescents)

Data from a small prospective, randomized, open-label study and two small observational studies in children with chronic immune thrombocytopenia support the use of pulsed high dose dexamethasone for chronic refractory ITP [Chen 1997], [Hedlund-Treutiger 2003], [Khüne 1997]. Additional trials may be necessary to further define the role of pulsed high-dose dexamethasone in pediatric patients with this condition.

The American Society of Hematology 2011 evidence-based practice guidelines for immune thrombocytopenia suggest high-dose dexamethasone may be considered for management of chronic, refractory immune thrombocytopenia (ITP) in pediatrics as an alternative to splenectomy or in patients who do not respond to splenectomy [Neunert 2011]. An international consensus panel report also suggests dexamethasone as a treatment option for chronic refractory ITP in children [Provan 2010].

Multiple myeloma

Data from large randomized phase III studies support the use of dexamethasone (in various combination regimens) in the treatment of newly diagnosed and relapsed or refractory multiple myeloma [Dimopoulos 2016a], [Lonial 2015], [Moreau 2015], [Palumbo 2016], [Rajkumar 2010], [San Miguel 2013], [Sonneveld 2012].

Prevention and treatment of acute mountain sickness and high altitude cerebral edema

Based on the Wilderness Medical Society Consensus Guidelines for the Prevention and Treatment of Acute Altitude Illness and a consensus statement specifically for children by an ad hoc committee of the International Society for Mountain Medicine, dexamethasone is effective and recommended for the prevention and treatment of acute mountain sickness and high altitude cerebral edema.

Contraindications

Hypersensitivity to dexamethasone or any component of the formulation; systemic fungal infections

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Adrenal crisis (shock due to adrenal insufficiency and unresponsive to conventional therapy) (off-label dose): IV: 4 to 10 mg as a single dose, which may be repeated if necessary. Note: Hydrocortisone is the preferred agent in this setting (ES [Bornstein 2016]).

Anti-inflammatory/immunosuppressive/endocrine disorders:

Oral, IM, IV: 0.5 to 9 mg/day in divided doses every 6 to 12 hours; dose depends upon condition being treated and response of patient.

Intra-articular, intralesional, or soft tissue injection: Dosage and frequency depend on the condition and the site of injection; frequency range: once every 3 to 5 days to once every 2 to 3 weeks

Large joints (eg, knee): Single dose: 2 to 4 mg

Small joints (eg, interphalangeal, temporomandibular): Single dose: 0.8 to 1 mg

Bursae: Single dose: 2 to 4 mg

Tendon Sheaths: Single dose: 0.4 to 1 mg

Soft tissue infiltration: Single dose: 2 to 6 mg

Ganglia: 1 to 2 mg

Brain tumor (palliative management of cerebral edema or neurological deficits associated with recurrent or inoperable brain tumors): Oral, IV: 2 mg 2 to 3 times daily may be effective; individualize dose based on disease response and patient tolerance.

Cerebral edema (associated with brain tumor or craniotomy): IM, IV: 10 mg IV immediately, followed by 4 mg IM every 6 hours until cerebral edema subsides, then switch to oral regimen; dosage may be reduced after 2 to 4 days and gradually discontinued over 5 to 7 days

Cushing syndrome, diagnostic (low dose): Oral: 1 mg at 11 PM, draw blood at 8 AM; greater accuracy for Cushing syndrome may be achieved with 0.5 mg every 6 hours for 48 hours (with 24-hour urine collection for 17-hydroxycorticosteroid excretion)

Differentiation of Cushing syndrome due to ACTH excess from Cushing due to other causes: Oral: 2 mg every 6 hours for 48 hours (with 24-hour urine collection for 17-hydroxycorticosteroid excretion)

Immune thrombocytopenia (primary), initial therapy: Oral: 40 mg once daily for 4 consecutive days; if platelet count continues to remain <30,000/mm3 or bleeding symptoms occur by day 10, may administer an additional 4-day course of 40 mg once daily (Wei 2016) or 40 mg once daily for 4 consecutive days, if platelets fall below 30,000/mm3 within 6 months a second course may be administered, followed by a prednisone taper (Cheng 2003). Pulsed dexamethasone dosing of 40 mg once daily for 4 days every 14 or 28 days for 4 to 6 cycles has also been used (Mazzucconi 2007; Provan 2010).

Multiple sclerosis (acute exacerbation):

Note: Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011], NICE 2014).

Oral: 30 mg/day for 1 week, followed by 4 to 12 mg every other day for 1 month

Acute mountain sickness (AMS)/high altitude cerebral edema (HACE) (off-label use):

Prevention: Oral: 2 mg every 6 hours or 4 mg every 12 hours starting on the day of ascent; may be discontinued after staying at the same elevation for 2 to 3 days or if descent is initiated; do not exceed a 10 day duration (Luks 2010). Note: In situations of rapid ascent to altitudes >3500 meters (such as rescue or military operations), 4 mg every 6 hours may be considered (Luks 2010).

Treatment: Oral, IM, IV:

AMS: 4 mg every 6 hours (Luks 2010)

HACE: Initial: 8 mg as a single dose; Maintenance: 4 mg every 6 hours until symptoms resolve (Luks 2010)

Accelerated fetal lung maturation (off-label use): IM: 6 mg every 12 hours for a total of 4 doses (ACOG 171 2016). A single course is recommended for women between 24 and 34 weeks of gestation, including those with ruptured membranes or multiple gestations, who are at risk of delivering within 7 days. A single course may be appropriate in some women beginning at 23 weeks gestation or late preterm (between 34 0/7 weeks and 36 6/7 weeks gestation). A single repeat course may be considered in some women with pregnancies less than 34 weeks gestation at risk for delivery within 7 days and who had a course of antenatal corticosteroids >14 days prior (ACOG 171 2016; ACOG 172 2016; ACOG 677 2016).

Airway edema or extubation (off-label use): IV: 0.5 mg/kg/dose (maximum dose: 10 mg/dose) 6 to 12 hours prior to extubation then every 6 hours for 5 doses (Khemani 2009) or 5 mg every 6 hours for 4 doses with extubation performed 24 hours after last injection (Lee 2007).

Chemotherapy-associated nausea and vomiting, prevention (off-label use):

High emetic potential chemotherapy: Oral, IV: 12 mg on day 1 prior to chemotherapy (in combination with aprepitant or fosaprepitant and a 5HT3 antagonist on day 1) followed by 8 mg on days 2 to 3 or days 2 to 4 (with aprepitant on days 2 and 3 if aprepitant used on day 1) (Basch 2011; Roila 2016) or (if aprepitant/fosaprepitant not used): 20 mg day 1 (in combination with a 5HT3 antagonist on day 1) followed by 8 mg twice daily for 3 to 4 days (Roila 2016)

Moderate emetic potential chemotherapy: Oral, IV: 8 mg on day 1 prior to chemotherapy (in combination with a 5HT3 antagonist on day 1) and 8 mg on days 2 and 3; may be administered as 4 mg twice daily (Basch 2011; Roila 2016)

Low emetic potential chemotherapy: Oral, IV: 4 to 8 mg prior to chemotherapy (Basch 2011; Roila 2016)

Dosing when used in combination with extended-release granisetron (Raftopoulos 2015):

Day 1: IV: 20 mg (for highly emetic chemotherapy) or 8 mg (for moderately emetic chemotherapy)

Days 2, 3, and 4: Oral: 8 mg twice daily (for highly emetic chemotherapy)

Dexamethasone suppression test (depression/suicide indicator) (off-label use): Oral: 1 mg at 11 PM, draw blood at 8 AM the following day for plasma cortisol determination

Glucocorticoid remediable aldosteronism, treatment (off-label use): Oral: Initial: 0.125 to 0.25 mg once daily, preferably at bedtime to suppress early morning ACTH surge (Funder 2016)

Multiple myeloma (off-label use): Note: Multiple dexamethasone-containing regimens are available for the treatment of multiple myeloma. Refer to appropriate literature/guidelines for additional details.

Oral: 40 mg once daily on days 1 to 4, 9 to 12, and 17 to 20 (as induction therapy) in combination with bortezomib and doxorubicin for 3 cycles (Sonneveld 2012) or 40 mg once weekly on days 1, 8, 15, and 22 every 28 days (in combination with lenalidomide) until disease progression (Rajkumar 2010) or 40 mg once weekly on days 1, 8, 15, and 22 every 28 days (in combination with pomalidomide) until disease progression or unacceptable toxicity (San Miguel 2013) or 40 mg once weekly on days 1, 8, 15, and 22 every 28 days (in combination with ixazomib and lenalidomide) until disease progression or unacceptable toxicity (Moreau 2015) or 28 mg orally plus 8 mg IV (prior to elotuzumab) on days 1, 8, 15, and 22 every 28 days for 2 cycles, followed by 28 mg orally plus 8 mg IV (prior to elotuzumab) on days 1 and 15 and 40 mg orally on days 8 and 22 every 28 days thereafter until disease progression or unacceptable toxicity (in combination with elotuzumab and lenalidomide) (Lonial 2015).

Oral or IV: 20 mg once daily days 1, 2, 4, 5, 8, 9, 11, and 12 every 21 days (in combination with daratumumab and bortezomib) for 8 cycles (Palumbo 2016) or 20 mg on days 1 (prior to daratumumab infusion) and 2 each week (in combination with daratumumab and lenalidomide) until disease progression or unacceptable toxicity (Dimopoulos 2016a); for patients >75 years of age, BMI <18.5, poorly controlled diabetes, or corticosteroid intolerance a reduced dexamethasone dose of 20 mg once a week was used (Dimopoulous 2016a; Palumbo 2016).

Dosing: Geriatric

Refer to adult dosing. Use cautiously in the elderly in the smallest possible dose.

Dosing: Pediatric

Anti-inflammatory/immunosuppressive/endocrine disorders: Infants, Children, and Adolescents: Oral, IM, IV: Initial dose range: 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m2/day) in divided doses every 6 to 12 hours; dose depends upon condition being treated and response of patient; dosage for infants and children should be based on disease severity and patient response

Asthma exacerbation: Limited data available: Infants, Children, and Adolescents: Oral, IM, IV: 0.6 mg/kg once daily as a single dose or once daily for 2 days; maximum dose: 16 mg/dose (Hegenbarth 2008; Keeney 2014; Quereshi 2001); single dose regimens as low as 0.3 mg/kg/dose and as high as 1.7 mg/kg/dose have also been reported (Keeney 2014; Qureshi 2001; Shefrin 2009). Note: Duration greater than 2 days is not recommended due to increased risk of metabolic effects (GINA 2014).

Cerebral edema: Infants, Children, and Adolescents: Oral, IM, IV: Loading dose: 1 to 2 mg/kg/dose as a single dose; maintenance: 1 to 1.5 mg/kg/day in divided doses every 4 to 6 hours; maximum: 16 mg/day (Kleigman 2007).

Congenital adrenal hyperplasia: Adolescents (fully grown): Oral: 0.25 to 0.5 mg once daily (AAP 2010; Speiser 2010). Note: For younger patients who are still growing, hydrocortisone or fludrocortisone are preferred.

Physiologic replacement: Infants, Children, and Adolescents: Oral, IM, IV: 0.03 to 0.15 mg/kg/day in divided doses every 6 to 12 hours (Kleigman 2007) or 0.2 to 0.25 mg/m2/day once daily; some patients may require 0.3 mg/m2/day (Gupta 2008)

Acute mountain sickness (AMS) (moderate)/high altitude cerebral edema (HACE) (off-label use): Limited data available: Infants, Children, and Adolescents: Oral, IM, IV: 0.15 mg/kg/dose every 6 hours; maximum dose: 4 mg/dose; consider using for high altitude pulmonary edema because of associated HACE with this condition (Luks 2010; Pollard 2001)

Airway edema or extubation (off-label use): Limited data available: Infants, Children, and Adolescents: IV: 0.5 mg/kg/dose (maximum dose: 10 mg/dose) 6 to 12 hours prior to extubation then every 6 hours for 5 doses (total dexamethasone dose: 3 mg/kg) (Anene 1996; Khemani 2009; Tellez 1991)

Bacterial meningitis (H. influenzae type b) (off-label use): Limited data available: Infants >6 weeks and Children: IV: 0.15 mg/kg/dose every 6 hours for the first 2 to 4 days of antibiotic treatment; start dexamethasone 10 to 20 minutes before or with the first dose of antibiotic; if antibiotics have already been administered, dexamethasone use has not been shown to improve patient outcome and is not recommended (Tunkel 2004).

Chemotherapy-associated nausea and vomiting, prevention (off-label use): Pediatric Oncology Group of Ontario guideline recommendations (Dupuis 2013): Infants, Children, and Adolescents:

High emetic potential chemotherapy: Oral, IV: 6 mg/m2/dose every 6 hours (in combination with a 5HT3 antagonist and aprepitant [if no interaction with aprepitant and if ≥12 years]); reduce dexamethasone dose by 50% if administered concomitantly with aprepitant

Moderate emetic potential chemotherapy: Oral, IV:

BSA ≤0.6 m2: 2 mg every 12 hours (in combination with a 5HT3 antagonist)

BSA >0.6 m2: 4 mg every 12 hours (in combination with a 5HT3 antagonist)

Croup (laryngotracheobronchitis) (off-label use): Limited data available: Infants and Children: Oral, IM, IV: 0.6 mg/kg once; usual maximum dose: 16 mg (doses as high as 20 mg have been used) (Bjornson 2004; Hegenbarth 2008; Rittichier 2000). Note: a single oral dose of 0.15 mg/kg has been shown effective in children with mild to moderate croup (Russell 2004; Sparrow 2006).

Immune thrombocytopenia (primary), second-line treatment (off-label use): Children and Adolescents:  Oral: 0.6 mg/kg/day for 4 days every 4 weeks up to 6 cycles  (Neunert 2011). Consider a maximum daily dose cap (eg, 24 mg or 40 mg) based on response, individual tolerance and/or institutional policy.

Immune thrombocytopenia, chronic (refractory) (off-label use): Children and Adolescents: Oral: 0.6 mg/kg/day for 4 days every 4 weeks for 6 cycles (Hedlund-Treutiger 2003; Neunert 2011) or 28 to 40 mg/m2/day for 4 days every 4 weeks for 6 cycles (response usually observed within 3 days); maximum dose: 40 mg/day (Chen 1997; Khune 1997; Provan 2010]). Consider a maximum daily dose cap (eg, 24 mg or 40 mg) based on response, individual tolerance and/or institutional policy.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Hemodialysis: Supplemental dose is not necessary (Aronoff 2007).

Peritoneal dialysis: Supplemental dose is not necessary (Aronoff 2007).

International Myeloma Working Group (IMWG) Recommendations: The International Myeloma Working Group (IMWG) recommendations suggest that dexamethasone may be administered without dosage adjustment in multiple myeloma patients with renal impairment, including those on dialysis. The IMWG recommends the use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (preferred) or the Modification of Diet in Renal Disease (MDRD) formula to evaluate renal function estimation in multiple myeloma patients with a stable serum creatinine (Dimopoulos 2016b).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Reconstitution

Oral: Oral administration of dexamethasone for croup may be prepared using a parenteral dexamethasone formulation and mixing it with an oral flavored syrup (Bjornson 2004).

IV: May be given undiluted or further diluted in NS or D5W. Use the preservative-free product in neonates, especially premature infants.

Administration

Oral: Administer with meals to help prevent GI upset. May administer antacids between meals to help prevent peptic ulcers.

Oral concentrate: Use only the calibrated dropper provided. Draw dose into dropper; squeeze dropper contents into a liquid or semi-solid food (water, juice, soda or soda-like beverage, applesauce, pudding). Gently stir for a few seconds. Administer the entire mixture immediately. Do not store for future use.

IV: Use preservative-free dosage forms in neonates. May administer 4 mg/mL or 10 mg/mL concentration undiluted over ≤1 minute (Gahart 2015). Rapid administration may be associated with perineal irritation (especially with higher doses); consider further dilution and administration by IV intermittent infusion over 5 to 15 minutes (Allan 1986; Neff 2002; Perron 2003; Singh 2011).

IM: Administer 4 mg/mL or 10 mg/mL concentration by deep IM injection.

Intra-articular: Administer into affected joint using the 4 mg/mL concentration only.

Intralesional injection: Administer into affected area using the 4 mg/mL concentration only.

Soft tissue injection: Administer into affected tissue using the 4 mg/mL concentration only.

Dietary Considerations

May be taken with meals to decrease GI upset. May need diet with increased potassium, pyridoxine, vitamin C, vitamin D, folate, calcium, and phosphorus.

Storage

Elixir: Store at 15°C to 30°C (59°F to 86°F); avoid freezing.

Injection: Store intact vials at 20°C to 25°C (68°F to 77°F). Protect from light, heat, and freezing. Do not autoclave. Diluted solutions should be used within 24 hours.

Oral concentrated solution (Intensol): Store at 20°C to 25°C (68°F to 77°F); do not freeze; do not use if precipitate is present; dispense only in original bottle and only with manufacturer-supplied calibrated dropper; discard open bottle after 90 days.

Oral solution, tablets: Store at 20°C to 25°C (68°F to 77°F); protect from moisture.

Drug Interactions

Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Monitor therapy

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy

Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. Monitor therapy

Antacids: May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Consider therapy modification

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment. Consider therapy modification

Asparaginase (E. coli): May increase the serum concentration of Dexamethasone (Systemic). This is thought to be due to an asparaginase-related decrease in hepatic proteins responsible for dexamethasone metabolism. Monitor therapy

Asparaginase (Erwinia): May increase the serum concentration of Dexamethasone (Systemic). This is thought to be due to an asparaginase-related decrease in hepatic proteins responsible for dexamethasone metabolism. Monitor therapy

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Monitor therapy

Caspofungin: Inducers of Drug Clearance may decrease the serum concentration of Caspofungin. Management: Consider using an increased caspofungin dose of 70 mg daily in adults (or 70 mg/m2, up to a maximum of 70 mg, daily in pediatric patients) when coadministered with known inducers of drug clearance. Consider therapy modification

CloZAPine: CYP3A4 Inducers (Weak) may decrease the serum concentration of CloZAPine. Monitor therapy

Cobicistat: Dexamethasone (Systemic) may decrease the serum concentration of Cobicistat. Dexamethasone (Systemic) may also counteract the boosting effects of Cobicistat on some agents. Management: Consider an alternative corticosteroid. Monitor patients receiving this combination closely for evidence of diminished response to the antiviral regimen. Consider therapy modification

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

CycloSPORINE (Systemic): Dexamethasone (Systemic) may decrease the serum concentration of CycloSPORINE (Systemic). Dexamethasone (Systemic) may increase the serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Dexamethasone (Systemic). Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Dexamethasone (Systemic). Management: Consider dexamethasone dose increases in patients receiving strong CYP3A4 inducers and monitor closely for reduced steroid efficacy. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Daclatasvir: Dexamethasone (Systemic) may decrease the serum concentration of Daclatasvir. Management: US labeling recommends increasing the daclatasvir dose to 90 mg once daily if used with dexamethasone. Canadian labeling states that the combination of daclatasvir and dexamethasone is contraindicated. Consider therapy modification

Dasatinib: Dexamethasone (Systemic) may decrease the serum concentration of Dasatinib. Management: Avoid when possible. If such a combination cannot be avoided, consider increasing dasatinib dose and monitoring clinical response and toxicity closely. Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Desirudin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Consider therapy modification

Desmopressin: Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin. Avoid combination

DilTIAZem: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Elvitegravir: Dexamethasone (Systemic) may decrease the serum concentration of Elvitegravir. Management: Consider using an alternative corticosteroid. Monitor patients receiving these agents in combination for diminished antiviral response. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Fosamprenavir: Dexamethasone (Systemic) may decrease the serum concentration of Fosamprenavir. Fosamprenavir may increase the serum concentration of Dexamethasone (Systemic). Monitor therapy

Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Consider therapy modification

Fosphenytoin: May decrease the serum concentration of Dexamethasone (Systemic). Dexamethasone (Systemic) may decrease the serum concentration of Fosphenytoin. Dexamethasone (Systemic) may increase the serum concentration of Fosphenytoin. Management: Consider dexamethasone dose increases when combined with fosphenytoin and monitor closely for reduced steroid efficacy. Monitor phenytoin levels closely, both increased and decreased phenytoin levels have been reported. Consider therapy modification

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

HYDROcodone: CYP3A4 Inducers (Weak) may decrease the serum concentration of HYDROcodone. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Imatinib: Dexamethasone (Systemic) may decrease the serum concentration of Imatinib. Management: Avoid concurrent use of imatinib with dexamethasone when possible. If such a combination must be used, increase imatinib dose by at least 50% and monitor clinical response closely. Consider therapy modification

Indacaterol: May enhance the hypokalemic effect of Corticosteroids (Systemic). Monitor therapy

Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination

Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Monitor therapy

Ixabepilone: Dexamethasone (Systemic) may decrease the serum concentration of Ixabepilone. Management: Avoid this combination whenever possible. If this combination must be used, a gradual increase in ixabepilone dose from 40 mg/m2 to 60 mg/m2 (given as a 4-hour infusion), as tolerated, should be considered. Consider therapy modification

Lapatinib: Dexamethasone (Systemic) may decrease the serum concentration of Lapatinib. Management: If therapy overlap cannot be avoided, consider titrating lapatinib gradually from 1,250 mg/day up to 4,500 mg/day (HER2 positive metastatic breast cancer) or 1,500 mg/day up to 5,500 mg/day (hormone receptor/HER2 positive breast cancer) as tolerated. Avoid combination

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Lenalidomide: Dexamethasone (Systemic) may enhance the thrombogenic effect of Lenalidomide. Consider therapy modification

Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Mifamurtide: Corticosteroids (Systemic) may diminish the therapeutic effect of Mifamurtide. Avoid combination

MiFEPRIStone: May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (e.g., for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Avoid combination

Mitotane: May decrease the serum concentration of Corticosteroids (Systemic). Consider therapy modification

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Nalmefene: Dexamethasone (Systemic) may decrease the serum concentration of Nalmefene. Monitor therapy

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Netupitant: May increase the serum concentration of Dexamethasone (Systemic). Management: Decrease dexamethasone doses to 12 mg on day 1, and if needed based on the emetic potential of the regimen, 8 mg daily on days 2 to 4 of chemotherapy when administered with netupitant. Consider therapy modification

Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Consider therapy modification

Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Monitor therapy

Nilotinib: Dexamethasone (Systemic) may decrease the serum concentration of Nilotinib. Avoid combination

NiMODipine: CYP3A4 Inducers (Weak) may decrease the serum concentration of NiMODipine. Monitor therapy

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Monitor therapy

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

Phenytoin: May decrease the serum concentration of Dexamethasone (Systemic). Dexamethasone (Systemic) may decrease the serum concentration of Phenytoin. Dexamethasone (Systemic) may increase the serum concentration of Phenytoin. Management: Consider dexamethasone dose increases when combined with phenytoin and monitor closely for reduced steroid efficacy. Monitor phenytoin levels closely when combined with dexamethasone, both increased and decreased phenytoin levels have been reported. Consider therapy modification

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Consider therapy modification

Quinolones: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Rilpivirine: Dexamethasone (Systemic) may decrease the serum concentration of Rilpivirine. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

RomiDEPsin: Dexamethasone (Systemic) may decrease the serum concentration of RomiDEPsin. Avoid combination

Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Monitor therapy

Sargramostim: Corticosteroids (Systemic) may enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Simeprevir: Dexamethasone (Systemic) may decrease the serum concentration of Simeprevir. Avoid combination

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

SUNItinib: Dexamethasone (Systemic) may decrease the serum concentration of SUNItinib. Consider therapy modification

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Telaprevir: Corticosteroids (Systemic) may decrease the serum concentration of Telaprevir. Telaprevir may increase the serum concentration of Corticosteroids (Systemic). Management: Concurrent use of telaprevir and systemic corticosteroids is not recommended. When possible, consider alternatives. If used together, employ extra caution and monitor closely for excessive corticosteroid effects and diminished telaprevir effects. Consider therapy modification

Temsirolimus: Dexamethasone (Systemic) may decrease serum concentrations of the active metabolite(s) of Temsirolimus. Monitor therapy

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Thalidomide: Dexamethasone (Systemic) may enhance the dermatologic adverse effect of Thalidomide. Dexamethasone (Systemic) may enhance the thrombogenic effect of Thalidomide. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tisagenlecleucel: Corticosteroids (Systemic) may diminish the therapeutic effect of Tisagenlecleucel. Management: Avoid use of corticosteroids as premedication or at any time during treatment with tisagenlecleucel, except in the case of life-threatening emergency (such as resistant cytokine release syndrome). Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Triazolam: Dexamethasone (Systemic) may decrease the serum concentration of Triazolam. Monitor therapy

Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification

VinCRIStine (Liposomal): Dexamethasone (Systemic) may decrease the serum concentration of VinCRIStine (Liposomal). Avoid combination

Voriconazole: Dexamethasone (Systemic) may decrease the serum concentration of Voriconazole. Monitor therapy

Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin. Monitor therapy

Test Interactions

May suppress the wheal and flare reactions to skin test antigens

Adverse Reactions

Some reactions listed are based on reports for other agents in this same pharmacologic class and may not be specifically reported for dexamethasone.

Frequency not defined:

Cardiovascular: Bradycardia, cardiac arrhythmia, cardiac failure, cardiomegaly, circulatory shock, edema, embolism (fat), hypertension, hypertrophic cardiomyopathy (premature infants), myocardial rupture (post-MI), syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis

Central nervous system: Depression, emotional lability, euphoria, headache, increased intracranial pressure, insomnia, malaise, myasthenia, neuritis, neuropathy, paresthesia, personality changes, pseudotumor cerebri (usually following discontinuation), psychic disorder, seizure, vertigo

Dermatologic: Acne vulgaris, allergic dermatitis, alopecia, atrophic striae, diaphoresis, ecchymoses, erythema, facial erythema, fragile skin, hyperpigmentation, hypertrichosis, hypopigmentation, perianal skin irritation (itching, burning, tingling; following IV injection), petechiae, skin atrophy, skin rash, subcutaneous atrophy, suppression of skin test reaction, urticaria, xeroderma

Endocrine & metabolic: Adrenal suppression, carbohydrate intolerance, Cushing syndrome, decreased glucose tolerance, decreased serum potassium, diabetes mellitus, fluid retention, glycosuria, growth suppression (children), hirsutism, HPA-axis suppression, hyperglycemia, hypokalemic alkalosis, menstrual disease, moon face, negative nitrogen balance, protein catabolism, redistribution of body fat, sodium retention, weight gain

Gastrointestinal: Abdominal distention, gastrointestinal hemorrhage, gastrointestinal perforation, hiccups, increased appetite, nausea, pancreatitis, peptic ulcer, pruritus ani (following IV injection), ulcerative esophagitis

Genitourinary: Defective (increased or decreased) spermatogenesis

Hematologic & oncologic: Kaposi sarcoma, petechial, tumor lysis syndrome

Hepatic: Hepatomegaly, increased serum transaminases

Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioedema, hypersensitivity

Infection: Infection, sterile abscess

Local: Postinjection flare (intra-articular use)

Neuromuscular & skeletal: Amyotrophy, aseptic necrosis of bones (femoral and humoral heads), bone fractures, Charcot-like arthropathy, myasthenia, myopathy (particularly in conjunction with neuromuscular disease or neuromuscular-blocking agents), osteoporosis, rupture of tendon, steroid myopathy, vertebral compression fracture

Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, subcapsular posterior cataract

Respiratory: Pulmonary edema

Miscellaneous: Wound healing impairment

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.

• Anaphylactoid reactions: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, cause activation of latent infections, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria, fungal infections, or viral hepatitis. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Myopathy: Acute myopathy has been reported with high dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatine kinase; recovery may be delayed.

• Perineal irritation: Perineal burning, tingling, pain and pruritus have been reported with IV administration. May occur more commonly in females, with higher doses, and with rapid administration. Symptom onset is sudden and usually resolves in <1 minute (Allan 1986; Neff 2002; Perron 2003; Singh 2011).

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, personality changes, severe depression to psychotic manifestations. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

Disease-related concerns:

• Adrenal insufficiency: Dexamethasone does not provide any mineralocorticoid activity in adrenal insufficiency (may be employed as a single dose while cortisol assays are performed). In the management/prevention of adrenal crisis in patients with known primary adrenal insufficiency, the Endocrine Society practice guidelines state dexamethasone (intravenous) is the least preferred alternative agent and should be used only if no other glucocorticoid is available. For the treatment of chronic primary adrenal insufficiency (ie, physiologic replacement), dexamethasone (oral) is not recommended due to the risk of Cushingoid side effects (ES [Bornstein 2016]).

• Cardiovascular disease: Use with caution in patients with HF and/or hypertension; use has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

• Diabetes: Use corticosteroids with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, ulcerative colitis, abscess or other pyogenic infection) due to perforation risk.

• Head injury: Increased mortality was observed in patients receiving high-dose IV methylprednisolone. High-dose corticosteroids should not be used for the management of head injury (BTF [Carney 2016]).

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Use with caution in patients with a history of ocular herpes simplex; corneal perforation has occurred; do not use in active ocular herpes simplex. Not recommended for the treatment of optic neuritis; may increase frequency of new episodes. Consider routine eye exams in chronic users.

• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.

• Seizure disorders: Use corticosteroids with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution in the elderly with the smallest possible effective dose for the shortest duration.

• Pediatric: May affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP ["Inactive" 1997]; Zar 2007).

• Sulfite: Some products may contain sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylaxis and life-threatening or less severe asthmatic episodes in susceptible patients.

Other warnings/precautions:

• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.

• Epidural injection: Corticosteroids are not approved for epidural injection. Serious neurologic events (eg, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke), some resulting in death, have been reported with epidural injection of corticosteroids, with and without use of fluoroscopy.

• Intra-articular injection: May produce systemic as well as local effects. Appropriate examination of any joint fluid present is necessary to exclude a septic process. Avoid injection into an infected site. Do not inject into unstable joints. Patients should not overuse 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.

• Stress: Patients may require higher doses when subject to stress (ie, trauma, surgery, severe infection).

Monitoring Parameters

Hemoglobin, occult blood loss, blood pressure, serum potassium, glucose, bone mineral density; IOP with systemic use >6 weeks; weight and height in children; HPA axis suppression

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed with corticosteroids in animal reproduction studies. Dexamethasone crosses the placenta (Brownfoot 2013); and is partially metabolized by placental enzymes to an inactive metabolite (Murphy 2007). Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie 2000; Pradat 2003). Systemic corticosteroids may have an effect on fetal growth (decreased birth weight); however, information is conflicting (Lunghi 2010). Hypoadrenalism may occur in newborns following maternal use of corticosteroids during pregnancy; monitor.

Because antenatal corticosteroid administration may reduce the incidence of intraventricular hemorrhage, necrotizing enterocolitis, neonatal mortality, and respiratory distress syndrome, the injection is often used for antenatal fetal lung maturation in patients with preterm premature rupture of membranes or preterm labor who are at risk of preterm delivery (most data is available for betamethasone). A single course of corticosteroids is recommended for women between 24 and 34 weeks gestation who are at risk of delivering within 7 days, including those with ruptured membranes or multiple gestations. A single course of corticosteroids may be considered for women beginning at 23 weeks gestation, who are at risk of delivering within 7 days, in consultation with the family. In addition, a single course of corticosteroids may be given to women between 34 0/7 weeks and 36 6/7 weeks who are at risk of preterm delivery within 7 days and who have not previously received corticosteroids; use of concomitant tocolytics is not currently recommended and administration of late preterm corticosteroids has not been evaluated in women with intrauterine infection, multiple gestations, pregestational diabetes, or women who delivered previously by cesarean section at term. Multiple repeat courses are not recommended. However, in women with pregnancies less than 34 weeks gestation at risk for delivery within 7 days and who had a course of antenatal corticosteroids >14 days prior, a single repeat course may be considered; use of a repeat course in women with premature rupture of membranes is controversial (ACOG 171 2016; ACOG 172 2016; ACOG 677 2016).

When systemic corticosteroids are needed in pregnancy, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Leachman 2006; Lunghi 2010; Makol 2011; Østensen 2009). Dexamethasone should not be used to treat primary adrenal insufficiency in pregnant women (Bornstein 2016).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, insomnia, or agitation. Have patient report immediately to prescriber signs of infection; signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit); signs of skin changes (acne, stretch marks, slow healing, or hair growth); signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat); signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting); signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss); signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities); severe fatigue; severe loss of strength and energy; irritability; tremors; tachycardia; confusion; sweating a lot; dizziness; shortness of breath; excessive weight gain; swelling of arms or legs; moon face; buffalo hump; severe headache; passing out; bradycardia; abnormal heartbeat; angina; menstrual changes; bone pain; joint pain; vision changes; behavioral changes; depression; seizures; burning or numbness feeling; bruising; bleeding; severe abdominal pain; black, tarry, or bloody stools; vomiting blood; or injection site irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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