Yes

Corticosteroid, Oral; Corticosteroid, Oral Inhaler; Corticosteroid, Nasal; Corticosteroid, Ophthalmic; Corticosteroid, Parenteral; Corticosteroid, Topical

Dental: Treatment of a variety of oral diseases of allergic, inflammatory or autoimmune origin

Medical: Systemically and locally for chronic swelling, allergic, hematologic, neoplastic, and autoimmune diseases; may be used in management of cerebral edema, septic shock, as a diagnostic agent, antiemetic

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Dexamethasone has been used in patients with premature labor (26-34 weeks gestation) to stimulate fetal lung maturation

Breast-feeding/lactation: No data on crossing into breast milk or effects on the infant

Active untreated infections; use in ophthalmic viral, fungal, or tuberculosis diseases of the eye

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; use with caution in patients with hypothyroidism, cirrhosis, hypertension, congestive heart failure, ulcerative colitis, thromboembolic disorders. Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in the elderly in the smallest possible dose and for the shortest possible time.

In studies involving inhaled corticosteroids, the average reduction in growth velocity was approximately 1 cm (about 1/3 of an inch) per year. It appears that the reduction is related to dose and how long the child takes the drug.

FDA's Pulmonary and Allergy Drugs and Metabolic and Endocrine Drugs advisory committees discussed this issue at a July 1998 meeting. They recommended that the agency develop class-wide labeling to inform health care providers so they would understand this potential side effect and monitor growth routinely in pediatric patients who are treated with inhaled corticosteroids, intranasal corticosteroids or both.

Long-term effects of this reduction in growth velocity on final adult height are unknown. Likewise, it also has not yet been determined whether patients' growth will "catch up" if treatment in discontinued. Drug manufacturers will continue to monitor these drugs to learn more about long-term effects. Children are prescribed inhaled corticosteroids to treat asthma. Intranasal corticosteroids are generally used to prevent and treat allergy-related nasal symptoms.

Patients are advised not to stop using their inhaled or intranasal corticosteroids without first speaking to their health care providers about the benefits of these drugs compared to their risks.

Systemic:

>10%:

Central nervous system: Insomnia, nervousness

Gastrointestinal: Increased appetite, indigestion

1% to 10%:

Dermatologic: Hirsutism

Endocrine & metabolic: Diabetes mellitus

Neuromuscular & skeletal: Arthralgia

Ocular: Cataracts

Respiratory: Epistaxis

<1%: Seizures, mood swings, headache, delirium, hallucinations, euphoria, skin atrophy, bruising, hyperpigmentation, acne, amenorrhea, sodium and water retention, Cushing's syndrome, hyperglycemia, bone growth suppression, abdominal distention, ulcerative esophagitis, pancreatitis, muscle wasting, hypersensitivity reactions

Topical: <1%: Itching, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, skin atrophy, striae; miliaria, local burning, irritation; secondary infection

Symptoms of overdose include moon face, central obesity, hypertension, psychosis, hallucinations, diabetes, hyperlipidemia, peptic ulcer, increased susceptibility to infection, electrolyte and fluid imbalance. When consumed in excessive quantities, systemic hypercorticism and adrenal suppression may occur; in those cases, discontinuation and withdrawal of the corticosteroid should be done judiciously.

CYP3A3/4 enzyme substrate; CYP3A3/4 enzyme inducer; CYP3A3/4 enzyme inhibitor

Dexamethasone 4 mg/mL injection solution is clear and colorless and dexamethasone 24 mg/mL injection solution is clear and colorless to light yellow. Injection solution should be protected from light and freezing.

Stability of injection of parenteral admixture at room temperature (25°C): 24 hours

Stability of injection of parenteral admixture at refrigeration temperature (4°C): 2 days; protect from light and freezing

Standard diluent: 4 mg/50 mL D₅W; 10 mg/50 mL D₅W

Minimum volume: 50 mL D₅W

Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; suppresses normal immune response

Duration of metabolic effect: Can last for 72 hours; acetate is a long-acting repository preparation with a prompt onset of action

Metabolism: In the liver

Half-life: Normal renal function: 1.8-3.5 hours; Biological half-life: 36-54 hours

Time to peak serum concentration: Oral: Within 1-2 hours; I.M.: Within 8 hours

Elimination: In the urine and bile

Neonates:

Airway edema or extubation: I.V.: Usual: 0.25 mg/kg/dose given 4 hours prior to scheduled extubation and then every 8 hours for 3 doses total; range: 0.25-1 mg/kg/dose for 1-3 doses; maximum dose: 1 mg/kg/day. Note: A longer duration of therapy may be needed with more severe cases.

Bronchopulmonary dysplasia (to facilitate ventilator weaning): Oral:, I.V.: Numerous dosing schedules have been proposed; range: 0.5-0.6 mg/kg/day given in divided doses every 12 hours for 3-7 days, then taper over 1-6 weeks

Children:

Antiemetic (prior to chemotherapy): I.V. (should be given as sodium phosphate): 10 mg/m²/dose (maximum: 20 mg) for first dose then 5 mg/m²/dose every 6 hours as needed

Anti-inflammatory immunosuppressant: Oral, I.M., I.V. (injections should be given as sodium phosphate): 0.08-0.3 mg/kg/day or 2.5-10 mg/m²/day in divided doses every 6-12 hours

Extubation or airway edema: Oral, I.M., I.V. (injections should be given as sodium phosphate): 0.5-2 mg/kg/day in divided doses every 6 hours beginning 24 hours prior to extubation and continuing for 4-6 doses afterwards

Cerebral edema: I.V. (should be given as sodium phosphate): Loading dose: 1-2 mg/kg/dose as a single dose; maintenance: 1-1.5 mg/kg/day (maximum: 16 mg/day) in divided doses every 4-6 hours for 5 days then taper for 5 days, then discontinue

Bacterial meningitis in infants and children >2 months: I.V. (should be given as sodium phosphate): 0.6 mg/kg/day in 4 divided doses every 6 hours for the first 4 days of antibiotic treatment; start dexamethasone at the time of the first dose of antibiotic

Physiologic replacement: Oral, I.M., I.V.: 0.03-0.15 mg/kg/day or 0.6-0.75 mg/m²/day in divided doses every 6-12 hours

Adults:

Acute nonlymphoblastic leukemia (ANLL) protocol: I.V.: 2 mg/m²/dose every 8 hours for 12 doses

Antiemetic (prior to chemotherapy): Oral/I.V. (should be given as sodium phosphate): 10 mg/m²/dose (usually 20 mg) for first dose then 5 mg/m²/dose every 6 hours as needed

Anti-inflammatory:

Oral, I.M., I.V. (injections should be given as sodium phosphate): 0.75-9 mg/day in divided doses every 6-12 hours

I.M. (as acetate): 8-16 mg; may repeat in 1-3 weeks

Intralesional (as acetate): 0.8-1.6 mg

Intra-articular/soft tissue (as acetate): 4-16 mg; may repeat in 1-3 weeks

Intra-articular, intralesional, or soft tissue (as sodium phosphate): 0.4-6 mg/day

Cerebral edema: I.V. 10 mg stat, 4 mg I.M./I.V. (should be given as sodium phosphate) every 6 hours until response is maximized, then switch to oral regimen, then taper off if appropriate; dosage may be reduced after 24 days and gradually discontinued over 5-7 days

Diagnosis for Cushing's syndrome: Oral: 1 mg at 11 PM, draw blood at 8 AM the following day for plasma cortisol determination

Physiological replacement: Oral, I.M., I.V. (should be given as sodium phosphate): 0.03-0.15 mg/kg/day OR 0.6-0.75 mg/m²/day in divided doses every 6-12 hours

Shock therapy:

Addisonian crisis/shock (ie, adrenal insufficiency/responsive to steroid therapy): I.V. (given as sodium phosphate): 4-10 mg as a single dose, which may be repeated if necessary

Unresponsive shock (ie, unresponsive to steroid therapy): I.V. (given as sodium phosphate): 1-6 mg/kg as a single I.V. dose or up to 40 mg initially followed by repeat doses every 2-6 hours while shock persists

Hemodialysis: Supplemental dose is not necessary

Peritoneal dialysis: Supplemental dose is not necessary

Ophthalmic:

Ointment: Apply thin coating into conjunctival sac 3-4 times/day; gradually taper dose to discontinue

Suspension: Instill 2 drops into conjunctival sac every hour during the day and every other hour during the night; gradually reduce dose to every 3-4 hours, then to 3-4 times/day

Topical: Apply 1-4 times/day. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

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

Hemoglobin, occult blood loss, serum potassium, and glucose

Dexamethasone suppression test, overnight: 8 AM cortisol <6 mg/100 mL (dexamethasone 1 mg); plasma cortisol determination should be made on the day after giving dose

Insomnia and nervousness are common; may cause euphoria, confusion, or hallucinations

Barbiturates and carbamazepine may decrease dexamethasone effects

No information available to require special precautions

No effects or complications reported

Take exactly as directed; do not increase dose or discontinue abruptly without consulting prescriber. Take oral medication with or after meals. Limit intake of caffeine or stimulants. Prescriber may recommend increased dietary vitamins, minerals, or iron. Diabetics should monitor glucose levels closely (antidiabetic medication may need to be adjusted). Inform prescriber if you are experiencing greater than normal levels of stress (medication may need adjustment). Some forms of this medication may cause GI upset (oral medication may be taken with meals to reduce GI upset; small frequent meals and frequent mouth care may reduce GI upset). You may be more susceptible to infection (avoid crowds and persons with contagious or infective conditions). Report promptly excessive nervousness or sleep disturbances; any signs of infection (sore throat, unhealed injuries); excessive growth of body hair or loss of skin color; changes in vision; excessive or sudden weight gain (>3 lb/week); swelling of face or extremities; difficulty breathing; muscle weakness; change in color of stools (tarry) or persistent abdominal pain; or worsening of condition or failure to improve. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Topical: For external use only. Not for eyes or mucous membranes or open wounds. Apply in very thin layer to occlusive dressing. Apply dressing to area being treated. Avoid prolonged or excessive use around sensitive tissues, genital, or rectal areas. Inform prescriber if condition worsens (swelling, redness, irritation, pain, open sores) or fails to improve.

Aerosol: Not for use during acute asthmatic attack. Follow directions that accompany product. Rinse mouth and throat after use to prevent candidiasis. Do not use intranasal product if you have a nasal infection, nasal injury, or recent nasal surgery. If using two products, consult prescriber in which order to use the two products. Inform prescriber if condition worsens or does not improve.

Topical formation is for external use, do not use on open wounds; apply sparingly to occlusive dressings; should not be used in the presence of open or weeping lesions; acetate injection is not for I.V. use

Aerosol:

Oral, as sodium phosphate: 84 mcg dexamethasone per activation (12.6 g)

Nasal, as sodium phosphate: 84 mcg dexamethasone/spray (12.6 g)

Topical: 0.01% (58 g); 0.04% (25 g)

Cream, as sodium phosphate: 0.1% (15 g, 30 g)

Elixir: 0.5 mg/5 mL (5 mL, 20 mL, 100 mL, 120 mL, 237 mL, 240 mL, 500 mL)

Injection, as acetate suspension: 8 mg/mL (1 mL, 5 mL); 16 mg/mL (1 mL, 5 mL)

Injection, as sodium phosphate: 4 mg/mL (1 mL, 5 mL, 10 mL, 25 mL, 30 mL); 10 mg/mL (1 mL, 10 mL); 20 mg/mL (5 mL); 24 mg/mL (5 mL, 10 mL)

Ointment, ophthalmic, as sodium phosphate: 0.05% (3.5 g)

Solution, oral:

Concentrate: 0.5 mg/0.5 mL (30 mL) (30% alcohol)

Oral: 0.5 mg/5 mL (5 mL, 20 mL, 500 mL)

Suspension, ophthalmic, as sodium phosphate: 0.1% with methylcellulose 0.5% (5 mL, 15 mL)

Tablet: 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg, 6 mg

Tablet, therapeutic pack: 6 x 1.5 mg; 8 x 0.75 mg

American Academy of Pediatrics Committee on Infectious Diseases, "Dexamethasone Therapy for Bacterial Meningitis in Infants and Children," Pediatrics, 1990, 86(1):130-3.

Bahal N and Nahata MC, "The Role of Corticosteroids in Infants and Children With Bacterial Meningitis," DICP, 1991, 25(5):542-5.

Brophy TR, McCafferty J, Tyrer JH, et al, "Bioavailability of Oral Dexamethasone During High Dose Steroid Therapy in Neurological Patients," Eur J Clin Pharmacol, 1983, 24(1):103-8.

Couser RJ, Ferrara TB, Falde B, et al, "Effectiveness of Dexamethasone in Preventing Extubation Failure in Preterm Infants at Increased Risk for Airway Edema," J Pediatr, 1992, 121(4):591-6.

"Dexamethasone, Granisetron, or Both for the Prevention of Nausea and Vomiting During Chemotherapy for Cancer. The Italian Group for Antiemetic Research," N Engl J Med, 1995, 332(1):1-5.

Duggan DE, Matalia N, Ditzler, CA, et al, "Bioavailability of Oral Dexamethasone," Clin Pharmacol Ther, 1975, 18(2):205-9.

Durand M, Sardesai S, and McEvoy C, "Effects of Early Dexamethasone Therapy on Pulmonary Mechanics and Chronic Lung Disease in Very Low Birth Weight Infants: A Randomized, Controlled Trial," Pediatrics, 1995, 95(4):584-90.

Kris MG, Baltzer L, Pisters KM, et al, "Enhancing the Effectiveness of the Specific Serotonin Antagonists. Combination Antiemetic Therapy With Dexamethasone," Cancer, 1993, 72(11 Suppl):3436-42.

Latreille J, Stewart D, Laberge F, et al, "Dexamethasone Improves the Efficacy of Granisetron in the First 24 h Following High-Dose Cisplatin Chemotherapy," Support Care Cancer, 1995, 3(5):307-12.

McDonnell M and Evans N, "Upper and Lower Gastrointestinal Complications With Dexamethasone Despite H2 Antagonists," J Paediatr Child Health, 1995, 31(2):152-4.

Ng PC, "The Effectiveness and Side Effects of Dexamethasone in Preterm Infants With Bronchopulmonary Dysplasia," Arch Dis Child, 1993, 68(3 Spec No):330-6.

Peterson C, Hursti TJ, Borjeson S, et al, "Single High-Dose Dexamethasone Improves the Effect of Ondansetron on Acute Chemotherapy-Induced Nausea and Vomiting But Impairs the Control of Delayed Symptoms," Support Care Cancer, 1996, 4(6):440-6.

Randin D, Vollenweider P, Tappy L, et al, "Suppression of Alcohol-Induced Hypertension by Dexamethasone," N Engl J Med, 1995, 332(26):1733-7.

Ruvinsky ED, Douvas SG, Roberts WE, et al, "Maternal Administration of Dexamethasone in Severe Pregnancy-Induced Hypertension," Am J Obstet Gynecol, 1984, 149(7):722-6.

Wald ER, Kaplan SL, and Mason, EO Jr, "Dexamethasone Therapy for Children With Bacterial Meningitis," Pediatrics, 1995, 95(1):21-8.