Demax

A. Approved Indications

• Inflammatory and Allergic Conditions:
• Severe allergic reactions (anaphylaxis, angioedema)
• Asthma exacerbations, COPD exacerbations
• Rheumatic disorders (e.g., rheumatoid arthritis, lupus)
• Dermatologic diseases (e.g., severe psoriasis, dermatitis)
• Inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)
• Multiple sclerosis exacerbations
• Adrenal insufficiency (as replacement therapy)
• Certain cancers: leukemia, lymphoma, multiple myeloma (as adjunctive therapy)
• Cerebral edema associated with tumors or trauma
• Nausea and vomiting associated with chemotherapy

B. Clinically Accepted Off-Label Uses

• COVID-19 severe respiratory illness:
• To reduce inflammation and immune-mediated lung injury
• Prevention of postoperative nausea and vomiting
• Treatment of croup in children
• Prevention and treatment of altitude sickness
• Management of ophthalmic inflammatory disorders

A. Adults

• Anti-inflammatory/Immunosuppressive:
• Typical oral doses range from 0.75 mg to 9 mg daily depending on severity.
• Dose and duration individualized; for severe conditions, initial high doses with gradual taper.
• Adrenal Insufficiency:
• 0.75–1.5 mg daily orally or by injection in divided doses.
• Cerebral Edema:
• 10 mg IV initially, then 4 mg every 6 hours.
• Chemotherapy-induced nausea:
• 8–20 mg IV prior to chemotherapy.
• COVID-19:
• 6 mg once daily orally or IV for up to 10 days.

B. Pediatrics

• Dosing varies widely by indication, typically 0.02 to 0.3 mg/kg/day.
• Close monitoring essential due to growth and development concerns.

C. Elderly

• Start at lower end of dosing range; monitor for side effects.

D. Renal/Hepatic Impairment

• No specific dose adjustments recommended; monitor clinical response.

E. Administration

• Oral, IV, IM, intra-articular, ophthalmic, topical, and inhalation routes depending on indication.

Dexamethasone is a potent synthetic glucocorticoid receptor agonist. It binds intracellular glucocorticoid receptors, modulating gene transcription to upregulate anti-inflammatory proteins and downregulate pro-inflammatory cytokines. This leads to suppression of immune cell activation, reduced migration of leukocytes, inhibition of phospholipase A2, decreased synthesis of prostaglandins and leukotrienes, and diminished capillary permeability. The net effect is a profound reduction in inflammation and immune response.

• Absorption:
• Well absorbed orally; peak plasma concentrations in 1–2 hours.
• Distribution:
• Widely distributed, including CNS penetration.
• Plasma protein binding ~77%.
• Metabolism:
• Hepatic metabolism primarily via CYP3A4 to inactive metabolites.
• Elimination:
• Half-life: 3–4.5 hours
• Excreted in urine mainly as metabolites.

• Pregnancy:
• Category C (FDA). Animal studies show risk; use only if benefits justify potential risk.
• Risk of cleft palate and intrauterine growth retardation reported in animals.
• Lactation:
• Excreted in breast milk in small amounts.
• Caution advised; monitor infant for adrenal suppression or growth issues.

• Primary Class: Corticosteroid
• Subclass: Glucocorticoid

• Known hypersensitivity to dexamethasone or corticosteroids
• Systemic fungal infections
• Administration of live or attenuated vaccines during systemic therapy
• Untreated systemic infections (except tuberculous meningitis treated concurrently)

• Risk of adrenal suppression with prolonged use; taper gradually to avoid withdrawal
• Increased susceptibility to infections; use caution with immunosuppressed patients
• Hyperglycemia and worsening diabetes mellitus
• Osteoporosis and increased fracture risk with long-term use
• Psychiatric effects including mood swings, psychosis, depression
• Fluid retention and hypertension
• Gastrointestinal perforation and ulceration risk, especially with NSAIDs
• Monitor for signs of Cushing’s syndrome
• Use cautiously in patients with hypertension, heart failure, or renal impairment

Common:

• Weight gain, fluid retention
• Insomnia, mood changes
• Increased appetite
• Hyperglycemia
• Hypertension
• Acne, skin thinning
• Muscle weakness

Serious:

• Peptic ulcer, GI bleeding
• Osteonecrosis of the femoral head
• Severe infections
• Psychiatric disturbances (mania, depression, psychosis)
• Glaucoma, cataracts with prolonged use

• CYP3A4 inducers (e.g., rifampin, phenytoin): May decrease dexamethasone levels
• CYP3A4 inhibitors (e.g., ketoconazole): May increase levels and toxicity
• NSAIDs: Increased risk of GI ulceration and bleeding
• Diuretics: Enhanced risk of hypokalemia
• Vaccines: Reduced efficacy; avoid live vaccines
• Antidiabetic drugs: May require dose adjustment due to hyperglycemia

• Widely used as standard of care for severe COVID-19 respiratory illness to reduce mortality.
• Updated corticosteroid tapering guidelines emphasize individualized taper schedules based on duration of therapy and patient risk factors.
• EMA and FDA have reinforced warnings on psychiatric side effects and infection risk.

• Store oral tablets and injectables at 20°C to 25°C (68°F to 77°F)
• Protect from moisture and light
• Keep vial/injection bottles sealed until use
• No refrigeration required
• Keep out of reach of children