Dexamethasone


Generic Medicine Info
Indications and Dosage
Intra-articular
Inflammatory joint diseases
Adult: As dexamethasone phosphate: 0.8-4 mg (equivalent to 0.3-3.3 mg dexamethasone base) as a single dose, depending on the degree of inflammation and size and location of the joint. Dose may be repeated at intervals of 3-21 days according to patient’s response.

Intramuscular, Intravenous
Cerebral oedema caused by malignancy
Adult: As dexamethasone phosphate: Initially, 10 mg via IV inj, followed by 4 mg via IM inj 6 hourly, until oedema subsides. Dose may be reduced after 2-4 days and gradually stopped over 5-7 days. Maintenance: 2 mg via IV or IM inj 2-3 times daily in patients with recurrent or inoperable malignancies.

Intramuscular, Intravenous
Anti-inflammatory or immunosuppressive
Adult: As dexamethasone base: Initially, 0.4-20 mg (equivalent to 0.5-24 mg as dexamethasone phosphate) daily given via slow IV inj or deep IM inj. Dosage is individualised according to the condition being treated and patient's response (refer to specific product guidelines).

Intravenous
Shock
Adult: In cases of haemorrhagic, traumatic, or surgical origin: As dexamethasone phosphate: 2-6 mg/kg as a single dose via slow IV inj; dose may be repeated in 2-6 hours if shock persists. Alternatively, initial dose may be followed by continuous infusion of 3 mg/kg per 24 hours.

Intravenous
Cerebral oedema
Adult: In acute life-threatening cases: As dexamethasone phosphate: Initially, 50 mg via IV inj, followed by 8 mg 2 hourly on Days 1-3. Then, reduce dose to 4 mg 2 hourly on Day 4, followed by 4 mg 4 hourly on Days 5-8. Thereafter, reduce dose to 4 mg daily.

Intravenous
Coronavirus disease 2019 (COVID-19)
Adult: In hospitalised patients requiring supplemental oxygen or mechanical ventilation: 6 mg once daily for up to 10 days until discharge if sooner.

Intravitreal
Diabetic macular oedema, Macular oedema secondary to retinal vein occlusion, Non-infectious uveitis of posterior segment of eye
Adult: As intravitreal implant containing 700 mcg injected into the affected eye.

Ophthalmic
Inflammatory eye disorders
Adult: As 1.5 mg/mL solution: Instil 1 drop into the conjunctival sac 3-4 times daily. As 0.1% solution or susp: Instil 1-2 drops into the affected eye(s) 4-6 times daily . Severe cases: 1-2 drops hourly, then gradually reduce to 1 drop 2-4 hourly to achieve favourable response. As 0.1% ointment: Apply a ribbon of ointment into the conjunctival sac(s) up to 4 times daily; may gradually reduce dose to once a day if favourable response is achieved. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).

Ophthalmic
Ocular itching associated with allergic conjunctivitis, Postoperative ocular inflammation
Adult: As ophthalmic insert delivering 0.4 mg dose for up to 30 days: 1 ophthalmic insert is placed into the lower lacrimal canaliculus by an eye care professional.

Oral
Anti-inflammatory or immunosuppressive
Adult: Usual dose: 0.5-10 mg daily; doses above 10 mg daily may be needed for more severe disease conditions. Dosage is individualised depending on the disease being treated and patient's response (refer to detailed product guideline).
Child: Usual initial dose: 0.02-0.3 mg/kg daily or 0.6-9 mg/m2 daily in divided doses 6-12 hourly. Dosage is individualised depending on the disease being treated and patient's response (refer to detailed product guideline).

Oral
Screening test for Cushing's syndrome
Adult: 1 mg at 11 pm, followed by a blood test for plasma cortisol at 8 am the following morning. Alternatively, 0.5 mg 6 hourly for 48 hours, then measure plasma cortisol at 8 am on the 3rd morning (with 24-hour urine collections for determination of 17-hydroxycoticosteroid excretion).

Oral
Coronavirus disease 2019 (COVID-19)
Adult: In hospitalised patients requiring supplemental oxygen or mechanical ventilation: 6 mg once daily for up to 10 days or until discharge if sooner.
Child: >12 years Same as adult dose.

Otic/Aural
Otic inflammation
Adult: As 0.1% solution: Instil 3-4 drops into the cleaned aural canal bid or tid, then reduce dose gradually if favourable response is achieved. Alternatively, pack the aural canal with a gauze wick saturated with the solution for 12-24 hours, may be repeated as necessary. Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).

Parenteral
Soft tissue inflammation
Adult: As dexamethasone phosphate: 2-6 mg (equivalent to 1.7-5 mg dexamethasone base) as a single dose given as local inj into soft tissue, may be repeated at intervals of 3-21 days according to patient’s response.
Administration
Should be taken with food.
Contraindications
Systemic fungal infection; systemic infection unless being treated with specific anti-infectives; stomach or duodenal ulcer. Administration of live vaccines. Epithelial herpes simplex keratitis (dendritic keratitis); active infectious stages of vaccinia, varicella, and many other viral diseases of cornea and conjunctiva; mycobacterial or fungal infection of the eye (ophthalmic). Drum membrane perforation (otic). Glaucoma with cup to disc ratios of >0.8, torn or ruptured posterior lens because of the risk of migration into the anterior chamber (intravitreal implant).
Special Precautions
Patient with myasthenia gravis, ocular herpes simplex, diabetes mellitus, CV disease (e.g. recent MI, heart failure, hypertension), migraine, glaucoma, systemic sclerosis, thyroid disease; high risk of tumour lysis syndrome (e.g. high proliferative rate, high tumour burden, high sensitivity to cytotoxic agents); known or suspected Strongyloides (threadworm) infestation; gastrointestinal diseases (e.g. diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, ulcerative colitis, abscess, other pyogenic infections), suspected or confirmed phaeochromocytoma; history of seizure disorder; chickenpox, measles; subjected to unusual stress (e.g. intercurrent illness, trauma, surgical procedure). Avoid abrupt withdrawal or rapid dose reduction. Renal and hepatic impairment (including cirrhosis). Neonates, children, and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Hypercotisolism or suppression of HPA axis; adrenocortical insufficiency, cushingoid appearance, serious anaphylactic reaction, visual disturbances, corneal perforation, increased IOP, open-angle glaucoma, subcapsular posterior cataract, psychological changes (e.g. euphoria, depression, psychotic reactions, suicidal tendencies), fluid retention, electrolyte disturbances, hypertension, myocardial rupture, reactivation of hepatitis B, gastrointestinal effects (e.g. peptic ulcer, dyspepsia, gastritis, abdominal distention, ulcerative oesophagitis), new-onset hyperglycaemia, exacerbation of diabetes mellitus, osteoporosis, vertebral compression fracture, myopathy, osteonecrosis; infection, including Pneumocystis jirovecii pneumonia (PJP), herpes zoster, tuberculosis, other common bacterial infections (prolonged use); tumour lysis syndrome (particularly in patients with haematological malignancies); acute adrenocortical failure (abrupt discontinuation of long-term therapy); dose-dependent inhibition of growth (infants and children); hypertrophic cardiomyopathy (premature infants); Charcot-like arthropathies (frequent intra-articular inj). Rarely, acute steroid myopathy. Intravitreal: Endophthalmitis, eye inflammation, retinal detachments.
Blood and lymphatic system disorders: Leucocytosis, lymphopenia, eosinopenia, polycythemia, abnormal coagulation.
Cardiac disorders: CHF, cardiac decompensation.
Eye disorders: Eye pruritus, abnormal sensation in the eye (ophthalmic); conjunctival haemorrhage, ocular hypertension (intravitreal), vitreous opacities, photopsia, conjunctival oedema, conjunctival hyperaemia.
Gastrointestinal disorders: Abdominal distention, dyspepsia, acute pancreatitis, flatulence, nausea, vomiting.
Immune system disorders: Hypersensitivity reaction, urticaria, allergic dermatitis.
Investigations: Weight gain, increased capillary fragility.
Metabolism and nutrition disorders: Negative protein and Ca balance, increased appetite, hypokalaemic alkalosis, hypercholesterolaemia, hypertriglyceridaemia.
Reproductive system and breast disorders: Impotence.
Respiratory, thoracic and mediastinal disorders: Hiccups.
Skin and subcutaneous tissue disorders: Hypertrichosis, skin atrophy, telangiectasia, striae, erythema, steroid acne, petechiae, thinning hair, hyperhidrosis, tendency to bruise, perioral dermatitis.
Vascular disorders: Vasculitis, increased atherosclerosis and risk of thrombosis or thromboembolism, ecchymosis.
Potentially Fatal: Phaeochromocytoma crisis.
IM/Intra-articular/Intralesional/Intravitreal/IV/Ophth/Otic/Parenteral/PO: C
Patient Counseling Information
This drug may cause confusional state, hallucinations, dizziness, somnolence, fatigue, syncope, and blurred vision, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor Hb, occult blood loss, blood glucose, creatine kinase (if myopathy occurs), serum K, BMD, blood pressure, IOP (with systemic use >6 weeks), height and weight in children, HPA axis suppression. Perform routine eye exams with chronic use. Intravitreal: Evaluate perfusion of optic nerve head immediately post inj; tonometry within 30 minutes, biomicroscopy between 2-7 days post inj.
Overdosage
Symptoms: Exaggeration of adverse effects including hypertension, oedema, peptic ulceration, altered mental state, and hyperglycaemia. Management: Symptomatic and supportive treatment. Administer epinephrine, aminophylline and provide positive pressure artificial respiration for anaphylactic and hypersensitivity reactions.
Drug Interactions
Increased risk of tendinitis and tendon rupture with fluoroquinolones. Increased incidence and severity of gastric ulcers with NSAIDs. May increase the renal clearance of salicylates. May decrease the therapeutic effect of antidiabetic drugs (e.g. insulin, sulfonylurea, metformin). May increase the hypokalaemic effect of acetazolamide, loop diuretics, thiazide diuretics, kaliuretics, amphotericin B inj (glucomineral)-corticosteroids, tetracosactide, laxatives. Increased risk of hypokalaemia with carbenoxolone. Increased risk of myopathies and cardiomyopathies with chloroquine, hydroxychloroquine, mefloquine. Increased risk of blood disorders with ACE inhibitors. Increased risk of toxic epidermal necrolysis with thalidomide. Concurrent use with cholinesterase inhibitors may cause serious muscle weakness in patients with myasthenia gravis. Increased risk of systemic side-effects with CYP3A inhibitors (including cobicistat-containing drugs). Increased plasma concentrations with CYP3A4 inhibitors (e.g. azole antifungals, HIV protease inhibitors, macrolides). Decreased plasma concentrations with CYP3A4 inducers (e.g. ephedrine, barbiturates, rifabutin, rifampicin, phenytoin, carbamazepine). Concomitant administration with aminoglutethimide can accelerate the reduction of dexamethasone and decrease its efficacy. Decreased absorption with bile acid resins (e.g. cholestyramine). Enhanced effect with estrogens (including oral contraceptives). May decrease plasma concentrations of praziquantel. Increased risk for cerebral seizures with ciclosporin. May either potentiate or weaken the effect of oral anticoagulants. Increased IOP with atropine and other anticholinergics. May reduce the effect of somatropin. Reduced increase in TSH with protirelin. May decrease plasma concentrations of isoniazid.
Potentially Fatal: May diminish therapeutic effect of live vaccines.
Lab Interference
May suppress skin reaction to allergy testing. May result in false-negative results with nitroblue tetrazolium test for bacterial infections.
Action
Description:
Mechanism of Action: Dexamethasone is a highly potent and long-acting corticosteroid with glucocorticoid activity which acts as an anti-inflammatory agent by suppressing neutrophil migration, decreasing production of inflammatory mediators, reversing increased capillary permeability, and suppressing immune response. It has minimal Na-retaining properties which makes it suitable for treating conditions where water retention is a disadvantage.
Pharmacokinetics:
Absorption: Readily absorbed from the gastrointestinal tract. Time to peak plasma concentration: 1-2 hours (oral); approx 30-120 minutes (IM).
Distribution: Crosses the placenta, enters breast milk. Plasma protein binding: Approx 77%.
Metabolism: Metabolised in the liver.
Excretion: Via urine. Elimination half-life: 4 ± 0.9 hours (oral); approx 1-5 hours (IV).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5743, Dexamethasone. https://pubchem.ncbi.nlm.nih.gov/compound/Dexamethasone. Accessed Aug. 25, 2023.

Storage
Tab/oral solution/inj/ophthalmic solution or ointment: Store between 20-25°C. Ophthalmic susp: Store between 8-27°C. Intravitreal implant: Store below 30°C. Ophthalmic insert: Store between 2-8°C. Do not freeze. Protect from light. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).
MIMS Class
Corticosteroid Hormones / Ear Corticosteroids / Eye Corticosteroids
ATC Classification
H02AB02 - dexamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
S01BA01 - dexamethasone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
S03BA01 - dexamethasone ; Belongs to the class of corticosteroids used in ophthalmologic and otologic preparations.
A01AC02 - dexamethasone ; Belongs to the class of local corticosteroid preparations. Used in the treatment of diseases of the mouth.
References
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Anon. Dexamethasone (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/06/2023.

Anon. Dexamethasone (Systemic). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/06/2023.

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Buckingham R (ed). Dexamethasone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/06/2023.

Dexamethasone 0.5 mg Tablets (Activase Pharmaceuticals Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2023.

Dexamethasone 1.5 mg Tablet (Larken Laboratories). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/06/2023.

Dexamethasone 10 mg Soluble Tablets (Aspire Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2023.

Dexamethasone 2 mg/5 mL Oral Solution (Martindale Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2023.

Dexamethasone 20 mg Tablets (Krka dd Novo mesto). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2023.

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Dexamethasone Injection 8 mg/2 mL (Komedic Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/06/2023.

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Dexamethasone Phosphate 1 mg/mL Eye Drops, Solution in a Single-dose Container (NTC S.r.l.). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2023.

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Dropodex 0.1% w/v Eye Drops, Solution (Rayner Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2023.

Etacortilen 1.5 mg/mL Eye Drops, Solution (SIFI Pharmaceuticals Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2023.

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Pharmacy Retailing (NZ) Limited Trading as Healthcare Logistics. Dexamethasone 0.4 mg and 0.5 mg Tablet data sheet 19 October 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 01/06/2023.

Disclaimer: This information is independently developed by MIMS based on Dexamethasone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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