Dexamethasone


Full Generic Medicine Info
Dosage/Direction for Use

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
As a 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.

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.

Parenteral
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.

Parenteral
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.

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.

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.

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.

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).

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).

Ophthalmic
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.

Ophthalmic
Ocular itching associated with allergic conjunctivitis
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.

Intravitreal
Non-infectious posterior uveitis
Adult: As intravitreal implant containing 700 mcg injected into the affected eye.
Child:

Intravitreal
Macular oedema secondary to retinal vein occlusion
Adult: As intravitreal implant containing 700 mcg injected into the affected eye.
Child:

Intravitreal
Diabetic macular oedema
Adult: As intravitreal implant containing 700 mcg injected into the affected eye.
Child:
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. Patient Counselling 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.
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. Nervous system disorders: Vertigo, headache. 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.
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
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.
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 (approx 10%). Elimination half-life: 4 ± 0.9 hours (oral); approx 1-5 hours (IV).
Storage
Intra-articular: Store between 20-25°C. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines). Intravenous: Store between 20-25°C. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines). Intravitreal: Store below 30°C. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines). Ophthalmic: 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). Oral: Store between 20-25°C. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines). Otic/Aural: Store between 20-25°C. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines). Parenteral: Store between 20-25°C. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).
CIMS Class
Corticosteroid Hormones / Ear Corticosteroids / Eye Corticosteroids
ATC Classification
C05AA09 - dexamethasone ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures.
H02AB02 - dexamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
D10AA03 - dexamethasone ; Belongs to the class of topical corticosteroids used in the treatment of acne.
S01BA01 - dexamethasone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
S02BA06 - dexamethasone ; Belongs to the class of corticosteroids used in the treatment of inflammation of the ear.
A01AC02 - dexamethasone ; Belongs to the class of local corticosteroid preparations. Used in the treatment of diseases of the mouth.
D07XB05 - dexamethasone ; Belongs to the class of moderately potent (group II) corticosteroids in other combinations. Used in the treatment of dermatological diseases.
S03BA01 - dexamethasone ; Belongs to the class of corticosteroids used in ophthalmologic and otologic preparations.
D07AB19 - dexamethasone ; Belongs to the class of moderately potent (group II) corticosteroids. Used in the treatment of dermatological diseases.
S01CB01 - dexamethasone ; Belongs to the class of corticosteroids/antiinfectives/mydriatics combinations. Used in the treatment of eye diseases.
R01AD03 - dexamethasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 CIMS. All rights reserved. Powered by CIMSAsia.com
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