Dexamethasone - oral


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Anti-inflammatory or immunosuppressive Initially, 0.5-9 mg/day in divided doses. Max: 1.5 mg/day. Dosage is individualised and adjusted depending on the disease being treated and patient response. Refer to detailed product guideline. Acute exacerbations in multiple sclerosis Initially, 30 mg daily for 1 week then 4-12 mg every other day for 1 month. As a screening test for Cushing’s syndrome 2 mg at 11 pm, followed by a blood test for plasma cortisol at 8 am the following morning. Alternatively, 500 mcg 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-hydroxycorticosteroid excretion). As a diagnostic test in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing’s syndrome 2 mg 6 hourly for 48 hours then measure plasma cortisol at 8 am on the morning following the last dose (with 24-hour urine collections for determination of 17-hydroxycorticosteroid excretion). IV/IM Shock 1.67-5 mg/kg slowly over several minutes, may be repeated within 2-6 hours until condition is stable and usually for up to 72 hours. Alternatively, initial dose may be followed by continuous infusion of 2.5 mg/kg per 24 hours. Cerebral oedema caused by malignancy Initially, 8.3 mg via IV followed by 3.3 mg via IM 6 hourly until symptoms subside, dose may be reduced after 2-4 days and gradually stopped over 5-7 days. Recurrent or inoperable neoplasms: Maintenance: 1.7 mg given bid or tid. Anti-inflammatory or immunosuppressive Initially, 0.4-20 mg/day depending on the condition being treated, may be maintained or adjusted until satisfactory response is achieved. Intra-articular Inflammatory joint diseases 333 mcg to 5 mg depending on the degree of inflammation and the size and location of the joint. For soft tissues: 2-6 mg. All doses are repeated once every 3-5 days for bursae to once every 2-3 weeks for joints. Refer to detailed product guideline. Intravitreal Macular oedema secondary to retinal vein occlusion; Diabetic macular oedema; Uveitis As intravitreal implant containing 700 mcg injected into the affected eye Retreat after approx 6 months in cases of loss or decrease in vision and/or increase in retinal thickness. Ophth Inflammatory eye disorders As 0.1% solution: Instill 1 drop 4-6 times/day. Severe conditions: Instill 1 drop hourly, then reduced to 1 drop 4 hourly as the inflammation subsides. Otic Otic inflammation As 0.1% solution: Instill 3-4 drops into the cleaned aural canal bid or tid, reduced dose gradually if favourable response is obtained. Alternatively, pack the aural canal with a gauze wick saturated with the solution for 12-24 hours, may be repeated as necessary.
Dosage Details
Intra-articular
Inflammatory joint diseases
Adult: 333 mcg to 5 mg depending on the degree of inflammation and the size and location of the joint. For soft tissues: 2-6 mg. All doses are repeated once every 3-5 days for bursae to once every 2-3 weeks for joints.  Refer to detailed product guideline.
Child: 167-333 mcg/kg daily.

Intravenous
Shock
Adult: 1.67-5 mg/kg slowly over several minutes, may be repeated within 2-6 hours until condition is stable and usually for up to 72 hours. Alternatively, initial dose may be followed by continuous infusion of 2.5 mg/kg per 24 hours.
Child: 167-333 mcg/kg daily.

Intravitreal
Diabetic macular oedema, Macular oedema secondary to retinal vein occlusion, Uveitis
Adult: As intravitreal implant containing 700 mcg injected into the affected eye. Retreat after approx 6 months in cases of loss or decrease in vision and/or increase in retinal thickness.

Ophthalmic
Inflammatory eye disorders
Adult: As 0.1% solution: Instill 1 drop 4-6 times daily. Severe conditions: Instill 1 drop hourly,  then reduced to 1 drop 4 hourly as the inflammation subsides.

Oral
Anti-inflammatory or immunosuppressive
Adult: Initially, 0.5-9 mg daily in divided doses. Max: 1.5 mg daily. Dosage is individualised and adjusted depending on the disease being treated and patient response. Refer to detailed product guideline.
Child: Initially, 0.02-0.3 mg/kg daily in 3-4 divided doses. Dose depends on disease severity and patient response. Refer to detailed product guideline.

Oral
Screening test for Cushing's syndrome
Adult: 2 mg at 11 pm, followed by a blood test for plasma cortisol at 8 am the following morning. Alternatively, 500 mcg 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-hydroxycorticosteroid excretion).

Oral
Acute exacerbations in multiple sclerosis
Adult: Initially, 30 mg daily for 1 week followed by 4-12 mg every other day for 1 month.

Oral
Diagnostic test in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome
Adult: 2 mg 6 hourly for 48 hours then measure plasma cortisol at 8 am on the morning following the last dose (with 24-hour urine collections for determination of 17-hydroxycorticosteroid excretion).

Otic/Aural
Otic inflammation
Adult: As 0.1% solution: Instill 3-4 drops into the cleaned aural canal bid or tid, reduced dose gradually if favourable response is obtained. Alternatively, pack the aural canal with a gauze wick saturated with the solution for 12-24 hours, may be repeated as necessary.

Parenteral
Cerebral oedema caused by malignancy
Adult: Initially, 8.3 mg via IV inj followed by 3.3 mg via IM inj 6 hourly until symptoms subside, dose may be reduced after 2-4 days and gradually stopped over 5-7 days. Recurrent or inoperable neoplasms: Maintenance: 1.7 mg given via IV/IM inj bid or tid.
Child: 167-333 mcg/kg daily.

Parenteral
Anti-inflammatory or immunosuppressive
Adult: Initially, 0.4-20 mg daily given via IV/IM inj depending on the condition being treated, may be maintained or adjusted until satisfactory response is achieved.
Child: 167-333 mcg/kg daily.
Administration
Should be taken with food.
Contraindications
Systemic fungal infections; systemic infection unless being treated with specific anti-infectives. Perforation of drum membrane (otic). Administration of live virus vaccine.
Special Precautions
Patient with hypertension, acute MI,  heart failure, diabetes mellitus, gastrointestinal diseases (e.g. diverticulitis intestinal anastomoses, active or latent peptic ulcer ulcerative colitis); ocular diseases (e.g. cataracts, glaucoma, history of ocular herpes simplex); osteoporosis, history of seizure disorder, thyroid disease. Renal and hepatic impairment. Elderly. Children. Pregnancy and lactation. Avoid abrupt withdrawal or rapid dose reduction.
Adverse Reactions
Significant: Adrenal suppression (e.g. hypercortisolism, suppression of hypothalamic-pituitary-adrenal [HPA] axis); Kaposi sarcoma; myopathy; perineal irritation, psychiatric disturbance, immunosuppression (e.g. secondary infections, activation of latent infections, mask acute infection); increased intra-ocular pressure, open-angle glaucoma and cataracts. Rarely, anaphylactoid reactions
Endocrine disorders: Growth retardation in children.
Eye disorders: Bacterial keratitis, eye irritation and pruritus, burning sensation, ocular discomfort.
General disorders and admin site conditions: Impaired wound healing.
Investigations: Weight gain.
Metabolism and nutrition disorders: Cushing’s syndrome, obesity.
Musculoskeletal and connective tissue disorders: Osteoporosis.
Nervous system disorders: Headache, muscle atrophy.
Psychiatric disorders: Euphoria, depression, suicidal tendencies.
Skin and subcutaneous tissue disorders: Skin fragility.
IM/Intra-articular/Intralesional/Intravitreal/IV/Ophth/Otic/Parenteral/PO: C
Patient Counseling Information
Ophth: This drug may cause blurring of vision, if affected, do not  drive or reinsert operate machinery. Remove contact lenses prior to ophthalmic administration and after 15 minutes.
MonitoringParameters
Monitor growth for children and intraocular pressure.
Overdosage
Symptoms: Anaphylactic and hypersensitivity reactions. Management: Supportive treatment. May administer adrenaline, aminophylline; provide  positive pressure ventilation.
Drug Interactions
Decreased plasma concentration with CYP3A4 inducers (e.g. barbiturates, carbamazepine, ephedrine, phenytoin, rifabutin, rifampicin). Increased plasma concentration with CYP3A4 inhibitors (e.g. erythromycin, ketoconazole, ritonavir). May increase renal clearance of salicylates. May enhances hypokalaemic effects of diuretics (acetazolamide, loop, thiazide), amphotericin B injection, corticosteroids, carbenoxolone, and K-depleting agents. May enhance anticoagulant effect of warfarin.
Potentially Fatal: May diminish therapeutic effect of live virus vaccines.
Lab Interference
False negative results with nitroblue tetrazolium test for bacterial infection.
Action
Description: Dexamethasone is a highly potent and long-acting glucocorticoid 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 lacks mineralocorticoid properties and 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); 5-10 minutes (IV).
Distribution: Crosses placenta and enters breast milk. Plasma protein binding: Approx 77%, mainly to albumins.
Metabolism: Metabolised in the liver by CYP3A4 enzyme.
Excretion: Via urine (up to 65%). Elimination half-life: 4±0.9 hours (oral); approx 1-5 hours (IV).
Chemical Structure

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Storage
Store below 25°C.
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.
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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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