Dexan Tablet
Dexamethasone oral
0.5mg
Chemist Laboratories Ltd.
| Pack size | 250's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1.00 AED |
Indications
Dexan Tablet is used for:
Shock, Bronchial asthma, Status asthmaticus, Rheumatoid arthritis, Gout, Severe allergies, Skin diseases, Hyperpyrexia, Bacteraemia, Toxaemia, Acute adrenocortical insufficiency, Cortisosteroid-responsive dermatoses, Eczema, Urticaria, Cerebral oedema, COVID-19 Disease (Off-label), other indications where glucocorticoid therapy is required.
Adult Dose
Oral
Suppression of inflammatory and allergic disorders
Adult: 0.5–10 mg daily in 2-4 divided doses
Screening test for Cushing's syndrome
Adult: 0.5 mg every 6 hr for 48 hr after determining baseline 24-hour urinary 17-hydroxycorticosteroid (17-OHCS) concentrations.
During the second 24 hr of dexamethasone administration, urine is collected and analysed for 17-OHCS.
Alternatively, after a baseline plasma cortisol determination, 1 mg may be given at 11 pm and plasma cortisol determined at 8 am the next morning.
Plasma cortisol and urinary output of 17-OHCS are depressed after dexamethasone administration in normal individuals but remain at basal levels in patients with Cushing's syndrome.
Acute exacerbations in multiple sclerosis
Adult: 30 mg daily for 1 wk followed by 4-12 mg daily for 1 mth.
Cerebral oedema associated with brain tumours
Adult: 0.5–10 mg daily
COVID-19 Disease (Off-label)
Based on preliminary evidence from the RECOVERY trial, NIH guidelines recommend dexamethasone to reduce mortality in hospitalized patients with COVID-19 disease who are receiving either invasive mechanical ventilation or oxygen alone, but not among those receiving no respiratory support
6 mg PO once daily for up to 10 days or discharge, whichever comes first
Child Dose
Oral
Anti-inflammatory
Child: 1 mth-18 yr: 10-100 mcg/kg daily in 1-2 divided doses via oral admin, adjusted according to response; up to 300 micrograms/kg daily may be used in emergency situations.
Alternatively
0.08-0.3 mg/kg/day PO divided 6 hourly or 12 hourly
Acute exacerbations in multiple sclerosis
Child: 1 mth-12 yr: 100-400 mcg/kg daily in 1-2 divided doses;
12-18 yr: Initially 0.5-24 mg daily.
Max. 24 mg daily.
Airway Edema
0.5-2 mg/kg/day PO divided 6 hourly, starting 24 hours before extubation and continued for 4-6 doses afterward
Croup
0.6 mg/kg PO once; not to exceed 16 mg
Adrenal Cortical Hyperfunction Test
After determination of baseline cortisol level, 1 mg PO at bedtime
Plasma cortisol level then determined at 8:00 AM on following morning; level will be decreased in normal individuals but at baseline level in Cushing syndrome
Renal Dose
Administration
Should be taken with food.
Contra Indications
Ocular herpes simplex is an example of an absolute contraindication to corticosteroid therapy.
Relative contraindications are:
Gastrointestinal ulcer, acute or chronic infections, osteoporosis, pregnancy, diabetes mellitus, renal insufficiency, hypertension, systemic fungal infection, cerebral malaria, history of psychotic illness, immediate before prophylactic immunization and finally hypersensitivity to Dexamethasone.
Administration of live or live-attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids
Precautions
Alterations in Endocrine Function: Hypothalamic-pituitary adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia can occur.
Monitor patients for these conditions with chronic use.
Immunosuppression and Increased Risk of Infections: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections.
Alteration in Cardiovascular/Renal Function: Monitor for elevated blood pressure and sodium, and for decreased potassium levels.
Venous and Arterial Thromboembolism: Risk increased; consider anticoagulant prophylaxis and monitor for evidence of thromboembolism.
Vaccination: Avoid the administration of live or live-attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.
Ophthalmic Effects: May include cataracts, infections, and glaucoma.
Gastrointestinal Perforation: Avoid use in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.
Osteoporosis: Increased risk; monitor for changes in bone density with chronic use.
Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis.
Monitor for signs and symptoms and manage promptly.
Kaposi’s Sarcoma: Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus.
Pregnancy-Lactation
Pregnancy
Corticosteroids readily cross the placenta
Adverse developmental outcomes including orofacial clefts (cleft lip with or without cleft palate), intrauterine growth restriction, and decreased birth weight have been reported with maternal use of corticosteroids during pregnancy
Pregnancy testing is recommended for females of reproductive potential before initiating treatment
Contraception
Use effective contraception during treatment and for at least 1 month following final dose
Infertility in males
Steroids may increase or decrease motility and number of spermatozoa in some patients
In animals, dexamethasone affects male spermatogenesis
Lactation
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects
Advise women not to breastfeed during treatment and for 2 weeks after the last dose
Interactions
Increased risk of hypokalaemia when used concurrently with potassium-depleting drugs such as amphotericin B and loop diuretics.
Reduces efficacy of isoniazid, salicylates, vaccines and toxoids.
Increased activity of dexamethasone and cyclosporin when used together.
Concurrent use with aspirin or ethanol may lead to increased GI side effects.
Avoid concomitant use of strong CYP3A4 inhibitors or inducers.
Concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thromboembolism.
Potentially Fatal: Reduced efficacy in combination with ephedrine, cholestyramine, phenytoin, phenobarbital and rifampicin.
Contraindicated (18)
apixaban
artemether/lumefantrine
cariprazine
cobimetinib
dienogest/estradiol valerate
elbasvir/grazoprevir
elvitegravir/cobicistat/emtricitabine/tenofovir DF
lumacaftor/ivacaftor
lumefantrine
lurasidone
mifepristone
naloxegol
ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
panobinostat
praziquantel
regorafenib
rilpivirine
roflumilast
Adverse Effects
Side effects of Dexamethasone oral :
Frequency Not Defined
Allergic reactions: Anaphylactoid reaction, anaphylaxis, angioedema
Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis
Dermatologic: Acne, allergic dermatitis, dry scaly skin, ecchymoses and petechiae, erythema, impaired wound healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria
Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, hyperglycemia, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients
Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention, tumor lysis syndrome
Gastrointestinal: Abdominal distention, elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis
Metabolic: Negative nitrogen balance due to protein catabolism Musculoskeletal: Aseptic necrosis of femoral and humeral heads, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures
Neurological/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo
Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, vision blurred
Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain
Mechanism of Action
Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.
Note
Dexan 0.5mg Tablet manufactured by Chemist Laboratories Ltd.. Its generic name is Dexamethasone oral. Dexan is availble in Bangladesh.
Farmaco BD drug index information on Dexan Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.