Dexamethasone Tablets

— THERAPEUTIC CATEGORIES —
  • Corticosteroid-responsive disorders

Dexamethasone Tablets Generic Name & Formulations

General Description

Dexamethasone 0.5mg, 0.75mg, 4mg, 6mg; tabs.

Pharmacological Class

Glucocorticoid.

How Supplied

Contact supplier

Mechanism of Action

Naturally occurring glucocorticoids, (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, including dexamethasone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Dexamethasone Tablets Indications

Indications

Steroid-responsive disorders.

Indications

  • Allergic States – Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

    • Seasonal or perennial allergic rhinitis

    • Asthma

    • Contact dermatitis

    • Atopic dermatitis

    • Serum sickness

    • Drug hypersensitivity reactions

  • Dermatologic Diseases

    • Pemphigus

    • Bullous dermatitis herpetiformis

    • Severe erythema multiforme (Stevens-Johnson syndrome)

    • Exfoliative erythroderma

    • Mycosis fungoides

  • Endocrine Disorders

    • Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)

    • Congenital adrenal hyperplasia

    • Hypercalcemia associated with cancer

    • Nonsuppurative thyroiditis

  • Gastrointestinal Diseases – To tide the patient over a critical period of the disease in:

    • Ulcerative colitis

    • Regional enteritis

  • Hematologic Disorders

    • Idiopathic thrombocytopenic purpura in adults

    • Secondary thrombocytopenia in adults

    • Acquired (autoimmune) hemolytic anemia

    • Erythroblastopenia (RBC anemia)

    • Congenital (erythroid) hypoplastic anemia

    • Pure red cell aplasia

  • Miscellaneous

    • Diagnostic testing of adrenocortical hyperfunction

    • Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy

    • Trichinosis with neurologic or myocardial involvement

  • Neoplastic Diseases – For palliative management of:

    • Leukemias and lymphomas 

  • Nervous System

    • Acute exacerbations of multiple sclerosis

    • Cerebral edema associated with primary or metastatic brain tumor

    • Craniotomy

    • Head injury

  • Ophthalmic Diseases

    • Sympathetic ophthalmia

    • Temporal arteritis

    • Uveitis

    • Ocular inflammatory conditions unresponsive to topical corticosteroids

  • Renal Diseases

    • To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus

  • Respiratory Diseases

    • Berylliosis

    • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy

    • Idiopathic eosinophilic pneumonias

    • Symptomatic sarcoidosis

  • Rheumatic Disorders – As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

    • Psoriatic arthritis

    • Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)

    • Acute gouty arthritis 

    • Acute rheumatic carditis 

    • Ankylosing spondylitis

  • Rheumatic Disorders – For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

Dexamethasone Tablets Dosage and Administration

Adult

See full labeling. Initially 0.75–9mg daily.

Adult

For oral administration

  • Dose requirements are variable and must be individualized according to the disease and patient’s response.

  • Initial dose varies from 0.75 to 9 mg per day based on the disease being treated.

  • Maintain or adjust initial dosage until a satisfactory response is noted.

  • Once the patient achieves a favorable response, determine the appropriate maintenance dose by decreasing the initial drug dose in small decrements.

  • Gradually withdraw if discontinuing treatment after long-term therapy.

Multiple Sclerosis

  • Treatment of acute exacerbations of multiple sclerosis: dexamethasone 30 mg daily for a week followed by 4 to 12 mg every other day for 1 month have been shown to be effective. (Same dosage range for prednisone and prednisolone.)

In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested:

  • Dexamethasone Sodium Phosphate injection, 4 mg per mL

    • First Day – 1 or 2 mL intramuscularly

  • Dexamethasone tablets, 0.75 mg:

    • Second Day – 4 tablets in 2 divided doses

    • Third Day – 4 tablets in 2 divided doses

    • Fourth Day – 2 tables in 2 divided doses

    • Fifth Day – 1 tablet

    • Sixth Day – 1 tablet

    • Seventh Day – No treatment

    • Eight Day – Follow up visit

In cerebral edema

  • Dexamethasone sodium phosphate injection is administered initially in a dosage of 10 mg intravenously followed by 4 mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. 

For palliative management of patients with recurrent or inoperable brain tumors

  • Maintenance therapy with either dexamethasone sodium phosphate injection or dexamethasone tablets in a dosage of 2 mg two or three times daily may be effective.

Dexamethasone Suppression Tests

  • Tests for Cushing’s syndrome: Give 1.0 mg of dexamethasone orally at 11:00 pm. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning. For greater accuracy, give 0.5 mg of dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

  • Test to distinguish Cushing’s syndrome due to pituitary ACTH excess from Cushing’s syndrome due to other causes: Give 2.0 mg of dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

Children

See full labeling. Initially 0.02–0.3mg/kg/day in 3–4 divided doses.

Children

For oral administration

  • Dose requirements are variable and must be individualized according to the disease and patient’s response.

  • Initial dose varies from 0.02 to 3 mg/kg/day in 3 or 4 divided doses (0.6 to 9 mg /m2bsa/day) based on the disease being treated.

  • Maintain or adjust initial dosage until a satisfactory response is noted.

  • Once the patient achieves a favorable response, determine the appropriate maintenance dose by decreasing the initial drug dose in small decrements.

  • Gradually withdraw if discontinuing treatment after long-term therapy.

Multiple Sclerosis

  • Treatment of acute exacerbations of multiple sclerosis: dexamethasone 30 mg daily for a week followed by 4 to 12 mg every other day for 1 month have been shown to be effective. (Same dosage range for prednisone and prednisolone.)

In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested:

  • Dexamethasone Sodium Phosphate injection, 4 mg per mL

    • First Day – 1 or 2 mL intramuscularly

  • Dexamethasone tablets, 0.75 mg:

    • Second Day – 4 tablets in 2 divided doses

    • Third Day – 4 tablets in 2 divided doses

    • Fourth Day – 2 tables in 2 divided doses

    • Fifth Day – 1 tablet

    • Sixth Day – 1 tablet

    • Seventh Day – No treatment

    • Eight Day – Follow up visit

In cerebral edema

  • Dexamethasone sodium phosphate injection is administered initially in a dosage of 10 mg intravenously followed by 4 mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. 

For palliative management of patients with recurrent or inoperable brain tumors

  • Maintenance therapy with either dexamethasone sodium phosphate injection or dexamethasone tablets in a dosage of 2 mg two or three times daily may be effective.

Dexamethasone Suppression Tests

  • Tests for Cushing’s syndrome: Give 1.0 mg of dexamethasone orally at 11:00 pm. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning. For greater accuracy, give 0.5 mg of dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

  • Test to distinguish Cushing’s syndrome due to pituitary ACTH excess from Cushing’s syndrome due to other causes: Give 2.0 mg of dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

Dexamethasone Tablets Contraindications

Contraindications

Systemic fungal infection. Live vaccination.

Dexamethasone Tablets Boxed Warnings

Not Applicable

Dexamethasone Tablets Warnings/Precautions

Warnings/Precautions

Cerebral malaria, optic neuritis, active ocular herpes simplex: not recommended. Strongyloides infestation. Tuberculosis. Exclude latent or active amebiasis prior to initiation in patients with unexplained diarrhea or traveled to the tropics. If exposed to chickenpox or measles, consider prophylactic passive immune therapy. Recent MI. CHF. Hypertension. Renal insufficiency. Peptic ulcers. Diverticulitis. Intestinal anastomoses. Ulcerative colitis. Cirrhosis. Postmenopausal women (osteoporosis risk). Diabetes. Thyroid disorder. Myasthenia gravis. Supplement with additional steroids in physiologic stress. Avoid abrupt cessation. Monitor thyroid, weight, growth, fluid, electrolyte balance and intraocular pressure (w. therapy >6wks). Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Warnings/Precautions

General

  • Anaphylactoid reactions have rarely been reported.

  • May need to increase the dose of rapidly acting corticosteroids in patients on corticosteroid therapy who are subjected to any unusual stress before, during, and after the stressful situation.

  • Use the lowest possible dose of corticosteroids to control the condition. Gradually reduce dose when possible.

  • For each individual, a risk/benefit decision must be made as to dose and duration of treatment and whether daily or intermittent therapy should be used.

  • Kaposi’s sarcoma has been reported to occur with corticosteroid therapy. 

Cardio-Renal

  • May cause elevated blood pressure, salt, and water retention, and increased excretion of potassium. May need to restrict dietary salt and administer potassium supplements. All corticosteroids increase calcium excretion.

  • Use great caution in patients after a recent myocardial infarction – there have been reports suggesting an association between corticosteroid use and left ventricular free wall rupture.

  • Use caution in patients with congestive heart failure, hypertension, or renal insufficiency.

Endocrine

  • Corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.

  • Adrenocortical insufficiency may result when corticosteroids are withdrawn too rapidly and may be minimized by gradual dose reduction.

  • May need to adjust dose for changes in thyroid status in patients.

Infections

  • May increase the risk of and may cause some signs of current infection. The rate of incidence of infectious complications increases with increasing doses of corticosteroids.

  • Fungal Infections: Avoid use in the presence of systemic fungal infections unless corticosteroids are needed to control life-threatening drug reactions.

  • Special Pathogens

    • Corticosteroids may activate latent disease or may exacerbate intercurrent infections due to pathogens, including those caused by Amoeba, Candida,Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma.

    • Rule out latent amebiasis or active amebiasis prior to initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea.

    • Use great care in patients with known or suspected Strongyloides (threadworm) infestation.

    • Do not use corticosteroids in cerebral malaria.

  • Tuberculosis

    • Restrict the use of corticosteroids  in active tuberculosis to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.

    • Monitor closely for reactivation of tuberculosis if corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity. Patients should receive chemoprophylaxis during prolonged corticosteroid therapy.

  • Vaccination:

    • Contraindicated to administer live or live, attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.

    • May administer killed or inactivated vaccines.

    • Immunization procedures are allowed in patients who are receiving corticosteroids as replacement therapy (eg, for Addison’s disease).

  • Viral Infections:

    • Chickenpox and measles can be more serious or even fatal in children and adults on corticosteroids. Avoid exposure in patients who have not had these diseases. 

    • If exposed to chickenpox or measles, consider therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobin (IVIG), as appropriate. If chickenpox develops, consider treating with antiviral agents.

  • Ophthalmic:

    • Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

    • Consider referring to an ophthalmologist for patients who develop ocular symptoms or use corticosteroid-containing products for more than 6 weeks.

    • Do not use oral corticosteroids in the treatment of optic neuritis because it may lead to an increase in the risk of new episodes.

    • Do not use in active ocular herpes simplex.

  • Gastrointestinal:

    • Use caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

    • There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.

  • Musculoskeletal:

    • Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (ie, decreasing absorption and increasing excretion) and inhibition of osteoblast function.

    • Prior to initiating corticosteroid therapy, give special consideration to patients at increased risk of osteoporosis (eg, postmenopausal women).

  • Neuro-Psychiatric:

    • An acute myopathy was observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (eg, myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (eg, pancuronium).

    • Psychic derangements may occur during treatment. Symptoms range from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. 

Pregnancy Considerations

Teratogenic Effects

  • Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. 

  • Use only during pregnancy if the potential benefit justifies the potential risk to the fetus.

  • Carefully observe infants born of mothers who received substantial doses of corticosteroids during pregnancy. Monitor for signs of hypoadrenalism.

Nursing Mother Considerations

  • A decision should be made on whether to discontinue nursing or to discontinue the drug due to the potential for serious adverse reactions.

Pediatric Considerations

  • The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations.

  • Pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.

  • Pediatric patients may experience a decrease in their growth velocity. Monitor the linear growth, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. 

  • In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Geriatric Considerations

  • Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 

  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 

  • In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.

Dexamethasone Tablets Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal. Half-life: 6.6±4.3 hours.

Dexamethasone Tablets Interactions

Interactions

Potentiated by CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, erythromycin, ritonavir, cobicistat-containing products), cyclosporine, estrogens. Antagonized by CYP3A4 inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin), ephedrine. May be antagonized by cholestyramine. May potentiate cyclosporine. May antagonize anticoagulants (monitor), isoniazid, other CYP3A4 substrates (eg, indinavir, erythromycin). Aminoglutethimide may diminish adrenal suppression by corticosteroids. Increased risk of arrhythmias with digitalis. May need to adjust dose of antidiabetic agents. Increased GI effects with aspirin or other NSAIDs. Monitor for hypokalemia with potassium-depleting drugs (eg, amphotericin B, diuretics). Toxic epidermal necrolysis possible with thalidomide. Concomitant indomethacin: may get false-negative on dexamethasone suppression test. May suppress reactions to skin tests.

Interactions

Aminoglutethimide

  • May diminish adrenal suppression by corticosteroids.

Amphotericin B injection and potassium-depleting agents

  • Monitor closely for hypokalemia when used with potassium-depleting agents (eg, amphotericin B, diuretics).

  • Reports of cardiac enlargement and congestive heart failure following concomitant use of amphotericin B and hydrocortisone.

Antibiotics

  • Reports of significant decrease in corticosteroid clearance with macrolide antibiotics.

Anticholinesterase 

  • May produce severe weakness in patients with myasthenia gravis. Anticholinesterase agents should be withdrawn for at least 24 hours prior to corticosteroid therapy if possible.

Anticoagulants (Oral)

  • May inhibit response to warfarin when administered with corticosteroids. Monitor coagulation indices frequently to maintain the desired anticoagulant effect.

Antidiabetics

  • May need to adjust dose of antidiabetic agents because corticosteroids may increase blood glucose levels.

Antitubercular drugs

  • May decrease serum concentration of isoniazid.

Cholestyramine

  • May increase clearance of corticosteroids.

Cyclosporine

  • Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.

Dexamethasone Suppression Test (DST)

  • Concomitant use with indomethacin may cause false-negative results on dexamethasone suppression test. 

Digitalis Glycosides

  • May increase the risk of arrhythmias due to hypokalemia when used with corticosteroids.

Ephedrine

  • May enhance the metabolic clearance of corticosteroids, thus requiring an increase in corticosteroid dosage.

Estrogens, including Oral Contraceptives

  • May decrease the hepatic metabolism of certain corticosteroids, thus enhancing their effect.

CYP3A4 Inducers

  • Drugs which induce cytochrome P450 3A4 (CYP3A4) enzyme activity (eg, barbiturates, phenytoin, carbamazepine, rifampin) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.

CYP3A4 Inhibitors

  • Concomitant use with erythromycin, a moderate CYP3A4 inhibitor, may increase plasma concentrations of dexamethasone.

  • Concomitant use with ketoconazole, a strong CYP3A4 inhibitor, has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. 

  • Concomitant use with other strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, ritonavir, cobicistat-containing products) may increase plasma concentrations of corticosteroids and increase the risk of systemic corticosteroid side effects. Consider the potential benefit/risk of concomitant use.

CYP3A4 Substrates

  • Dexamethasone may increase the clearance of CYP3A4 substrates (eg, indinavir, erythromycin) leading to decreased plasma concentration.

Nonsteroidal Anti-Inflammatory Agents (NSAIDS)

  • Increased risk of GI side effects when corticosteroids are used with aspirin (or other NSAIDs). 

Phenytoin

  • Concomitant use with dexamethasone may result in both increases and decreases in phenytoin levels, resulting in changes to seizure control.

Skin Tests

  • Corticosteroids may suppress reactions to skin tests.

Thalidomide

  • Use caution for concomitant use with thalidomide – risk of toxic epidermal necrolysis has been reported.

Vaccines

  • Patients may have a decreased response to toxoids and live or inactivated vaccines.

  • Do not administer routine vaccines or toxoids until corticosteroid therapy is discontinued if possible.

Dexamethasone Tablets Adverse Reactions

Adverse Reactions

HPA axis suppression, masks infection, increased susceptibility to infection, glaucoma, cataracts, secondary infections, hypokalemia, hypocalcemia, hypernatremia, hypertension, psychic disorders, myopathy, osteoporosis, peptic ulcer, dermal atrophy, increased intracranial pressure, hyperglycemia.

Adverse Reactions

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.

Dexamethasone Tablets Clinical Trials

See Literature

Dexamethasone Tablets Note

Notes

Formerly known under the brand name Decadron.

Dexamethasone Tablets Patient Counseling

Patient Counseling

Information for Patients

  • Avoid abrupt discontinuation of corticosteroids or without medical supervision.

  • Advise patients that prolonged use may cause adrenal insufficiency and make the dependent on corticosteroids – seek medical advise once they develop an acute illness (eg, fever or other signs of infection).

  • Following prolonged therapy, symptoms of the corticosteroid withdrawal syndrome may occur after withdrawal of corticosteroids.

  • Avoid exposure to chickenpox or measles. If exposed, seek medical advise immediately.