Indications and Usage
Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.
Dermatologic Diseases
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis.
Gastrointestinal Diseases
To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.
Hematologic Disorders
Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia.
Miscellaneous
Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
Neoplastic Diseases
For the palliative management of leukemias and lymphomas.
Nervous System
Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.
Ophthalmic Diseases
Sympathetic ophthalmia, temporal arteritis, uveitis, and 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 DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low- dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Dosage and Administration
For Oral Administration
The initial dosage varies from 0.75 mg to 9 mg a day depending on the disease being treated.
It Should Be Emphasized That Dosage Requirements Are Variable And Must Be Individualized On The Basis Of The Disease Under Treatment And The Response Of The Patient.
After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached.
Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation, it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of dexamethasone for a week followed by 4 mg to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS, Neuro-psychiatric).
In pediatric patients, the initial dose of dexamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 mg to 0.3 mg/kg/day in three or four divided doses (0.6 mg to 9 mg/m2 bsa/day).
For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids:
Cortisone, 25 mg
Triamcinolone, 4 mg
Hydrocortisone, 20 mg
Paramethasone, 2 mg
Prednisolone, 5 mg
Betamethasone, 0.75 mg
Prednisone, 5 mg
Dexamethasone, 0.75 mg
Methylprednisolone, 4 mg
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
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 two divided doses
Third Day
4 tablets in two divided doses
Fourth Day
2 tablets in two divided doses
Fifth Day 1 tablet Sixth Day 1 tablet
Seventh Day
No treatment
Eighth Day
Follow-up visit
This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.
In cerebral edema, dexamethasone sodium phosphate injection is generally 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 mg of dexamethasone orally at 11:00 p.m. 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 mg of dexamethasone orally every 6 hours for 48 hours. Twenty four-hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.
Contraindications
Systemic fungal infections (see WARNINGS, Fungal Infections).
Dexamethasone tablets are contraindicated in patients who are hypersensitive to any components of this product.
Adverse Reactions
(Listed alphabetically, under each subsection)
The following adverse reactions have been reported with dexamethasone or other corticosteroids:
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 (see WARNINGS, Cardio-renal), 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.
Overdosage
Treatment of overdosage is by supportive and symptomatic therapy. In the case of acute overdosage, according to the patient's condition, supportive therapy may include gastric lavage or emesis.
Description
Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 Aluminum Lake (4 mg, 6 mg), D&C Red #27 Aluminum Lake (1.5 mg), FD&C Red #40 Aluminum Lake (1.5 mg), D&C Yellow #10 Aluminum Lake (1.5 mg, 4 mg, 6 mg).
The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is
[structure]
Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water.
FDA approved dissolution test specifications differ from USP.
Clinical Pharmacology
Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems.
At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.
How Supplied / Storage and Handling
Dexamethasone Tablets, USP are available as follows:
1.5 mg tablets are supplied as a pink, round, shallow, biconvex tablet, scored on one side and debossed with “N 401” on the other side.
NDC 70954-401-10: Bottle of 100 Tablets
2 mg tablets are supplied as a white to off white, round, shallow, biconvex tablet, scored on one side and debossed with “N 402” on the other side.
NDC 70954-402-10: Bottle of 100 Tablets
4 mg tablets are supplied as a green, round, shallow, biconvex tablet, scored on one side and debossed with “N 403” on the other side.
NDC 72189-511-10: Bottle of 10 Tablets
6 mg tablets are supplied as an aqua, round, shallow, biconvex tablet, scored on one side and debossed with “N 404” on the other side.
NDC 70954-404-10: Bottle of 100 Tablets