Overview
DESCRIPTION Dexamethasone Tablets USP, 1.5 mg Each tablet contains: Dexamethasone USP … 1.5 mg. For oral administration.
Mechanism of Action
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.
Indications
- INDICATIONS AND USAGE A l l ergic States: Control of severe or incapacitating a llergic 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: Bul l ous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome).
Common Doses
- 9 mg
- 30 mg
- 12 mg
- 0.3 mg
Dosage
DOSAGE AND ADMINISTRATION For Oral Administration The initial dosage varies from 0.75 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.
Contraindications
- CONTRAINDICATIONS Contraindicated in systemic fungal infections (see WARNINGS : Infections: Fungal Infections ) and patients with known hypersensitivity to the product and its consituents.
Side Effects
- ADVERSE REACTIONS (listed alphabetica ll y, under each subsection) The following adverse reactions have been reported with dexamethasone or other corticosteroids: A ll ergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory co l apse, 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,...
Interactions
- Drug Interactio ns Aminoglutethimide: Aminoglutethimide may diminish adrenal suppression by corticosteroids. Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.