Dexamethasone

Dexamethasone

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Questions & Answers

Side Effects & Adverse Reactions

General:

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS).

Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation.

Cardio-Renal:

Average and large doses of corticosteroids can cause elevation of blood pressure, sodium and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

Endocrine:

Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased.

Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.

Infections
General:

Patients who are on corticosteroids are more susceptible to infections than healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents. These infections may be mild to severe. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also mask some signs of current infection.

Fungal Infections:

Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B injection and potassium-depleting agents).

Special Pathogens:

Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma.

It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea.

Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Corticosteroids should not be used in cerebral malaria.

Tuberculosis:

The use of corticosteroids in active tuberculosis should be restricted 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.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Vaccination:

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.

Viral infections:

Chickenpox and measles can have a more serious or even fatal course in pediatric and adults patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immune globulin (IG) may be indicated. (See the respective package inserts for VZIG and IG for complete prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Ophthalmic:

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 bacteria, fungi, or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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, seasonal or perennial allergic rhinitis and serum sickness.

Dermatologic Diseases

Bullous dermatitis herpetiformis, exfoliative erythroderma, mycisis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine Disorders

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first 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 (Diamon-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 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 Disorders

As 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.

History

There is currently no drug history available for this drug.

Other Information

Dexamethasone Tablets 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg are for oral administration. Each tablet contains 0.5 mg, 0.75 mg, 1.5 mg, 4 mg or 6 mg of dexamethasone.

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. It is designated chemically as 9-fluoro-11β, 17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione.

The structural formula is represented below:

Chemical Structure-Dexamethasone Tablets

C22H29FO5

MW 392.47


Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 0.5 mg tablet contains D&C Yellow #10 and FD&C Yellow #5. The 0.75 mg tablet contains D&C Yellow #10 and FD&C Blue #1. The 1.5 mg tablet contains FD&C Red #40. The 6 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6.

Dexamethasone Manufacturers


  • Blenheim Pharmacal, Inc.
    Dexamethasone Tablet [Blenheim Pharmacal, Inc.]
  • A-s Medication Solutions Llc
    Dexamethasone Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Dexamethasone Tablet [A-s Medication Solutions Llc]
  • Agri Laboratories Ltd.
    Dexamethasone Injection, Solution [Agri Laboratories Ltd.]
  • A-s Medication Solutions Llc
    Dexamethasone Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Dexamethasone Tablet [A-s Medication Solutions Llc]
  • Dexamethasone (Dexamethasone) Tablet Dexamethasone (Dexamethasone) Solution, Concentrate Dexamethasone (Dexamethasone) Solution
  • Roxane Laboratories, Inc
    Dexamethasone Tablet Dexamethasone Intensol Solution, Concentrate Dexamethasone Solution [Roxane Laboratories, Inc]
  • Physicians Total Care, Inc
    Dexamethasone Tablet [Physicians Total Care, Inc]
  • Vettek
    Dexamethasone Injection [Vettek]
  • Ecr Pharmaceuticals
    Dexamethasone Tablet [Ecr Pharmaceuticals]
  • Ecr Pharmaceuticals
    Dexamethasone Tablet [Ecr Pharmaceuticals]
  • Ecr Pharmaceuticals
    Dexamethasone Tablet [Ecr Pharmaceuticals]
  • Physicians Total Care, Inc.
    Dexamethasone Tablet [Physicians Total Care, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Dexamethasone Tablet [Pd-rx Pharmaceuticals, Inc.]
  • H.j. Harkins Company, Inc.
    Dexamethasone Tablet [H.j. Harkins Company, Inc.]
  • Dispensing Solutions, Inc.
    Dexamethasone Tablet [Dispensing Solutions, Inc.]
  • Rebel Distributors Corp
    Dexamethasone Tablet [Rebel Distributors Corp]
  • Cardinal Health
    Dexamethasone Tablet [Cardinal Health]
  • Rebel Distributors Corp
    Dexamethasone Tablet [Rebel Distributors Corp]
  • Par Pharmaceutical Inc.
    Dexamethasone Tablet [Par Pharmaceutical Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Dexamethasone Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Ecr Pharmaceuticals
    Dexamethasone Tablet [Ecr Pharmaceuticals]
  • Stat Rx Usa Llc
    Dexamethasone Tablet [Stat Rx Usa Llc]
  • Bryant Ranch Prepack
    Dexamethasone Tablet [Bryant Ranch Prepack]
  • Clipper Distributing Company, Llc
    Dexamethasone Injection, Solution [Clipper Distributing Company, Llc]
  • Vettek
    Dexamethasone Injection, Solution [Vettek]
  • Agri Laboratories, Ltd.
    Dexamethasone Injection, Solution [Agri Laboratories, Ltd.]
  • Vedco, Inc.
    Dexamethasone Injection, Solution [Vedco, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Dexamethasone Tablet [Pd-rx Pharmaceuticals, Inc.]
  • A-s Medication Solutions Llc
    Dexamethasone Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Dexamethasone Tablet [A-s Medication Solutions Llc]
  • Preferred Pharmaceuticals, Inc
    Dexamethasone Tablet [Preferred Pharmaceuticals, Inc]
  • Pd-rx Pharmaceuticals, Inc.
    Dexamethasone Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Aidarex Pharmaceuticals Llc
    Dexamethasone Tablet [Aidarex Pharmaceuticals Llc]
  • Clipper Distributing Company, Llc.
    Dexamethasone Injection, Solution [Clipper Distributing Company, Llc.]
  • Bryant Ranch Prepack
    Dexamethasone Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Dexamethasone Tablet [Bryant Ranch Prepack]
  • Proficient Rx Lp
    Dexamethasone Tablet [Proficient Rx Lp]

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