Decadron_Tablets (Dexamethasone)

DECADRON® Tablets

MSD

Dexamethasone

Corticosteroid

Indications And Clinical Uses: Allergic States: Control of severe or incapacitating allergic conditions not responsive to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.

Rheumatic Disorders: as adjunctive therapy for short-term administration during an acute episode or exacerbation of: psoriatic arthritis, rheumatoid arthritis including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis.

Dermatologic Diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis.

Ophthalmic Diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia.

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; nonsuppurative thyroiditis; hypercalcemia associated with cancer.

Respiratory Diseases: symptomatic sarcoidosis, Laffler’s syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculous chemotherapy, aspiration pneumonitis.

Hematologic Disorders: idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.

Neoplastic Diseases: For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.

Edematous States: To induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia, of the idiopathic type or that due to lupus erythematosus.

Cerebral Edema: Dexamethasone may be administered orally to treat patients with cerebral edema from various causes. Patients with cerebral edema associated with primary or metastatic brain tumors may benefit from oral administration of dexamethasone. It may be used also in the preoperative preparation of patients with increased intracranial pressure secondary to brain tumors, and also for palliation of patients with inoperable or recurrent brain neoplasms, and in the management of cerebral edema associated with neurosurgery. Some patients with cerebral edema due to head injury or pseudotumor cerebri also may benefit from therapy with oral dexamethasone. Its use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.

Gastrointestinal Diseases: During a critical period of the disease in: ulcerative colitis, regional enteritis.

Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when concurrently accompanied by appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus, acute rheumatic carditis. In combination with ondansetron for the management of nausea and vomiting associated with cisplatin and non-cisplatin emetogenic chemotherapy.

Diagnostic testing of adrenocortical hyperfunction.

Contra-Indications: systemic fungal infections; hypersensitivity to any components of this drug; administration of live virus vaccine (see Warnings).

Manufacturers’ Warnings In Clinical States: Administration of live virus vaccines is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained. However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison’s disease.

The use of dexamethasone 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.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions due to amphotericin B. Moreover, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive failure.

In cerebral malaria, the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding.

Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.

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.

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.

Pregnancy: Since human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy or women of child-bearing potential requires that the anticipated benefits be weighed against the potential hazards to the mother, the embryo or the fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Lactation: Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.

Precautions: The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt, 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.

Drug-induced secondary 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, corticosteroid therapy should be reinstituted or the current dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency.

Steroids should be used with caution in: nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer, renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Fat embolism has been reported as a possible complication of hypercortisonism.

There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability of psychotic tendencies may be aggravated by corticosteroids.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Steroids may increase or decrease motility and number of spermatozoa in some patients.

Drug Interactions: ASA should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Phenytoin, phenobarbital, ephedrine and rifampin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs.

False-negative results in the dexamethasone suppression test in patients being treated with indomethacin have been reported.

The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies.

When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.

Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false-negative results.

Patients who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. The risk of developing a disseminated infection varies among individuals and may be related to the dose, route and duration of corticosteroid administration as well as to the underlying disease. Exposed patients should be advised to seek medical advice without delay. If exposed to measles, prophylaxis with i.m. pooled immunoglobulin (IG) may be indicated. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated (see the respective Product Monographs for VZIG and IG for complete prescribing information). If chickenpox develops, treatment with antiviral agents should be considered.

Adverse Reactions: Fluid and Electrolyte Disturbances: sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension.

Musculoskeletal: muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, tendon rupture.

Gastrointestinal: peptic ulcer with possible perforation and hemorrhage, perforation of the small and large bowel, particularly in patients with inflammatory bowel diseases. Pancreatitis; abdominal distention; ulcerative esophagitis.

Dermatologic: impaired wound healing; thin fragile skin; petechiae and ecchymoses; erythema; increased sweating; may suppress reactions to skin tests; other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema.

Neurologic: convulsions; increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment; vertigo; headache; psychic disturbances.

Endocrine: menstrual irregularities; development of cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; increased requirements for insulin or oral hypoglycemic agents in diabetes; hirsutism.

Ophthalmic: posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos.

Metabolic: negative nitrogen balance due to protein catabolism.

Cardiovascular: myocardial rupture following recent myocardial infarction (see Precautions).

Other: hypersensitivity; thromboembolism; weight gain; increased appetite; nausea; malaise; hiccups.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: There is no known antidote but gastric lavage should be performed.

Dosage And Administration: Dosage requirements are variable and must be individualized according to the severity of the disease and the response of the patient. The usual initial dosage varies from 0.5 to 15 mg a day depending on the disease being treated. (For infants and children, the recommended doses usually will have to be reduced, but dosage should be dictated by the severity of the condition rather than by age or body weight.)

Corticosteroid therapy is an adjunct to, not a replacement of conventional therapy, which should be instituted as indicated.

Dosage must be decreased or therapy discontinued gradually when administration has been continued for more than a few days.

In acute conditions where prompt relief is urgent, large doses are permissible and may be mandatory for a short period. When symptoms have been suppressed adequately, dosage should be maintained at the minimum amount capable of providing sufficient relief without excessive hormonal effects.

Chronic conditions are subject to periods of spontaneous remission. When such periods occur, corticosteroids should be discontinued gradually.

Routine laboratory studies such as urinalysis, 2-hour post-prandial blood sugar, determinations of blood pressure and body weight, and a chest x-ray should be carried out at regular intervals during prolonged therapy. Periodic determinations of serum potassium are advisable if large doses are being used.

Patients may be transferred to dexamethasone from any other glucocorticoid with the proper adjustment in dosage.

Milligram for milligram, dexamethasone is approximately equivalent to betamethasone, 4 to 6 times more potent than methylprednisolone and triamcinolone, 6 to 8 times more potent than prednisone and prednisolone, 25 to 30 times more potent than hydrocortisone, and about 35 times more potent than cortisone. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

Specific Dosage Recommendations: In chronic, usually nonfatal diseases including endocrine and chronic rheumatic disorders, edematous states, respiratory and gastrointestinal diseases, some dermatologic diseases and hematologic disorders, start with a low dose (0.5 to 1 mg a day) and gradually increase dosage to the smallest amount that gives the desired degree of symptomatic relief.

Dosage may be administered 2, 3 or 4 times a day.

In congenital adrenal hyperplasia, the usual daily dose is 0.5 to 1.5 mg.

In acute, nonfatal diseases, including allergic states, ophthalmic diseases, acute and subacute rheumatic disorders, dosage ranges between 2 and 3 mg a day, however, higher doses are necessary in some patients. Since the course of these conditions is self-limited, prolonged maintenance therapy is not usually necessary.

Antiemetic Prophylaxis During Emetogenic Chemotherapy, dexamethasone administered concomitantly with ondansetron has been demonstrated to achieve enhanced efficacy for antiemetic prophylaxis during emetogenic chemotherapy. Various dosing schedules have been used in clinical studies; however, the following is suggested for this combination: 8 to 20 mg of dexamethasone infused over 5 to 15 minutes just prior to chemotherapy, followed by 4 mg of dexamethasone orally every 4 to 6 hours, or by 8 mg orally every 8 hours, and tapered in either strength or frequency of administration over 2 to 3 days. In general the total treatment duration for this indication should not exceed 5 days beyond chemotherapy. Alternatively, injectable dexamethasone can be infused i.v. in lieu of an oral formulation of dexamethasone using various schedules.

For the recommended dosing of ondansetron, see the Product Monograph for Zofran.

Admixtures containing 8 mg of ondansetron and 20 mg of dexamethasone phosphate, in 50 mL of 5% dextrose infusion fluid stored in 50 mL polyvinyl chloride infusion bags, have been shown to be physically and chemically stable for up to 2 days at room temperature or up to seven days at 2 to 8°C. In addition, these same admixtures have demonstrated compatibility with Continu-Flo administration sets.

In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders (e.g., acute allergic rhinitis, acute attacks of seasonal allergic bronchial asthma, urticaria medicamentosa, and contact dermatoses), the following dosage schedule, combining parenteral and oral therapy.

In chronic, potentially fatal diseases such as systemic lupus erythematosus, pemphigus, symptomatic sarcoidosis, the recommended initial dosage is 2 to 4.5 mg a day; higher doses may be necessary in some patients.

When the disease is acute and life-threatening (e.g., acute rheumatic carditis, crisis of systemic lupus erythematosus, severe allergic reactions, pemphigus, neoplastic diseases), the initial dosage is between 4 and 10 mg a day, administered in at least 4 divided doses.

Epinephrine is the drug of immediate choice in severe allergic reactions. Dexamethasone is useful either concurrently or as supplementary therapy.

In cerebral edema, when maintenance therapy is required. For palliative management of patients with recurrent or inoperable brain tumors, a dosage of 2 mg 2 or 3 times a day may be effective. The smallest dosage necessary to control cerebral edema should be utilized.

In the adrenogenital syndrome, daily dosages of 0.5 to 1.5 mg may keep children in remission and prevent the recurrence of abnormal excretion of 17-ketosteroids.

As massive therapy in certain conditions, such as acute leukemia, the nephrotic syndrome, and pemphigus, the recommended dosage is from 10 to 15 mg a day. Patients receiving such a high dosage must be observed very closely for the appearance of severe reactions.

Dexamethasone Suppression Test: 1. Tests for Cushing’s syndrome: Give 1 mg 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 dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

2. 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.

Availability And Storage: 0.5 mg: Each white compressed, pentagonal-shaped tablet, scored on one side with MSD 41 on the other, contains: dexamethasone 0.5 mg. Nonmedicinal ingredients: calcium phosphate dibasic, cornstarch, lactose and magnesium stearate. Gluten- and tartrazine-free. Bottles of 100.

4 mg: Each white compressed, pentagonal shaped tablet, scored on one side with MSD 97 on the other, contains: dexamethasone 4 mg. Nonmedicinal ingredients: calcium phosphate dibasic, cornstarch, lactose and magnesium stearate. Gluten- and tartrazine-free. Bottles of 50.

Store at 15 to 30°C.

DECADRON® Tablets MSD Dexamethasone Corticosteroid

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