Dexabliss

What is Dexabliss and how is it used?

Dexabliss is a prescription medicine used to treat the symptoms of inflammation,multiple sclerosis,cerebral edema,shock, allergic conditions, andmultiple myeloma. Dexabliss may be used alone or with other medications.

Dexabliss belongs to a class of drugs called Corticosteroids; Anti-Inflammatory Agents.

What are the possible side effects of Dexabliss?

Dexabliss may cause serious side effects including:

• muscle tightness,
• weakness,
• limp feeling,
• blurred vision,
• tunnel vision,
• eye pain,
• seeing halos around lights,
• shortness of breath,
• swelling,
• rapid weight gain,
• severe depression,
• unusual thoughts or behavior,
• seizure(convulsions),
• bloody or tarry stools,
• coughing up blood,
• fast or slow heart rate,
• weakpulse,
• pancreatitis,
• severe pain in your upper stomach spreading to your back,
• nausea,
• vomiting,
• leg cramps,
• constipation,
• irregular heartbeats,
• fluttering in your chest,
• increased thirst or urination,
• numbness or tingling,
• severe headache,
• pounding in your neck,
• anxiety, and
• nosebleed

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Dexabliss include:

• fluid retention,
• increased appetite,
• mood changes,
• trouble sleeping,
• skin rash,
• bruising or discoloration,
• acne,
• increased sweating,
• increased hair growth,
• headache,
• dizziness,
• nausea,
• vomiting,
• upset stomach,
• changes in your menstrual periods, and
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts and waist)

告诉医生如果你有任何的副作用,bothers you or that does not go away.

These are not all the possible side effects of Dexabliss. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dexabliss
(dexamethasone) Tablets USP, 1.5 mg

DESCRIPTION

Dexamethasone Tablets USP, 1.5 mg

Each Tablet contains: Dexamethasone USP, 1.5 mg

For oral administration

Inactive Ingredients

Dexamethasone Tablets USP, 1.5 mg contain lactose monohydrate, magnesium stearate, starch and compressible sugar.

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. The molecular formula is C₂₂N₂₉FO₅. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11B,17,21 -trihydroxy-16 a – methylpregna-1,4-diene-3,20-dione and the structural formula

INDICATIONS

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 Disease

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 Disease

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 Disease 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.

DOSAGE AND ADMINISTRATION

No Information provided

HOW SUPPLIED

Dexabliss Tablets USP, 1.5 mgare supplied as white, round shaped tablets debossed “702” on one side and bisected on the opposite side the bisect on the tablet provides for a functional scoring of the tablets to ensure accurate breaking. They are supplied in packages of 39 tablets, with child-resistant closure, 11-day Dose Pack, (NDC# 71905-400-11).

Store And Dispense

Store at 20° to 25° C (68° to 77°F) [seeUSP controlled room temperature]. Protect from moisture. Dispense in a well-closed, light-resistant container as defined in the USP/NF.

Call your doctor for medical advice about your side effects. You may report side effects to FDA at 1-800-FDA-1088.

Distributed by: Levins Pharmaceuticals, LLC, Biloxi, MS 39532. Revised: Apr 2020

SIDE EFFECTS

(listed alphabetically, under each subsection)

The following adverse reactions have been reported withdexamethasoneor other corticosteroids:

Allergic Reactions

Anaphylactoid reaction,anaphylaxis,angioedema.

Cardiovascular

Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement,circulatorycollapse,congestive heart failure,fat embolism,hypertension,hypertrophic cardiomyopathyin premature infants, myocardialrupturefollowing recentmyocardial infarction(seeWARNINGS:Cardio-Renal), edemapulmonary edema,syncope,tachycardia,thromboembolism,thrombophlebitis,vasculitis.

DermatologicAcne, allergicdermatitis, dry scaly skin, ecchymoses andpetechiae,erythema, impaired wound healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair,urticaria.

Endocrine

Decreasedcarbohydrateand glucose tolerance, development ofcushingoidstate,hyperglycemia, glycosuria,hirsutism, hypetrichosis, increased requirements forinsulinor oralhypoglycemicagents indiabetes, manifestations oflatentdiabetes mellitus, menstrual irregularities, secondary adrenocortical andpituitaryunresponsiveness (particularly in times ofstress, as intrauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid And Electrolyte Disturbances

Congestiveheart failurein susceptible patients, fluid retention, hypokalemicalkalosis,potassiumloss, sodium retention, tumorlysissyndrome.

Gastrointestinal

AbdominalDistention, elevation in serum liver enzyme levels (usually reversible upon discontinuation),hepatomegaly, increased appetite, nausea, pancreatitis,peptic ulcerwith possible perforation andhemorrhage, perforation of the small andlarge intestine(particularly in patients withinflammatory bowel disease), ulcerativeesophagitis.

Metabolic Negativenitrogenbalance due to proteincatabolism.

Musculoskeletal

Aseptic necrosisoffemoraland humeral heads, loss of muscle mass, muscle weakness,osteoporosis,pathologic fracture长骨头,steroidmyopathy,tendonrupture, vertebralcompressionfractures.

Neurological/Psychiatric

Convulsions, depression, emotional instability,euphoria, headache, increased intracranial pressure withpapilledema(pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis,neuropathy,paresthesia, personality changes, psychic disorders,vertigo.

Ophthalmic

Exophthalmos,glaucoma, increasedintraocular pressure,posteriorsubcapsular cataracts.

Other

Abnormal fat deposits, decreased resistance to infection,hiccups, increased or decreased motility and number of spermatozoa,malaise, moon face, weight gain.

DRUG INTERACTIONS

Aminoglutethhimide

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 ofhypokalemia. 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.

Antibiotics

Macrolideantibiotics have been reported to cause a significant decrease incorticosteroidclearance (seeDRUG INTERACTIONS:Hepatic Enzyme Inducers, Inhibitors and Substrates).

Anticholinesterases

Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients withmyasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.

Anticoagulants, Oral

Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore,coagulationindices should be monitored frequently to maintain the desiredanticoagulanteffect.

Antidiabetics

Because corticosteroids may increaseblood glucoseconcentrations, dosage adjustments of antidiabetic agents may be required.

Antitubercular Drugs

Serum concentrations of isoniazid may be decreased.

Cholestyramine

Cholestyramine may increase the 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)

False-negative results in the dexamethasone suppression test (DST in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.

Digitalis Glycosides

Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

Ephedrine

Ephedrine may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessenedphysiologicactivity, thus requiring an increase in corticosteroid dosage.

雌激素,包括口头Contraceptives

Estrogensmay decrease the hepaticmetabolismof certain corticosteroids, thereby increasing their effect.

Hepatic Enzyme Inducers, Inhibitors And Substrates

Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g.barbiturates, phenytoin, carbamazepine, rifampin) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, macrolide antibiotics such aserythromycin) may increase their clearance, resulting in decreased plasma concentration.

Ketocanazole

ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.

Nonsteroidal Anti-inflammatory Agents (NSAIDS)

Concomitant use of asprin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk ofgastrointestinalside effects. Asprin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.

Phenytoin

In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alteration in seizure control.

Skin Tests

Corticosteroids may suppress reactions to skin tests.

Thalidomide

Co-administration with thalidomide should be employed cautiously, as toxicepidermalnecrolysis has been reported with concomitant use.

Vaccines

Pateints on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivatedvaccinesdue to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in liveattenuatedvaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (seeWARNINGS:Infections:Vaccination).

WARNINGS

General

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (seeADVERSE 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 andwater retention, and increased excretion of potassium. These effects are less likely to occur with the syntetic derivative 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 leftventricularfree wall rupture after a recent myocardial infraction; therefore, therapy with corticosteroids should be used with great caution in these patients.

Endocrine

糖皮质激素可以产生黑白棋ble hypothalamic-pituitary adrenal (HPA)axissuppression 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 therapyshould 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 hypertheroid patients. Changes inthyroidstatus of the patient may necessitate adjustment in dosage.

Infections

General

Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with anypathogen(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 otherimmunosuppressiveagents. 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 controle 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 (seePRECAUTIONS: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 byAmoeba, Candida, Cryptococcus,Mycobacterium, Nocardia,Pneumocystis, Toxoplasma.

It is recommended that the latentamebiasisor 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 sued with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroidinducedimmunosuppressionmay lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatalgram-negative septicermia.

Corticosteroids should not be used in cerebralmalaria

Tuberculosis

The use of corticosteroids inactive tuberculosisshould be restricted to those cases of fulminating or disseminatedtuberculosisin 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 ortuberculinreactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should reeivechemoprophylaxis.

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.Immunizationprocedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, E.g., for Addison’s disease.

Viral Infections

Chickenpoxandmeasles可以有一个更严重的甚至致命的体育课程吗diatric and adult 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,prophylaxiswithvaricellazoster 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 withantiviralagents should 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 secondaryocularinfections due to bacteria, fungi, orviruses. 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 ocularherpessimplex.

PRECAUTIONS

General

The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual.

Since complications of treatment with corticosteroids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

Kaposi’ssarcomahas been reported to occur in patients receiving corticosteroid therapy most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.

Cardio-Renal

As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.

Endocrine

Drug-induced secondary adrenocortical insufficiency 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. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

Gastrointestinal

Steroids should be used with caution in active or latent peptic ulcers,diverticulitis, fresh intestinal anastomoses, and nonspecificulcerative colitis, since they may increase the risk of a perforation.

Signs ofperitonealirritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent.

There is an enhanced effect due to decreased metabolism of corticosteroids in patients withcirrhosis.

Musculoskeletal

Corticosteroids decrease bone formation and increase boneresorptionboth through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition ofosteoblastfunction. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteoporosis (e.g.,绝经后women) before initiating corticosteroid therapy.

Neuro-Psychiatric

Although controlled clinical trials have shown corticosteroids to be effective in speeding theresolutionof acute exacerbations of multiplesclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (SeeDOSAGE AND ADMINISTRATION).

An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders ofneuromusculartransmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result inquadriparesis. Elevation ofcreatinekinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.

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 or psychotic tendencies may be aggravated by corticosteroids.

Ophthalmic

Intraocularpressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis ormutagenesis.

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

Pregnancy

Teratogenic Effects

Pregnancy Category C. Corticosteroids have been shown to beteratogenicin many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence ofcleft palate的后代。没有足够的和controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere withendogenouscorticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

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. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1month of age). Other indications for pediatric use of corticosteroids, e.g., severeasthmaandwheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and theirpathophysiologyare considered to be substantially similar in both populations.

在pediatri糖皮质激素的副作用c patients are similar to those in adults (seeADVERSE REACTIONS). Like adults, 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 who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basalcortisolplasma levels). Growht velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patints than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored 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 lowesteffective dose.

Geriatric Use

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elder and younger patients. 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.

OVERDOSE

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, and adequate clinical response is reached.

Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions of 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 to 12 mg every other day for one month have been shown to be effective (seePRECAUTIONS: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 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m²bsa/day).

For the purpose of comparison, the following is the equivalentmilligramdosage of the various corticosteroids:

Dexamethasone, 1.5 Methylprednisolone, 8
Prednisone, 10 Triamcinolone, 8
Prednisolone, 10 Betamethasone, 1.5
Hydrocortisone, 40 Paramethasone, 4
Cortisone, 50

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 combiningparenteraland 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 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 withrecurrentor inoperable brain tumors,maintenance therapywith 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

1. Tests for Cushing’s syndrome

Give 1.0 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.

2. 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.

CONTRAINDICATIONS

Contraindicated in systemic fungal infections (SeeWARNINGS:infections: fungal infections) and patients with known hypersensitivity to the product and its constituents.

CLINICAL PHARMACOLOGY

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from thegastrointestinal 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.

PATIENT INFORMATION

Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop ofacute illnessincluding fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including,myalgia,arthralgia, and malaise.

Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.