Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/300
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Decadron (Tablet)
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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. 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 bestopped, 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is recommended that it be withdrawn gradually rather than abruptly.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 (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 to 0.3 mg/kg/day in three or four divided doses (0.6
to 9 mg/mbsa/day). For the purpose of comparison, the following is
the equivalent milligram dosage of the various corticosteroids: 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, USP 4 mg per mL: First
Day 1 or 2 mL, intramuscularly DECADRON 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,
USP 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, USP or DECADRON tablets ina dosage of 2 mg
two or three times daily may be effective.<br/>Dexamethasone suppression tests:
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DECADRON(dexamethasone tablets, USP) tablets, for oral administration, are
supplied in two potencies, 0.5 mg and 0.75 mg. Inactive
ingredients are calcium phosphate, lactose, magnesium stearate, and
starch. Tablets DECADRON 0.5 mg also contain D&C Yellow 10
and FD&C Yellow 6. Tablets DECADRON 0.75 mg also contain
FD&C Blue 1.
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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.
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Systemic fungal infections . DECADRON tablets are contraindicated in
patients who are hypersensitive to any components of this product.
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Tablets DECADRON are compressed, pentagonal-shaped
tablets, colored to distinguish potency. They are scored and coded
on one side and embossed with DECADRON on the other. They are available
as follows: No. 7601----0.75 mg, bluish-green
in color and coded MSD 63. NDC 0006-0063-12 5-12 PAK(package
of 12) NDC 0006-0063-68 bottles
of 100. No. 7598----0.5 mg, yellow in color
and coded MSD 41. NDC 0006-0041-68
bottles of 100.<br/>Storage: Store at controlled room temperature 20 to 25��C
(68 to 77��F). Rx only Merck&Co., Inc., Whitehouse Station, NJ 08889, USA Issued May 2004 Printed in
USA 7921151
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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's sarcoma has been reported
to occur in patients receiving corticosteroid therapy, most often
for chronic conditions. Discontinuation of corticosteroids may result
in clinical improvement.<br/>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.<br/>Endocrine: Drug-induced secondary adrenocortical insufficiency
may be minimized by gradual reduction of dosage. This type of relativeinsufficiency 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.<br/>Gastrointestinal: Steroids should be used with caution in active or
latent peptic ulcers, diverticulitis, fresh intestinal anastomoses,
and nonspecific ulcerative colitis, since they may increase the risk
of a perforation. Signs of peritoneal irritation
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
with cirrhosis.<br/>Musculoskeletal: Corticosteroids decrease bone formation and increase
bone resorption both through their effect on calcium regulation (i.e.,
decreasing absorption and increasing excretion) and inhibition of
osteoblast function. 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., postmenopausal women) before initiating
corticosteroid therapy.<br/>Neuro-psychiatric: Although controlled clinical trials have shown corticosteroids
to be effective in speeding the resolution of acute exacerbations
of multiple sclerosis, 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. An acute myopathy has been observed with
the use of high doses of corticosteroids, most often occurring in
patients with disorders of neuromuscular transmission (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 in quadriparesis.
Elevation of creatinine kinase 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.<br/>Ophthalmic: Intraocular pressure may become elevated in some
individuals. If steroid therapy is continued for more than 6 weeks,
intraocular pressure should be monitored.<br/>Information for Patients: 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 an acute illness including 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.<br/>Drug Interactions: 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. Antibiotics: Macrolide
antibiotics have been reported to cause a significant decrease in
corticosteroid clearance (see Drug Interactions, Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids
may produce severe weakness in patients with myasthenia 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,
coagulation indices should be monitored frequently to maintain the
desired anticoagulant effect. Antidiabetics: Because corticosteroids
may increase blood glucose concentrations, 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 lessened physiologic activity, thus
requiring an increase in corticosteroid dosage. Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of 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 as erythromycin) have the potential
to result in increased plasma concentrations of corticosteroids. Dexamethasone
is a moderate inducer of CYP 3A4. Co-administration with other drugs
that are metabolized by CYP 3A4 (e.g.,
indinavir, erythromycin) may increase their clearance, resulting
in decreased plasma concentration. Ketoconazole: 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
synthesis and may cause adrenal insufficiency during corticosteroid
withdrawal. Nonsteroidal
anti-inflammatory agents (NSAIDS): Concomitant use of aspirin
(or other nonsteroidal anti-inflammatory agents) and corticosteroids
increases the risk of gastrointestinal side effects. Aspirin 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 alterations in seizure
control. Skin tests: Corticosteroids may suppress reactions to skin tests. Thalidomide: Co-administration
with thalidomide should be employed cautiously, as toxic epidermal
necrolysis has been reported with concomitant use. Vaccines: Patients on corticosteroid
therapy may exhibit a diminished response to toxoids and live or inactivated
vaccines due to inhibition of antibody response. Corticosteroids may
also potentiate the replication of some organisms contained in live
attenuated vaccines. Routine administration of vaccines or toxoids
should be deferred until corticosteroid therapy is discontinued if
possible (see WARNINGS,
Infections, Vaccination).<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No adequate studies have been conducted in animals
to determine whether corticosteroids have a potential for carcinogenesis
or mutagenesis. Steroids may increase or decrease
motility and number of spermatozoa in some patients.<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category C.: Corticosteroids have been shown to be teratogenic
in 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 of cleft
palate in the offspring. There are no adequate and well-controlled
studies in pregnant women. Corticosteroidsshould 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.<br/>Nursing Mothers: Systemically administered corticosteroids appear
in human milk and could suppress growth, interfere with endogenous
corticosteroid 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.<br/>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>1 month
of age). Other indications for pediatric use of corticosteroids, e.g.,
severe asthma and wheezing, are based on adequate and well-controlled
trials conducted in adults, on the premises that the course of the
diseases and their pathophysiology are considered to be substantially
similar in both populations. The adverse effects
of corticosteroids in pediatric patients are similar to those in adults
(see ADVERSE
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 basalcortisol plasma levels). Growth velocity may
therefore be a more sensitive indicator of systemic corticosteroid
exposure in pediatric patients 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 lowest effective dose.<br/>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 elderly 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.
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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.
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Dexamethasone
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Decadron (Tablet)
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General: Rare instances of anaphylactoid reactions have occurred
in patients receiving corticosteroid therapy . 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.<br/>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.<br/>Endocrine: Corticosteroids can produce reversible hypothalamic-pituitary
adrenal (HPA) axis suppression with the potential for glucocorticosteroid
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.<br/>Infections:<br/>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 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.<br/>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 ).<br/>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.<br/>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.<br/>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.<br/>Viral Infections: Chickenpox and measles can have a more serious or
even fatal course in pediatric 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, prophylaxiswith 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 should be considered.<br/>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.
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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 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.
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Decadron
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