Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/42
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Dexamethasone Sodium Phosphate (Injection)
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Dexamethasone
Sodium Phosphate Injection, 4 mg/mL-For
intravenous, intramuscular, intra-articular, intralesional and soft
tissue injection. Dexamethasone
Sodium Phosphate Injection, 10 mg/mL-For
intravenous and intramuscular injection only. Dexamethasone
Sodium Phosphate Injection can be given directly from the vial or it can
be added to Sodium Chloride Injection or Dextrose Injection and
administered by intravenous drip. Solutions used for
intravenous administration or further dilution of this product should be
preservative-free when used in the neonate, especially the premature
infant. When it is mixed
with an infusion solution, sterile precautions should be observed. Since
infusion solutions generally do not contain preservatives, mixtures
should be used within 24 hours. DOSAGE REQUIREMENTS ARE VARIABLE AND MUST
BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF
THE PATIENT.<br/>INTRAVENOUS AND
INTRAMUSCULAR INJECTION: The initial
dosage of Dexamethasone Sodium Phosphate Injection varies from
0.5 to 9 mg a day depending on the disease being treated. In
less severe diseases doses lower than 0.5 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial
dosage should be maintained or adjusted until the patient's
response is satisfactory. If a satisfactory clinical response
does not occur after a reasonable period of time, discontinue
Dexamethasone Sodium Phosphate Injection and transfer the
patient to other therapy. After a
favorable initial response, the proper maintenance dosage should
be determined by decreasing the initial dosage in small amounts
to the lowest dosage that maintains an adequate clinical
response. Patients
should be observed closely for signs that might require dosage
adjustment, including changes in clinical status resulting from
remissions or exacerbations of the disease, individual drug
responsiveness and the effect of stress (e.g., surgery,
infection, trauma). During stress it may be necessary to
increase dosage temporarily. If the drug
is to be stopped after more than a few days of treatment, it
usually should be withdrawn gradually. When the
intravenous route of administration is used, dosage usually
should be the same as the oral dosage. In certain overwhelming,
acute, life-threatening situations, however, administration in
dosages exceeding the usual dosages may be justified and may be
in multiples of the oral dosages. The slower rate of absorption
by intramuscular administration should be
recognized.<br/>Shock: There is a tendency in current medical practice to use
high (pharmacologic) doses of corticosteroids for the
treatment of unresponsive shock. The following dosages
of Dexamethasone Sodium Phosphate Injection have been
suggested by various authors: Administration of high dose corticosteroid therapy
should be continued only until the patient's condition
has stabilized and usually not longer than 48 to 72
hours. Although adverse reactions associated with high dose, short term corticosteroid therapy are uncommon, peptic
ulceration may occur.<br/>Cerebral
Edema: Dexamethasone Sodium Phosphate Injection is generally
administered initially in a dosage of 10 mg
intravenously followed by four 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 two mg two or three times a day may be
effective.<br/>Acute
Allergic Disorders: 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, 4 mg/mL -First day, 1
or 2 mL (4 or 8 mg) intramuscularly. Dexamethasone tablets, 0.75 mg - Second and third days,
4 tablets in two divided doses each day; fourth day 2 tablets
in two divided doses; fifth
and sixth days, 1 tablet each day;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.<br/>Intra-articular,
Intralesional and Soft Tissue Injection: Intra-articular, intralesional and soft tissue injections are
generally employed when the affected joints or areas are limited
to one or two sites. Dosage and frequency of injection varies
depending on the condition and the site of injection. The usual
dose is from 0.2 to 6 mg. The frequency usually ranges from once
every three to five days to once every two to three weeks.
Frequent intra-articular injection may result in damage to joint
tissues. Some of the usual single doses are: Dexamethasone Sodium Phosphate Injection is particularly
recommended for use in conjunction with one of the less soluble,
longer-acting steroids for intra-articular and soft tissue
injection. Parenteral drug products should be
inspected visually for particulate matter and discoloration
prior to administration, whenever the solution and container
permit.
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| dailymed-instance:descripti... |
Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or
slightly yellow crystalline powder. It is freely soluble in water and is
exceedingly hygroscopic. The molecular weight is 516.41. It is
designated chemically as
9-fluoro-11��,17-dihydroxy-16��-methyl-21-(phosphonooxy)pregna-1,4-diene-3,
20-dione disodium salt. The molecular
formula is: CHFNaOP
and the structural formula is: Dexamethasone
Sodium Phosphate Injection is a sterile solution of dexamethasone sodium
phosphate for intravenous and intramuscular use. The 4 mg/mL strength
may also be used for intra-articular, intralesional and soft tissue
administration. Each mL of
Dexamethasone Sodium Phosphate Injection 4 mg/mL contains dexamethasone
sodium phosphate, equivalent to 4 mg dexamethasone phosphate or 3.33 mg
dexamethasone. Inactive ingredients per mL: 1 mg sodium sulfite
anhydrous, 19.4 mg sodium citrate anhydrous and 10.42 mg (0.01 mL)
benzyl alcohol (preservative) in Water for Injection. Each mL of
Dexamethasone Sodium Phosphate Injection 10 mg/mL contains dexamethasone
sodium phosphate, equivalent to 10 mg dexamethasone phosphate or 8.33 mg
dexamethasone. Inactive ingredients per mL: 1.5 mg sodium sulfite
anhydrous, 16.5 mg sodium citrate anhydrous and 10.42 mg (0.01 mL)
benzyl alcohol (preservative) in Water for Injection. The pH of both
concentrations is 7.0-8.5; sodium hydroxide and/or citric acid used, if
needed, for pH adjustment. Sealed under nitrogen.
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Dexamethasone
sodium phosphate injection has a rapid onset but short duration of
action when compared with less soluble preparations. Because of this, it
is suitable for the treatment of acute disorders responsive to
adrenocortical steroid therapy. Naturally occurring
glucocorticoids (hydrocortisone and cortisone), which also have
salt-retaining properties, are used as replacement therapy in
adrenocortical deficiency states. Their synthetic analogs, including
dexamethasone, are primarily used for their potent anti-inflammatory
effects in disorders of many organ systems. Glucocorticoids
cause profound and varied metabolic effects. In addition, they modify
the body's immune responses to diverse stimuli. 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 (see WARNINGS
regarding amphotericin B). Hypersensitivity to
any component of this product, including sulfites .
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Dexamethasone
Sodium Phosphate Injection, USP is available in the following package: 10 mg/mL 1 mL DOSETTE vials
packaged in 25s (NDC 0641-0367-25)<br/>Storage: Protect from light: Keep covered in
carton until time of use. Store at 20��-25��C (68��-77��F),
excursions permitted to 15��-30��C (59��-86��F) [see USP
Controlled Room Temperature]. Avoid freezing. Do not use if
solution is hazy or has a precipitate. Do not
autoclave.
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General: This
product, like many other steroid formulations, is sensitive to
heat. Therefore, it should not be autoclaved when it is
desirable to sterilize the exterior of the vial. 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. There is an
enhanced effect of corticosteroids in patients with
hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with
ocular herpes simplex for fear of corneal perforation. The lowest
possible dose of corticosteroid should be used to control the
condition under treatment, and when reduction in dosage is
possible, the reduction must be gradual. 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. Aspirin
should be used cautiously in conjunction with corticosteroids in
hypoprothrombinemia. Steroids
should be used with caution in nonspecific ulcerative colitis,
if there is a probability of impending perforation, abscess, or
other pyogenic infection, also in 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. When large
doses are given, some authorities advise that antacids be administered between meals to help prevent peptic ulcer. Growth and
development of infants and children on prolonged corticosteroid
therapy should be carefully followed. Steroids
may increase or decrease motility and number of spermatozoa in
some patients. 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 (DST) in
patients being treated with indomethacin have been reported.
Thus, results of the DST should be interpreted with caution in
these patients. 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. Intra-articular injection of a corticosteroid may produce
systemic as well as local effects. Appropriate
examination of any joint fluid present is necessary to exclude a
septic process. A marked
increase in pain accompanied by local swelling, further
restriction of joint motion, fever and malaise is suggestive of
septic arthritis. If this complication occurs and the diagnosis
of sepsis is confirmed, appropriate antimicrobial therapy should
be instituted. Injection
of a steroid into an infected site is to be avoided. Corticosteroids should not be injected into unstable joints. Patients
should be impressed strongly with the importance of not
overusing joints in which symptomatic benefit has been obtained
as long as the inflammatory process remains active. Frequent
intra-articular injection may result in damage to joint tissues. The slower
rate of absorption by intramuscular administration should be
recognized.<br/>Information for
Patients: Persons who
are on immunosuppressant doses of 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.
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Reports of acute
toxicity and/or death following overdosage of glucocorticoids are rare.
In the event of overdosage, no specific antidote is available; treatment
is supportive and symptomatic. The oral
LDof dexamethasone in female mice was 6.5 g/kg. The
intravenous LDof dexamethasone sodium phosphate in female
mice was 794 mg/kg.
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Dexamethasone Sodium Phosphate
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Dexamethasone Sodium Phosphate (Injection)
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Fluid and
Electrolyte Disturbances: Sodium
retention Fluid
retention Congestive
heart failure in susceptible patients Potassium
loss Hypokalemic
alkalosis Hypertension<br/>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<br/>Gastrointestinal: Peptic
ulcer with possible subsequent perforation and hemorrhage Perforation
of the small and large bowel, particularly in patients with
inflammatory bowel disease Pancreatitis Abdominal
distention Ulcerative
esophagitis<br/>Dermatologic: Impaired
wound healing Thin,
fragile skin Petechiae
and ecchymoses Erythema Increased
sweating May
suppress reactions to skin tests Burning or
tingling, especially in the perineal area (after IV injection) Other
cutaneous reactions, such as allergic dermatitis, urticaria,
angioneurotic edema<br/>Neurologic: Convulsions Increased
intracranial pressure with papilledema (pseudotumor cerebri)
usually after treatment Vertigo Headache Psychic
disturbances<br/>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
diabetics Hirsutism<br/>Ophthalmic: Posterior
subcapsular cataracts Increased
intraocular pressure Glaucoma Exophthalmos<br/>Metabolic: Negative
nitrogen balance due to protein catabolism<br/>Cardiovascular: Myocardial
rupture following recent myocardial infarction<br/>Other: Anaphylactoid or hypersensitivity reactions Thromboembolism Weight gain Increased
appetite Nausea Malaise Hiccups The
following additional
adverse reactions are related to parenteral corticosteroid
therapy: Rare
instances of blindness associated with intralesional therapy
around the face and head Hyperpigmentation or hypopigmentation Subcutaneous and cutaneous atrophy Sterile
abscess Postinjection flare (following intra-articular use) Charcot-like arthropathy
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Because rare
instances of anaphylactoid reactions have occurred in patients receiving
parenteral corticosteroid therapy, appropriate precautionary measures
should be taken prior to administration, especially when the patient has
a history of allergy to any drug. Anaphylactoid and hypersensitivity
reactions have been reported for Dexamethasone Sodium Phosphate
Injection (see ADVERSE
REACTIONS). Dexamethasone
Sodium Phosphate Injection contains sodium sulfite, a sulfite that may
cause allergic-type reactions including anaphylactic symptoms and
life-threatening or less severe asthmatic episodes in certain
susceptible people. The overall prevalence of sulfite sensitivity in the
general population is unknown and probably low. Sulfite sensitivity is
seen more frequently in asthmatic than in nonasthmatic people. 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 followedby cardiac enlargement and congestive failure. In patients on
corticosteroid therapy subjected to unusual stress, increased dosage of
rapidly acting corticosteroids before, during and after the stressful
situation is indicated. 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, hormone therapy should be reinstituted. If
the patient is receiving steroids already, dosage may have to be
increased. Since mineralocorticoid secretion may be impaired, salt
and/or a mineralocorticoid should be administered concurrently. Corticosteroids may
mask some signs of infection, and new infections may appear during their
use. There may be decreased resistance and inability to localize
infections when corticosteroids are used. Moreover, corticosteroids may
affect the nitroblue-tetrazolium test for bacterial infection and
produce false-negative results. In cerebral
malaria, a double blind trial has shown that 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. 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. Average and large
doses of cortisone or hydrocortisone 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. Administration of
live virus vaccines, including smallpox, 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. Persons 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, particularcare should be taken to avoid
exposure. How the dose, route and duration of corticosteroid
administration affects the risk of developing a disseminated infection
is unknown. 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 pool intramuscular
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. The use of Dexamethasone Sodium Phosphate Injection 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 antituberculosis 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. 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/>Usage in Pregnancy: Since
adequate human reproduction studies have not been done with
corticosteroids, use of these drugs in pregnancy or in women of
childbearing potential requires that the anticipated benefits be
weighed against the possible hazards to the mother and embryo or
fetus. Infants born of mothers who have received substantial
doses of corticosteroids during pregnancy should be carefully
observed for signs of hypoadrenalism. 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.
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A. By Intravenous
or Intramuscular Injection When Oral Therapy is not Feasible::<br/>1.
Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice;
synthetic analogs may be used in conjunction with
mineralocorticoids where applicable; in infancy,
mineralocorticoid supplementation is of particular
importance) Acute adrenocortical insufficiency (hydrocortisone or
cortisone is the drug of choice; mineralocorticoid
supplementation may be necessary, particularly when
synthetic analogs are used) Preoperatively, and in the event of serious trauma or
illness, in patients with known adrenal insufficiency or
when adrenocortical reserve is doubtful Shock unresponsive to conventional therapy if
adrenocortical insufficiency exists or is suspected Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer<br/>2.
Rheumatic Disorders: As
adjunctive therapy for short-term administration (to
tide the patient over an acute episode or exacerbation)
in: Post-traumatic osteoarthritis Synovitis of osteoarthritis Rheumatoid arthritis, including juvenile rheumatoid
arthritis (selected cases may require low-dose
maintenance therapy) Acute and subacute bursitis Epicondylitis Acute nonspecific tenosynovitis Acute gouty arthritis Psoriatic arthritis Ankylosing spondylitis<br/>3. Collagen
Diseases: During an exacerbation or as maintenance therapy in
selected cases of: Systemic lupus erythematosus Acute rheumatic carditis<br/>4.
Dermatologic Diseases: Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Bullous dermatitis herpetiformis Severe seborrheic dermatitis Severe psoriasis Mycosis fungoides<br/>5. Allergic
States: Control of severe or incapacitating allergic conditions
intractable to adequate trials of conventional treatment
in: Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Urticarial transfusion reactions Acute noninfectious laryngeal edema (epinephrine is the drug of first choice)<br/>6.
Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory
processes involving the eye, such as: Herpes zoster ophthalmicus Iritis, iridocyclitis Chorioretinitis Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia Anterior segment inflammation Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers<br/>7.
Gastrointestinal Diseases: To
tide the patient over a critical period of the disease
in: Ulcerative colitis (Systemic therapy) Regional enteritis (Systemic therapy)<br/>8.
Respiratory Diseases: Symptomatic sarcoidosis Berylliosis Fulminating or disseminated pulmonary tuberculosis when
used concurrently with appropriate antituberculous
chemotherapy Loeffler's syndrome not manageable by other means Aspiration pneumonitis<br/>9.
Hematologic Disorders: Acquired (autoimmune) hemolytic anemia Idiopathic thrombocytopenic purpura in adults (IV only;
IM administration is contraindicated) Secondary thrombocytopenia in adults Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia<br/>10.
Neoplastic Diseases: For
palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood<br/>11.
Edematous States: To
induce diuresis or remission of proteinuria in the
nephrotic syndrome, without uremia, of the idiopathic
type, or that due to lupus erythematosus<br/>12.
Miscellaneous: Tuberculous meningitis with subarachnoid block or
impending block when used concurrently with appropriate
antituberculous chemotherapy Trichinosis with neurologic or myocardial
involvement<br/>13.
Diagnostic Testing Of Adrenocortical Hyperfunction:<br/>14.
Cerebral Edema associated with primary or metastatic brain
tumor, craniotomy or head injury. Use in cerebral edema is
not a substitute for careful neurosurgical evaluation and
definitive management such as neurosurgery or other specific
therapy.:<br/>B. By
Intra-Articular or Soft Tissue Injection: As
adjunctive therapy for short-term administration (to tide the
patient over an acute episode or exacerbation) in: Synovitis
of osteoarthritis Rheumatoid
arthritis Acute and
subacute bursitis Acute gouty
arthritis Epicondylitis Acute
nonspecific tenosynovitis Post-traumatic osteoarthritis<br/>C. By Intralesional
Injection: Keloids Localized
hypertrophic, infiltrated, inflammatory lesions of: lichen
planus, psoriatic plaques, granuloma annulare, and lichen
simplex chronicus (neurodermatitis) Discoid
lupus erythematosus Necrobiosis
lipoidica diabeticorum Alopecia
areata May also be
useful in cystic tumors of an aponeurosis or tendon
(ganglia).
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Dexamethasone Sodium Phosphate
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