Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/558
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Azmacort (Aerosol, Metered)
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Adults: The usual recommended dosage is
two inhalations (150 mcg) given three to four times a day or four
inhalations (300 mcg) given twice daily. The maximal daily intake
should not exceed 16 inhalations (1200 mcg) in adults. Higher initial
doses (12 to 16 inhalations per day) may be considered in patients
with more severe asthma. Children 6 to 12 Years of Age: The usual
recommended dosage is one or two inhalations (75 to 150 mcg) given
three to four times a day or two to four inhalations (150 to 300
mcg) given twice daily. The maximal daily intake should not exceed
12 inhalations (900 mcg) in children 6 to 12 years of age. Insufficient
clinical data exist with respect to the safety and efficacy of the
administration of Azmacort Inhalation
Aerosol to children below the age of 6. The long-term effects of inhaled
steroids, including Azmacort Inhalation Aerosol, on growth are still not fully known. Rinsing the mouth after
inhalation is advised. Different considerations must be given to the following groups of
patients in order to obtain the full therapeutic benefit of Azmacort Inhalation Aerosol: Note : In all patients, it is desirable to titrate to
the lowest effective dose once asthma stability has been achieved. Patients Not Receiving Systemic Corticosteroids: Patients who require maintenance therapy of their asthma may benefit
from treatment with Azmacort Inhalation Aerosol at the doses recommended above. In patients who
respond to Azmacort Inhalation
Aerosol, improvement in pulmonary function is usually apparent within
one to two weeksafter the initiation of therapy. Patients Maintained on Systemic Corticosteroids: Clinical studies have shown that Azmacort Inhalation Aerosol may be effective in the management of asthmatics
dependent or maintained on systemic corticosteroids and may permit
replacement or significant reduction in the dosage of systemic corticosteroids. The patient's asthma
should be reasonably stable before treatment with Azmacort Inhalation Aerosol is started.
Initially, Azmacort Inhalation
Aerosol should be used concurrently with the patient's usual
maintenance dose of systemic corticosteroid. After approximately one
week, gradual withdrawal of the systemic corticosteroid is started
by reducing the daily or alternate daily dose. Reductions may be made
after an interval of one or two weeks, depending on the response of
the patient. A slow rate of withdrawal is strongly recommended. Generally,
these decrements should not exceed 2.5 mg of prednisone or its equivalent.
During withdrawal, some patients may experience symptoms of systemic
corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude,
and depression, despite maintenance or even improvement in pulmonary
function. Such patients should be encouraged to continue with the
inhaler but should be monitored for objective signs of adrenal insufficiency.
If evidence of adrenal insufficiency occurs, the systemic corticosteroid
doses should be increased temporarily and thereafter withdrawal should
continue more slowly. Inhaled corticosteroids should be used with
caution when used chronically in patients receiving prednisone regimens,
either daily or alternate day. During periods of stress or a severe asthma attack, transfer patients
may require supplementary treatment with systemic corticosteroids. Directions for Use: An illustrated leaflet
of patient instructions for proper use accompanies each package of Azmacort Inhalation Aerosol.
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dailymed-instance:descripti... |
Triamcinolone acetonide,
USP, the active ingredient in Azmacort Inhalation Aerosol, is a corticosteroid with a
molecular weight of 434.5 and with the chemical designation 9-Fluoro-11��,16��,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
cyclic 16,17-acetal with acetone. (CHFO). Azmacort Inhalation Aerosol is a metered-dose aerosol unit containing a microcrystalline
suspension of triamcinolone acetonide in the propellant dichlorodifluoromethane
and dehydrated alcohol USP 1% w/w. Each canister contains 60 mg triamcinolone
acetonide. The canister must be primed prior to the first use. After
an initial priming of 2 actuations, each actuation delivers 200 mcg
triamcinolone acetonide from the valve and 75 mcg from the spacer-mouthpiece
under defined in vitro test
conditions. The canister will remain primed for 3 days. If the canister
is not used for more than 3 days, then it should be reprimed with
2 actuations. There are at least 240 actuations in one Azmacort Inhalation Aerosol canister. After 240 actuations, the amount delivered per actuation
may not be consistent and the unit should be discarded.
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Triamcinolone acetonide
is a more potent derivative of triamcinolone. Although triamcinolone
itself is approximately one to two times as potent as prednisone in
animal models of inflammation, triamcinolone acetonide is approximately
8 times more potent than prednisone. The precise mechanism of the action of glucocorticoids in asthma
is unknown. However, the inhaled route makes it possible to provide
effective local anti-inflammatory activity with reduced systemic corticosteroid
effects. Though highly effective for asthma, glucocorticoids do not
affect asthma symptoms immediately. While improvement in asthma may
occur assoon as one week after initiation of Azmacort Inhalation Aerosol therapy, maximum improvement
may not be achieved for 2 weeks or longer. Based upon intravenous dosing of triamcinolone acetonide phosphate
ester, the half-life of triamcinolone acetonide was reported to be
88 minutes. The volume of distribution (Vd) reported was 99.5 L (SD��27.5) and clearance was 45.2 L/hour (SD��9.1) for triamcinolone
acetonide. The plasma half-life of glucocorticoids does not correlate
well with the biologic half-life. The pharmacokinetics of radiolabeled triamcinolone acetonide [C] were evaluated following a single oral dose of 800 mcg
to healthy male volunteers. Radiolabeled triamcinolone acetonide was
found to undergo relatively rapid absorption following oral administration
with maximum plasma triamcinolone acetonide and [C]-derived
radioactivity occurring between 1.5 and 2 hours. Plasma protein binding
of triamcinolone acetonide appears to be relatively low and consistent
over a wide plasma triamcinolone acetonide concentration range as
a function of time. The overall mean percent fraction bound was approximately
68%. The metabolism
and excretion of triamcinolone acetonide were both rapid and extensive
with no parent compound being detected in the plasma after 24 hours
post-dose and a low ratio (10.6%) of parent compound AUCto total [C] radioactivity AUC. Greater than 90% of the oral [C]-radioactive dose
was recovered within 5 days after administration in 5 out of the 6
subjects in the study. Of the recovered [C]-radioactivity,
approximately 40% and 60% were found in the urine and feces, respectively. Three metabolites of triamcinolone
acetonide have been identified. They are 6��-hydroxytriamcinolone
acetonide, 21-carboxytriamcinolone acetonide and 21-carboxy-6��-hydroxytriamcinolone
acetonide. All three metabolites are expected to be substantially
less active than the parent compound due to (a) the dependence of
anti-inflammatory activity on the presence of a 21-hydroxyl group,
(b) the decreased activity observed upon 6-hydroxylation, and (c)
the markedly increased water solubility favoring rapid elimination.
There appeared to be some quantitative differences in the metabolites
among species. No differences were detected in metabolic pattern as
a function of route of administration.
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Azmacort Inhalation Aerosol is contraindicated
in the primary treatment of status asthmaticus or other acute episodes
of asthma where intensive measures are required. Hypersensitivity to triamcinolone acetonide or any of the other ingredients
in this preparation contraindicates its use.
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Azmacort Inhalation Aerosol contains 60
mg triamcinolone acetonide in a 20 gram package which delivers at
least 240 actuations. It is supplied with a white plastic actuator,
a white plastic spacer-mouthpiece and patient's leaflet of instructions:
box of one. NDC 0074���3014���60. Each actuation delivers
200 mcg triamcinolone acetonide from the valve and 75 mcg from the
spacer-mouthpiece under defined in vitro test conditions. Avoid
spraying in eyes. For best results, the canister should be at room temperature before
use. Shake well before
using. CONTENTS UNDER PRESSURE. Do not puncture.
Do not use or store near heat or open flame. Exposure to temperatures
above 120��F may cause bursting. Never throw canister into fire
or incinerator. Keep out of reach of children unless otherwise prescribed.
Store at Controlled Room Temperature 20 to 25��C (68 to 77��F)
[see USP]. Note: The
indented statement below is required by the Federal government's
Clean Air Act for all products containing or manufactured with chlorofluorocarbons
(CFCs): WARNING: Contains
CFC-12, a substance which harms public health and the environment
by destroying ozone in the upper atmosphere. A notice similar to the above WARNING has been placed in the���Information
For The Patient���portion of this package insert under the Environmental
Protection Agency's (EPA's) regulations. The patient's
warning states that the patient should consult his or her physician
if there are questions about alternatives. ��2007 Abbott LaboratoriesManufactured for:Abbott
LaboratoriesNorth Chicago, IL 60064 U.S.A.
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Orally inhaled corticosteroids
may cause a reduction in growth velocity when administered to pediatric
patients (see PRECAUTIONS,
Pediatric Use). Because of the possibility of
systemic absorption of inhaled corticosteroids, patients treated with
these drugs should be observed carefully for any evidence of systemic
corticosteroid effects including suppression of growth in children.
Particular care should be taken in observing patients postoperatively
or during periods of stress for evidence of a decrease in adrenal
function. During withdrawal from oral steroids,
some patients may experience symptoms of systemically active steroid
withdrawal, e.g., joint and/or muscular pain, lassitude, and depression,
despite maintenance or even improvement of respiratory function. Although steroid withdrawal effects are usually transient
and not severe, severe and even fatal exacerbation of asthma can occur
if the previous daily oral corticosteroid requirement had significantly
exceeded 10 mg/day of prednisone or equivalent. In responsive patients, inhaled corticosteroids will often permit
control of asthmatic symptoms with less suppression of HPA function
than therapeutically equivalent oral doses of prednisone. Since triamcinolone
acetonide is absorbed into the circulation and can be systemically
active, the beneficial effects of Azmacort
Inhalation Aerosol in minimizing or preventing HPA dysfunction
may be expected only when recommended dosages are not exceeded. Suppression of HPA function has
been reported in volunteers who received 4000 mcg daily of triamcinolone
acetonide by oral inhalation. In addition, suppression of HPA function
has been reported in some patients who have received recommended doses
for as little as 6 to 12 weeks. Since the response of HPA function
to inhaled corticosteroids is highly individualized, the physician
should consider this information when treating patients. When used at excessive doses or
at recommended doses in a small number of susceptible individuals,
systemic corticosteroid effects such as hypercorticoidism and adrenal
suppression may appear. If such changes occur, Azmacort Inhalation Aerosol should be discontinued slowly, consistent with
accepted procedures for reducing systemic steroid therapy and for
management of asthma symptoms. Azmacort Inhalation Aerosol should be used with caution, if at all, in patients
with active or quiescent tuberculosis infection of the respiratory
tract; untreated systemic fungal, bacterial, parasitic, or viral infections;
or ocular herpes simplex. The long-term local and systemic effects of Azmacort Inhalation Aerosol in human subjects are still
not fully known. While there has been no clinical evidence of adverse
experiences, the effects resulting from chronic use of Azmacort Inhalation Aerosol on developmental
or immunologic processes in the mouth, pharynx, trachea, and lung
are unknown. Information for Patients: Patients being
treated with Azmacort Inhalation
Aerosol should receive the following information and instructions.
This information is intended to aid them in the safe and effective
use of this medication. It is not a complete disclosure of all possible
adverse or intended effects. Patients should use Azmacort Inhalation
Aerosol at regular intervals as directed. Results of clinical trials
indicate that significant improvement in asthma may occur by 1 week,
but maximum benefit may not be achieved for 2 weeks or more. The patient
should not increase the prescribed dosage but should contact the physician
if symptoms do not improve or if the condition worsens. In clinical studies and
post-marketing experience with Azmacort Inhalation Aerosol, local infections of the oropharynx with Candida albicans have occurred. When
such an infection develops, it should be treated with appropriate
local or systemic (i.e., oral antifungal) therapy while remaining
on treatment with Azmacort Inhalation
Aerosol. However, at times therapy with Azmacort Inhalation Aerosol may need to be interrupted. Patients should be instructed
to track their use of Azmacort Inhalation Aerosol and to dispose of the canister after 240 actuations
since reliable dose delivery cannot be assured after 240 doses. Patients who are on immunosuppressant
doses of corticosteroids should be warned to avoid exposure to chickenpox
or measles and, if exposed, to obtain medical advice. Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence of treatment-related carcinogenicity was demonstrated
after two years of once daily gavage of triamcinolone acetonide at
doses of 0.05, 0.2, and 1.0 mcg/kg (approximately 0.02, 0.07, and
0.4% of the maximum recommended human daily inhalation dose on a mcg/mbasis) in the rat and 0.1, 0.6, and 3.0 mcg/kg (approximately
0.02, 0.1, and 0.6% of the maximum recommended human daily inhalation
dose on a mcg/mbasis) in a mouse. Mutagenesis studies with triamcinolone acetonide have not been carried
out. No evidence
of impaired fertility was manifested when oral doses of up to 15.0
mcg/kg (8% of the maximum recommended human daily inhalation dose
on a mcg/mbasis) were administered to female and male
rats. However, triamcinolone acetonide at oral doses of 8 mcg/kg (approximately
4% of the maximum recommended human daily inhalation dose on a mcg/mbasis) caused dystocia and prolonged delivery and at oral
doses of 5.0 mcg/kg (approximately 2.5% of the maximum recommended
human daily inhalation dose on a mcg/mbasis) and above
caused increases in fetal resorptions and stillbirths and decreases
in pup body weight and survival. At a lower dose of 1.0 mcg/kg (approximately
0.5% of the maximum recommended human daily inhalation dose on a mcg/mbasis) it did not induce the above mentioned effects. Pregnancy: Pregnancy Category C. Triamcinolone
acetonide has been shown to be teratogenic at inhalational doses of
20, 40, and 80 mcg/kg in rats (approximately 0.1, 0.2, and 0.4 times
the maximum recommended human daily inhalation dose on a mcg/mbasis, respectively), in rabbits at the same doses (approximately
0.2, 0.4, and 0.8 times the maximum recommended human daily inhalation
dose on a mcg/mbasis, respectively) and in monkeys, at
an inhalational dose of 500 mcg/kg (approximately 5 times the maximum
recommended human daily inhalation dose on a mcg/mbasis).
Dose related teratogenic effects in rats and rabbits included cleft
palate and/or internal hydrocephaly and axial skeletal defects whereas
the teratogenic effects observed in the monkey were CNS and/or cranial
malformations. There are no adequate and well controlled studies in
pregnant women. Triamcinolone acetonide should be used during pregnancy
only if the potential benefit justifies the potential risk to the
fetus. Experience
with oral glucocorticoids since their introduction in pharmacologic
as opposed to physiologic doses suggests that rodents are more prone
to teratogenic effects from glucocorticoids than humans. In addition,
because there is a natural increase in glucocorticoid production during
pregnancy, most women will require a lower exogenous steroid dose
and many will not need glucocorticoid treatment during pregnancy. Nonteratogenic Effects: Hypoadrenalism
may occur in infants born of mothers receiving corticosteroids during
pregnancy. Such infants should be carefully observed. Nursing Mothers: It is not known whether
triamcinolone acetonide is excreted in human milk. Because other corticosteroids
are excreted in human milk, caution should be exercised when Azmacort Inhalation Aerosol is administered
to nursing women. Pediatric Use: Safety and effectiveness
have not been established in pediatric patients below the age of 6. Controlled clinical studies have shown that orally inhaled
corticosteroids may cause a reduction in growth velocity in pediatric
patients. In these studies, the mean reduction in growth velocity
was approximately one centimeter (cm) per year (range 0.3 to 1.8 cm
per year; 0.12 to 0.71 inches) and appears to depend upon dose and
duration of exposure. [The specific growth effects of Azmacort have also been studied in a
controlled clinical trial (see data below)]. This effect was observed
in the absence of laboratory evidence of hypothalamic-pituitary-adrenal
(HPA) axis suppression, suggesting that growth velocity is a more
sensitive indicator of systemic corticosteroid exposure in pediatric
patients than some commonly used tests of HPA axis function. To assess if Azmacort has an effect on growth, a one-year, randomized, open-label study
of pre-pubescent boys and girls ages 6-11 with moderate to severe
asthma was conducted. Children with moderate asthma were randomized
to a nonsteroidal treatment or to Azmacort, children with severe asthma to Azmacort plus prednisone or just prednisone alone. A sex and age matched
group of healthy non-asthmatic children was also included. The average
daily dose of Azmacort was 400
mcg (range 75 to 1600 mcg/day, dose adjustments were permitted).
Non-asthmatic children (mean 8.2 years) grew 5.93 cm/year (n=96).
In the moderate asthma groups, the Azmacort children (mean 8.2 years) grew 5.34 cm/year (n=101) and the nonsteroidal
children (mean 8.5 years) grew 6.13 cm/year (n=95). In the severe
groups, the Azmacort plus prednisone
children (mean 8.2 years) grew 5.46 cm/year (n=33) and the prednisone
only children (mean 8.0 years) grew 5.59 cm/year (n=31). Due to low
enrollment in the severe patient groups, there was insufficient power
to interpret the statistical analyses on these groups. The long-term effects of this reduction in growth velocity
associated with orally inhaled corticosteroids, including the impact
on final adult height, are unknown. The potential for���catch
up���growth following discontinuation of treatment with orally
inhaled corticosteroids has not been adequately studied. The growth
of children and adolescents receiving orally inhaled corticosteroids,
including Azmacort, should be
monitored routinely (e.g. via stadiometry). The potential growth
effects of prolonged treatment should be weighed against the clinical
benefits obtained and the risk associated with alternative therapies.
To minimizethe systemic effects of orally inhaled corticosteroids,
including Azmacort , each patient
should be titrated to the lowest dose that effectively controls his/her
symptoms. Geriatric Use: Clinical studies of Azmacort Inhalation Aerosol 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 drugtherapy.
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dailymed-instance:overdosag... |
There are no data available
on the effects of acute or chronic overdose. However, acute overdosing
with Azmacort Inhalation Aerosol
is unlikely in view of the total amount of active ingredient present
and the route of administration. The maximum total daily dose (1200
mcg) has been well tolerated when administered as a single dose of
16 consecutive inhalations to adult asthmatics in a controlled clinical
trial. Chronic overdosage may result in signs/symptoms of hypercorticoidism.
The risk of candidiasis could also be increased.
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Triamcinolone acetonide
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dailymed-instance:fullName |
Azmacort (Aerosol, Metered)
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dailymed-instance:adverseRe... |
The table below describes
the incidence of common adverse experiences based upon three placebo-controlled,
multicenter US clinical trials of 507 patients (297 female and 210
male adults (age range 18-64)). These trials included asthma patients
who had previously received inhaled beta-agonists alone,
as well as those who previously required inhaled corticosteroid therapy
for the control of their asthma. The patients were treated with Azmacort Inhalation Aerosol (including
doses ranging from 150 to 600 mcg twice daily for 6 weeks) or placebo. Adverse events that occurred
at an incidence of 1-3% in the overall Azmacort Inhalation Aerosol treatment group and greater than placebo included: Body as a whole: facial edema, pain, abdominal
pain, photosensitivity Digestive system: diarrhea, oral monilia, toothache, vomiting Metabolic
and Nutrition: weight gain Musculoskeletal
system: bursitis, myalgia, tenosynovitis Nervous system: dry mouth Organs of special sense: rash Respiratory system: chest congestion,
voice alteration Urogenital system: cystitis, urinary tract infection, vaginal monilia In older controlled clinical
trials of steroid dependent asthmatics, urticaria was reported rarely.
Anaphylaxis was not reported in these controlled trials. Typical steroid
withdrawal effects including muscle aches, joint aches, and fatigue
were noted in clinical trials when patients were transferred from
oral steroid therapy to Azmacort Inhalation Aerosol. Easy bruisability was also noted in these trials. Hoarseness, dry throat, irritated
throat, dry mouth, facial edema, increased wheezing, and cough have
been reported. These adverse effects have generally been mild and
transient. Cases of oral candidiasis occurring with clinical use have
been reported. Cases of growth suppression have
been reported for orally inhaled corticosteroids (see PRECAUTIONS, Pediatric Use
section). Post Marketing: In addition to adverse
events reported from clinical trials, the following events have been
identified during post approval use of Azmacort Inhalation Aerosol where these events were reported voluntarily
from a population of unknown size, and the frequency of occurrence
cannot be determined precisely. These include rare reports of anaphylaxis,
cataracts, glaucoma and very rare reports of bone mineral density
loss and osteoporosis, especially with prolonged use, which may lead
to an increased risk of fractures.
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Particular care is needed
in patients who are transferred from systemically active corticosteroids
to Azmacort Inhalation Aerosol
because deaths due to adrenal insufficiency have occurred in asthmatic
patients during and after transfer from systemic corticosteroids to
aerosolized steroids in recommended doses. After withdrawal from systemic
corticosteroids, a number of months is usually required for recovery
of hypothalamic-pituitary-adrenal (HPA) function. For some patients
who have received large doses of oral steroids for long periods of
time before therapy with Azmacort Inhalation Aerosol is initiated, recovery may be delayed for one
year or longer. During this period of HPA suppression, patients may
exhibit signs and symptoms of adrenal insufficiency when exposed to
trauma, surgery, or infections, particularly gastroenteritis or other
conditions with acute electrolyte loss. Although Azmacort Inhalation Aerosol may provide
control of asthmatic symptoms during these episodes, in recommended
doses it supplies only normal physiological amounts of corticosteroidsystemically and does NOT provide the increased systemic steroid which
is necessary for coping with theseemergencies. During periods of stress or a severe asthmatic attack, patients who
have been recently withdrawn from systemic corticosteroids should
be instructed to resume systemic steroids (in large doses) immediately
and to contact their physician for further instruction. These patients
should also be instructed to carry a warning card indicating that
they may need supplementary systemic steroids during periods of stress
or a severe asthma attack. Localized infections with Candida albicans have occurred infrequently in the mouth and pharynx. These areas
should be examined by the treating physician at each patient visit.
The percentage of positive mouth and throat cultures for Candida albicans did not change during
a year of continuous therapy. The incidence of clinically apparent
infection is low (2.5%). These infections may disappear spontaneously
or may require treatment with appropriate antifungal therapy or discontinuance
of treatment with Azmacort Inhalation
Aerosol. Children
who are on immunosuppressant drugs are more susceptible to infections
than healthy children. Chickenpox and measles, for example, can have
a more serious or even fatal course in children on immunosuppressant
doses of corticosteroids. In such children, or in adults who have
not had these diseases, particular care should be taken to avoid exposure.
If exposed, therapy with varicella zoster immune globulin (VZIG) or
pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated.
If chickenpox develops, treatment with antiviral agents may be considered. Azmacort Inhalation Aerosol is not to
be regarded as a bronchodilator and is not indicated for rapid relief
of bronchospasm. As
with other inhaled asthma medications, bronchospasm may occur with
an immediate increase in wheezing following dosing. If bronchospasm
occurs following use of Azmacort Inhalation Aerosol, it should be treated immediately with a fast-acting
inhaled bronchodilator. Treatment with Azmacort Inhalation Aerosol should be discontinued and alternative treatment
should be instituted. Patients should be instructed to contact their physician immediately
when episodes of asthma which are not responsive to bronchodilators
occur during the course of treatment with Azmacort Inhalation Aerosol. During such episodes, patients
may require therapy with systemic corticosteroids. The use of Azmacort Inhalation
Aerosol with systemic prednisone, dosed either daily or on alternate
days, could increase the likelihood of HPA suppression compared to
a therapeutic dose of either one alone. Therefore, Azmacort Inhalation Aerosol should be
used with caution in patients already receiving prednisone treatment
for any disease. Transfer
of patients from systemic steroid therapy to Azmacort Inhalation Aerosol may unmask allergic conditions
previously suppressed by the systemic steroid therapy, e.g., rhinitis,
conjunctivitis, and eczema.
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Azmacort
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