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892-B
AzmaCOrt (triamcinolone acetonide) inhaler
Brief Summary For Oral Inhalation Only
INDICATIONS: Azmacort itriamcinolone acetoniclei inhaler is indicated only for patients
who require chronic treatment with corticosteroids tor the control ol the symptoms
ot bionchial asthma Such patients would include those already receiving systemic
codicosleroids and selected patients who are inadequately controlled on a non-steroid
regimen and in whom steroid therapy has been withheld because ot concern over
potential adverse effects
Azmacort" inhaler Is WO/" indicated: 1 For relief of asthma which can be controlled Oy
bronchodilators and other non-steroid medications 2 In patients who require systemic
corticosteroid treatment infrequently 3 In the treatment of non-asthmatic bronchitis
CONTRAINDICATIONS: Azmacort inhaler is contraindicated in the pnmary treatment
ol status asthmaticus or olher acute episodes of asthma where intensive measures
are required
Hypersensitivity to any ol the ingredients of this preparation contramrticates its use
WARNINGS:
Particular caie is needed in patients who are transferred from systemically active
corticosteroids to Azmacort " inhaler because deaths due to adrenal insufficiency
have occurred in asthmatic patients during and after Iransfer Irom systemic
corticosteroids to aerosolized steroids in recommended doses After withdrawal
Irom systemic corticosteroids, a number of months is usually required for recovery
ol hypothalamic piimtaiy adicuai iHPA; function For some patients who have
iccmvcd l.iii|i: dose:; of (u.il M-muds 1 nr lung pounds nl tuns; liiilcit' Ihi'iapy v.-111
Azmacort inhaler is initiated recovery may be delayed for one year or longer
During this period ol 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
inhaler may provide control ol asthmatic symptoms during these episodes, in
'ecommended doses n supplies only normal physiological amounts of corticosteroid
systemically and does NOT provide the increased systemic steroid which is
necessary for coping with these emergencies.
During periods of stress or a severe asthmatic attach patients who have been
recently withdiawrt from systemic coiticosteioids should be instructed lo resume
systemic steroids (in large doses> immediately and to contact their physician
lor 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 T he percentage ol positive mouih and thioat cultures for Candida
albicans did not change dunng a yeai ol continuous therapy The incidence ol
clinically apparent infection is low |2 5%!. These infections may disappear spontaneously
oi may require treatment with appropriate antifungal therapy or discontinuance of
treatment with Azmacort inhaler
Azmacort inhaler is not to be regarded as a bronchodilator and is not mdicalec
lot rapid relief of bronchospasm
Patients should be instructed to contact then physician immediately when episodes of
asthma which aie not responsive to bronchodilators occur during the course of tieatment
with Azmacort inhaler Dunng such episodes patients may require therapy with
systemic corticosteroids.
There is no evidence that control of asthma can De achieved by the administration
of Azmacort"'' inhaler in amounts greater than the recommended doses which appear lo
be the therapeutic equivalent ol approximately 10 mg/day of oral prednisone
Theoretically, the use of inhaled corticosteroids with alternate day prednisone oral
therapy should be accompanied by more HPA suppression than a therapeutically
equivalent regimen of either alone
Transfer of patients from systemic steroid therapy to Azmacort inhaler may unmask
allergic conditions previously suppressed by the systemic steroid therapy, e.g.. rhinitis
conjunctivitis and eczema
PRECAUTIONS: During withdiawal from oral steroids some patients may experience
symptoms of systemically active steroid withdrawal eg joint and or muscular pain
lassitude and depression, despite maintenance or even improvement of respiratory
(unction (See DOSAGE AND ADMINISTRATION lor delailsi Although steroid withdrawal
effects are usually transient and not severe, severe and even fatal exacerbation
of asthma can occui if Ihe previous daily oral conirostcmid requirement had significantly
exceeded 10 mg day ol prednisone or equivalent
In responsive patients inhaled corticosteroids will often permit control of asthmatic
symptoms wiin less suppression of HPA function than therapeutically equivalent oral
doses of prednisone Since triamcinolone acetonide is absorbed into the circulation aim
can be systemically active, the beneficial effects of Azmacort inhaler in minimizing
or preventing HPA dysfunction may be expected only when recommended dosages
are not exceeded
Suppression ol HPA function has been reported in volunteers who received 4000 meg
daily ot triamcinolone acetonide In addition suppression ol HPA function has been
reported in some patients who have leceived recommended doses lor as little as
6-12 weeks Since the response ol HPA function to inhaled corticosteroids is highly
individualized the physician should consider this information when treating patients
Because of the possibility of systemic absorption of inhaled corticosteroids patients
healed with these drugs should be observed carefully for any evidence of systemic
corticosteroid elfects including suppression of growth in children Particular care
should be taken in observing patients postoperatively oi during periods of stress lor
evidence ol a decrease in adrenal lunciion
The long-term effects of triamcinolone acetonide inhaler in human subjects are not
completely known although patients have received Azmacort inhaler on a continuous
basis for periods of two years or longer While there has been no cluneal evidence
ol adverse experiences the local elfects of the agent on developmental or immunologic
processes in the mouth, pharynx, trachea and lung are also unknown
The potential elfects of Azmacort inhaler on acute recurrent or chronic pulmonary
nfections including active or quiescent tubercu osi! an nol km ivn For this reason
since systemic administration of corticosteroids may mask some signs of lungal
bacterial or viral infection, the same caution should be observed when treating patients
with Azmacort ' inhaler. The potential effects of long-term administration of Azmacort
inhaler on lung or other tissues are unknown However pulmonary infiltrates with
eosinophils have occurred in patients receiving olher inhaled corticosteroid's
Pregnancy: Pregnancy Category D Azmacort triamcinolone acetonide' has been
•• :• v/iitngc'iic n rats ;ind •abb ts .'.I'-en in doses aimpa'a:] e tc no
highest dose recommended foi humanuse approximately 0 032 mg kq day Administration
of aeiosol inhalation to pregnant rats and rabbits produced emoryotoxic and
fetotoxic effects which were comparable lo those produced by administration by
other routes.
Teratogenic elfects in both species included a low incidence of cleft palate and/or
internal hydrocephaly and axial skeletal defects These findings lepiesenl known
effects of glucocorticoids in laboratory animals
There aie no well-controlled studies in pregnant women Experience with other dosage
forms of triamcinolone acetonide does not include any positive evidence of adverse
elfects on the fetus However, since such experience cannot exclude possibility of
fetal damage, Azmacort"'' inhaler should be used during pregnancy only if the benefit
clearly justifies the potential risk to Ihe fetus Infants born to mothers who have
received substantial doses of corticosteroids during pregnancy should be carefully
observed lor hypoartrenahsm
Nursing mothers: It is not known whether this drug is excreted in human milk
Because of the potential for tumorigenicity shown for triamcinolone acetonide in animal
studies, a decision should be made whether to discontinue nursing or to discontinue
the drug, taking info account Ihe importance of the drug to the mother
ADVERSE REACTIONS: A few cases of oral candidiasis have been reported isee
1 WARNINGS In addition, some patients receiving Azmacort inhaler have experienced
hoarseness dry thioat irritated throal and dry mouth Increased wheezing and cough
have been reported infrequently as has facial edema These adverse elfects have
generally been mild and transient.
RORER PHARMACEUTICALS
KB RORERPHARMACEUTICAL CORPORATION
HSI FORT WASHINGTON PA 19034
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AMERICAN
COLLEGE OF
CHEST
PHYSICIANS
Postgraduate Courses
54th ANNUAL
SCIENTIFIC ASSEMBLY
POSTGRADUATE COURSES
Date:
October 3,1988
Location:
Anaheim, California
This year's Annual Scientific Assembly,
to be held October 3-7, will feature a
"track" focusing on "New/High
Technology in Chest Medicine and
Surgery". The following postgraduate
courses will be held at the Meeting.
• Perioperative Management of the
Cardiothoracie Patient
• Invasive and Noninvasive Diagnosis in
Lung Cancer
• The Pleural Space
• Cardiac Disease in the ICU (Non-MI)
• Chest Imaging
• Overview of Pulmonary Infections
Sponsor:
American College of Chest Physicians
For further information contact:
Division of Education, ACCP
911 Busse Highway
Park Ridge, IL 60068-2375
(312) 698-2200