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`Rev. May 2003
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`Rx only
`Azmacort®
`
`(triamcinolone acetonide)
`Inhalation Aerosol
`For Oral Inhalation Only
`Shake Well Before Using
`DESCRIPTION
`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-
`11ß,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone.
`(C24H31FO6).
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`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 100 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.
`CLINICAL PHARMACOLOGY
`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 as soon 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
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`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 [14C] 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 [14C]-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 AUC0-∞ to total [14C] radioactivity AUC0-∞. Greater than 90% of the oral
`[14C]-radioactive dose was recovered within 5 days after administration in 5 out of the 6 subjects
`in the study. Of the recovered [14C]-radioactivity, approximately 40% and 60% were found in the
`urine and feces, respectively.
`identified. They are 6ß-
`Three metabolites of
`triamcinolone acetonide have been
`hydroxytriamcinolone acetonide, 21-carboxytriamcinolone acetonide and 21-carboxy-6ß-
`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.
`CLINICAL TRIALS
`Double-blind, placebo-controlled efficacy and safety studies have been conducted in asthma
`patients with a range of asthma severities, from those patients with mild disease to those with
`severe disease requiring oral steroid therapy.
`The efficacy and safety of Azmacort Inhalation Aerosol given twice daily was demonstrated in
`two placebo-controlled clinical trials. In two separate studies, 222 asthmatic patients were
`randomized to receive either Azmacort Inhalation Aerosol 400 mcg twice daily or matching
`placebo for a treatment period of 6 weeks. Patients were adult asthmatics who were using inhaled
`beta2-agonists on more than an occasional basis (at least three times weekly), either without or
`with inhaled corticosteroids, for control of their asthma symptoms. For the combined studies,
`48% (52/109) patients randomized to placebo and 41% (46/113) patients randomized to
`Azmacort Inhalation Aerosol treatment were previously treated with inhaled corticosteroids.
`Results of weekly lung function tests (FEV1) from one of these trials is presented graphically
`below. Results of the second study are presented in tabular form as the changes in asthma
`measures from baseline to the end of the treatment period.
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`0.6
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`0.5
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`3.4
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`2.3
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`Mean Changes in Asthma Measures from Baseline to Endpointa
`All-Treated Patients
`Results from a Placebo-Controlled, 6 Week Study
`Placebo
`Azmacort 400 mcg bid
`(N=61)
`(N=60)
`2.8%
`17.5%
`6.7
`45.9
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`
`Asthma Measure
`Percent Change in FEV1(%)
`Increase in Morning Peak
`Flow Rate (L/min)
`Decrease in Albuterol Use
`(puffs/day)
`Decrease in Daily Asthma Symptom
`Score (units/day)b
`aEndpoint Results are obtained from the last evaluable data, regardless of whether the patient completed 6 weeks of
`treatment
`bScale (0-6) with 0 = no symptom: Maximum Score (AM + PM) =12
`In both studies, treatment with Azmacort Inhalation Aerosol (400 mcg twice daily) resulted in
`significant improvements in all clinical asthma measures (lung functions, asthma symptoms, use
`of as-needed beta2-agonist medications) when compared to placebo.
`INDICATIONS
`Azmacort Inhalation Aerosol is indicated in the maintenance treatment of asthma as
`prophylactic therapy. Azmacort Inhalation Aerosol is also indicated for asthma patients who
`require systemic corticosteroid administration, where adding Azmacort may reduce or eliminate
`the need for the systemic corticosteroids.
`Azmacort Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.
`CONTRAINDICATIONS
`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.
`WARNINGS
`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
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`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 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 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.
`PRECAUTIONS
`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
`(See DOSAGE AND
`maintenance or even
`improvement of
`respiratory
`function.
`ADMINISTRATION.) Although steroid withdrawal effects are usually transient and not severe,
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`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® (triamcinolone acetonide) 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.
`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.
`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.
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`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/m2 basis) 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/m2 basis) 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/m2 basis) 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/m2
`basis) 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/m2 basis) 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/m2 basis) 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/m2 basis, 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/m2 basis, 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/m2 basis). 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. Oral corticosteroids have been shown to cause growth suppression in children and
`teenagers, particularly with higher doses over extended periods. If a child or teenager on any
`corticosteroid appears to have growth suppression, the possibility that they are particularly
`sensitive to this effect of steroids should be considered.
`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
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`Adverse Event
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`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.
`ADVERSE REACTIONS
`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 beta2-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 200 to 800 mcg twice daily for 6 weeks) or placebo.
`Adverse Events Occurring at an Incidence of Greater Than 3%
`and Greater Than Placebo
`Placebo
`Azmacort Dose
`
`800 mcg bid
`400 mcg bid
`200 mcg bid
`(n=167)
`(n=57)
`(n=170)
`(n=57)
`6 (4%)
`1 (2%)
`7 (4%)
`5 (9%)
`Sinusitis
`19 (11%)
`10 (18%)
`42 (25%)
`4 (7%)
`Pharyngitis
`24 (14%)
`7 (12%)
`35 (21%)
`4 (7%)
`Headache
`5 (3%)
`1 (2%)
`8 (5%)
`2 (4%)
`Flu Syndrome
`3 (2%)
`2 (4%)
`3 (2%)
`2 (4%)
`Back Pain
`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:
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`facial edema, pain, abdominal pain, photosensitivity
`Digestive system:
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`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:
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`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. (See WARNINGS.)
`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,
`and glaucoma.
`OVERDOSAGE
`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 (1600 mcg) has
`been well tolerated when administered as a single dose of 16 consecutive inhalations to adult
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`asthmatics in a controlled clinical trial. Chronic overdosage may result in signs/symptoms of
`hypercorticoidism. (See PRECAUTIONS.) The risk of candidiasis could also be increased.
`DOSAGE AND ADMINISTRATION
`Adults: The usual recommended dosage is two inhalations (200 mcg) given three to four times a
`day or four inhalations (400 mcg) given twice daily. The maximal daily intake should not exceed
`16 inhalations (1600 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 (100
`to 200 mcg) given three to four times a day or two to four inhalations (200 to 400 mcg) given
`twice daily. The maximal daily intake should not exceed 12 inhalations (1200 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 weeks after 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.
`(See WARNINGS.)
`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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`HOW SUPPLIED
`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 0075-0060-37. Each
`actuation delivers 200 mcg triamcinolone acetonide from the valve and 100 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.
`Rx only
`
`Aventis Pharmaceuticals Inc.
`Bridgewater, NJ 08807 USA
`
`©2002 Aventis Pharmaceuticals Inc.
`
`Rev. May 2003
`
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`INFORMATION FOR THE PATIENT
`Your Guide to the
`
`
`
`Special Delivery System
`
`Your doctor has prescribed Azmacort® (triamcinolone acetonide) Inhalation Aerosol to help
`control your asthma. Your Azmacort Inhalation Aerosol is one of the most efficient and easy-to-
`use devices available to help you take your prescribed medication. Used properly, it will
`effectively and reliably relieve your asthma symptoms.
`To receive the maximum benefit, it is very important that you carefully read and follow all
`the instructions contained in this booklet for the daily use and care of your Azmacort
`Inhalation Aerosol.
`IMPORTANT NOTE: If you’ve used other metered-dose inhalers before, you may expect the
`Azmacort Inhalation Aerosol to deliver a noticeable “blast” of medication into your mouth.
`Your AZMACORT Inhalation Aerosol, however, is designed to provide a gentle mist, not a
`“blast,” when used.
`This gentle action makes it possible for your medication to be more effectively delivered into the
`passageways to your lungs, with very little left to linger in your mouth. In fact, you may not even
`feel the medication entering your mouth, but rest assured, that is how the Azmacort Inhalation
`Aerosol works.
`IMPORTANT: Please read all instructions in this guide carefully before using your Azmacort
`Inhalation Aerosol.
`BEFORE STARTING TO TAKE THIS MEDICINE, TELL YOUR DOCTOR:
`•
`If you are pregnant or intending to become pregnant.
`•
`If you are breast-feeding a baby.
`•
`If you are allergic to Azmacort Inhalation Aerosol or any other orally inhaled glucocorticoid.
`•
`If you are taking other medications. In some circumstances, this medication may not be
`suitable and your doctor may wish to give you a different medicine.
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`PREPARE YOUR AZMACORT INHALATION AEROSOL
`INHALER FOR USE
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`STEP 1
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`1. Line up the arrows on the inhaler.
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`STEP 2
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`2. Gently pull the inhaler to its fully extended position. You will see the valve (small hole)
`where the medication will come out.
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`STEP 3
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`3. Adjust the inhaler into an “L” shape. It is hinged to swing in one direction only.
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`STEP 4
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`4. The ridge on the top part of the inhaler should fit into the notch on the bottom part.
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`STEP 5
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`5. Remove the mouthpiece cap. To prepare your Azmacort Inhalation Aerosol for use, the
`inhaler must be primed prior to the first use. To prime, hold the inhaler upright, with the
`mouthpiece facing away from you. Shake the inhaler gently, then press the canister firmly
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`and quickly. Repeat this procedure again so a total of 2 puffs are released. Your Azmacort
`Inhalation Aerosol is now ready for use.
`Repriming is only necessary when your inhaler has not been used for more than 3 days. To
`reprime, shake the inhaler and release one puff. Repeat this procedure again so a total of two
`puffs are released.
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`USING YOUR AZMACORT INHALATION AEROSOL INHALER
`
`STEP 6
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`6. The metal Azmacort canister has already been inserted into the inhaler. Once you have
`opened the inhaler, shake it well before each use. IMPORTANT: You must shake the
`inhaler each and every time before inhaling the medication. If your doctor has instructed
`you to take more than one breath of medication at a time, you must shake the inhaler
`EACH TIME before each inhalation of medication, NOT JUST ONCE.
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`STEP 7
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`7. Breathe out to empty your lungs completely before using the inhaler! This is important to
`make sure that you can breathe the medication deeply into your lungs.
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`STEP 8
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`8. Place mouthpiece into your mouth, and close your lips tightly around it. Press down firmly
`and steadily on the metal canister while breathing in slowly and deeply THROUGH YOUR
`MOUTH ONLY. (If necessary, pinch your nose closed.) Be sure to release your finger
`pressure