Professional Information

Fluticasone (Inhalation-Local)

VA CLASSIFICATION
Primary: RE110
Secondary: RE190

Commonly used brand name(s): Flovent; Flovent Diskus; Flovent Rotadisk.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Category:

Anti-inflammatory (inhalation)—

antiasthmatic—

Indications

Accepted

Asthma, chronic (treatment)—Fluticasone is indicated as maintenance treatment in chronic asthma to improve lung function and reduce asthma symptoms. Use of fluticasone in patients who require oral corticosteroid therapy may allow the reduction or elimination of oral corticosteroids over time. ^{01} ^{02}

Unaccepted
Fluticasone is not indicated in the primary treatment of status asthmaticus or other acute asthma symptoms where intensive measures, such as rapid bronchodilation, are required ^{01} ^{02}^{08}.

Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Synthetic.
Molecular weight—
    Fluticasone propionate: 500.58^{09}

Mechanism of action/Effect:

Fluticasone acts as a human glucocorticoid receptor agonist with an affinity for the receptor that is 18 times greater than that of dexamethasone, almost twice that of beclomethasone-17-monopropionate, and over three times that of budesonide ^{01}^{07}^{08}.

Studies have demonstrated that the clinical effectiveness of inhaled fluticasone is due to its direct local effect rather than an indirect effect through systemic absorption. ^{01}

The anti-inflammatory actions of fluticasone may contribute to its efficacy in asthma; however, its precise mechanisms are unknown. Glucocorticoids have been shown to inhibit mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils. Glucocorticoids also inhibit production or secretion of cell mediators such as histamine, leukotrienes, cytokines, and eicosanoids. ^{01}^{07}^{08}

Absorption:

Inhalation aerosol—Systemic bioavailability averages approximately 30% of the dose delivered from the actuator of fluticasone propionate ^{01}^{07}.

Powder for inhalation—Systemic bioavailability of fluticasone propionate averages about 13.5% of the nominal dose ^{02}^{08}.

Oral—Studies using radiolabeled and nonradiolabeled drug have demonstrated that the systemic bioavailability is less than 1%, primarily due to incomplete absorption and presystemic metabolism in the intestine and liver ^{01}^{07}^{08}.

Distribution:

The average volume of distribution (Vol _D) is 4.2 liters per kilogram of body weight (L/kg). ^{01}^{07}^{08}

Protein binding:

Plasma proteins—Very high (91%). ^{01}^{07}^{08} Fluticasone is weakly and reversibly bound to erythrocytes. ^{01}^{07}^{08} It is not significantly bound to transcortin. ^{01}^{07}^{08}

Biotransformation:

The total clearance of fluticasone is high, with renal clearance accounting for less than 0.02%. In humans, one circulating metabolite, formed through the cytochrome P450 3A4 pathway, ^{01}^{07}^{08} the 17–β carboxylic acid derivative, is detectable; in vitro studies using human lung cytosol show that this metabolite has significantly less affinity for the glucocorticoid receptor than does the parent drug. ^{01}^{07}^{08}

Half-life:

After intravenous administration—7.8 hours ^{01}^{07}^{08} ^{02}.

Onset of action:

Improvement following inhalation can occur within 24 hours ^{01}^{07}^{08}.

Peak plasma concentration

Inhalation aerosol—Ranges from 0.1 to 1 nanogram per mL following an 880-microgram (mcg) dose ^{01}^{07}.

Powder for inhalation—Ranges from 0.1 to 1 nanogram per mL following a 1000-mcg dose ^{02}^{08}.

Time to peak effect:

Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment ^{01}^{07}^{08}.

Duration of action:

Asthma stability persists for several days after withdrawal of corticosteroids ^{01} ^{02}^{07}^{08}.

Elimination:
    Fecal, as parent drug and metabolites ^{02}^{05}^{06}.
    Renal, less than 5% as metabolites ^{02}^{05}^{06}.

Precautions to Consider

Carcinogenicity/Tumorigenicity

Fluticasone showed no tumorigenic potential in a 78-week study in mice given oral doses of up to 1000 mcg per kg of body weight (mcg/kg) (approximately 2 and 10 times the maximum recommended daily [MRD] human inhalation dose) on a mcg per square meter of body surface area (mcg/m ²) basis in adults and children, respectively,^{08} and in a 104-week study in rats given inhalation doses of up to 57 mcg/kg (approximately one fourth the MRD human inhalation dose) in adults and comparable to the MRD human dose in children, on a mcg/m² basis^{01}^{02}^{07}^{08}.

Mutagenicity

Fluticasone was not mutagenic at high oral or subcutaneous doses in in vitro tests in prokaryotic or eukaryotic cells or in human peripheral lymphocytes or in an in vivo mouse micronucleus test. No clastogenic effect was seen in cultured human in vitro or mouse assays.^{07}^{08} Fluticasone did not delay erythroblast division in bone marrow in vitro. ^{01} ^{02}^{07}^{08}

Pregnancy/Reproduction
Fertility—
No evidence of impairment of fertility was seen in male and female rats given fluticasone subcutaneously in doses of up to 50 mcg/kg (approximately one fourth^{07} or one fifth^{08} the MRD human inhalation dose of the inhalation aerosol or powder for inhalation, respectively, on a mcg/m² basis). However, prostate weight was significantly reduced at a subcutaneous dose of 50 mcg/kg.^{01}^{07}^{08}

Pregnancy—
Adequate and well-controlled studies in humans have not been done^{01}^{02}^{07}^{08}^{10}.

Inhalation aerosol—Less than 0.008% of a dose crosses the placenta following oral administration of fluticasone to rats and rabbits in doses of 100 mcg/kg and 300 mcg/kg (approximately one half and three times^{07} the MRD human inhalation dose), respectively, on a mcg/m² basis. Studies in mice and rats given fluticasone subcutaneously in doses of 45 mcg/kg and 100 mcg/kg (approximately one tenth and one half the MRD human inhalation) on a mcg/m ² basis, respectively, showed fetal toxicity characteristic of potent glucocorticoids, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification^{07}. In rabbits, fetal weight reduction and cleft palate were observed following subcutaneous doses of 4 mcg/kg (approximately one twenty-fifth^{07} of the MRD human inhalation dose) on a mcg/m² basis. However, following oral administration of fluticasone to rabbits in doses of 300 mcg/kg (approximately three times^{07} the MRD human inhalation dose) on a mcg/m² basis, no maternal effects or increased incidence of external, visceral, or skeletal fetal defects were shown.^{01}^{07}

Powder for inhalation—Studies in mice and rats at subcutaneous doses of 45 and 100 mcg/kg, respectively (approximately one tenth and one third, respectively, the MRD inhalation dose in adults on a mcg/m ² basis) found fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. Studies in rabbits at subcutaneous doses of 4 mcg/kg (approximately one thirtieth the MRD inhalation dose in adults on a mcg/m² basis) found fetal weight reduction and cleft palate. However, no teratogenic effects were reported at oral doses of up to 300 mcg/kg (approximately twice the MRD inhalation dose in adults on a mcg/m² basis); in addition, no fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration. Fluticasone propionate crosses the placenta following oral administration of 100 mcg/kg to rats or 300 mcg/kg to rabbits (approximately one third and two times, respectively, the MRD inhalation dose in adults on a mcg/m² basis).^{02}^{08}

Experience suggests that rodents are more susceptible to the teratogenic effects of pharmacologic doses of oral glucocorticoids than are humans. Additionally, because production of glucocorticoid increases naturally during pregnancy, most women will require a lower exogenous glucocorticoid dose and many may not need glucocorticoid treatment during pregnancy.^{01}^{07}^{08}

FDA Pregnancy Category C.^{01}^{07}^{08}

Breast-feeding

It is not known whether fluticasone is distributed into human breast milk. However, subcutaneous administration of radiolabeled fluticasone to lactating rats, in doses of approximately one twentieth the maximum human daily inhalation aerosol dose of 10 mcg/kg (approximately one twenty-fifth of the dose of the powder for inhalation) in adults on a mcg/m² basis, resulted in measurable radioactivity in milk.^{01}^{02}^{08} Because other corticosteroids are distributed into human breast milk, caution should be exercised when fluticasone propionate inhalation aerosol or powder is administered to nursing women.^{07}^{08}^{10}

Pediatrics

Clinical trials in 1300 children with asthma showed that fluticasone aerosol (200 micrograms per day [mcg/day]) and fluticasone powder for inhalation (100 and 200 mcg/day) are effective in the treatment of childhood asthma.^{10}

Safety and efficacy in children younger than 4 years of age^{08} have not been established.^{01}^{02}^{10}

Plasma concentrations of fluticasone after an inhaled dose of 100 mcg were higher in children 4 to 11 years of age (median 58.7 picograms per mL) than in adults (median 39.5 picograms per mL)^{02}.

Orally inhaled corticosteroids, including fluticasone, are valuable and highly effective therapies in the management of asthma in pediatric patients. The Food and Drug Administration (FDA) and its advisory committees consider these products to be safe and effective in children when used according to their labeling guidelines.^{05} However, recent controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients.^{05} In these studies (over a period of about 1 year), the mean reduction in growth velocity was approximately 1 centimeter (cm) per year (range 0.3 to 1.8 cm).^{05} This reduction appears to be related to the dose and the duration of exposure to the inhaled corticosteroid.^{05} This effect was observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, which suggests that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than are some commonly used tests of HPA axis function.^{05} The long-term effects of this reduction in growth velocity, including the impact on the final adult height, are unknown.^{05} The potential for “catch up” growth following the discontinuation of treatment has not been adequately studied.^{05} The growth of pediatric patients receiving orally inhaled corticosteroids should be monitored routinely, for example, via stadiometry.^{05}^{10} The potential effects on growth velocity of prolonged treatment with inhaled corticosteroids should be weighed against the clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives.^{05} To minimize the systemic effects of orally inhaled corticosteroids, the dose should be titrated to the lowest effective dose for the patient.^{05}

In addition, patients using fluticasone may be more susceptible to infection; therefore, exposure to chickenpox or measles should be avoided.^{01}^{02}^{07}^{08}

Geriatrics

Studies performed with the inhalation aerosol in 574 patients and with the powder for inhalation in 173 patients 65 years of age and older have not demonstrated geriatrics-specific problems that would limit the usefulness of fluticasone in the elderly^{01}^{02}^{07}^{08}.

Surgical

Because of the possibility of systemic absorption of inhaled corticosteroids, postoperative patients treated with these drugs should be observed carefully for evidence of inadequate adrenal response^{01}.

Critical/Emergency care

Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with these drugs should be observed carefully during periods of stress for evidence of inadequate adrenal response^{01}.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Cytochrome P450 3A4 isoenzyme inhibitors, other    (may cause increased plasma concentrations of fluticasone or reductions in plasma cortisol area under the curve [AUC]^{02}^{08})

Ketoconazole    (concurrent use with fluticasone propionate powder for inhalation has been reported to lead to increased plasma fluticasone concentrations, decreased plasma cortisol AUC, and no effect on urinary excretion of cortisol; this effect may be related to inhibition, by ketoconazole, of the cytochrome P450 3A4 isoenzyme system, which is involved in metabolism of fluticasone^{02}^{08})

Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Hypothalamic-pituitary-adrenal (HPA) axis function as assessed by short cosyntropin test    (may occasionally be decreased with high doses^{02}^{08})

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).

Except under special circumstances, this medication should not be used when the following medical problems exist:
» Allergy to lactose or milk for fluticasone powder for inhalation^{10}
» Herpes simplex, ocular or^{01}^{02}^{07}^{08}
» Infections, systemic, bacterial, fungal, parasitic, or viral, untreated^{01}^{02}^{07}^{08}     (possible increased risk of severe, uncontrollable infections)

Sensitivity to fluticasone^{01}^{02}^{07}^{08}
» Tuberculosis, pulmonary, active or quiescent^{01}^{02}^{07}^{08}     (may be exacerbated or reactivated)

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

» Growth and development in children and adolescents^{01}    (careful monitoring of growth, for example via stadiometry, is recommended periodically during therapy with inhaled corticosteroids^{05})

Side/Adverse Effects

Note: Some clinically important cases of growth suppression have been reported for orally inhaled corticosteroids. ^{05} ^{06} See also Pediatrics section.
Rarely, systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, especially with the use of higher doses. ^{01} ^{02}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more common
—>3%
Oropharyngeal candidiasis^{07}^{08} (white patches in mouth or throat)

Incidence less common
—1–3%
Conjunctivitis (redness or discharge of eye, eyelid, or lining of the eyelid)^{07}^{08}

dyspnea ( shortness of breath)^{07}^{08}

gastroenteritis/colitis (diarrhea; lower abdominal pain; vomiting)^{07}^{08}

nausea ^{07}^{08}

otitis media (ear ache; fever)^{07}^{08}

pelvic inflammatory disease ( lower abdominal pain)^{07}^{08}

tonsillitis ( trouble in swallowing; fever; sore throat )^{07}^{08}

vaginal candidiasis (creamy white vaginal discharge)^{07}^{08}

vaginitis/vulvovaginitis (increased vaginal discharge; itching; pain on passing urine)^{07}^{08}

vomiting ^{07}^{08}

Incidence rare

Angioedema ^{01}^{07}^{08}(large hives)

bronchospasm, paradoxical or hypersensitivity-induced ^{01}^{07}^{08}(shortness of breath; tightness in chest; troubled breathing ; wheezing)

cushingoid features (bone fractures ; diabetes mellitus [increased hunger, thirst, or urination] ; excessive facial hair in women; fullness or roundness of face, neck, and trunk; high blood pressure ; impotence in males; lack of menstrual periods; muscle wasting; weakness; growth velocity retardation in children or adolescents)

glaucoma
increased intraocular pressure
or cataracts ^{02}^{07}^{08} (blindness; blurred vision; eye pain)

hypersensitivity reaction, immediate or delayed, (swelling of face, lips, or eyelids)^{01}, such as skin rash or urticaria ^{01}^{07}^{08}(hives and rash)

systemic eosinophilic conditions (e.g., Churg-Strauss syndrome) (cardiac complications; neuropathy [numbness and weakness of hands and feet]; vasculitic rash [skin rash]; worsening asthma [shortness of breath, troubled breathing, wheezing])^{07}^{08}

Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
—> 3%
Bronchitis ^{07}^{08}(cough; shortness of breath )

dysphonia ^{01}(hoarseness or other voice changes)

fatigue ^{01}(unusual tiredness)

influenza ^{01}( fever; general aches and pains; diarrhea ; headache; loss of appetite; weakness)

diarrhea

insomnia ^{01}(trouble in sleeping)

malaise ^{01} ( general feeling of illness)^{01}

nasal problems, such as nasal congestion ^{01}(stuffy nose), nasal discharge ^{07}^{08}
rhinitis ^{01}(runny or stuffy nose), pain in nasal sinuses ^{01}
or sinusitis ^{01}(headache), nasopharyngitis (sore nose or throat)^{07}^{08}

upper respiratory infections (greenish-yellow mucus; stuffy nose)^{01}

Incidence less frequent

Abdominal pain or discomfort (stomach pain or burning)

dermatitis ( rash)

dizziness

dysmenorrhea (faintness; nausea; vomiting; irregular or painful menstrual period )

epistaxis ( bloody mucus or unexplained nosebleeds)

eye irritation

giddiness

irritation due to inhalant

joint pain

migraines

mouth irritation

muscle soreness, sprain, or strain

sneezing
^{07}^{08}
Incidence rare

Aggression

agitation

depression

ecchymoses, or contusions (bruising)

pruritus (itching)

restlessness

weight gain

Overdose

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Chronic

Hypercorticism (e.g. Cushing's syndrome)^{01}^{07}^{08} (bone fractures ; diabetes mellitus [increased hunger, thirst, or urination] ; excessive facial hair in women; fullness or roundness of face, neck, and trunk; high blood pressure ; impotence in males; lack of menstrual periods; muscle wasting; weakness)

Treatment of overdose
The fluticasone dose should be reduced gradually, consistent with accepted procedures for reducing systemic corticosteroids and for management of the patient"s asthma symptoms. ^{01}^{07}^{08}

Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Fluticasone (Inhalation-Local) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Hypersensitivity to fluticasone propionate

Breast-feeding—Cautious use in nursing women because other corticosteroids pass into breast milk

Use in children—Chronic use may result in decreased growth velocity; monitoring of growth and development is important; exposure to chickenpox or measles should be avoided

Other medical problems, especially active or quiescent pulmonary tuberculosis, allergy to lactose or milk when using the powder for inhalation, herpes simplex infection of the eye, or untreated systemic bacterial, fungal, parasitic, or viral infections

Proper use of this medication
» Not using to relieve acute asthma attacks; continuing use of fluticasone even if using other medications for asthma attack

» Importance of not using more than the amount prescribed

» Compliance with therapy by using every day in regularly spaced doses

Rinsing mouth with water after each dose; not swallowing rinse water

» Reading patient instructions carefully; checking frequently with health care professional for proper use of inhaler

» Proper dosing
Missed dose: Using as soon as possible; using any remaining doses for that day at regularly spaced intervals; not doubling doses

» Proper storage

For inhalation aerosol^{03}
Testing inhaler before using first time

Proper administration technique^{03}

Proper cleaning procedure for inhaler

For powder for inhalation^{04}
Proper loading technique for inhaler

Proper administration technique

Proper cleaning procedure for inhaler

Precautions while using this medication
» Checking with physician in the following circumstances:

• Periods of unusual stress

• A severe asthma attack occurs

• Asthma symptoms do not improve or condition worsens

• Exposure to chickenpox or measles occurs

Carrying medical identification stating that supplemental systemic corticosteroid therapy may be required in emergency situations, periods of unusual stress, or acute asthma attack

» Caution if any kind of surgery or emergency treatment is required; informing health care professional that inhalation corticosteroid is being used

Side/adverse effects
Signs of potential side effects, especially angioedema, bronchospasm (paradoxical or hypersensitivity-induced), cataracts, conjunctivitis, cushingoid features, dyspnea, gastroenteritis/colitis, glaucoma, hypersensitivity reactions (immediate or delayed), increased intraocular pressure, nausea, oropharyngeal candidiasis, otitis media, pelvic inflammatory disease, systemic eosinophilic conditions, tonsillitis, vaginal candidiasis, vaginitis/vulvovaginitis, vomiting

General Dosing Information
Pharmacologic doses of fluticasone should be carefully titrated to the minimum effective dose to control asthma symptoms and prevent systemic effects. ^{07} This is especially important for pediatric patients. ^{05} See also Pediatrics section.

Caution is recommended when patients are transferred from systemic corticosteroids to inhaled fluticasone because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, several months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. Patients who have been maintained on the equivalent of 20 mg or more of prednisone per day may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, infection (particularly gastroenteritis), or other conditions associated with severe electrolyte loss. In recommended doses, fluticasone by inhalation may control asthma symptoms during these episodes but supplies lower-than-normal physiological amounts of glucocorticoid systemically and does not provide the mineralocorticoid activity necessary for coping with these emergencies. During periods of stress or if a severe asthma attack occurs, patients who have been withdrawn from systemic corticosteroids should be instructed to immediately resume oral corticosteroids in large doses and to contact their physician for further instructions. These patients should also be instructed to carry a warning card indicating that they may need systemic corticosteroids during periods of stress or if a severe asthma attack occurs. ^{01} ^{02}

After at least 1 week of fluticasone inhalation therapy, the dose of oral corticosteroid should be tapered slowly. The daily prednisone dose should be reduced no faster than by 2.5 mg per day on a weekly basis^{07}. Reduction of the prednisone dose should be done only when lung function, asthma symptoms, and as-needed beta-adrenergic bronchodilator use are better than or comparable to that seen before starting the prednisone dose reduction. Careful monitoring of lung function forced expiratory volume (FEV) or a.m. peak expiratory flow rate (PEFR), beta-adrenergic agonist use, and asthma symptoms is recommended during withdrawal of oral corticosteroids. In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, hypotension, lassitude, nausea, vomiting, or weakness. ^{01}^{07}^{08}

Transfer of patients from systemic corticosteroid therapy to fluticasone propionate by inhalation may unmask conditions previously suppressed by the systemic corticosteroid therapy, such as rhinitis, conjunctivitis, eczema, and arthritis ^{01} ^{02}. During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, such as joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function ^{01} ^{02}.

If bronchospasm, with an immediate increase in wheezing, occurs after dosing, it should be treated immediately with a fast-acting inhaled bronchodilator. It is recommended that treatment with inhaled fluticasone be discontinued and alternative therapy instituted. ^{01} ^{02}

Patients who are on medications that suppress the immune system are more susceptible to infections; therefore, children or adults using fluticasone who have not had diseases such as chickenpox or measles should avoid exposure. If the patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If the patient is exposed to measles, prophylaxis with intramuscular pooled immune globulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered. ^{01} ^{02}

After asthma stability has been achieved with the initial dose of fluticasone, titration to the lowest effective dose is desirable to reduce the possibility of side effects. For patients who do not respond adequately to the initial dose after 2 weeks, higher doses may provide better asthma control. ^{01}^{07}^{08}

If symptoms of hypercorticism or adrenal suppression occur, the dosage of fluticasone should be reduced slowly. ^{01}

For treatment of adverse effects
Recommended treatment consists of the following:    • Appropriate local or systemic antifungal therapy should be given to treat localized infections of Candida albicans while fluticasone therapy is continued. ^{01} Interruption of fluticasone therapy rarely is required. ^{01}^{07}^{08}

Inhalation Dosage Forms

FLUTICASONE PROPIONATE INHALATION AEROSOL

Usual adult and adolescent dose
Asthma, chronic (treatment)
Previous asthma therapy consisting of bronchodilators alone: Oral inhalation, 88 to 440 mcg two times a day.^{01}^{07}

Previous asthma therapy including inhaled corticosteroids: Oral inhalation, 88 to 440 mcg two times a day. Initial doses above 88 mcg two times a day may be considered for patients with inadequate asthma control or those who have required inhaled corticosteroids in the higher dosing range for that medication.^{01}^{07}

Previous asthma therapy including systemic corticosteroids: Oral inhalation, 880 mcg two times a day. After at least one week of therapy, slow reduction of the oral corticosteroid dosage may be considered.^{01}^{07}
Canadian labeling recommends: Oral inhalation, 100 to 500 mcg two times a day. Patients should be given starting dose of inhaled fluticasone propionate which is appropriate for the severity of their disease, as follows:

• Mild asthma: 100 to 250 mcg two times a day.^{10}

• Moderate asthma: 250 to 500 mcg two times a day.^{10}

• Severe asthma: 500 mcg two times a day. Very severe asthma such as in patients currently requiring oral corticosteroids may use doses up to 1000 mcg two times a day.^{10}

Usual adult and adolescent prescribing limits
1660 mcg per day for patients previously taking oral corticosteroids.^{01}^{07}
880 mcg per day for patients previously using inhaled corticosteroids or bronchodilators alone.^{01}^{07}

Canadian labeling recommends doses up to 2000 mcg per day.^{10}

Usual pediatric dose
Asthma, chronic (treatment)
Children younger than 12 years of age: Safety and efficacy have not been established.^{01}^{07}

Children 12 years of age and older: See Usual adult and adolescent dose.^{01}^{07}
Canadian labeling recommends:

• For children 16 years of age and older: See Usual adult and adolescent dose.

• For children 4 to 16 years of age: Oral inhalation, 50 to 100 mcg two times a day; the dose should then be adjusted until control is achieved or reduced to the lowest effective dose according to individual response.^{10}For children up to 4 years of age: Safety and efficacy have not been established.^{10}

Usual geriatric dose
See Usual adult and adolescent dose ^{07}.

Strength(s) usually available
U.S.—

44 mcg per metered spray (Rx) [Flovent (chlorofluorocarbons)]

110 mcg per metered spray (Rx) [Flovent (chlorofluorocarbons)]

220 mcg per metered spray (Rx) [Flovent (chlorofluorocarbons)]

Note: Each strength is available as a 7.9-gram and a 13-gram canister that provides 60 and 120 metered sprays, respectively.^{01}^{07}

Canada—

25 micrograms per metered spray (Rx) [Flovent (chlorofluorocarbons)]

50 micrograms per metered spray (Rx) [Flovent (chlorofluorocarbons)]

125 micrograms per metered spray (Rx) [Flovent (chlorofluorocarbons)]

250 micrograms per metered spray (Rx) [Flovent (chlorofluorocarbons)]

Note: Each strength is available in aluminum canisters that provide either 60 or 120 metered sprays.^{10}

Packaging and storage:
Store between 2 and 30 °C (36 and 86 °F). Store canister with nozzle end down. Protect from freezing and direct sunlight.^{01}^{07}^{08}^{10}

Auxiliary labeling:
   • Shake well before using.

Note: Include patient instructions when dispensing.
Demonstrate administration technique.

Additional information:
This product contains trichlorofluoromethane and dichlorodifluoromethane, substances that harm public health and the environment by destroying ozone in the upper atmosphere.

FLUTICASONE PROPIONATE POWDER FOR INHALATION

Usual adult and adolescent dose
Asthma, chronic (treatment)
Previous asthma therapy consisting of bronchodilators alone: Oral inhalation, 100 to 500 mcg two times a day.^{02}^{08}

Previous asthma therapy including inhaled corticosteroids: Oral inhalation, 100 to 500 mcg two times a day.^{08} Initial doses above 100 mcg two times a day may be considered for patients with inadequate asthma control or those who have required inhaled corticosteroids in the higher dosing range.^{02}^{08}

Previous asthma therapy including systemic corticosteroids: Oral inhalation, 1000 mcg two times a day.^{08} After at least one week of therapy, slow reduction of the oral corticosteroid dosage may be considered.^{02}^{08}
Canadian labeling recommends: Oral inhalation, 100 to 500 mcg two times a day. Patients should be given starting dose of inhaled fluticasone propionate which is appropriate for the severity of their disease, as follows:

• Mild asthma: 100 to 250 mcg two times a day.^{10}

• Moderate asthma: 250 to 500 mcg two times a day.^{10}

• Severe asthma: 500 mcg two times a day. Very severe asthma such as in patients currently requiring oral corticosteroids may use doses up to 1000 mcg two times a day.^{10}

Usual adult and adolescent prescribing limits
2000 mcg per day for patients previously taking oral corticosteroids.^{08}^{10}
1000 mcg per day for patients previously using inhaled corticosteroids or bronchodilators alone^{02}.

Note: The 2000-mcg-per-day limit recommendation is based on clinical data from a study using fluticasone inhalation aerosol; no dosing-limit studies have been done with the powder for inhalation^{02}.

Usual pediatric dose
Asthma, chronic (treatment)
Children older than 12 years of age: See Usual adult and adolescent dose ^{02}.
Children 4 to 11 years of age:

• Previous asthma therapy consisting of bronchodilators alone—Oral inhalation, 50 to 100 mcg two times a day^{02}^{08}.

• Previous asthma therapy including inhaled corticosteroids—Oral inhalation, 50 to 100 mcg two times a day^{02}^{08}.

Children younger than 4 years of age: Safety and efficacy have not been established^{02}^{08}.
Canadian labeling recommends:

• For children 16 years of age and older: See Usual adult and adolescent dose.

• For children 4 to 16 years of age: Oral inhalation, 50 to 100 mcg two times a day; the dose should then be adjusted until control is achieved or reduced to the lowest effective dose according to individual response.^{10}For children up to 4 years of age: Safety and efficacy have not been established.^{10}

Usual pediatric prescribing limits
Children 4 to 11 years of age—200 mcg per day.^{08}

Usual geriatric dose
See Usual adult and adolescent dose ^{02}.

Strength(s) usually available
U.S.—

50 mcg per disk (delivering 44 mcg) (Rx) [Flovent Rotadisk (lactose)]

100 mcg per disk (delivering 88 mcg) (Rx) [Flovent Rotadisk (lactose)]

250 mcg per disk (delivering 220 mcg) (Rx) [Flovent Rotadisk (lactose)]

Note: This product is supplied with 15 disks and one inhaler device per carton. The disks are in a white plastic tube that is protected from moisture by a foil pouch. Each circular disk comes in a double-foil pack containing four blisters of the medication.^{02}

Canada—

50 micrograms per blister (Rx) [Flovent Diskus (lactose)]

100 micrograms per blister (Rx) [Flovent Diskus (lactose)]

250 micrograms per blister (Rx) [Flovent Diskus (lactose)]

500 micrograms per blister (Rx) [Flovent Diskus (lactose)]

Note: The product is supplied with a plastic inhaler device containing a foil strip with 60 blisters.^{10}

Packaging and storage:
Store between 20 and 25 °C (68 and 77 °F). Protect from moisture.^{02}

Canadian product should be stored between 2 and 30 °C (36 and 86 °F) in a dry place. Protect from frost and direct sunlight.^{10}

Note: Include patient instructions when dispensing.
Demonstrate administration technique.

Developed: 10/16/1996
Revised: 06/22/2000

References

Flovent inhalation aerosol package insert (Glaxo Wellcome—US), Rev 7/97, Rec 6/98.

Flovent powder for inhalation package insert (Glaxo Wellcome—US), Rev 11/97, Rec 4/98.

Flovent inhalation aerosol patient package insert (Glaxo Wellcome—US), Rev 3/96, Rec 6/98.

Flovent powder for inhalation patient package insert (Glaxo Wellcome—US), Rev 11/97, Rec 6/98.

FDA Talk Paper. Class labeling for intranasal and orally inhaled corticosteroid containing drug products regarding the potential for growth suppression in children. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pulmonary Drug Products; 1998 Nov 9. Available from: URL: http://www.fda.gov/cder/news/cs-label.htm

Panel comment, 1/99.

Product Information: Flovent®, fluticasone propionate inhalation aerosol. GlaxoWellcome, Research Triangle Park, NC, USA, Revised 12/98.

Product Information: Flovent Rotadisk®, fluticasone propionate powder for inhalation. GlaxoWellcome, Research Triangle Park, NC, USA, Revised 1/99.

Canada JR, editor. USP Disctionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention Inc; 1997. p.323.

Product Information: Flovent®, fluticasone propionate inhalation aerosol and Flovent® Diskus®, fluticasone propionate powder for inhalation. Glaxo Wellcome, Mississauga, Ontario, (PI revised 1/2000) reviewed 6/2000.

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