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Medication Safety Issues
Sound-alike/look-alike issues:
Cutivate® may be confused with Ultravate®
International issues:
Allegro® [Israel] may be confused with Allegra® which is a brand name for fexofenadine in the U.S.
Allegro®: Brand name for frovatriptan in Germany
Flovent® may be confused with Flogen® which is a brand name for naproxen in Mexico
Pronunciation
(floo TIK a sone)
U.S. Brand Names
Index Terms
Generic Available
Yes: Cream, nasal spray, ointment
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Oral inhalation: Maintenance treatment of asthma as prophylactic therapy; also indicated for patients requiring oral corticosteroid therapy for asthma to assist in total discontinuation or reduction of total oral dose
Intranasal:
Flonase®: Management of seasonal and perennial allergic rhinitis and nonallergic rhinitis
Veramyst™: Management of seasonal and perennial allergic rhinitis
Avamys™ [CAN]: Management of seasonal allergic rhinitis
Topical: Relief of inflammation and pruritus associated with corticosteroid-responsive dermatoses; atopic dermatitis
Pregnancy Risk Factor
C
Pregnancy Considerations
Teratogenic events have been observed in some, but not all, animal studies. There are no adequate and well-controlled studies using inhaled fluticasone in pregnant women. Oral corticosteroid use has shown animals to be more prone to teratogenic effects than humans. Due to the natural increase in corticosteroid production during pregnancy, most women may require a lower steroid dose; use with caution.
Lactation
Excretion in breast milk unknown/use caution
Breast-Feeding Considerations
Systemic corticosteroids are excreted in human milk. The extent of topical absorption is variable. Use with caution while breast-feeding; do not apply to nipples.
Contraindications
Hypersensitivity to fluticasone or any component of the formulation; primary treatment of status asthmaticus or acute bronchospasm
Topical: Do not use if infection is present at treatment site, in the presence of skin atrophy, or for the treatment of rosacea or perioral dermatitis
Warnings/Precautions
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Topical application may also cause suppression of HPA axis, especially when used on large areas of the body, denuded areas, for prolonged periods of time, or with an occlusive dressing. Pediatric patients may be more susceptible to systemic toxicity. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Concurrent use of ritonavir (and potentially other strong inhibitors of CYP3A4) may increase fluticasone levels and effects on HPA suppression. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.
• Bronchospasm: May occur with wheezing after inhalation; if this occurs, stop steroid and treat with a fast-acting bronchodilator.
•Delayed wound healing: Avoid nasal corticosteroid use in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma until healing has occurred.
• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only in conjunction with antituberculosis treatment).
• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.
• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Pre-existing psychiatric conditions may be exacerbated by corticosteroid use.
• Vasculitis: Rare cases of vasculitis (Churg-Strauss syndrome) or other eosinophilic conditions can occur.
Disease-related concerns:
• Asthma: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Not to be used in status asthmaticus or for the relief of acute bronchospasm.
• Cardiovascular disease: Use with caution in patients with HF; long-term use has been associated with fluid retention and hypertension.
• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.
• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, peptic ulcer, ulcerative colitis) due to perforation risk.
• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred, especially during initial treatment with corticosteroids.
• Myocardial infarct (MI): Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.
• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.
• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.
• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.
• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.
Special populations:
• Pediatrics: Orally-inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range 0.3-1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally-inhaled and intranasal corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• Flovent® Diskus®: Contains lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy.
Other warnings/precautions:
• Discontinuation of therapy: Withdraw systemic therapy with gradual tapering of dose. There have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.
Adverse Reactions
Oral inhalation (includes reactions from Flovent® HFA and Flovent® Diskus® trials):
>10%:
Central nervous system: Headache (2% to 14%)
Respiratory: Upper respiratory tract infection (14% to 21%), throat irritation (3% to 13%)
3% to 10%:
Central nervous system: Fever (1% to 7%)
Gastrointestinal: Nausea/vomiting (1% to 8%), gastrointestinal infection (viral) (1% to 5%), gastrointestinal discomfort/pain (1% to 4%)
Neuromuscular & skeletal: Musculoskeletal pain (2% to 5%), muscle injury (1% to 5%)
Respiratory: Sinusitis/sinus infection (4% to 10%), cough (1% to 6%), bronchitis (?8%), hoarseness/dysphonia (2% to 6%), upper respiratory tract inflammation (?5%), viral respiratory infection (1% to 5%), rhinitis (1% to 4%)
Miscellaneous: Oral candidiasis (<1% to 9%), viral infection (1% to 5%)
1% to 3%:
Cardiovascular: Chest symptoms, edema, palpitation
Central nervous system: Cranial nerve paralysis, dizziness, fatigue, malaise, migraine, mood disorders, pain, sleep disorder
Dermatologic: Acne, dermatitis/dermatosis, eczema, folliculitis, photodermatitis, pruritus, rash, urticaria
Endocrine metabolic: Fluid disturbance, goiter, uric acid metabolism disturbance
Gastrointestinal: Abdominal discomfort/pain, appetite changes, diarrhea, dyspepsia, gastroenteritis, hyposalivation, oral discomfort/pain, oral erythema/rash, oral ulcerations, tooth decay, weight gain
Genitourinary: Urinary tract infection
Hematologic: Hematoma
Hepatic: Cholecystitis
Neuromuscular & skeletal: Arthralgia, articular rheumatism, muscle cramps/spasms, muscle pain, muscle stiffness/tightness/rigidity, musculoskeletal inflammation
Ocular: Blepharoconjunctivitis, conjunctivitis, keratitis
Otic: Otitis
Respiratory: Epistaxis, laryngitis, lower respiratory tract infection, nasal sinus disorder, pharyngitis/throat infection, rhinorrhea/postnasal drip, throat constriction
Miscellaneous: Infection (bacterial, fungal); injuries (including muscle, soft tissue); polyps (ear, nose, throat); tonsillitis
Postmarketing and/or case reports: Aggression, agitation, anaphylactic reaction, angioedema, anxiety, aphonia, asthma exacerbation, behavioral changes (eg, hyperactivity and irritability in children; rare), bronchospasm (immediate and delayed), cataracts, chest tightness, Churg-Strauss syndrome, contusion, Cushingoid features, cutaneous hypersensitivity, depression, dyspnea, ecchymoses, facial edema, growth velocity reduction in children/adolescents, HPA axis suppression, hyperglycemia, hypersensitivity reactions (immediate and delayed), oropharyngeal edema, osteoporosis, paradoxical bronchospasm, pneumonia, restlessness, throat soreness, urticaria, vasculitis, wheeze
Nasal inhalation (includes reactions from Flonase®, Veramyst™, and Avamys™ [CAN] trials):
>10%: Central nervous system: Headache (7% to 16%)
1% to 10%:
Central nervous system: Dizziness (1% to 3%), fever (1% to 5%)
Gastrointestinal: Nausea/vomiting (3% to 5%), abdominal pain (1% to 3%), diarrhea (1% to 3%)
Neuromuscular & skeletal: Back pain (1%)
Respiratory: Pharyngitis (6% to 8%), epistaxis (4% to 7%), asthma symptoms (3% to 7%), cough (3% to 4%), pharyngolaryngeal pain (2% to 4%), blood in nasal mucous (1% to 3%), bronchitis (1% to 3%), runny nose (1% to 3%), nasal ulcer (1%)
Miscellaneous: Aches and pains (1% to 3%), flu-like syndrome (1% to 3%)
<1% and postmarketing reports: Alteration or loss of sense of taste and/or smell, anaphylaxis/anaphylactoid reactions, angioedema, AST increased, AV block (second degree), blurred vision, bronchospasm, cataracts, conjunctivitis, dry/irritated eyes, dry throat, dyspnea, edema (face and tongue), glaucoma, hoarseness, hypersensitivity reactions, increased intraocular pressure, nasal candidiasis, nasal septal perforation (rare), palpitations, pruritus, psychomotor hyperactivity, sinus congestion, skin rash, sore throat, throat irritation, tremor, urticaria, vaginal candidiasis, voice changes, wheezing
Topical: Pruritus (3%), skin irritation (3%), exacerbation of eczema (2%), dryness (1%), numbness of fingers (1%)
Reported with other topical corticosteroids (in decreasing order of occurrence): Irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, pustular psoriasis from chronic plaque psoriasis
Metabolism/Transport Effects
Substrate of CYP3A4 (major)
Drug Interactions
Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy
Antidiabetic Agents: Corticosteroids (Orally Inhaled) may diminish the hypoglycemic effect of Antidiabetic Agents. In some instances, corticosteroid-mediated HPA axis suppression has led to episodes of acute adrenal crisis, which may manifest as enhanced hypoglycemia, particularly in the setting of insulin or other antidiabetic agent use. Risk C: Monitor therapy
Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Corticosteroids (Orally Inhaled). Risk C: Monitor therapy
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Risk D: Consider therapy modification
Loop Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy
Protease Inhibitors: May decrease the metabolism of Corticosteroids (Orally Inhaled). Risk D: Consider therapy modification
Thiazide Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Thiazide Diuretics. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Herb/Nutraceutical: In theory, St John's wort may decrease serum levels of fluticasone by inducing CYP3A4 isoenzymes.
Storage
Nasal spray:
Flonase®: Store between 4°C to 30°C (39°F to 86°F).
Veramyst™: Store between 15°C to 30°C (59°F to 86°F); do not refrigerate or freeze. Store in upright position with cap on.
Avamys™ [CAN]: Store between 4°C to 30°C (39°F to 86°F); do not refrigerate or freeze. Store in upright position with cap on.
Oral inhalation:
Flovent® HFA: Store at 15°C to 30°C (59°F to 86°F). Store with mouthpiece down.
Flovent® Diskus®: Store at 20°C to 25°C (68°F to 77°F) in a dry place away from direct heat or sunlight. Discard after 6 weeks from removal from protective foil pouch or when all blisters have been used (device is not reusable).
Topical, cream: Store at 15°C to 30°C (59°F to 86°F).
Cutivate® lotion: Store at 15°C to 30°C (59°F to 86°F). do not refrigerate.
Cutivate® cream, ointment: Store at 2°C to 30°C (36°F to 86°F).
Mechanism of Action
Fluticasone belongs to a group of corticosteroids which utilizes a fluorocarbothioate ester linkage at the 17 carbon position; extremely potent vasoconstrictive and anti-inflammatory activity; has a weak HPA inhibitory potency when applied topically, which gives the drug a high therapeutic index. The effectiveness of inhaled fluticasone is due to its direct local effect. The mechanism of action for all topical corticosteroids is believed to be a combination of three important properties: anti-inflammatory activity, immunosuppressive properties, and antiproliferative actions.
Pharmacodynamics/Kinetics
Onset of action: Intranasal: Maximal benefit may take several days
Flovent® HFA, Flovent® Diskus®: Maximal benefit may take 1-2 weeks or longer
Absorption:
Topical cream: 5% (increased with inflammation)
Oral inhalation: Absorbed systemically (Flovent® Diskus®: ~18%) primarily via lungs, minimal GI absorption (<1%) due to presystemic metabolism
Distribution: Propionate: 4.2 L/kg
Protein binding: 91% to 99%
Metabolism: Hepatic via CYP3A4 to 17?-carboxylic acid (negligible activity)
Bioavailability: Nasal: ?2%; Oral inhalation: (~18% to 21%)
Excretion: Feces (as parent drug and metabolites); urine (<5% as metabolites)
Dosage
Children:
Asthma: Inhalation, oral:
Flovent® HFA:
Children 4-11 years: 88 mcg twice daily
Children ?12 years: Refer to adult dosing.
NIH Asthma Guidelines (NIH, 2007) (administer in divided doses twice daily):
“Low” dose:
0-4 years: 176 mcg/day
5-11 years: 88-176 mcg/day
?12 years: 88-264 mcg/day
“Medium” dose:
0-4 years: >176-352 mcg/day
5-11 years: >176-352 mcg/day
?12 years: >264-440 mcg/day
“High” dose:
0-4 years: >352 mcg/day
5-11 years: >352 mcg/day
?12 years: >440 mcg/day
Flovent® Diskus® (U.S. labeling):
Children 4-11 years: Usual starting dose: 50 mcg twice daily; may increase to 100 mcg twice daily in patients not adequately controlled after 2 weeks of therapy. Higher starting doses may be considered in patients with poorer asthma control or those requiring high ranges of inhaled corticosteroids. Titrate to the lowest effective dose once asthma stability is achieved (maximum dose: 100 mcg twice daily)
Children >11 years: Refer to adult dosing.
Flovent® Diskus® (Canadian labeling):
Children 4-16 years: Usual starting dose: 50-100 mcg twice daily; may increase to 200 mcg twice daily in patients not adequately controlled; titrate to the lowest effective dose once asthma stability is achieved
Children ?16 years: Refer to adult dosing.
Corticosteroid-responsive dermatoses: Topical: Children ?3 months: Cream: Apply sparingly to affected area twice daily. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Note: Safety and efficacy of treatment >4 weeks duration have not been established.
Atopic dermatitis: Topical:
Children ?3 months: Cream: Apply sparingly to affected area 1-2 times/day. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Children ?1 year: Lotion: Apply sparingly to affected area once daily
Note: Safety and efficacy of treatment >4 weeks duration have not been established.
Rhinitis: Intranasal:
Flonase® (fluticasone propionate): Children ?4 years and Adolescents: Initial: 1 spray (50 mcg/spray) per nostril once daily; patients not adequately responding or patients with more severe symptoms may use 2 sprays (100 mcg) per nostril. Depending on response, dosage may be reduced to 100 mcg daily. Total daily dosage should not exceed 2 sprays in each nostril (200 mcg)/day. Dosing should be at regular intervals.
Veramyst™ (fluticasone furoate):
Children 2-11 years: Initial: 1 spray (27.5 mcg/spray) per nostril once daily (55 mcg/day); patients not adequately responding may use 2 sprays per nostril once daily (110 mcg/day). Once symptoms are controlled, dosage may be reduced to 55 mcg once daily. Total daily dosage should not exceed 2 sprays in each nostril (110 mcg)/day.
Children ?12 years and Adolescents: Initial: 2 sprays (27.5 mcg/spray) per nostril once daily (110 mcg/day). Once symptoms are controlled, dosage may be reduced to 1 spray per nostril once daily (55 mcg/day). Total daily dosage should not exceed 2 sprays in each nostril (110 mcg)/day.
Avamys™ [CAN] (fluticasone furoate): Children ?12 years: 2 sprays (27.5 mcg/spray) in each nostril once daily (110 mcg/day). Total daily dosage should not exceed 2 sprays in each nostril (110 mcg)/day.
Adults:
Asthma: Inhalation, oral: Note: Titrate to the lowest effective dose once asthma stability is achieved
Flovent® HFA: Manufacturers labeling: Dosing based on previous therapy
Bronchodilator alone: Recommended starting dose: 88 mcg twice daily; highest recommended dose: 440 mcg twice daily
Inhaled corticosteroids: Recommended starting dose: 88-220 mcg twice daily; highest recommended dose: 440 mcg twice daily; a higher starting dose may be considered in patients previously requiring higher doses of inhaled corticosteroids
Oral corticosteroids: Recommended starting dose: 440 mcg twice daily
Highest recommended dose: 880 mcg twice daily; starting dose is patient dependent. In patients on chronic oral corticosteroids therapy, reduce prednisone dose no faster than 2.5-5 mg/day on a weekly basis; begin taper after 1 week of fluticasone therapy.
NIH Asthma Guidelines (NIH, 2007) (administer in divided doses twice daily):
“Low” dose: 88-264 mcg/day
“Medium” dose: >264-440 mcg/day
“High” dose: >440 mcg/day
Flovent® Diskus® (U.S. labeling): Note: May increase dose after 2 weeks of therapy in patients not adequately controlled. Higher starting doses may be considered in patients with poorer asthma control or those requiring high ranges of inhaled corticosteroids. Titrate to the lowest effective dose once asthma stability is achieved.
Bronchodilator alone: Recommended starting dose: 100 mcg twice daily; maximum recommended dose: 500 mcg twice daily
Inhaled corticosteroids: Recommended starting dose: 100-250 mcg twice daily; maximum recommended dose: 500 mcg twice daily
Oral corticosteroids: Recommended starting dose: 500-1000 mcg twice daily; maximum recommended dose: 1000 mcg twice daily. Starting dose is patient dependent. In patients on chronic oral corticosteroids therapy, reduce prednisone dose no faster than 2.5 mg/day on a weekly basis; begin taper after 1 week of fluticasone therapy.
Flovent® Diskus® (Canadian labeling):
Mild asthma: 100-250 mcg twice daily
Moderate asthma: 250-500 mcg twice daily
Severe asthma: 500 mcg twice daily; may increase to 1000 mcg twice daily in very severe patients requiring high doses of corticosteroids
Corticosteroid-responsive dermatoses: Topical: Cream, lotion, ointment: Apply sparingly to affected area twice daily. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Atopic dermatitis: Topical: Cream, lotion: Apply sparingly to affected area once or twice daily. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Rhinitis: Intranasal:
Flonase® (fluticasone propionate): Initial: 2 sprays (50 mcg/spray) per nostril once daily; may also be divided into 100 mcg twice a day. After the first few days, dosage may be reduced to 1 spray per nostril once daily for maintenance therapy.
Veramyst™ (fluticasone furoate): Initial: 2 sprays (27.5 mcg/spray) per nostril once daily (110 mcg/day). Once symptoms are controlled, may reduce dosage to 1 spray per nostril once daily (55 mcg/day) for maintenance therapy.
Avamys™ [CAN] (fluticasone furoate): 2 sprays (27.5 mcg/spray) in each nostril once daily (110 mcg/day). Total daily dosage should not exceed 2 sprays in each nostril (110 mcg)/day.
Elderly: No differences in safety have been observed in the elderly when compared to younger patients. Based on current data, no dosage adjustment is needed based on age.
Dosage adjustment in hepatic impairment: Fluticasone is primarily cleared in the liver. Fluticasone plasma levels may be increased in patients with hepatic impairment, use with caution; monitor.
Administration: Inhalation
Aerosol inhalation: Flovent® HFA: Shake container thoroughly before using. Take 3-5 deep breaths. Use inhaler on inspiration. Allow 1 full minute between inhalations. Rinse mouth with water after use to reduce aftertaste and incidence of candidiasis; do not swallow. Flovent® HFA inhaler must be primed before first use, when not used for 7 days, or if dropped. To prime the first time, release 4 sprays into air; shake well before each spray and spray away from face. If dropped or not used for 7 days, prime by releasing a single test spray. Discard after 120 actuations; do not use “float” test to determine contents
Nasal spray: Administer at regular intervals. Shake bottle gently before using. Blow nose to clear nostrils. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray. Discard after labeled number of doses has been used, even if bottle is not completely empty.
Flonase®: Prime pump (press 6 times until fine spray appears) prior to first use or if spray unused for ?7 days. Once weekly, nasal applicator may be removed and rinsed with warm water to clean.
Veramyst™, Avamys™ [CAN]: Prime pump (press 6 times until fine spray appears) prior to first use, if spray unused for ?30 days, or if cap left off bottle for ?5 days. After each use, nozzle should be wiped with a clean, dry tissue. Once weekly, inside of cap should be cleaned with a clean, dry tissue.
Powder for oral inhalation: Flovent® Diskus®: Do not use with a spacer device. Do not exhale into Diskus®. Do not wash or take apart. Use in horizontal position. Mouth should be rinsed with water after use (do not swallow). Discard after 6 weeks once removed from protective pouch or when all blisters have been used (device is not reusable).
Administration: Topical
Cream, lotion, ointment: Apply sparingly in a thin film. Rub in lightly. Unless otherwise directed by healthcare professional, do not use with occlusive dressing; do not use on children's skin covered by diapers or plastic pants.
Monitoring Parameters
Growth (adolescents and children); signs/symptoms of HPA axis suppression/adrenal insufficiency; possible eosinophilic conditions (including Churg-Strauss syndrome); FEV1, peak flow, and/or other pulmonary function tests; asthma symptoms
Dietary Considerations
Flovent® Diskus® contains lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy.
Patient Education
Use as directed; do not overuse and use only for length of time prescribed. Although you may see improvement within a few hours of use, the full benefit of the medication may not be achieved for several days. Do not change the prescribed dosage without consulting prescriber. Avoid exposure to chickenpox or measles. If exposed, inform your prescriber as soon as possible. May cause headache. Report signs of infection or change in vision to prescriber. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Metered-dose inhalation: Sit when using. Take deep breaths for 3-5 minutes, and clear nasal passages before administration (use decongestant as needed). Hold breath for 5-10 seconds after use, and wait 1-3 minutes between inhalations. Follow package insert instructions for use. Do not exceed maximum dosage. If also using inhaled bronchodilator, use before fluticasone. Rinse mouth and throat after use to reduce aftertaste and prevent candidiasis.
Nasal spray: Shake gently before use. Use at regular intervals, no more frequently than directed. Report unusual cough or spasm; persistent nasal bleeding, burning, or irritation; or worsening of condition.
Powder for oral inhalation: Flovent® Diskus®: Do not attempt to take device apart. Do not use with a spacer device. Do not exhale into the Diskus®; use in a level horizontal position. Do not wash the mouthpiece.
Topical: For external use only. Apply thin film to affected area only; rub in lightly. Do not apply occlusive covering unless advised by prescriber. Wash hand thoroughly after use; avoid contact with eyes. Notify prescriber if skin condition persists or worsens. Do not use for treatment of diaper dermatitis or under diapers or plastic pants.
Geriatric Considerations
No specific geriatric information is available. No differences in safety have been observed in the elderly when compared to younger patients. Based on current data, no dosage adjustment is needed based on age.
Additional Information
Effects of inhaled/intranasal steroids on growth have been observed in the absence of laboratory evidence of 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. The long-term effects of this reduction in growth velocity associated with orally-inhaled and intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth following discontinuation of treatment with inhaled corticosteroids has not been adequately studied. The product labeling notes that intranasal administration was not associated with a statistically-significant reduction in growth velocity (based on a small study conducted over 1 year).
In the United States, dosage for the metered dose inhaler (Flovent® HFA) is expressed as the amount of drug which leaves the actuater and is delivered to the patient. This differs from other countries, which express the dosage as the amount of drug which leaves the valve.
Anesthesia and Critical Care Concerns/Other Considerations
Surgery: For patients who have received oral systemic corticosteroids during the past 6 months and for selected patients on long-term, high-dose, inhaled corticosteroid (ICS), give stress doses of hydrocortisone intravenously during the surgical period and reduce the dose rapidly within 24 hours after surgery (Expert Panel Report 3, 2007). Clinically important adrenal suppression has been reported in patients receiving high doses of an ICS, particularly children.
Dental Health: Effects on Dental Treatment
Localized infections with Candida albicans or Aspergillus niger have occurred frequently in the mouth and pharynx with repetitive use of oral inhaler of corticosteroids. These infections may require treatment with appropriate antifungal therapy or discontinuance of treatment with corticosteroid inhaler.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause agitation, aggression, anxiety, depression, hyperactivity, irritability, and restlessness
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Monitor effectiveness of therapy and adverse reactions at beginning of therapy and periodically with long-term use. May take as long as 2 weeks before full benefit of medication is known. Encourage regular eye exams with long-term use. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report. Monitor for possible eosinophilic conditions (including Churg-Strauss syndrome); growth (adolescents and children); and signs/symptoms of HPA axis suppression/adrenal insufficiency.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [CAN] = Canadian brand name
Aerosol for oral inhalation, as propionate [CFC free]:
Flovent® HFA: 44 mcg/inhalation (10.6 g) [120 metered actuations]
Flovent® HFA: 110 mcg/inhalation (12 g) [120 metered actuations]
Flovent® HFA: 220 mcg/inhalation (12 g) [120 metered actuations]
Cream, as propionate: 0.05% (15 g, 30 g, 60 g)
Cutivate®: 0.05% (30 g, 60 g)
Lotion, as propionate:
Cutivate®: 0.05% (60 mL)
Ointment, as propionate: 0.005% (15 g, 30 g, 60 g)
Cutivate®: 0.005% (30 g, 60 g)
Powder for oral inhalation, as propionate:
Flovent® Diskus® [U.S.]: 50 mcg (60s) [contains lactose; prefilled blister pack]
Flovent® Diskus® [CAN]: 50 mcg (28s, 60s) [contains lactose; prefilled blister pack] [not available in the U.S.]
Flovent® Diskus® [CAN]: 100 mcg (28s, 60s) [contains lactose; prefilled blister pack] [not available in the U.S.]
Flovent® Diskus® [CAN]: 250 mcg (28s, 60s) [contains lactose; prefilled blister pack] [not available in the U.S.]
Flovent® Diskus® [CAN]: 500 mcg (28s, 60s) [contains lactose; prefilled blister pack] [not available in the U.S.]
Suspension, intranasal, as furoate [spray]:
Avamys™ [CAN]: 27.5 mcg/inhalation (4.5 g) [30 metered actuations; contains benzalkonium chloride]; (10 g) [120 metered actuations; contains benzalkonium chloride] [not available in the U.S.]
Veramyst™: 27.5 mcg/inhalation (10 g) [120 metered actuations; contains benzalkonium chloride]
Suspension, intranasal, as propionate [spray]: 50 mcg/inhalation (16 g) [120 metered actuations]
Flonase®: 50 mcg/inhalation (16 g) [120 metered actuations; contains benzalkonium chloride]
Pricing: U.S. (www.drugstore.com)
Aerosol (Flovent HFA)
44 mcg/ACT (10.6): $95.95
110 mcg/ACT (12): $125.46
220 mcg/ACT (12): $204.04
Cream (Cutivate)
0.05% (15): $25.99
0.05% (30): $37.99
0.05% (60): $85.99
Cream (Fluticasone Propionate)
0.05% (15): $14.99
0.05% (30): $18.99
0.05% (60): $27.99
Lotion (Cutivate)
0.05% (60): $114.99
0.05% (120): $229.98
Ointment (Cutivate)
0.005% (15): $25.99
0.005% (30): $37.99
0.005% (60): $89.99
Ointment (Fluticasone Propionate)
0.005% (15): $14.99
0.005% (30): $23.99
0.005% (60): $28.99
Suspension (Flonase)
50 mcg/ACT (16): $85.99
Suspension (Fluticasone Propionate)
50 mcg/ACT (16): $59.99
Suspension (Veramyst)
27.5 mcg/spray (10): $85.99
References
Expert Panel Report 3, “Guidelines for the Diagnosis and Management of Asthma,” Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 08-4051, prepublication 2007. Available at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm
Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,” J Natl Cancer Inst, 2002, 94(22):1712-8.
Todd GR, Acerini CL, Buck JJ, et al, "Acute Adrenal Crisis in Asthmatics Treated With High-Dose Fluticasone Propionate," Eur Respir J, 2002, 19(6):1207-9.
Todd GR, Acerini CL, Ross-Russell R, et al, "Survey of Adrenal Crisis Associated With Inhaled Corticosteroids in the United Kingdom," Arch Dis Child, 2002, 87(6):457-61.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2008
Content last modified August 2008
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