- Cream 0.05%
- Lotion 0.05%
- Ointment 0.005%
- Nasal spray 50 mcg/actuation
- Powder, inhalation 50 mcg/actuation
- Powder, inhalation 100 mcg/actuation
- Powder, inhalation 250 mcg/actuation
- Aerosol 44 mcg/actuation
- Aerosol 110 mcg/actuation
- Aerosol 220 mcg/actuation
- Nasal spray 27.5 mcg/actuation
Exerts potent anti-inflammatory effect on nasal passages.
C max is 0.1 to 1 ng/mL. Systemic bioavailability is 18% ( Diskus ), 5% (cream, ointment), and about 30% of the dose delivered from the CFC inhaler ( Flovent HFA ). Absolute bioavailability is less than 2% ( Flonase ) and 0.5% (fluticasone furoate).
The average Vd is 4.2 L/kg, and the drug is about 91% protein bound. Following IV administration, Vd is 608 L. Plasma protein binding is more than 99% (fluticasone furoate).
The major metabolite is a 17β-carboxylic acid derivative metabolized in the liver via the CYP-450 3A4 pathway.
The half-life is about 7.8 h. It is primarily excreted in the feces as parent drug and metabolites, with less than 5% excreted in the urine as metabolites. The half-life is 15.1 h following IV administration. Excretion is primarily in the feces (fluticasone furoate).
At least 1 to 2 wk.
Special PopulationsRenal Function Impairment
No dosage adjustment is needed in patients with renal function impairment.Hepatic Function Impairment
Since fluticasone undergoes extensive first-pass metabolism, the pharmacokinetics may be altered in patients with hepatic function impairment.Gender
No differences in pharmacokinetics have been observed between men and women.
Indications and Usage
Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses ( Cutivate cream in patients 3 mo of age or older and ointment in adults); relief of inflammatory and pruritic manifestations of atopic dermatitis ( Cutivate lotion); management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and children 4 yr of age and older ( Flonase ); maintenance treatment of asthma as prophylactic therapy in patients 4 yr of age and older ( Flovent Diskus , Flovent HFA ); treatment of symptoms of seasonal and perennial allergic rhinitis in patients 2 yr of age and older ( Veramyst ); patients requiring oral corticosteroid therapy for asthma ( Flovent Diskus , Flovent HFA ).
Primary treatment of status asthmaticus or other acute episodes of asthma in which intensive measures are required ( Flovent Diskus , Flovent HFA ); hypersensitivity to any component of the product.
Dosage and AdministrationCutivate
Atopic dermatitis Adults and Children 3 mo of age and older
Topical Cutivate cream: Apply thin film of cream to affected areas 1 to 2 times daily. Rub in gently. If improvement is not seen within 2 wk, reassessment of the diagnosis may be necessary.Adults and Children 1 yr of age and older
Topical Cutivate lotion: Apply thin film of lotion to affected areas once daily. Rub in gently. If improvement is not seen within 2 wk, reassessment of the diagnosis may be necessary.Adults
Topical Cutivate ointment: Apply thin film of ointment to affected areas 2 times daily. Rub in gently. If improvement is not seen within 2 wk, reassessment of the diagnosis may be necessary.Corticosteroid-Responsive Dermatoses Adults and Children 3 mo of age and older
Topical Cutivate cream: Apply thin film of cream to affected areas 2 times daily. Rub in gently. If improvement is not seen within 2 wk, reassessment of the diagnosis may be necessary.Flonase
Nasal inhalation Starting dose is 2 sprays in each nostril every day (total daily dose, 200 mcg). Same dose divided into 100 mcg twice daily also is effective. After the first few days, dose may be reduced to 100 mcg (1 spray each nostril daily) for maintenance therapy. Max daily dose, 200 mcg.Children 4 yr of age and older
Starting dose is 1 spray in each nostril every day (total daily dose, 100 mcg). May be increased to 200 mcg/day (2 sprays in each nostril) if not adequately responding. Depending on response, dosage may be decreased to 100 mcg/day. Max daily dose, 200 mcg.Flovent Diskus
Individual patients will experience a variable time to onset and degree of symptom relief. Max benefit may take 1 to 2 wk or longer. After achieving stability, titrate to the lowest effective dose in order to reduce adverse reactions.Adults and Children 12 yr of age and older
Oral Inhalation For patients who do not respond adequately to the starting dose after 2 wk of therapy, higher dosages may provide additional asthma control. The recommended starting dose based on the patient's prior asthma therapy are: 1) bronchodilators alone, start with 100 mcg twice daily (max, 500 mcg twice daily); 2) inhaled corticosteroids, start with 100 to 250 mcg twice daily (max 500 mcg twice daily); 3) oral corticosteroids, start with 500 to 1,000 mcg twice daily (max, 1,000 mcg twice daily). For patients currently receiving chronic oral corticosteroid therapy, prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 wk of therapy with Flovent Diskus .Children 4 to 11 yr of age
Oral inhalation For patients who do not respond adequately to the starting dose after 2 wk of therapy, higher dosages may provide additional asthma control. The recommended starting dose, based on the patient's prior asthma therapy, is: bronchodilators alone or inhaled corticosteroids, start with 50 mcg twice daily (max, 100 mcg twice daily). Because individual responses may vary, children previously maintained on other inhaled corticosteroids may require dosage adjustments upon transfer to Flovent Diskus .Flovent HFA
Individuals will experience variable time to onset and degree of symptom relief. Max benefit may take 1 to 2 wk or longer. After achieving stability, titrate to lowest effective dose to reduce adverse reactions.Adults and Children 12 yr of age and older
Inhalation aerosol For patients not responding adequately to the starting dose after 2 wk, higher doses may provide additional asthma control. The recommended starting doses, based on prior asthma therapy, are: 1) bronchodilators alone, start with 88 mcg twice daily (max, 440 mcg twice daily); 2) inhaled corticosteroids, start with 88 to 220 mcg twice daily (max, 440 mcg twice daily); and 3) oral corticosteroids, start with 440 mcg twice daily (max, 880 mcg twice daily). Inhaled corticosteroid therapy Starting dosages above 88 mcg twice daily may be considered for patients with poorer asthma control or who have previously required doses of inhaled corticosteroids in the higher range for that specific agent. Chronic oral corticosteroid therapy Prednisone should be reduced no faster than 2.5 mg to 5 mg/day on a weekly basis, beginning after at least 1 wk of therapy with Flovent HFA .Children 4 to 11 yr of age
Start with 88 mcg twice daily (max, 88 mcg twice daily).Veramyst
Adults and Children 12 yr of age and older
Nasal spray Start with 110 mcg once daily administered as 2 sprays (27.5 mcg/spray) in each nostril. Titrate to the minimum effective dosage. When the max benefit has been achieved and symptoms have been controlled, reducing the dosage to 55 mcg (1 spray in each nostril) once daily may be effective in maintaining control of allergic rhinitis symptoms.Children 2 to 11 yr of age
Nasal spray Start with 55 mcg once daily administered as 1 spray (27.5 mcg/spray) in each nostril. Children not adequately responding to 55 mcg may use 110 mcg (2 sprays in each nostril) once daily. Once symptoms have been controlled, the dosage may be decreased to 55 mcg once daily.
- Oral inhalation of aerosol
- For oral inhalation only. Avoid spraying into the nose or eyes.
- Shake well before each use.
- If patient is also receiving bronchodilators by inhalation, administer bronchodilator 5 min before fluticasone to enhance penetration of latter drug into bronchial tree.
- Before oral inhalation, give patient drink of water to moisten throat. Place inhaler mouthpiece 2 fingerbreadths away from patient's mouth. Tilt patient's head back slightly. Instruct patient to take slow, deep breaths while inhaler is being activated and to hold breath for 5 to 10 sec and then breathe out slowly. A spacing device (eg, Aerochamber ) may be used to enhance delivery of medication. Have patient rinse mouth after inhalations are complete.
- If more than 1 spray/dose is ordered, administer each spray individually, waiting a few seconds between sprays.
- Nasal inhalation
- Shake well before each use.
- Actuate the pump 6 times to prime before first use or after a period of nonuse of more than 1 wk.
- Before nasal inhalation, instruct patient to blow nose gently to clear nasal passages. If needed, a topical decongestant may be used 5 to 10 min before administration to ensure adequate tissue penetration. Nasal lavage with saline also may help remove secretions. Clean outer portion of nose with a damp tissue. Wash and dry hands.
- Insert nozzle into patient's nostril. Use finger to keep other nostril closed. Instruct patient to inhale through nostril while you activate the spray pump. Repeat with other nostril.
- If 2 sprays/dose are ordered, administer 1 spray in each nostril, wait a few seconds, and administer second spray into each nostril.
- Cutivate cream or lotion
- Do not use with occlusive dressings or apply in diaper areas or plastic pants; diapers and plastic pants may constitute as an occlusive dressing.
- Flovent HFA
- Prime inhaler before using for first time by releasing 4 test sprays into air away from face, shaking well for 5 seconds before each spray. In the event that inhaler is not used for more than 7 days or when it is dropped, prime inhaler again by shaking well for 5 seconds before each spray and releasing 1 test spray into air.
- Have patient rinse mouth after inhalations are complete.
- Flovent Diskus
- Should not be used with a spacer device.
- Discard 50 mcg strength 6 wk and the 100 or 250 mcg strengths 8 wk after removal from the moisture-protective foil pouch or after all blisters have been used (ie, when the dose indicator reads 0), whichever comes first.
- Prime inhaler before using for first time by shaking contents well and releasing 6 test sprays into air away from face. In the event that nasal spray is not used for more than 30 days or if cap has been left off bottle for 5 days or longer, prime pump again until a fine mist appears.
- Shake the container well before each use.
Storage/StabilityCutivate cream and ointment
Store at 36° to 86°F.Cutivate lotion
Store at 59° to 86°F. Do not refrigerate. Keep container tightly sealed.Flonase
Store at 39° to 86°F. Protect from freezing.Flovent Diskus
Store at 68° to 77°F. Store in a dry place away from direct heat or sunlight.Flovent HFA
Store at 59° to 86°F. Store inhaler with mouthpiece down. For best results, use inhaler at room temperature. Shake well before using.Veramyst
Store at 59° to 86°F. Store in the upright position with the cap in place. Do not freeze or refrigerate.
Concomitant use may increase fluticasone concentrations and reduce plasma cortisol AUC.Ritonavir
Can significantly increase plasma fluticasone exposure, resulting in significantly reduced serum cortisol concentrations. Systemic effects, including Cushing syndrome and adrenal suppression, have been reported.
Laboratory Test Interactions
None well documented.
Palpitations (1% to 3%).
Headache (16%); dizziness (1% to 3%).Flovent Diskus
Fatigue and malaise (16%); headache (14%); dizziness, migraines, mood disorders, paralysis of cranial nerves, sleep disorders (1% to 3%); aggression, agitation, anxiety, depression, hyperactivity, irritability, restlessness (postmarketing).Flovent HFA
Headache (11%); dizziness (1% to 3%); aggression, agitation, anxiety, behavioral changes including hyperactivity and irritability, depression, restlessness (postmarketing).Veramyst
Headache (9%); pyrexia (5%).
Facial telangiectasias (5%); skin irritation (3%); burning sensation, dusky erythema, erythematous rash, exacerbation of eczema and pruritus, non-facial telangiectasias, urticaria (2%); dry skin, erythema, infected eczema (1%).Cutivate cream and ointment
Acute urticarial reaction, including edema, pruritus, throat swelling, and urticaria (postmarketing).Cutivate lotion
Dry skin (7%); stinging at application site (5%); burning/stinging skin, excoriation (2%).Flonase
Dizziness (1% to 3%).Flovent Diskus
Skin rash (8%); pruritus (6%); acne, dermatitis and dermatosis, eczema, folliculitis, fungal skin infections, photodermatitis, urticaria, viral skin infections (1% to 3%); contusions, ecchymosis (postmarketing).Flovent HFA
Viral skin infections (1% to 3%); contusions, cutaneous hypersensitivity reactions, ecchymosis, pruritus (postmarketing).
EENTCutivate cream and ointment
Blurred vision (postmarketing).Flonase
Pharyngitis (8%); nosebleed (7%); nasal burning and itching (3%); blood in nasal mucus, runny nose (1% to 3%); alteration or loss of sense of taste and/or smell, blurred vision, cataract, conjunctivitis, eye dryness and irritation, glaucoma, hoarseness, increased IOP, nasal septal perforation, nasal ulcer, sore throat, throat irritation and dryness, voice change (postmarketing).Flovent Diskus
Sinusitis/sinus infection (33%); oral candidiasis (31%); throat irritation (22%); nasal congestion/blockage (16%); rhinitis (13%); hoarseness/dysphonia (9%); allergic ear, nose, and throat disorders; blepharoconjunctivitis; conjunctivitis and keratitis; contusions and hematomas; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; ear signs and symptoms; epistaxis; laryngitis; nasal signs and symptoms; otitis; rhinorrhea/postnasal drip; throat constriction; tonsillitis; unspecified oropharyngeal plaques (1% to 3%); aphonia, cataracts, facial and oropharyngeal edema, throat soreness (postmarketing).Flovent HFA
Throat irritation (10%); sinusitis/sinus infection (7%); hoarseness/dysphonia (6%); laryngitis, nasal sinus disorder, pharyngitis/throat infection, rhinitis, rhinorrhea/postnasal drip (1% to 3%); aphonia, cataracts, facial and oropharyngeal edema including angioedema and throat soreness and irritation (postmarketing).Veramyst
Epistaxis (6%); nasopharyngitis (5%); pharyngolaryngeal pain (4%); nasal ulceration (1%).
Diarrhea, vomiting (1%).Flonase
Nausea/vomiting (5%); abdominal pain, diarrhea (1% to 3%).Flovent Diskus
Nausea and vomiting (9%); GI viral infection (5%); GI discomfort and pain (4%); abdominal discomfort and pain, dental discomfort and pain, diarrhea, gastroenteritis, GI infections, GI signs and symptoms, mouth and tongue disorders, oral discomfort and pain, oral erythema and rashes, oral ulcerations, tooth decay (1% to 3%).Flovent HFA
Candidiasis mouth/throat and nonsite specific (5%); diarrhea, dyspeptic symptoms, GI discomfort and pain, GI signs and symptoms, hyposalivation, viral GI infections (1% to 3%).
Bacterial reproductive infections, urinary infections (1% to 3%).Flovent HFA
Urinary infections (1% to 3%).
Hematologic-LymphaticCutivate cream and ointment
Leukopenia, thrombocytopenia (postmarketing).Flovent Diskus
Eosinophilic conditions (postmarketing).Flovent HFA
Eosinophilic conditions (postmarketing).
Cholecystitis (1% to 3%).
Delayed and immediate hypersensitivity reactions including angioedema, bronchospasm, and rash (less than 2%); anaphylactic reaction in patients with severe milk protein allergy (postmarketing).
Metabolic-NutritionalCutivate cream and ointment
Glycosuria, hyperglycemia (postmarketing).Flovent Diskus
Appetite disturbances, disorders of uric acid metabolism, fluid disturbances, goiter, weight gain (1% to 3%); Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, osteoporosis (postmarketing).Flovent HFA
Cushingoid features, growth velocity reduction in children and adolescents, hyperglycemia, osteoporosis, weight gain (postmarketing).
Arthralgia and articular rheumatism (17%); musculoskeletal pain (12%); muscle injury (5%); mobility disorders, muscle cramps and spasms, muscle pain, musculoskeletal inflammation (1% to 3%).Flovent HFA
Injuries, muscle injuries, muscle pain, muscle stiffness/tightness/rigidity, musculoskeletal pain, soft-tissue injuries (1% to 3%).Veramyst
Back pain (1%).
Influenza (2%).Cutivate cream and ointment
Pneumocystis carinii pneumonia (postmarketing).Flonase
Asthma symptoms (7%); cough (4%); bronchitis (1% to 3%).Flovent Diskus
Upper respiratory tract infection (31%); cough, viral respiratory tract infection (9%); bronchitis (8%); lower respiratory viral infection, upper respiratory inflammation (5%); lower respiratory infection (1% to 3%); asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, wheezing (postmarketing).Flovent HFA
Upper respiratory tract infection (18%); bronchitis, cough (6%); upper respiratory inflammation (5%); asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed bronchospasm, paradoxical bronchospasm, pneumonia, wheezing (postmarketing).Veramyst
Common cold (4%).Cutivate cream and ointment
Cushing syndrome, generalized body edema, immunosuppression (postmarketing).Cutivate ointment
Aches and pains, fever, flu-like symptoms (1% to 3%); growth suppression, hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, dyspnea, edema of the face and tongue, pruritus, skin rash, urticaria, and wheezing (postmarketing).Flovent Diskus
Pain (10%); fever (7%); viral infection (5%); bacterial infections, burns, chest symptoms, cysts, edema and swelling, fungal infections, lumps and masses, poisoning, postoperative complications, pressure-induced disorders, soft-tissue injuries, toxicity, wounds and lacerations (1% to 3%).Flovent HFA
Chest symptoms, fever, pain, viral infections (1% to 3%); anaphylactic reaction (postmarketing).
Assess patient's symptoms before initiating therapy and periodically during treatment. Monitor patients for any evidence of systemic corticosteroid effect. Since glaucoma and/or cataracts can occur with use of nasal and inhaled fluticasone, closely monitor patients with vision changes or with history of increased IOP, glaucoma, and/or cataracts.
Category C .
Undetermined; however, other corticosteroids have been detected in human milk.
Safety and efficacy not established in children younger than 3 mo of age.Cutivate lotion
Safety and efficacy not established in children younger than 1 yr of age.Cutivate ointment
Safety and efficacy not established.Flonase
Safety and efficacy not established in children younger than 4 yr of age.Flovent Diskus
Safety and efficacy not established in children younger than 4 yr of age.Flovent HFA inhalation aerosol
Safety and efficacy not established for children younger than 4 yr of age.Veramyst
Safety and efficacy not established in children younger than 2 yr of age.
ElderlyFlovent HFA , Veramyst
Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.Flovent Diskus
No difference in safety and efficacy between patients 65 yr of age and older compared with younger patients.
Reactions, including anaphylaxis, may occur.
No dosage adjustment is needed in patients with renal function impairment.
Since fluticasone is predominately cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone in plasma. Closely monitor patients with hepatic function impairment.Veramyst
Use with caution.
Special Risk Patients
Use with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Prolonged therapy may lead to hypothalamic-pituitary-adrenal (HPA) suppression.
Serious systemic eosinophilic conditions have been reported with inhaled corticosteroid use, including fluticasone.
Local fungal infections have rarely developed. Antifungal treatment or discontinuance of drug may be necessary.
Wheezing, nasal septum perforation, cataracts, glaucoma, and increased IOP may occur.
A reduction in growth velocity may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment.
Immunosuppressed individuals are more susceptible to infections than healthy persons. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using fluticasone.
Impaired wound healing
Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use Veramyst until healing has occurred.
Drug may mask signs of infection and may decrease host-defense mechanisms.
Particular caution is needed when transferring patient from systemically active corticosteroids to fluticasone inhaler because deaths caused by adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic to aerosol corticosteroids.
Because deaths caused by adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids, particular care is needed for patients who are transferred from systemically active corticosteroids to fluticasone. After withdrawal from systemic corticosteroids, a number of months are needed for recovery of HPA function. Patients maintained on prednisone 20 mg/day or more (or its equivalent) may be most susceptible, especially when the systemic corticosteroid is almost completely withdrawn.
Chronic overdosage may result in signs and symptoms of hypercorticism. Because of the routes of administration and quantity of fluticasone per container, acute overdosage is unlikely.
- Advise patient to continue taking other medications for same condition as prescribed by health care provider.
- Review proper administration technique. Have patient demonstrate technique.
- Advise patient that dose may be changed periodically depending on how well symptoms are controlled.
- Instruct patient not to exceed prescribed dose.
- Explain that effects of drug are not immediate. Benefit requires daily use as instructed and usually occurs after 1 to 2 days, but full relief may take 1 to 2 wk.
- Instruct patient not to stop the medication once symptoms have been controlled. Continued daily use is necessary to continue to control symptoms.
- Advise patient not to increase dose and to inform health care provider if symptoms do not improve or if they worsen.
- If patient is being converted from oral corticosteroids to inhaled or intranasal corticosteroids, review signs and symptoms of adrenal insufficiency, which may occur days or weeks after conversion is complete. Advise patient to carry medical identification (eg, card, bracelet) indicating they may need supplemental systemic corticosteroids during periods of stress or a severe asthma attack.
- Advise patient to discard the aerosol canister or nasal spray bottle when the labeled number of doses has been used. Advise patient using dry powder inhalation device on storage and expiration dates once device or blisters are removed from moisture-protective foil overwrap.
- Advise patient to avoid exposure to chickenpox and measles, and to seek medical advice immediately if exposed.
- Cutivate cream, lotion, and ointment
- Explain that product is for external use only and to avoid contact with the eyes.
- Advise patients not to bandage or otherwise cover or wrap area so as to be occlusive unless directed by health care provider.
- Advise patients to report any sign of local adverse reactions to health care provider.
- Inform patients that this product should not be used on the face, underarms, or groin areas unless directed by health care provider.
- Instruct patients to contact health care provider if no improvement is seen within 2 wk.
- Advise parents not to use this product to treat diaper dermatitis or to apply product to diaper areas because diapers or plastic pants may constitute occlusive dressing ( Cutivate cream, lotion).
- Flovent HFA
- Advise patient to clean inhaler at least once a week after the evening dose to prevent medicine buildup.
- Caution patient to never immerse the canister into water to determine the amount remaining in the canister.
- Nasal inhalation
- Instruct patient to use with caution if sores develop or injuries occur in nasal passages. Drug may prevent or slow proper healing.
- Advise patient to report the following symptoms to health care provider: sneezing, nasal irritation, nosebleed.
- Oral inhalation
- Warn patient that drug is an “asthma controller” and is not to be used to treat an acute asthma attack. They must use their “rescue medication” (bronchodilator) to obtain rapid relief of asthma symptoms.
- Instruct patient to carry medical identification (eg, card, bracelet) if experiencing acute severe asthma attacks requiring rapid systemic treatment.
- Advise patient to rinse mouth with water after inhalations are complete. Instruct patient to spit rinse water out and not to swallow rinse water.
- Advise patient to report the following symptoms to health care provider: sore throat or mouth, cough, dry mouth, rash, facial swelling, or worsening asthma symptoms (eg, increasing need for bronchodilator).
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