fluticasone propionate
Cutivate, Flonase, Flovent

Pharmacologic classification:corticosteroid
Therapeutic classification:topical and inhaled anti-inflammatory
Pregnancy risk category C


Available forms
Available by prescription only
Cream:0.05%
Inhalation aerosol:44 mcg/actuation, 110 mcg/actuation, 220 mcg/actuation
Inhalation powder:50-mcg, 100-mcg, 250-mcg Rotadisk
Metered nasal spray:50 mcg/actuation
Ointment:0.005%

Indications and dosages
 Relief of inflammation and pruritus from corticosteroid-responsive dermatoses. Adults: Apply sparingly to affected area b.i.d. and rub in gently and completely.
 Management of nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis. Adults: 2 sprays in each nostril once daily or 1 spray b.i.d. Maintenance therapy is 1 spray in each nostril once daily. Alternatively, for seasonal symptomatic relief, 2 sprays in each nostril once daily as needed.
Adolescents and children age 4 and older: Initially, 1 spray (50 mcg) in each nostril once daily. If patient doesn’t respond or symptoms are severe, increase to 2 sprays in each nostril daily. Once adequate control is achieved, decrease dose to 1 spray in each nostril daily. Maximum dose is 2 sprays in each nostril daily.
 Maintenance treatment of asthma as prophylactic therapy. Inhalation aerosolAdults and children age 12 and older: For patients previously on bronchodilator therapy alone, 88 mcg inhalation aerosol b.i.d.; highest recommended dose is 440 mcg b.i.d. For patients previously on inhaled corticosteroids, 88 to 220 mcg inhalation aerosol b.i.d.; highest recommended dose is 440 mcg b.i.d. For patients previously on oral corticosteroids, 880 mcg inhalation aerosol b.i.d.; highest recommended dose is 880 mcg b.i.d.
Inhalation powder
Adults and adolescents: For patients previously on bronchodilators alone, 100 mcg inhalation powder b.i.d.; highest recommended dose is 500 mcg b.i.d. For patients previously on inhaled corticosteroids, 100 to 250 mcg inhalation powder b.i.d.; highest recommended dose is 500 mcg b.i.d. For patients previously on oral corticosteroids, 1,000 mcg inhalation powder b.i.d.; highest recommended dose is 1,000 mcg b.i.d.
Children ages 4 to 11: For patients previously on bronchodilators alone, 50 mcg inhalation powder b.i.d.; highest recommended dose is 100 mcg b.i.d. For patients previously on inhaled corticosteroids, 50 mcg inhalation powder b.i.d.; highest recommended dose is 100 mcg b.i.d.

Pharmacodynamics
Anti-inflammatory action: Fluticasone stimulates synthesis of enzymes needed to decrease inflammation.

Pharmacokinetics
Absorption: Amount absorbed depends on the amount applied, application site, vehicle used, use of occlusive dressing, and integrity of epidermal barrier. Some systemic absorption does occur.
Distribution: Distributed throughout the local skin.
Metabolism: Metabolized primarily by the skin. Absorbed drug is extensively metabolized by the liver.
Excretion: Less than 5% is excreted in urine as metabolites; rest is excreted in feces as parent drug and metabolites.

Route Onset Peak Duration
Topical, inhalation Unknown Unknown Unknown


Contraindications and precautions
Contraindicated in patients hypersensitive to drug or its components and in patients with viral, fungal, herpetic, or tubercular skin lesions. Flovent inhalation aerosol and powder are contraindicated as the primary treatment in status asthmaticus or other acute episodes of asthma where intensive measures are required.
  Use care when transferring patients from systemically active corticosteroids to Flovent inhalation aerosol or powder; deaths have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhalation corticosteroids. During periods of stress or severe asthma attack, instruct patients who have been withdrawn from systemic corticosteroids to resume oral corticosteroids in large doses immediately and to call for further assistance.

Interactions
Drug-drug. Ketoconazole: Increases mean fluticasone levels. Use care when giving fluticasone with long-term ketoconazole and other cytochrome P-450 3A4 inhibitors.

Adverse reactions
CNS: dizziness, giddiness, fever.
GU: dysmenorrhea.
Metabolic: hyperglycemia, glucosuria.
Musculoskeletal: pain in joints, sprain or strain aches and pains, pain in limbs.
Respiratory: bronchitis, chest congestion.
Skin: stinging, burning, pruritus, irritation, dryness, erythema, folliculitis, skin atrophy, leukoderma, vesicles, numbness of fingers, rash, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria.
Other: hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome.

Effects on lab test results
• May increase glucose levels.

Special considerations
• Not used for treatment of rosacea, perioral dermatitis, or acne.
• Mixing with other bases or vehicles may affect potency far beyond expectations.
• Flovent inhalation aerosol and powder aren’t indicated for relief of acute bronchospasm.
• The Rotadisk device eliminates the need for hand-breath coordination because it is breath-activated.
• During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, such as joint or musculoskeletal pain, malaise, and depression, despite maintenance or improvement of respiratory function.
• Because of the possibility of systemic absorption of inhalation corticosteroids, carefully observe patients treated with these drugs for any evidence of systemic corticosteroid effects. Take special care during periods of stress or postoperatively for adrenal insufficiency.
Pregnant patients
• Use drug during pregnancy only when potential benefits justify risks to fetus.
Breast-feeding patients
• It isn’t known whether topical or inhaled corticosteroids undergo sufficient absorption to produce systemic effects in the infant. Use cautiously in breast-feeding women.
Pediatric patients
• Safety and efficacy of topical form haven’t been established in children.
• Safety and efficacy of nasal form haven’t been established in children younger than age 12; use of drug isn’t recommended in these patients.
• Growth velocity may be reduced in children or teenagers from use of corticosteroids for treatment or from inadequate control of chronic disease such as asthma. The benefits of asthma control from corticosteroid therapy must be weighed against the possibility of growth suppression in these patients.

Patient education
• Advise patient that proper application includes washing area before application and applying agent sparingly and rubbing it in lightly.
• Instruct patient to report burning, irritation, or persistent or worsened condition.
• Tell patient to avoid prolonged use, contact with eyes, or use around genital area, rectal area, on face, and in skin creases.
• Urge patient to rinse mouth well after corticosteroid inhalation.
• Urge patient receiving inhaled corticosteroids to avoid exposure and to call immediately if he has been exposed to chickenpox or measles.
• Explain proper administration using the nasal spray pump, including the need to prime the pump.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use