Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients; monitor growth of pediatric patients receiving ICS routinely (eg. via stadiometry); to minimize systemic effects of orally inhaled corticosteroids, titrate each patient’s dosage to lowest dosage that effectively controls his/her symptoms Decreases in bone mineral density (BMD) reported with long-term administration of products containing ICS; clinical significance of small changes in BMD with regard to longterm consequences such as fracture is unknown; monitor and treat patients with established standards of care patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids) Anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose reported; patients with severe milk protein allergy should not use product Therapy not to be regarded as bronchodilator and not indicated for rapid relief of bronchospasm; instruct patient to contact physicians immediately when episodes of asthma that are not responsive to bronchodilators occur during course of treatment; during such episodes, patients may require therapy with oral corticosteroids Eosinophilic conditions In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions; some patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy; these events, have been associated (not always) with reduction and/or withdrawal of oral corticosteroid therapy following introduction of fluticasone propionate Cases of serious eosinophilic conditions have also been reported with other ICS in this clinical setting; physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients; a causal relationship between fluticasone propionate and these underlying conditions not established Transferring patients from systemic corticosteroid therapy Particular care needed for patients transferred from systemically active corticosteroids to ICS; deaths due to adrenal insufficiency during and after transfer from systemic corticosteroids to less systemically available ICS After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function During periods of stress or a severe asthma attack, instruct patients who have been withdrawn from systemic corticosteroids to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction; patients should carry warning card indicating possible need for supplementary systemic steroids in such emergencies Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to ICS; prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with ICS Lung function (mean forced expiratory volume in 1 second [FEV1] or morning peak expiratory flow [AM PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids Patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension Transfer of patients from systemic corticosteroid therapy to ICS may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions) Systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects; if effects occur, ICS dose should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and other treatments for management of asthma symptoms should be considered Pregnancy There are no randomized clinical studies in pregnant women; in women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes (eg, pre-eclampsia in the mother, prematurity, low birth weight, and small for gestational age in the neonate;) Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control Lactation Fluticasone propionate concentrations in plasma after inhaled therapeutic doses are low; concentrations in human breast milk are likely to be correspondingly low Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or from underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Anti-inflammatory corticosteroid; exact mechanism of action is unknown, but agent has been shown to exhibit anti-inflammatory effect on neutrophils, eosinophils, macrophages, mast cells, lymphocytes, and mediators (histamine, leukotrienes, cytokines, eicosanoids) Absorption Bioavailability: 30% Onset: 24 hr (maximum, 1-2 wk) Distribution Protein bound: 99% Vd: 4.2 L/kg Metabolism Metabolized in liver by CYP3A4 Metabolites: 17-Beta carboxylic acid Elimination Half-life: 11-12 hr Excretion: Feces (parent drug), urine (<5% metabolites) Orally Inhaled Administration Aerosol Prime inhaler (4 actuations into air) before first use and after prolonged (>7 days) idleness Shake well before each actuation Valve holding chamber and face mask may be used for younger patients Powder Does not require priming Do not use with a spacer Keep the inhaler in a cool dry place; never wash or put any part of the inhaler in water Routine maintenance is not required; if the mouthpiece needs cleaning, gently wipe with a dry cloth or tissue as needed Hold your breath for about 10 seconds after inhaling; then breathe out fully After each dose, rinse your mouth with water and spit it out; do not swallow the water Diskus Always use in a level, flat position Make sure the lever firmly clicks into place Storage Store at 68-77ºF (20-25ºC); excursions permitted to 59-86ºF (15-30ºC) Flovent HFA Contents under pressure: Do not puncture, do not use or store near heat or open flame Exposure to temperatures >120ºF may cause bursting; never throw canister into fire or incinerator Store inhaler with mouthpiece down Flovent Diskus Store in a dry place away from direct heat or sunlight Discard 6 wk (50-mcg strength) or 2 months (100- and 250-mcg strengths) after opening foil pouch or when counter reads “0”, whichever comes first Inhaler is not reusable; do not attempt to take inhaler apart ArmonAir Digihaler Avoid exposure to extreme heat, cold, or humidity Discard 30 days after opening foil pouch or when counter reads “0”, whichever comes first Inhaler is not reusable; do not attempt to take inhaler apart BRAND FORM. UNIT PRICE PILL IMAGE fluticasone propionate topical- 0.05 % creamfluticasone propionate topical- 0.05 % creamfluticasone propionate topical- 0.005 % ointmentfluticasone propionate topical- 0.005 % ointmentfluticasone propionate topical- 0.005 % ointmentfluticasone propionate topical- 0.05 % creamfluticasone propionate topical- 0.05 % creamfluticasone propionate topical- 0.05 % creamfluticasone propionate topical- 0.05 % creamfluticasone propionate topical- 0.05 % lotionfluticasone propionate topical- 0.05 % creamfluticasone propionate topical- 0.05 % creamfluticasone propionate topical- 0.005 % ointmentfluticasone propionate topical- 0.005 % ointmentfluticasone propionate topical- 0.005 % ointmentfluticasone propionate topical- 0.05 % lotionfluticasone propionate topical- 0.05 % creamfluticasone propionate topical- 0.05 % lotionClariSpray nasal- 50 mcg/actuation suspensionfluticasone propionate inhalation- 110 mcg/actuation aerosolfluticasone propionate inhalation- 44 mcg/actuation aerosolBeser topical- 0.05 % lotionArmonAir Digihaler inhalation- 113 mcg/actuation aerosolXhance nasal- 93 mcg/actuation aerosolXhance nasal- 93 mcg/actuation aerosolChildren's Flonase Allergy Relief nasal- 50 mcg/actuation suspensionChildren's Flonase Allergy Relief nasal- 50 mcg/actuation suspensionFlovent Diskus inhalation- 100 mcg/actuation aerosolFlovent Diskus inhalation- 250 mcg/actuation aerosolFlovent Diskus inhalation- 100 mcg/actuation aerosolFlovent Diskus inhalation- 250 mcg/actuation aerosolFlovent Diskus inhalation- 50 mcg/actuation aerosolFlovent HFA inhalation- 220 mcg/actuation aerosolFlovent HFA inhalation- 44 mcg/actuation aerosolFlovent HFA inhalation- 110 mcg/actuation aerosolFlonase Allergy Relief nasal- 50 mcg/actuation suspensionFlonase Allergy Relief nasal- 50 mcg/actuation suspensionFlonase Allergy Relief nasal- 50 mcg/actuation suspensionFlonase Allergy Relief nasal- 50 mcg/actuation suspensionFlonase Allergy Relief nasal- 50 mcg/actuation suspensionFlonase Allergy Relief nasal- 50 mcg/actuation suspensionfluticasone propionate nasal- 50 mcg/actuation aerosolfluticasone propionate nasal- 50 mcg/actuation aerosolfluticasone propionate nasal- 50 mcg/actuation suspensionfluticasone propionate nasal- 50 mcg/actuation suspensionfluticasone propionate nasal- 50 mcg/actuation suspensionfluticasone propionate nasal- 50 mcg/actuation aerosolfluticasone propionate nasal- 50 mcg/actuation aerosolfluticasone propionate nasal- 50 mcg/actuation suspensionfluticasone propionate nasal- 50 mcg/actuation suspensionfluticasone propionate nasal- 50 mcg/actuation aerosolfluticasone propionate nasal- 50 mcg/actuation aerosolfluticasone propionate nasal- 50 mcg/actuation suspensionCopyright © 2010 First DataBank, Inc.Select a drug:fluticasone propionate topicalfluticasone propionate inhalationfluticasone propionate nasalPrint Patient Educationfluticasone propionate topical FLUTICASONE - TOPICAL (floo-TIK-a-sone) COMMON BRAND NAME(S): Cutivate USES: This medication is used to treat a variety of skin conditions (such as eczema, psoriasis, rash). Fluticasone reduces swelling (inflammation), itching, and redness. This medication is a medium-strength corticosteroid. It is available in several forms, including cream, ointment, and lotion. Your doctor will choose the type of product based on your skin condition and the area of your body to be treated.Fluticasone ointment is not recommended for use by children because of the risk of serious side effects. HOW TO USE: Use this medication on the skin only. However, do not use it on the face, groin, or underarms, or for diaper rash, unless directed to do so by your doctor.Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in as directed by your doctor, usually once or twice daily. Do not bandage, cover, or wrap the area unless directed to do so by your doctor.Wash your hands after each use, unless you are using this medication to treat the hands. Avoid getting this medication in your eyes because it may worsen or cause glaucoma. Also avoid getting it in your nose or mouth. If medication gets in these areas, rinse with plenty of water.Use this medication only for the condition prescribed. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.Tell your doctor if your condition does not improve in 2 weeks or if it worsens. SIDE EFFECTS: Burning, itching, stinging, or dryness may occur when you apply this medication, but usually only lasts a short time. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: stretch marks, skin thinning/discoloration, acne, excessive hair growth, small red bumps on the skin (folliculitis).Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before using fluticasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as formaldehyde), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, immune system problems.Corticosteroids can make skin infections worse and more