fluticasone inhaled (Rx)

Brand and Other Names:Flovent Diskus, Flovent HFA, more...ArmonAir RespiClick
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

aerosol for inhalation (Flovent HFA)

  • 44mcg/actuation
  • 110mcg/actuation
  • 220mcg/actuation

powder for inhalation (Flovent Diskus)

  • 50mcg/actuation
  • 100mcg/actuation
  • 250mcg/actuation

powder for inhalation (ArmonAir RespiClick)

  • 55mcg/actuation
  • 113mcg/actuation
  • 232mcg/actuation
more...

Asthma

Maintenance treatmentas prophylactic therapy; not indicated for relief of acute bronchospasm

Starting dosage is based on prior asthma therapy and disease severity

Inhaled aerosol (Flovent HFA)

  • Prior bronchodilator use: 88 mcg (2 actuations of 44 mcg) inhaled PO q12hr; not to exceed 440 mcg q12hr
  • Prior inhaled corticosteroid use: 88-220 mcg inhaled PO q12hr; not to exceed 440 mcg q12hr
  • Prior PO corticosteroid use: 440 mcg inhaled PO q12hr; not to exceed 880 mcg q12hr

Inhaled powder (Flovent Diskus)

  • Prior bronchodilator use: 100 mcg inhaled PO q12hr; not to exceed 500 mcg q12hr
  • Prior inhaled corticosteroid use: 100-250 mcg inhaled PO q12hr; not to exceed 500 mcg q12hr
  • Prior PO corticosteroid use: 500-1000 mcg inhaled PO q12hr; not to exceed 1000 mcg q12hr

Inhaled powder (ArmonAir RespiClick)

  • Starting dose for patients not on inhaled corticosteroids: 55 mcg inhaled PO q12hr
  • For patients who do not respond after 2 weeks, increase to a higher dose or add additional controller therapies
  • Do not exceed 232 mg q12hr

Eosinophilic Esophagitis (Orphan)

Not FDA-approved for orphan indication

Orphan sponsor

  • Aptalis Pharma US, Inc, 100 Somerset Corporate Blvd, Bridgewater, NJ 08807

Dosing Considerations

Starting dosages >100 mcg q12hr may be considered in patients who have poorer asthma control or previously required higher-than-usual dosages of inhaled corticosteroids

Patients on long-term PO corticosteroid therapy: Do not reduce prednisone faster than 2.5-5 mg/day on weekly basis, beginning after >1 week of therapy with inhaled powder; monitor carefully

Prior PO corticosteroid use: Starting dose should be determined on basis of individual patient assessment

Esophagitis (Orphan)

Orphan designation for treatment of eosinophilic esophagitis

Sponsors

  • Aptalis Pharma US, Inc, 100 Somerset Corporate Blvd, Bridgewater, NJ 08807
  • Banner Life Sciences, LLC; 4125 Premier Drive; High Point, North Carolina 27265

Dosage Forms & Strengths

aerosol for inhalation (Flovent HFA)

  • 44mcg/actuation
  • 110mcg/actuation
  • 220mcg/actuation

powder for inhalation (Flovent Diskus)

  • 50mcg/actuation
  • 100mcg/actuation
  • 250mcg/actuation

powder for inhalation (ArmonAir RespiClick)

  • 55mcg/actuation
  • 113mcg/actuation
  • 232mcg/actuation
more...

Asthma

Maintenance treatment as prophylactic therapy; not indicated for relief of acute bronchospasm

Starting dosage is based on prior asthma therapy and disease severity

Inhaled aerosol (Flovent HFA)

  • <4 years: Safety and efficacy not established
  • 4-12 years: 88 mcg (2 actuations of 44 mcg) PO q12hr
  • >12 years (prior inhaled corticosteroid use): 88-220 mcg PO q12hr; not to exceed 440 mcg q12hr
  • >12 years (prior PO corticosteroid use): 440 mcg PO q12hr; not to exceed 880 mcg q12hr

Inhaled powder (Flovent Diskus)

  • <4 years: Safety and efficacy not established
  • 4-12 years: 50-100 mcg PO q12hr
  • >12 years (prior bronchodilator use): 100 mcg PO q12hr; not to exceed 500 mcg q12hr
  • >12 years (prior inhaled corticosteroid use): 100-250 mcg PO q12hr; not to exceed 500 mcg q12hr
  • >12 years (prior PO corticosteroid use): 500-1000 mcg PO q12hr; not to exceed 1000 mcg q12hr

Inhaled powder (ArmonAir RespiClick)

  • Not on inhaled corticosteroids: 55 mcg inhaled PO q12hr
  • For patients who do not respond after 2 weeks, increase to a higher dose or add additional controller therapies
  • Do not exceed 232 mg q12hr
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Interactions

Interaction Checker

and fluticasone inhaled

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Oral candidiasis (<31%)

            Throat irritation (3-22%)

            Upper respiratory tract infection (16-18%)

            Fatigue or malaise (16%)

            Nasal congestion (16%)

            Rhinitis (≤13%)

            Musculoskeletal pain (2-12%)

            Headache (5-11%)

            1-10%

            Nasal congestion (8%)

            Sinusitis or sinus infection (4-7%)

            Cough (4-6%)

            Bronchitis (2-6%)

            Hoarseness or dysphonia (2-6%)

            Allergic rhinitis (5%)

            Nasal discharge (5%)

            Upper respiratory inflammation (2-5%)

            Muscle injury (≤5%)

            Gastrointestinal (GI) discomfort or pain (1-4%)

            Frequency Not Defined

            Hypersensitivity reactions (including anaphylaxis, angioedema, rash, urticaria)

            Respiratory: Rhinitis, rhinorrhea or postnasal drip, nasal sinus disorders, laryngitis

            GI: Diarrhea, loss of taste, viral infections, dyspeptic symptoms, discomfort, pain, hyposalivation

            Muscular: Musculoskeletal pain, stiffness, tightness, rigidity, injuries, soreness

            Other: Dizziness, migraine, fever, viral infection, pain, chest symptoms, viral skin infections, soft tissue injuries, urinary infections

            Postmarketing Reports

            Special senses: Aphonia, facial and oropharyngeal edema, throat soreness, irritation, cataracts

            Endocrine: Cushingoid features, growth velocity reduction in children and adolescents, hyperglycemia, osteoporosis, weight gain

            GI: Dental caries, tooth discoloration, esophageal candidiasis

            Psychiatry: Agitation, aggression, anxiety, depression, restlessness; behavioral changes, including hyperactivity and irritability (rarely and primarily in children)

            Immunologic: Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, angioedema, bronchospasm

            Respiratory: Asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed bronchospasm, paradoxical bronchospasm, pneumonia, wheezing

            Skin: Contusions, cutaneous hypersensitivity reactions, ecchymoses, pruritus

            Rare cases of systemic eosinophilic conditions (some with features of vasculitis consistent with Churg-Strauss syndrome, which is often treated with systemic corticosteroids)

            Nervous system disorders: Tremor

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            Warnings

            Contraindications

            Hypersensitivity to drug, components or milk proteins, which may result in anaphylaxis, angioedema, rash, and urticaria

            Primary treatment of status asthmaticus, acute bronchospasm

            Cautions

            Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex; care must be taken to avoid exposure

            Nasal septum perforation, epistaxis, wheezing

            Cataracts, glaucoma, increased intraocular pressure may occur; monitor for glaucoma and cataracts

            Risk of more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure

            Hypercorticism and adrenal suppression may occur with high dosages or at regular dosage in susceptible individuals; if such changes occur, taper withdrawal gradually

            May decrease growth velocity in children; monitor growth of pediatric patients

            Assess for decrease in bone mineral density initially and periodically thereafter

            Use with caution in immunocompromised patients

            Prolonged use of corticosteroids may increase incidence of secondary infection

            Risk of infections of nose and pharynx, including Candida albicans; must rinse mouth after inhalation to reduce risk

            Excessive use may suppress hypothalamic-pituitary-adrenal function; monitor closely, especially postoperatively or during periods of stress

            During periods of stress or severe status asthmaticus, supplementary systemic corticosteroids may be immediately required; patient should carry warning card indicating possible need for supplementary systemic steroids in such emergencies

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            Pregnancy & Lactation

            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 condition

            Pregnancy 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.

            more...
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            Pharmacology

            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)

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            Administration

            Orally Inhaled Administration

            Aerosol

            • Prime inhaler (4 actuations into air) before first use and after prolonged (>7 days) idleness
            • 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
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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