fluticasone intranasal (Rx, OTC)

Brand and Other Names:Flonase Allergy Relief, ClariSpray, more...Flonase Sensimist Allergy Relief, Children's Flonase Allergy Relief, Veramyst, Xhance
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

nasal spray

  • 27.5mcg/actuation (Flonase Sensimist Allergy Relief [OTC])
  • 50mcg/actuation (Flonase Allergy Relief [OTC], ClariSpray [OTC], FlutiCare [OTC])
  • 93 mcg/actuation (Xhance [Rx])
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Allergic Rhinitis

Flonase Allergy Relief: 1 spray in each nostril (100 mcg/day) for maintenance therapy; OTC not for use for >6 months unless instructed by healthcare provider

ClariSpray, FlutiCare: 2 sprays in each nostril qDay x 1 wk, THEN 1-2 sprays in each nostril qDay as needed to treat symptoms for up to 6 mo unless directed by physician to use longer

Flonase Sensimist Allergy Relief: 2 sprays in each nostril qDay (ie, 110 mcg/day); after symptoms controlled, may reduce dose to 1 spray in each nostril qDay (ie, 55 mcg/day) for maintenance therapy

Nasal Polyps

Xhance: 1 spray in each nostril q12hr (372 mcg/day); not to exceed 2 sprays in each nostril q12hr (744 mcg/day)

See Administration

Dosage Forms & Strengths

nasal spray

  • 27.5mcg/actuation (Flonase Sensimist Allergy Relief [OTC])
  • 50mcg/actuation (Flonase Allergy Relief [OTC], ClariSpray [OTC])
more...

Allergic Rhinitis

Limit duration of use of OTC nasal corticosteroids to 2 months a year in children unless otherwise directed by physician

Flonase Allergy Relief, Children's Flonase Allergy Relief

  • ≥4-11 years: 1 spray (50 mcg) in each nostril qDay; may increase up to 2 sprays/nostril qDay if not responding adequately, reduce to 1 spray in each nostril qDay once symptoms are controlled
  • >12 years: 2 sprays in each nostril qDay (ie, 200 mcg/day); reduce to 1 spray in each nostril qDay once symptoms are controlled

ClariSpray, FlutiCare

  • <4 years: Safety and efficacy not estabished
  • 4-11 years: 1 spray in each nostril qDay for up to 2 months annually unless directed by physician to use longer
  • ≥12 years: 2 sprays in each nostril qDay x 1 wk, THEN 1-2 sprays in each nostril qDay as needed to treat symptoms for up to 6 mo unless directed by physician to use longer

Flonase Sensimist Allergy Relief

  • 2-12 years: 1 spray (27.5 mcg) in each nostril qDay; may increase up to 2 sprays/nostril qDay if not responding adequately, reduce to 1 spray in each nostril qDay once symptoms are controlled
  • >12 years: 2 sprays in each nostril qDay (ie, 110 mcg/day); reduce to 1 spray in each nostril qDay once symptoms are controlled
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Interactions

Interaction Checker

and fluticasone intranasal

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            Adverse Effects

            >10%

            Headache (17%)

            URI (15%)

            Epistaxis, Xhance 186 mcg (11.9%)

            1-10%

            Nasal congestion (8%)

            Pharyngitis (6-8%)

            Asthma symptoms (3-7%)

            Fever (1-5%)

            Dysphonia (4%)

            Cough (3-4%)

            Nasal discharge (1-3%)

            Aches and pains (1-3%)

            Flu-like syndrome (1-3%)

            Bronchitis (1-3%)

            Diarrhea (1-3%)

            Abdominal pain (1-3%)

            Nasal ulcer (1%)

            Xhance 186 mcg

            • Nasal septal ulceration (6.9%)
            • Nasal mucosal erythema (5.6%)
            • Headache (5%)
            • Nasal congestion (4.4%)
            • Acute sinusitis (4.4%)
            • Nasal mucosal ulceration (3.8%)
            • Nasal septal erythema (3.8%)
            • Nasopharyngitis (1.9%)
            • Pharyngitis (1.3%)

            Xhance 372 mcg

            • Epistaxis (9.9%)
            • Nasopharyngitis (7.5%)
            • Nasal septal ulceration (7.5%)
            • Nasal congestion (5.6%)
            • Acute sinusitis (5%)
            • Nasal mucosal erythema (5%)
            • Nasal septal erythema (4.3%)
            • Headache (3.7%)
            • Pharyngitis (3.1%)
            • Nasal mucosal ulceration (2.5%)
            • Nasal dryness (≥1%)
            • Sinusitis (≥1%)
            • Oropharyngeal pain (≥1%)
            • Toothache (≥1%)
            • Intraocular pressure increase (≥1%)

            Frequency Not Defined

            Loss of taste

            Postmarketing Reports

            Respiratory, thoracic, and mediastinal disorders: Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness, and nasal septal perforation

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            May mask acute infection, including fungal infection, exacerbate viral infections or limit response to vaccines; not for use in untreated localized infection involving nasal mucosa; administer antimicrobial therapy if bacterial infection of sinuses suspected or confirmed; respiratory tract fungal or bacterial infections, parasitic infections, ocular herpes simplex may occur

            Chickenpox and measles: Serious or fatal course in susceptible individuals; unvaccinated or immunologically unexposed children or adults should avoid exposure

            Delays wound healing of nasal septal ulcers, trauma, or surgery; best to administer after healing has occurred

            May increase risk of hypercorticism or hypothalamic-pituitary adrenal (HPA) axis suppression, especially in younger patients receiving high doses for prolonged periods; HPA suppression may lead to adrenal crisis; withdraw or discontinue slowly; pediatric patients may be more susceptible to systemic toxicity

            Nasal corticosteroids, including fluticasone propionate, may result in the development of glaucoma and/or cataracts; closely monitor vision changes or patients with a history of increased intraocular pressure (IOP), glaucoma, and/or cataracts

            Intranasal corticosteroids may cause a reduction in growth velocity in children and adolescents; safety and efficacy has not been established in pediatric patients

            Decreases in bone mineral density (BMD) have been observed with long-term oral inhalation of products containing corticosteroids into lungs; monitor and appropriately treat patients with major risk factors for decreased bone mineral content (eg, 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])

            Avoid in patients with known hypersensitivity to fluticasone propionate or any ingredient of Xhance; see Contraindications

            Avoid concomitant use with strong CYP3A4 (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole)

            Local nasal effects

            • Epistaxis, nasal erosions, and nasal ulcerations were reported
            • Nasal septal perforations have been reported; patients treated over several months or longer should be examined periodically for possible changes in the nasal mucosa
            • If a septal perforation is noted, discontinue treatment; avoid spraying directly on septum
            • Localized Candida albicans infections have been observed; if such an infection develops, consider appropriate local therapy and discontinuation treatment; periodically examine for evidence of candidal infection in the nasal and oropharyngeal mucosa
            • Avoid use in patients who have experienced recent nasal ulcerations, nasal surgery, or nasal trauma
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            Pregnancy & Lactation

            Pregnancy

            Available data on inhaled or intranasal fluticasone propionate use in pregnant women have not reported a clear association with adverse developmental outcomes

            Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits

            Lactation

            There are no available data on fluticasone propionate in human milk, effects on breastfed child, or effects on milk production

            Developmental and health benefits of breastfeeding should be considered and adverse effects on breastfed child from treatment or from an 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.

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            Pharmacology

            Mechanism of Action

            Potent anti-inflammatory corticosteroid with vasoconstrictive properties

            Available in 2 salt forms, fluticasone propionate (Flonase, Xhance) and fluticasone furoate (Veramyst)

            Absorption

            Peak plasma concentration, 186 mcg dose: 17.2 pg/mL

            Peak plasma concentration, 372 mcg dose: 25.3 pg/mL

            AUC, 186 mcg dose: 111.7 pg·h/mL

            AUC, 372 mcg dose: 171.7 pg·h/mL

            Bioavailability: ≤2%

            Onset of action: May take several days to achieve optimum benefit

            Distribution

            Vd: 4.2 L/kg

            Protein binding: 99%

            Metabolism

            Metabolized by CYP3A4 pathway; only circulating metabolite detected in humans is 17β-carboxylic acid derivative of fluticasone propionate

            Elimination

            Half-life: 7.8 hr

            Clearance: 1093 mL/min

            Renal clearance: <0.02% of total clearance

            Excretion: Urine (<5%); feces (remaining amount excreted as parent drug and metabolites)

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            Administration

            Nasal Spray Preparation

            ClariSpray

            • Gently shake bottle
            • Prime spray when starting new bottle; have not used spray in a week, or just cleaned nozzle
            • Aim away from face; grasp spray bottle and pump until fine mist appears
            • Blow nose gently to clear nostrils

            Flonase Allergy Relief

            • Gently shake bottle
            • Remove green cap
            • Blow your nose gently to clear nostrils

            Flonase Sensimist Allergy Relief

            • Shaken vigorously with the cap on
            • Prime spray when starting a new bottle, using a bottle you haven't used in 30 days, when cap has been left off for ≥5 days, or when device doesn't seem to be working correctly
            • Aim away from face and grasp spray bottle on either side
            • Pump until fine mist appears
            • Blow nose gently to clear nostrils

            Xhance

            • Avoiding spraying directly on the nasal septum
            • Shake before each use
            • Before initial use, prime by first gently shaking and then press bottle until a fine mist appears (≥7 times)
            • Direct the spray into the air, away from the face
            • If nasal spray has not been used ≥7 days, prime pump again by shaking and releasing 2 sprays into the air, away from face

            Nasal Spray Administration

            Flonase Allergy Relief and Clarispray

            • Aim slightly away from center of nose
            • Spray once or twice; breathe out through mouth
            • Repeat in other nostril

            Flonase Sensimist Allergy Relief

            • Aim tip of spray nozzle into a nostril and tilt head forward while keeping bottle upright
            • Press button in all the way once or twice (according to proper dosing) Breathe out through your mouth
            • Repeat in other nostril
            • Wipe spray nozzle with clean tissue and replace cap

            Xhance

            • Administer intranasal route only
            • Insert tapered tip of cone-shaped nosepiece into one nostril and form a tight seal between nosepiece and nostril
            • Next, place flexible mouthpiece into the mouth, bending it as necessary to maintain a tight seal
            • Blow into mouthpiece, and while continuing to blow, push the bottle up to actuate the spray pump
            • Continuing to blow through mouth, but not inhaling/exhaling through the nose, at time of actuation is important to achieve intended drug deposition
            • Repeat process in other nostril for a full dose

            Storage

            ClariSpray, Flonase, Flonase Allergy Relief: Store at 4-30°C (39-86°F)

            Flonase Sensimist: Store at 15-30°C (59-86°F); do not refrigerate or freeze

            Xhance: Store at room temperature 15-25°C (59-77°F), excursions permitted from 15-30°C (59-86°F); avoid exposure to extreme heat, cold or light

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            Formulary

            FormularyPatient Discounts

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

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            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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