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Fluticasone Propionate eent

Pronunciation

Class: Corticosteroids
VA Class: NT200
Molecular Formula: C25H31F3O5S
CAS Number: 80474-14-2
Brands: Flonase

Introduction

Synthetic trifluorinated corticosteroid.1 2 3 6 7 8 26 48 65 66

Uses for Fluticasone Propionate

Seasonal and Perennial Rhinitis

Symptomatic treatment of seasonal or perennial rhinitis when conventional therapy with antihistamines or decongestants is ineffective or is not tolerated.1 2 7 16 19 27 33 34 46 51 54 55 57 71 73 74 76 78 110 113 122 123

Generally provides symptomatic relief of watery rhinorrhea, nasal congestion, sneezing, postnasal drip, and nasal itching;1 2 7 16 19 27 33 34 46 51 55 59 122 123 124 generally does not relieve signs and symptoms of conjunctivitis, although improvement in ophthalmic manifestations may occur.19 62 110 113

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Relieves symptoms in both allergic1 2 7 16 19 27 33 34 46 51 54 55 71 73 74 76 78 110 113 122 123 and nonallergic1 57 113 rhinitis, although experience is more extensive with allergic rhinitis.1 2 7 16 19 27 33 34 46 51 54 55 57 71 73 74 76 78 110 113 122 123

Has been used successfully prior to the onset of the pollen season for the prophylaxis of symptoms of seasonal allergic rhinitis.21

Fluticasone Propionate Dosage and Administration

Administration

Intranasal Administration

Administer by nasal inhalation using a metered-dose nasal spray pump.1 6

Avoid contact with the eyes.1

If used once daily, administer preferably in the morning.18 46 110 113 Generally, initiate therapy with once-daily dosing; some patients may obtain greater relief with twice-daily divided dosing.1

Although regular dosing generally provides optimal benefit, as needed (prn) dosing may be adequate in some patients with seasonal allergic rhinitis.1

Clear nasal passages prior to administration.6 b If nasal passages are blocked, a topical nasal decongestant can be administered 5–15 minutes before intranasal administration.2 67 75 79 113

Prime pump prior to initial use or after a period of nonuse (i.e., ≥1 week).1 6 b

Tilt the head slightly forward, insert the nasal adapter into one nostril,6 b and point the tip of the adapter toward the inflamed nasal turbinates and away from the nasal septum.67 79

Pump the drug into one nostril6 b while holding the other nostril closed and concurrently inspire through the nose.6 b Repeat procedure for the other nostril.6 b

After removing the nasal adapter and dust cap, these pieces should be rinsed in warm water and dried thoroughly;6 do not clean by inserting a sharp object into the piece.6

Dosage

Nasal inhaler delivers about 50 mcg of fluticasone propionate per metered spray and about 120 metered sprays per 16-g container.1

Adjust dosage according to individual requirements and response.1 110

Therapeutic effects of intranasal corticosteroids, unlike those of decongestants, are not immediate.1 6 13 16 27 46 48 51 52 115 This should be explained to the patient in advance to ensure compliance and continuation of the prescribed treatment regimen.1

Generally assess response to the initial dosage 4–7 days after starting therapy; a reduction in maintenance dosage may be possible at that time.1

Pediatric Patients

Seasonal Rhinitis
Intranasal Inhalation

Adolescents and children ≥4 years of age: 1 spray (50 mcg) in each nostril once daily (total dose: 100 mcg/day).1 Increase dosage to 2 sprays (100 mcg) in each nostril daily (total dose: 200 mcg/day) if response is inadequate.1

Reduce dosage to 1 spray in each nostril (total dose: 100 mcg/day) once adequate symptom control is achieved.

Some patients ≥12 years of age with seasonal allergic rhinitis may find as needed (prn) use of 200 mcg (100 mcg in each nostril) doses (no more frequently than once daily) to be effective in controlling symptoms.1 Greater symptom control may be achieved with regular dosing.1

Perennial Rhinitis
Intranasal Inhalation

Adolescents and children ≥4 years of age: 1 spray (50 mcg) in each nostril daily (total dose: 100 mcg/day).1 Increase dosage to 2 sprays (100 mcg) in each nostril daily (total dose: 200 mcg/day) if response is inadequate.1

Maintenance dose is 1 spray in each nostril (total dose: 100 mcg/day) once adequate symptom control is achieved.

Adults

Seasonal Rhinitis
Treatment
Intranasal Inhalation

Usual initial dose is 2 sprays (100 mcg) in each nostril once daily (total 200 mcg/day).1 Alternatively, 1 spray (50 mcg) in each nostril twice daily (total 200 mcg/day).1 16 17 18 19 27 46 51 55

Maintenance dose is 1 spray in each nostril (total dose: 100 mcg/day) once adequate symptom control is achieved.1 96

Some patients with seasonal allergic rhinitis may find as needed (prn) use of 200-mcg (100 mcg in each nostril) doses (no more frequently than once daily) to be effective in controlling symptoms.1 Greater symptom control may be achieved with regular dosing.1

Prophylaxis
Intranasal Inhalation

Maintenance dose is 2 sprays (100 mcg) in each nostril daily (200 mcg total).121

Perennial Rhinitis
Intranasal Inhalation

Usual initial dose is 2 sprays (100 mcg) in each nostril once daily (total dose: 200 mcg/day).1 Alternatively, 1 spray (50 mcg) in each nostril twice daily (total 200 mcg/day).1 16 17 18 19 27 46 51 55

Maintenance dose is 1 spray in each nostril (total dose: 100 mcg/day) once adequate symptom control is achieved.1 96

Prescribing Limits

No evidence that higher than recommended dosages or increased frequency of administration is beneficial.13 15 110 113

Exceeding the maximum recommended daily dosage may only increase the risk of adverse systemic effects (e.g., HPA-axis suppression, Cushing’s syndrome).1

Pediatric Patients

Seasonal Rhinitis
Intranasal Inhalation

Adolescents and children ≥4 years of age: Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1

Perennial Rhinitis
Intranasal Inhalation

Adolescents and children ≥4 years of age: Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1

Adults

Seasonal Rhinitis
Intranasal Inhalation

Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1

Perennial Rhinitis
Intranasal Inhalation

Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1

Special Populations

Hepatic Impairment

No specific dosage recommendations for hepatic impairment.1

Renal Impairment

No specific dosage recommendations for renal impairment.1

Geriatric Patients

No specific geriatric dosage recommendations.1

Cautions for Fluticasone Propionate

Contraindications

  • Known hypersensitivity to fluticasone or any ingredient in the formulation.1 110

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Patients being switched from prolonged systemic corticosteroids to intranasal therapy should be monitored carefully since corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, and/or severe symptomatic exacerbation of asthma or other clinical conditions may occur.1 115

Systemic corticosteroid dosage should be tapered, and patients should be carefully monitored during dosage reduction.1 115

Infection, Trauma, or Surgery

Use cautiously, if at all, in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; ocular herpes simplex infections; or septal ulcers, trauma, or surgery in the nasal region.1

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Avoid higher than recommended dosages since suppression of HPA function may occur.1

Immunosuppression

Although risk with intranasal use is unknown, consider the possibility that corticosteroid-induced immunosuppression could occur.1 Avoid exposure to varicella and measles in previously unexposed patients.1

Sensitivity Reactions

Possible immediate hypersensitivity reactions (e.g., wheezing, contact dermatitis, rash, dyspnea, anaphylaxis/anaphylactoid reactions, pruritus, urticaria, angioedema, edema of the face and tongue, and bronchospasm).1 112

General Precautions

Systemic Corticosteroid Effects

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may cause systemic corticosteroid effects (e.g., Cushing’s syndrome, adrenal suppression).1

Nasopharyngeal Effects

Temporary or permanent loss of smell may occur.1

Rarely, localized candidal infections of the nose and/or pharynx.1 104 105 119 Treat suspected local infection appropriately;1 115 may require discontinuance of fluticasone therapy.1 17

Rarely, nasal septal perforations.1 110 113 115

Avoid use until healing occurs in patients with recurrent epistaxis, recent nasal septal ulcers, nasal surgery, or nasal trauma.1

Ophthalmic Effects

Possible increased IOP.1

Cataracts, ocular dryness and irritation, conjunctivitis, blurred vision, and glaucoma have been reported.1 17 84

Oral Effects

Temporary or permanent loss of taste may occur.1

Specific Populations

Pregnancy

Category C.1

Lactation

Other corticosteroids known to be distributed into milk.1 48 Caution if used in nursing women.1

May cause adverse effects (e.g., growth suppression) in nursing infants if distributed into milk.1

Pediatric Use

May be a useful therapeutic alternative to oral corticosteroids in children ≥4 years of age with seasonal or perennial allergic rhinitis since intranasal administration is associated with a decreased risk of adverse systemic effects.

Intranasal corticosteroids may reduce growth velocity in pediatric patients.1 Children 3–9 years of age receiving 200 mcg of fluticasone propionate daily for 1 year did not show evidence of reduction in normal growth velocity.1 No clinically relevant changes in HPA axis or bone mineral density (as assessed by dual X-ray absorptiometry) observed.1

Safety and efficacy not established in children <4 years of age.1 87

Geriatric Use

Adverse effect profile similar to profile in younger adults.1

Common Adverse Effects

Mild, transient nasal burning and stinging,1 3 16 17 21 27 46 51 54 55 aftertaste1 , epistaxis,13 16 17 19 21 22 46 51 54 55 112 124 headache,1 112 124 nausea and vomiting,1 21 abdominal bloating,1 pharyngitis,1 16 17 27 112 cough1 124 and asthma symptoms1 124 are most common.

Interactions for Fluticasone Propionate

Metabolized by CYP3A4.

Drugs Affecting Hepatic Microsomal Enzymes

Drugs that affect CYP3A4 activity: Potential pharmacokinetic interaction (altered metabolism of fluticasone).1 Exercise caution when potent CYP3A4 inhibitors are used concomitantly.1

Specific Drugs

Drug

Interaction

Comments

Corticosteroids

Potential pharmacodynamic interaction (increased the risk of hypercorticism, suppression of the HPA axis, decreased growth rate in children) with concomitant use of other inhaled and/or systemically absorbed corticosteroids1 38 79 84

Concomitant use not recommended

Erythromycin

Does not affect the pharmacokinetics of fluticasone1

Ketoconazole

Possible increase in mean plasma fluticasone concentrations and toxicity1

Exercise caution1

Ritonavir

Increases plasma fluticasone concentrations, resulting in decreased plasma cortisol AUC1

Cushing’s syndrome and adrenal suppression reported1

Concomitant use not recommended unless potential benefit outweighs the risk of adverse effects1

Fluticasone Propionate Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from the respiratory and GI tracts following nasal inhalation.8 51 52

Systemic bioavailability of less than 2% based on indirect calculations.1 7

Onset

Symptomatic relief usually is evident within 12–48 hours of initiation of therapy in adults and within 36 hours in children.1 13 16 27 46 48 51 52

Optimum effectiveness generally requires 2–4 days in most patients.1 13 16 27 46 48 51 52

Duration

Following discontinuance, symptoms of rhinitis do not recur for 1–2 weeks.10 13 16 27 46 48 52 62

Distribution

Extent

Placental distribution in humans is unknown, but fluticasone crosses the placenta in animals.1

Distribution into milk unknown, but other corticosteroids are distributed.1

Plasma Protein Binding

Approximately 91%.1 48

Elimination

Metabolism

Rapidly metabolized in the liver by the CYP3A4.1 3 8 48 117

Elimination Route

Following oral administration, about 87–100% is excreted in the feces, and less than 5% of the dose is excreted in the urine.2 14 7 8 48 103

Half-life

Plasma half-life: about 3 hours after IV administration.1 7 8 48 103

Stability

Storage

Nasal Suspension

4–30°C.1

Discard the nasal pump spray after 120 sprays.1

Actions

  • Potent glucocorticoid and weak mineralocorticoid effects.48 110 113 117

  • Local anti-inflammatory and vasoconstrictor effects17 22 55 58 63 result from local actions of the deposited inhaled dose on the nasal mucosa.1 13 22 56 67

  • Reduces the number of mediator cells (basophils,2 5 7 13 17 27 35 46 51 55 57 58 eosinophils,2 4 5 7 9 13 17 27 35 46 50 51 55 57 58 60 61 63 116 helper-inducer [CD4+, T4+] T-cells,4 60 116 mast cells,7 50 60 61 116 and neutrophils)2 7 13 35 in the nasal mucosa. Also reduces nasal reactivity to allergens and release of inflammatory mediators63 and proteolytic enzymes.63

  • May inhibit nasal postcapillary venule dilation and permeability.22 55 62

  • May facilitate nasomucociliary clearance of nasal secretions.22 55 62

  • May decrease nasal turbinate swelling, mucosal inflammation,22 55 and nasal hyperreactivity.2 4 5 9 10 49

Advice to Patients

  • Proper techniques for assembly and priming of nasal spray pump and for administration and storage of the nasal solution.1

  • Importance of not administering the entire dose (i.e., 2–4 sprays) into a single nostril.1

  • Give patients a copy of the manufacturer’s patient instructions.1

  • Advise patients to cleanse the nasal spray adapter and/or pump at least once weekly.6 110 b

  • Importance of shaking containers of nasal spray gently prior to each use.b

  • Importance of discarding the container after 120 actuations or once the expiration date on the label is reached.1 b

  • Caution against spraying into eyes or directly on nasal septum.1 67 79

  • Advise patients that effects are not immediate; full benefit requires regular use and usually can be achieved in several days.1 110

  • Importance of taking as directed and not exceeding prescribed dosage.1

  • Importance of informing clinician if symptoms fail to improve or if symptoms worsen.1

  • Importance of not increasing dosage unless directed by a clinician.1

  • Importance of advising clinician if sneezing or nasal irritation occurs.1

  • Advise that concomitant nasal decongestants and/or oral antihistamines may be needed until effects of fluticasone are optimal.

  • If receiving immunosuppressive doses of corticosteroids, importance of avoiding exposure to chickenpox or measles, and if exposed, to notify a clinician.1 89 98 99 100

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Fluticasone Propionate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Suspension, for intranasal use only

50 mcg/metered spray

Flonase Nasal Spray (with benzalkonium chloride and phenylethyl alcohol)

GlaxoSmithKline

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Flonase 50MCG/ACT Suspension (GLAXO SMITH KLINE): 16/$89.99 or 48/$260.98

Fluticasone Propionate 50MCG/ACT Suspension (ROXANE): 16/$60.99 or 48/$170.96

Veramyst 27.5MCG/SPRAY Suspension (GLAXO SMITH KLINE): 10/$112.99 or 30/$320.96

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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