Fluticasone Propionate

A to Z Drug Facts

 Action Exerts potent anti-inflammatory effect on nasal passages.

 Indications Management of the nasal symptoms of seasonal and perennial allergic and nonalleric rhinitis in adults and pediatric patients 4 yr and older.

 Contraindications Untreated localized infections involving the nasal mucosa; hypersensitivity to the drug or any component of the product.

 Route/Dosage

Adults: Starting dose is 2 sprays in each nostril qd (total daily dose, 200 mcg). Same dose divided into 100 mcg bid also is effective. After the first few days, dosage may be reduced to 100 mcg (1 spray each nostril daily) for maintenance therapy. Max daily dose, 200 mcg. Children 4 yr and older: Starting dose is 1 spray in each nostril qd (total daily dose, 100 mcg). May be increased to 200 mcg/day (2 sprays in each nostril) if not adequately responding. Depending on response, dosage may be decreased to 100 mcg/day. Max daily dose, 200 mcg.

 Interactions

Ketoconazole: Concomitant use may increase fluticasone concentrations and reduce plasma cortisol AUC. No studies with nasal spray have been done. Use with caution.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Headache; dizziness. EENT: Alteration or loss of sense of taste or smell. GI: Pharyngitis; nausea; vomiting; diarrhea; abdominal pain. RESPIRATORY: Nasal burning/irritation; epistaxis; cough; asthma symptoms; bloody discharge; rhinorrhea; bronchitis. OTHER: Flu-like symptoms; aches and pains; fever; hypersensitivity reactions with rash, urticaria, angioedema and bronchospasm; facial edema.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established for children younger than 4 yr. Adrenal suppression: Prolonged therapy may lead to hypothalamic-pituitary-adrenal suppression. Fungal Infections: Local fungal infections have rarely developed. Antifungal treatment or discontinuance of drug may be necessary. Hypersensitivity: Reactions including anaphylaxis may occur. Infections: Drug may mask signs of infection and may decrease host-defense mechanisms. Route change: Particular caution is needed when transferring patient from systemically active corticosteroids to fluticasone inhaler because deaths caused by adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic to aerosol corticosteroids. Withdrawal: Abrupt discontinuation may result in adrenal insufficiency.

 Administration/Storage

• May be administered alone or in combination with systemic corticosteroids.
• Shake well before each use.

Oral inhalation of aerosol

• For oral inhalation only. Avoid spraying into the nose or eyes.
• If patient also receiving bronchodilators by inhalation, administer bronchodilator 5 min before fluticasone to enhance penetration of latter drug into bronchial tree.
• Before oral inhalation, give patient drink of water to moisten throat. Place inhaler mouthpiece 2 fingerbreadths away from patient's mouth. Tilt patient's head back slightly. Instruct patient to take slow, deep breath while inhaler is being activated and to hold breath for 5 to 10 sec and then breathe out slowly. A spacing device (eg, Aerochamber) may be used to enhance delivery of medication. Have patient rinse mouth after inhalations are complete.
• If more than 1 spray/dose is ordered, administer each spray individually, waiting a few seconds between sprays.
• Store at controlled room temperature (36° to 86°F). Protect from freezing and direct sunlight. Store pressurized canister with nozzle end down.
• Do not puncture or discard pressurized canister in incinerator.

Oral inhalation of dry powder

• For oral inhalation only.
• Activate and use the inhalation device in a level, horizontal position.
• Prepare dose by activating inhalation device immediately prior to administration. Have patient exhale fully then place inhaler mouthpiece between lips. Do not close teeth. Instruct patient to take slow, deep breath and to hold breath for 5 to 10 sec and then breathe out slowly. Have patient rinse mouth after inhalations are complete.
• Do not use with a spacer device (eg, Aerochamber). Do not exhale into the inhalation device, wash or attempt to take the inhalation device apart.
• Store at controlled room temperature (68° to 77°F) in a dry place. Protect from direct heat or sunlight. Discard 50 mcg strength Diskus 6 wk (or 100 and 250-mcg strength 2 mo) after removal from moisture-protective foil overwrap or when the dose indicator reads “0.” Discard Rotadisk blisters 2 mo after opening moisture-protective foil overwrap or before expiration date, whichever comes first.

Nasal inhalation

• Actuate the pump 6 times to prime before first use or after a period of non-use of more than 1 wk.
• Before nasal inhalation, instruct patient to blow nose gently to clear nasal passages. If needed, a topical decongestant may be used 5 to 10 min before administration to ensure adequate tissue penetration. Nasal lavage with saline may also help remove secretions. Clean outer portion of nose with a damp tissue. Wash and dry hands.
• Insert nozzle into patient's nostril. Use finger to keep other nostril closed. Instruct patient to inhale through nostril while you activate the spray pump. Repeat with other nostril.
• If 2 sprays/dose are ordered, administer 1 spray in each nostril, wait a few seconds and administer second spray into each nostril.
• Store at controlled room temperature (39° to 86°F). Protect from freezing. Store pressurized canister with nozzle end down.
• Do not puncture or discard pressurized canister in incinerator.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• If change is made from systemic (oral) corticosteroids to inhaled or intranasal corticosteroids, observe patient carefully for signs of adrenal insufficiency (eg, nausea, fatigue, dizziness, hypotension, depression, or abdominal, joint or muscle pain). Notify health care provider if these signs occur. Deaths caused by adrenal insufficiency have occurred during and after converting to aerosol corticosteroids.
• Assess patient's symptoms before initiating therapy and periodically during treatment. Notify health care provider if symptoms do not improve or worsen.
• Notify health care provider if oral, nasal, or pharyngeal irritation occurs or if symptoms worsen.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient to read the “Patient's Instructions for Use” before starting therapy and again with each refill.
• Review proper administration technique. Have patient demonstrate technique.
• Advise patient that dose may be changed periodically depending on how well symptoms are controlled.
• Instruct patient not to exceed prescribed dose.
• Explain that effects of drug are not immediate. Benefit requires daily use as instructed and usually occurs after 1 to 2 days but full relief may take 1 to 2 wk.
• Instruct patient to not stop the medication once symptoms have been controlled. Continued daily use is necessary to continue to control symptoms.
• Advise patient not to increase dose and to inform health care provider if symptoms do not improve or worsen.
• If patient is being converted from oral corticosteroids to inhaled or intranasal corticosteroids, review signs and symptoms of adrenal insufficiency, which may occur days or weeks after conversion is complete. Advise patient to carry Medi-Alert card indicating they may need supplemental systemic corticosteroids during periods of stress or a severe asthma attack.
• Advise patient to discard the aerosol canister or nasal spray bottle when the labeled number of doses has been used. Advise patient using dry powder inhalation device on storage and expiration dates once device or blisters are removed from moisture-protective foil overwrap.
• Advise patient to avoid exposure to chickenpox and measles and to seek medical advice immediately if exposed.
• Instruct women to contact health care provider if pregnant, planning to become pregnant, or breastfeeding.
• Caution patient to not take any prescription or OTC medications, or dietary supplements unless advised by health care provider.
• Advise patient that followup visits may be required to monitor therapy and to keep appointments.

Oral inhalation (dry powder or aerosol)

• Warn patient that drug is an “asthma controller” and is not to be used to treat an acute asthma attack. They must use their “rescue medication” (bronchodilator) to obtain rapid relief of asthma symptoms.
• Instruct patient to carry Medi-Alert card if experiencing acute severe asthma attacks requiring rapid systemic treatment.
• Advise patient to report the following symptoms to health care provider: sore throat or mouth, cough, dry mouth, rash, facial swelling, or worsening asthma symptoms (eg, increasing need for bronchodilator).

Nasal inhalation

• Instruct patient to use with caution if sores develop or injuries occur in nasal passages. Drug may prevent or slow proper healing.
• Advise patient to report the following symptoms to health care provider: sneezing, nasal irritation, nosebleed.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts