- Aerosol approximately 80 mcg flunisolide hemihydrate (78 mcg flunisolide)/actuation
- Nasal spray 0.025% (29 mcg/actuation)
Has potent anti-inflammatory effects on respiratory tract and nasal mucosa.
Systemic bioavailability is 40% (oral inhalation) and 50% (nasal inhalation).
Converted to the 6β-OH metabolite and water-soluble conjugates in the liver.
The t ½ is 1.8 h.
Indications and UsageInhalation
Maintenance treatment of asthma for patients requiring chronic treatment with corticosteroids.Intranasal
Symptoms of perennial or seasonal rhinitis.
Primary treatment of status asthmaticus or acute asthma when intensive measures are required (inhalation use); untreated local infection of the nasal mucosa (intranasal use); hypersensitivity to any component of the product.
Dosage and AdministrationAsthma
Adults and Children 6 to 15 yr of age
Inhalation 2 inhalations (500 mcg) twice daily. Do not exceed 4 inhalations twice daily (2 mg/day) in adults or 2 inhalations twice daily (1 mg/day) in children.Adults and Children 12 yr of age and older ( AeroSpan )
Inhalation 2 inhalations (160 mcg) twice daily (max, 320 mcg twice daily).Children 6 to 11 yr of age ( AeroSpan )
Inhalation 1 inhalation (80 mcg) twice daily (max, 160 mcg twice daily).Seasonal or Perennial Rhinitis
Adults and Children 15 yr of age and older
Initial dose: Intranasal 2 sprays (58 mcg) in each nostril twice daily (232 mcg/day). Max: 8 sprays in each nostril daily (464 mcg/day).Children 6 to 14 yr of age
Initial dose: Intranasal 1 spray (29 mcg) in each nostril 3 times daily (174 mcg/day) or 2 sprays (58 mcg) in each nostril twice daily (232 mcg/day. Max: 4 sprays in each nostril daily (232 mcg/day).
- Inhalation aerosol
- May be administered alone or in combination with systemic corticosteroids.
- For oral inhalation only. Avoid spraying into the nose or eyes.
- Shake well before each use.
- If patient also is receiving bronchodilators by inhalation, administer bronchodilator 5 min before flunisolide to enhance penetration of latter drug into bronchial tree.
- To administer flunisolide hemihydrate, open and place aerosol canister in position. Prime AeroSpan inhalation aerosol before first use, or when inhaler has not been used for more than 2 wk, by releasing 2 test sprays into the air, away from face. Have patient exhale and empty lungs as completely as possible, place inhaler in mouth, and close lips around mouthpiece, keeping tongue below mouthpiece. Have patient start breathing in slowly and then fully depress metal canister for at least 1 sec while patient continues to breathe in for 3 more sec. Have patient hold breath for at least 10 sec, or as long as comfortable, before exhaling through mouth. After inhalations are complete, have patient rinse mouth thoroughly with water and spit, or brush teeth.
- If more than 1 spray per dose is ordered, administer each spray individually, waiting 20 seconds between sprays.
- Nasal Inhalation
- For intranasal use only. Avoid spraying into the eyes, mouth, or directly into the nasal septum.
- Shake well before each use.
- Actuate the pump 5 to 6 times, or until a fine mist appears, to prime before first use. If pump has not been used for 5 or more consecutive days, or has been disassembled for cleaning, reprime the pump until fine mist appears.
- Clear nasal passages of secretions prior to use. If patient is congested, use topical, short-acting decongestant just before administration to ensure adequate penetration of spray.
- Saline nasal lavage may help remove secretions.
- Place nasal adapter into 1 nostril and gently close other nostril with finger. While inhaling from nostril, activate canister. Repeat process on other side.
- Do not blow nose immediately after administration.
- If 2 sprays per dose are ordered, administer 1 spray in each nostril, wait a few seconds and administer second spray into each nostril.
Store between 59° and 86°F, away from heat or open flame. Protect from freezing and prolonged exposure to sunlight. Do not puncture or discard pressurized canisters in incinerator.
None well documented.
Palpitations (3% to 9%); hypertension, tachycardia (1% to 3%).
Headache (25%); dizziness, irritability, nervousness, shakiness (3% to 9%); anxiety, depression, faintness, fatigue, hyperactivity, hypoactivity, insomnia, migraine, moodiness, numbness, oral inhalation, vertigo (1% to 3%).
Eczema, itching, rash (3% to 9%); acne, erythema multiforme, hives, pruritus, urticaria (1% to 3%).
Sore throat (20%); ear infection, loss of smell or taste, rhinitis, sinus congestion, sinus drainage, sinus infection, sinusitis (3% to 9%); blurred vision, conjunctivitis, dry throat, earache, eye discomfort, eye infection, glossitis, nasal irritation and discomfort, pharyngitis, phlegm, throat irritation (1% to 3%).Nasal spray
Burning and stinging (13%); epistaxis, nasal dryness, pharyngitis (greater than 1%).
Nausea/vomiting (25%); diarrhea, unpleasant taste, upset stomach (10%); abdominal pain, Candida infection, heartburn (3% to 9%); constipation, dyspepsia, gas, mouth irritation, oral moniliasis (1% to 3%).Nasal spray
Aftertaste (17%); nausea (greater than 1%).
Menstrual disturbances (3% to 9%); vaginitis (1% to 3%).
Capillary fragility, enlarged lymph nodes (1% to 3%).
Weight gain (1% to 3%).
UTI (25%); cold symptoms, nasal congestion (15%); chest congestion, cough, hoarseness, sneezing, sputum, wheezing (3% to 9%); bronchitis, chest tightness, dyspnea, epistaxis, head stuffiness, laryngitis, pleurisy, pneumonia, voice alteration (1% to 3%).Nasal spray
Increased cough (greater than 1%).
Flu (10%); chest pain, decreased appetite, edema, fever (3% to 9%); chills, increased appetite, malaise, myalgia, peripheral edema, sweating, weakness (1% to 3%).
Document disease state activity and/or symptoms before starting therapy and periodically during treatment. Notify health care provider if symptoms do not improve or worsen. Ensure that therapy is periodically reviewed to determine if therapy needs to be continued without change or if a dose change (eg, increase, decrease, discontinuation) is indicated.
Category C .
Undetermined. Because other corticosteroids are excreted in human milk, use caution.
Safety and efficacy of Aerospan in children younger than 4 y not established. Oral corticosteroids may suppress growth in children and adolescents, particularly with higher doses over extended periods. Routinely monitor growth of children receiving inhaled corticosteroids.
Dose selection should be cautious, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic and renal function, and comorbidity.
Immediate and delayed reactions have occurred.
Special Risk Patients
Use inhaled corticosteroids with caution in patients with active or quiescent tuberculosis infection, untreated systemic fungal, bacterial, parasitic or viral infections, or ocular herpes simplex.
Not indicated for rapid relief of bronchospasm.
Transfer from oral to inhaled or intranasal corticosteroids may unmask allergic conditions previously suppressed by the systemic corticosteroid (eg, eczema, rhinitis).
Inhaled flunisolide may cause bronchospasm with an immediate increase in wheezing after dosing. If bronchospasm occurs, treat immediately with a fast-acting bronchodilator, discontinue inhaled flunisolide, and institute alternative therapy.
Antifungal therapy and discontinuance of steroid may be necessary.
Patients receiving immunosuppressant agents (eg, corticosteroids) are more susceptible to infections than healthy individuals. If a patient is exposed to measles or chickenpox, appropriate prophylaxis and treatment may be indicated.
Use with caution, if at all, in patients with untreated active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex. Inhaled corticosteroid therapy has been associated with localized fungal infections in the mouth, pharynx, and larynx (nose and pharynx with intranasal administration); may require antifungal therapy and/or discontinuation of the inhaled corticosteroid.
Lowest effective dose
Titrate inhaled or intranasal corticosteroid to lowest effective dose to minimize systemic effects.
Glaucoma, increased IOP, and cataracts have been rarely reported following long-term use of inhaled corticosteroids.
Transfer from oral to inhaled corticosteroids has resulted in death because of adrenal insufficiency related to lower systemic availability. Use cautiously in patients taking alternate-day prednisone or who have been recently withdrawn from systemic corticosteroids. Be prepared to provide supplemental systemic corticosteroids to such patients during periods of stress (eg, infection, surgery, trauma). Exceeding recommended daily dose of inhaled corticosteroid may cause systemic effects.
Because of inhibitory effect of corticosteroids on wound healing, use intranasal corticosteroids with caution in patients with recent nasal septal ulcers, recurrent epistaxis, nasal surgery or trauma, until healing has occurred.
No clinically deleterious effects were observed following the administration of flunisolide 18 mg over a 3-h period.
- Advise patient to read the patient information leaflet carefully before starting therapy, and to read and check for new information each time the medication is refilled.
- Advise parent or caregiver to supervise use of medication in children.
- Advise patient to continue taking other medications for same condition as prescribed by health care provider.
- Advise patient that effectiveness of medication depends on regular use and proper administration technique.
- Advise patient that dose may be changed periodically depending on how well symptoms are controlled.
- Explain that effects of drug are not immediate. Benefit requires daily use as instructed and usually begins to occur within 1 or 2 days; but full benefit may take 2 to 4 wk depending on the condition being treated and the dose and route of administration.
- Instruct patient not to stop the medication once symptoms have been controlled. Continued daily use is necessary to continue to control symptoms.
- Advise patient that if a dose is missed to take the next scheduled dose when it is due. Caution patient not to double the dose to catch up.
- Caution patient not to decrease the dose or stop taking unless advised by health care provider.
- Caution patient not to increase dose or frequency of administration if symptoms do not seem to be improving or are worsening. Advise patient to inform health care provider if symptoms are not improving or are worsening.
- Instruct patient to notify health care provider if asthma attack does not respond to rescue medication or if more rescue medication than usual is needed.
- 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 medical identification (eg, card, bracelet) indicating the need for supplemental systemic corticosteroids during periods of stress or a severe asthma attack.
- Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed and to inform health care provider of significant changes in readings.
- Advise patient to avoid exposure to chickenpox and measles and to seek medical advice immediately if exposed.
- Inhalation aerosol
- Review proper administration technique. Have patient demonstrate technique to ensure ability to use the inhalation aerosol effectively.
- Ensure that patient understands how to prepare the inhaler and spacer and properly administer dose. Advise patient to prime inhaler by releasing 2 test sprays into air away from face before first use or when inhaler has not been used for more than 2 wk.
- Advise patient to rinse mouth thoroughly with water or brush teeth to remove residual medication from mouth and throat.
- Warn patient that drug is an asthma controller and is not to treat an acute asthma attack. Instruct patient to use rescue medication (bronchodilator) to obtain rapid relief of asthma symptoms.
- Advise patient that increased wheezing may occur after taking inhalations. Instruct patient to use short-acting bronchodilator (rescue medication) if this occurs, not take further doses of flunisolide, and immediately contact health care provider for further instructions.
- Advise patient to discard the complete inhaler unit when labeled number of doses has been used. Caution patient not to perform float test in water in attempt to determine amount of medication remaining in inhaler canister.
- Instruct patient to carry medical identification (eg, card, bracelet) if he or she experiences acute severe asthma attacks requiring rapid systemic treatment.
- Advise patient to report the following symptoms to health care provider: cough, dry mouth, facial swelling, rash, sore throat or mouth, or worsening asthma symptoms (increasing need for bronchodilator).
- Nasal inhalation
- Review proper administration technique. Have patient demonstrate technique to ensure ability to use the nasal spray effectively.
- 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: nasal irritation, nosebleed, or sneezing.
- Advise patient to discard bottle when labeled number of sprays have been used even if bottle is not completely empty.
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