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Flunisolide (Oral Inhalation)

Medically reviewed by Drugs.com. Last updated on Aug 10, 2020.

Pronunciation

(floo NISS oh lide)

Index Terms

  • AeroBid
  • Flunisolide Hemihydrate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Aerosol Solution, Inhalation:

Aerospan: 80 mcg/actuation (5.1 g [DSC], 8.9 g [DSC])

Brand Names: U.S.

  • Aerospan [DSC]

Pharmacologic Category

  • Corticosteroid, Inhalant (Oral)

Pharmacology

Decreases airway inflammation by suppression of endogenous inflammatory mediators (kinins, histamine, liposomal enzymes, prostaglandins). Inhibits inflammatory cell migration and reverses increased capillary permeability to decrease access of inflammatory cells to the site of inflammation; does not depress hypothalamus.

Absorption

Rapid

Distribution

Extensive; Vd: 170-350 L

Metabolism

Rapid and extensive hepatic metabolism via CYP3A4 to a minimally active metabolite (6 beta-OH flunisolide); also undergoes conjugation

Excretion

Rapid; not detectable in plasma 12-hours post dose; urine (<1% as unchanged drug)

Time to Peak

Within 5-10 minutes

Half-Life Elimination

1.3-1.7 hours

Use: Labeled Indications

Asthma: Maintenance treatment of asthma as prophylactic therapy in patients ≥6 years.

Limitations of use: Not indicated for relief of acute bronchospasm.

Contraindications

Primary treatment of status asthmaticus or other acute asthma episodes of asthma requiring intensive measures

Dosing: Adult

Note: Aerospan has been discontinued in the US for more than 1 year.

Note: The recommended starting dose is based upon previous asthma therapy and disease severity; may increase dose after 2 weeks of therapy in patients who are not adequately controlled. Titrate to the lowest effective dose once asthma is controlled.

Asthma: Oral inhalation: Metered-dose inhaler: Note: To decrease the severity or duration of an asthma exacerbation, may consider temporarily quadrupling the dose (early in the course of illness) in patients with mild to moderate asthma with a mild flare in symptoms. Reserve this approach for patients with no prior history of life-threatening asthma exacerbations, and in those with good self-management skills; return to baseline dose after normalization of symptoms or at a maximum of 14 days of the quadrupled dose (GINA 2020; McKeever 2018).

Patients not currently on inhaled corticosteroids: Initial: 160 mcg twice daily; maximum dose: 320 mcg twice daily.

Asthma Guidelines (NAEPP 2007): Metered-dose inhaler:

Low-dose therapy: 320 mcg/day in 2 divided doses

Medium-dose therapy: >320 to 640 mcg/day in 2 divided doses

High-dose therapy: >640 mcg/day in 2 divided doses

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Aerospan has been discontinued in the US for more than 1 year.

Asthma:

Maintenance therapy: Oral inhalation (80 mcg/inhalation): If adequate response is not seen after 3 to 4 weeks of initial dosage, increase dosage; doses should be titrated to the lowest effective dose once asthma is controlled.

Manufacturer's recommendations:

Children 6 to 11 years: Initial: One inhalation (80 mcg) twice daily; maximum daily dose: Two inhalations (160 mcg) twice daily (320 mcg/day).

Children ≥12 years and Adolescents: Initial: Two inhalations (160 mcg) twice daily; maximum daily dose: Four inhalations (320 mcg) twice daily (640 mcg/day).

Asthma Guidelines: National Asthma Education and Prevention Program (NAEPP 2007) (administer in divided doses twice daily):

Children 5 to 11 years:

"Low" dose: 160 mcg daily.

"Medium" dose: 320 mcg daily.

"High" dose: ≥640 mcg daily.

Children ≥12 years and Adolescents:

"Low" dose: 320 mcg daily.

"Medium" dose: >320 to 640 mcg daily.

"High" dose: >640 mcg daily.

Mild flare, exacerbation: Limited data available:

Children ≥12 years and Adolescents with mild to moderate asthma, no prior history of life-threatening asthma exacerbations, and with good self-management skills:

It is recommended to temporarily quadruple the inhaled corticosteroid dose early in the course of a mild flare to decrease the severity of an asthma exacerbation. After symptoms stabilize or after a maximum of 14 days of quadrupled dose, whichever occurs first, patients should be returned to their baseline dose (GINA 2019). Quadrupling the inhaled corticosteroid dose has been shown to decrease the severity of an asthma exacerbation in select patients. In a randomized trial of adolescents ≥16 years and adults (n=1,871), temporarily quadrupling the inhaled corticosteroid dose when asthma control began to deteriorate resulted in fewer severe asthma exacerbations (ie, less treatment with systemic glucocorticoids or unscheduled appointments for asthma) compared to patients who maintained their inhaled corticosteroid dose (McKeever 2018). No data for quadrupling the dose in patients <16 years of age has been published. Quintupling the dose of inhaled corticosteroids (fluticasone) in children 5 to 11 years of age was not shown to reduce the rate of severe exacerbations and may have been associated with adverse effects (decreased linear growth, particularly in patients <8 years of age) (GINA 2019; Jackson 2018).

Conversion from oral systemic corticosteroid to orally-inhaled corticosteroid: Initiation of oral inhalation therapy should begin in patients whose asthma is reasonably stabilized on oral corticosteroids (OCS). A gradual dose reduction of OCS should begin ~7 days after starting inhaled therapy. US labeling recommends reducing prednisone dose no more rapidly than ≤2.5 mg/day (or equivalent of other OCS) every 1 to 2 weeks in children ≥6 years and adolescents. If adrenal insufficiency occurs, temporarily increase the OCS dose and follow with a more gradual withdrawal. Note: When transitioning from systemic to inhaled corticosteroids, supplemental systemic corticosteroid therapy may be necessary during periods of stress or during severe asthma attacks.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Administration

Metered-dose inhaler: Shake well before using. Prime inhaler prior to first use and when the inhaler has not been used for >2 weeks by releasing 2 test sprays away from the face. Rinse mouth with water without swallowing after each use. Do not immerse the canister into water to determine remaining amount in the canister (ie, “float test”). Inhaler comes with a built-in spacer; do not use with any external spacer or holding chamber device; no cleaning is required. Discard inhaler after 60 or 120 sprays have been used even if canister is not empty (refer to product for number of actuations).

Storage

Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F). For best results, the canister should be at room temperature before use. Discard inhaler when the labeled number of actuations have been used.

Contents under pressure; do not puncture. Do not use or store near heat or open flame. Protect from freezing temperatures and prolonged exposure to sunlight. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw into fire or incinerator.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Monitor therapy

Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Avoid combination

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Monitor therapy

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not always defined.

>10%:

Central nervous system: Headache (9% to 14%)

Respiratory: Pharyngitis (17% to 18%), rhinitis (4% to 16%)

1% to 10%:

Cardiovascular: Chest pain (1% to 3%), edema (1% to 3%), capillary fragility (≥1%), chest tightness (≥1%), hypertension (≥1%), palpitations (≥1%), peripheral edema (≥1%), tachycardia (≥1%)

Central nervous system: Pain (2% to 5%), dizziness (1% to 3%), insomnia (1% to 3%), migraine (1% to 3%), voice disorder (1% to 3%), anosmia (≥1%), anxiety (≥1%), depression (≥1%), fatigue (≥1%), hyperactivity (≥1%), hypoactivity (≥1%), irritability (≥1%), malaise (≥1%), mood changes (≥1%), numbness (≥1%), shakiness (≥1%), vertigo (≥1%)

Dermatologic: Skin rash (2% to 4%), erythema multiforme (1% to 3%), acne vulgaris (≥1%), diaphoresis (≥1%), eczema (≥1%), pruritus (≥1%), urticaria (≥1%)

Endocrine & metabolic: Weight gain (≥1%), adrenal suppression, adrenocortical insufficiency, growth suppression (children and adolescents), hypercorticoidism

Gastrointestinal: Vomiting (≤5%), dyspepsia (2% to 4%), abdominal pain (1% to 3%), diarrhea (1% to 3%), dysgeusia (1% to 3%), gastroenteritis (1% to 3%), nausea (1% to 3%), oral candidiasis (1% to 3%), ageusia (≥1%), constipation (≥1%), decreased appetite (≥1%), epigastric fullness (≥1%), flatulence (≥1%), glossitis (≥1%), heartburn (≥1%), mouth irritation (≥1%), sore throat (≥1%), stomach discomfort (≥1%), oropharyngeal candidiasis

Genitourinary: Urinary tract infection (1% to 4%), dysmenorrhea (1% to 3%), vaginitis (1% to 3%)

Hematologic & oncologic: Lymphadenopathy (≥1%)

Hypersensitivity: Hypersensitivity reaction (4% to 5%)

Infection: Bacterial infection (4%), infection (1% to 3%), cold symptoms (≥1%), influenza (≥1%)

Neuromuscular & skeletal: Back pain (1% to 3%), myalgia (1% to 3%), neck pain (1% to 3%), weakness (≥1%), decreased bone mineral density

Ophthalmic: Conjunctivitis (1% to 3%), blurred vision (≥1%), eye discomfort (≥1%), eye infection (≥1%), cataract, glaucoma, increased intraocular pressure

Otic: Otalgia (1% to 3%), otitis (≥1%)

Respiratory: Cough (9%), sinusitis (7% to 9%), epistaxis (3%), bronchitis (1% to 3%), laryngitis (1% to 3%), bronchospasm (≥1%), chest congestion (≥1%), dry throat (≥1%), dyspnea (≥1%), hoarseness (≥1%), increased bronchial secretions (≥1%), nasal congestion (≥1%), nasal mucosa irritation (≥1%), pleurisy (≥1%), pneumonia (≥1%), rhinorrhea (≥1%), sinus congestion (≥1%), sinus discomfort (≥1%), sinus drainage (≥1%), sinus infection (≥1%), sneezing (≥1%), throat irritation (≥1%), upper respiratory tract infection (≥1%), wheezing (≥1%), exacerbation of asthma

Miscellaneous: Fever (1% to 7%)

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections (particularly gastroenteritis), or other conditions with severe electrolyte loss. Select surgical patients on long-term, high-dose, inhaled corticosteroid (ICS) should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).

• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; reaction should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue flunisolide and institute alternative therapy.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use, if possible, in patients with ocular herpes, active or quiescent respiratory tuberculosis, or untreated viral, fungal, parasitic or bacterial systemic infections. Exposure to chickenpox and measles should be avoided; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled intramuscular immunoglobulin, respectively, may be indicated; if chickenpox develops, treatment with antiviral agents may be considered.

• Oral candidiasis: Local oropharyngeal Candida albicans infections have been reported; if this occurs, treat appropriately while continuing therapy. Patients should be instructed to rinse mouth with water without swallowing after each use.

Disease-related concerns:

• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Use is contraindicated in status asthmaticus or during other acute asthma episodes requiring intensive measures.

• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count such as 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 or oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.

Special populations:

• Pediatric: Orally-inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range: 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally-inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Other warnings/precautions:

• Discontinuation of therapy: A gradual tapering of dose may be required prior to discontinuing therapy; there have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.

• Transfer to oral inhaler: When transferring to oral inhalation therapy from systemic corticosteroid therapy, previously suppressed allergic conditions (rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions) may be unmasked. Withdraw systemic corticosteroid therapy by gradually tapering the dose. Monitor lung function, beta-agonist use, asthma symptoms and for signs and symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea/vomiting, hypotension) during withdrawal.

Monitoring Parameters

Growth (adolescents and children via stadiometry); signs/symptoms of HPA axis suppression/adrenal insufficiency; signs/symptoms of oral candidiasis; possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]); FEV1, peak flow, and/or other pulmonary function tests; asthma symptoms; bone mineral density; glaucoma/cataracts

Pregnancy Considerations

Maternal use of inhaled corticosteroids (ICS) in usual doses is not associated with an increased risk of fetal malformations; a small risk of malformations was observed in one study following high maternal doses of an alternative ICS. Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes) (ERS/TSANZ [Middleton 2020]; GINA 2020).

ICS are recommended for the treatment of asthma during pregnancy (GINA 2020). Pregnant females adequately controlled on flunisolide for asthma may continue therapy; if initiating treatment during pregnancy, use of an agent with more data in pregnant females may be preferred. The lowest dose that maintains asthma control should be used. Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]).

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant females in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) (877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.

Patient Education

What is this drug used for?

• It is used to treat asthma.

• Do not use this drug to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stuffy nose

• Headache

• Sore throat

• Nausea

• Runny nose

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss

• Severe loss of strength and energy

• Severe fatigue

• Irritability

• Tremors

• Fast heartbeat

• Confusion

• Sweating

• Dizziness

• Thrush

• Trouble breathing

• Wheezing

• Cough

• Bone pain

• Joint pain

• Vision changes

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.