Aerospan

Name: Aerospan

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of flunisolide inhalation is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Aerospan (flunisolide inhalation) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine;

  • sores or white patches in your mouth or throat;

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;

  • worsening asthma symptoms;

  • dizziness, tiredness, muscle weakness;

  • nausea, vomiting, loss of appetite, diarrhea, weight loss; or

  • fever, chills, body aches.

Flunisolide inhalation can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • runny nose, sinus pain;

  • cough, sore throat;

  • nausea; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cautions for Aerospan

Contraindications

  • Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids) are required.105 107 109

Warnings/Precautions

Infections

Localized fungal infections (Candida albicans or Aspergillus niger) of the mouth, pharynx, and occasionally the larynx reported.105 If infection occurs, appropriate local or systemic antifungal treatment and/or temporary interruption of therapy may be required.105

Use with caution, if at all, in patients with untreated active or quiescent Mycobacterium tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex.105

Acute Exacerbations of Asthma

Treat acute asthma symptoms with a short-acting β2-agonist bronchodilator.105 If symptoms persist, promptly reevaluate asthma therapy and consider initiating systemic corticosteroids.105

Immunosuppressed Patients

Increased susceptibility to infections in patients receiving immunosuppressant drugs compared with healthy individuals.105 Certain infections (e.g., varicella [chickenpox], measles) can have a more serious (even fatal) outcome in such patients.105

Avoid exposure to varicella and measles in previously unexposed patients who are not properly immunized.105 If exposure to varicella (chickenpox) or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled immune globulin (IG), respectively.105 Consider treatment with an antiviral agent if varicella develops.105

Withdrawal of Systemic Corticosteroid Therapy

Possible corticosteroid withdrawal symptoms (e.g., joint or muscular pain, lassitude, depression);105 acute adrenal insufficiency;105 or symptomatic exacerbation of allergic conditions if prolonged systemic corticosteroid therapy is replaced with oral inhalation corticosteroid therapy.105

Taper dosage of the systemic corticosteroid; carefully monitor patients during dosage reduction for objective signs of adrenal insufficiency (e.g., hypotension, fatigue, lassitude, weakness, nausea, vomiting).105

Systemic Corticosteroid Effects

Administration of orally inhaled flunisolide, particularly at higher than recommended dosages, may result in manifestations of hypercorticism and suppression of HPA function.105 Periodically monitor patients receiving such therapy for effects on the HPA axis.105 If such effects occur, slowly reduce dosage of oral inhalation therapy.105

Carefully monitor patients during periods of stress (e.g., infections, trauma, surgery) for manifestations of hypoadrenalism.105

Reduction in Bone Mineral Density

Decreased bone mineral density (BMD) reported following long-term administration of inhaled corticosteroids, including flunisolide.105

Monitor patients with risk factors for decreased BMD (e.g., prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, prolonged use of drugs [e.g., anticonvulsants, corticosteroids] that may reduce bone mass).105

Ocular Effects

Glaucoma, increased IOP, and cataracts reported following long-term administration of inhaled corticosteroids, including flunisolide.105

Closely monitor patients, especially those with vision changes or with history of increased IOP, glaucoma, or cataracts.105

Acute Paradoxical Bronchospasm

Possible acute paradoxical bronchospasm.105 If such a reaction occurs, discontinue orally inhaled flunisolide and initiate therapy with a short-acting inhaled bronchodilator immediately; institute alternative therapy.105

Specific Populations

Pregnancy

Category C.105

Monitor infants born to women who receive corticosteroids during pregnancy for possible hypoadrenalism.105

Lactation

Not known whether distributed into milk.105 Since other corticosteroids are distributed into milk, use caution in nursing women.105

Pediatric Use

Safety and efficacy not established in children <6 years of age.105

Periodically monitor (e.g., via stadiometry) the growth and development of children receiving orally inhaled flunisolide.105 Weigh potential benefits of corticosteroid therapy against possibility of growth suppression and risks/benefits of treatment alternatives.105 Use the lowest possible dosage that effectively controls asthma.105

Common Adverse Effects

Pharyngitis,105 rhinitis,105 headache,105 increased cough,105 sinusitis.105

Actions

  • Potent glucocorticoid and minimal mineralocorticoid activity.105

  • Demonstrates marked anti-inflammatory activity.105

  • Improves lung function (e.g., FEV1, morning peak expiratory flow).105

  • Minimal systemic activity at recommended dosages.105

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Flunisolide Hemihydrate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral Inhalation

Aerosol

80 mcg (of flunisolide) per metered spray

Aerospan Inhalation Aerosol (with hydrofluoroalkane propellant)

Acton

Dosage Forms and Strengths

Inhalation aerosol: Pressurized metered dose inhaler with a built in spacer that delivers 60 or 120 metered 80 mcg doses.

Contraindications

Aerospan is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
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