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Aerospan HFA

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Aerospan HFA

Aerospan HFA Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Aerospan (flunisolide HFA, 80 mcg) Inhalation Aerosol is a corticosteroid used for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. Common side effects include headache, allergic reactions, vomiting, stomach upset, sore throat, nasal congestion, cough, and sinusitis.

The recommended starting dose of Aerospan for adults and adolescents 12 and older is 160 mcg twice daily, with a maximum dose of 320 mcg twice daily. The recommended starting dose of Aerospan for children age 6 to 11 is 80 mcg twice daily, with a maximum dose of 160 mcg twice daily. Aerospan may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Aerospan should be used only if prescribed. It is unknown if this drug passes into breast milk. Because other corticosteroids are excreted in human milk, nursing women should exercise caution if using Aerospan. Consult your doctor before breastfeeding.

Our Aerospan (flunisolide HFA, 80 mcg) Inhalation Aerosol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aerospan HFA FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following table shows the adverse reactions that were reported in patients previously receiving bronchodilators and/or orally inhaled corticosteroids in two double-blind, placebo-controlled US clinical trials, in which 519 adult and pediatric patients age 4-78 years (279 males and 240 females) were treated with the AEROSPAN Inhalation Aerosol (80 mcg to 320 mcg twice daily for 12 weeks) or placebo. The mean duration of exposure was 76.7, 78.2, 80.5, and 69.4 days for AEROSPAN Inhalation Aerosol 80 mcg, 160 mcg, 320 mcg, and placebo, all dosed twice daily, respectively. The table includes all reactions that occurred at a rate of > 3% in any AEROSPAN Inhalation Aerosol group. In considering these data, the increased average duration of exposure for AEROSPAN Inhalation Aerosol patients should be taken into account, compared with placebo-treated patients.

Adverse Reactions with > 3% incidence reported in controlled clinical studies with AEROSPAN Inhalation Aerosol (% of patients)

ADVERSE REACTION PLACEBO
(n = 220)
AEROSPAN Inhalation Aerosol
80 MCG
(n = 189)
160 MCG
(n = 217)
320 MCG
(n = 113)
BODY AS AWHOLE
  Headache 12.7 9.0 13.8 8.8
  Allergic Reaction 2.3 4.2 4.6 4.4
  Infection, Bacterial 0.9 3.7 0.9 0.9
DIGESTIVESYSTEM
  Vomiting 4.1 4.2 4.6 0.0
  Dyspepsia 1.4 2.1 3.2 3.5
RESPIRATORY SYSTEM
  Pharyngitis 13.2 17.5 16.6 16.8
  Rhinitis 10.0 9.0 15.7 3.5
  Cough Increased 7.7 8.5 5.5 1.8
  Sinusitis 5.5 7.4 4.1 8.8
  Epistaxis 0.9 3.2 0.9 0.0
UROGENITAL SYSTEM
  Urinary Tract Infection 0.5 1.1 0.9 3.5

The following other adverse reactions occurred in patients in these clinical trials using AEROSPAN Inhalation Aerosol with an incidence of 1 to 3% and were more common in AEROSPAN Inhalation Aerosol than in the placebo group.

Body As A Whole: abdominal pain, chest pain, infection, neck pain

Digestive System: diarrhea, gastroenteritis, nausea, oral moniliasis

Metabolic And Nutritional Disorders: edema

Musculoskeletal System: myalgia

Nervous System: dizziness, insomnia, migraine

Respiratory System: bronchitis, laryngitis, voice alteration

Skin And Appendages: erythema multiforme

Special Senses: conjunctivitis, ear pain, taste perversion

Urogenital System: dysmenorrhea, vaginitis

Long-Term Clinical Trials

Two 52-week open label safety trials of AEROSPAN Inhalation Aerosol were conducted in 162 asthma patients 12 to 60 years of age and in 152 asthma patients 4 to 11 years of age. The adverse reaction profile exhibited in these trials was similar to that seen in the two 12-week studies.

Adverse Reactions from Other Sources

The following additional adverse reactions were derived from clinical trials conducted with flunisolide CFC inhalation aerosol with a frequency of ≥ 1% and not described above:

Body as a Whole: flu, decreased appetite, chills, increased appetite, weight gain, malaise, peripheral edema, sweating, weakness

Gastrointestinal System: upset stomach, heartburn, constipation, gas, abdominal fullness

Cardiovascular System: palpitations, hypertension, tachycardia

Nervous System: headache, irritability, shakiness, anxiety, depression, faintness, fatigue, hyperactivity, hypoactivity, moodiness, numbness, vertigo

Respiratory System: cold symptoms, nasal congestion, upper respiratory tract infection, chest congestion, hoarseness, runny nose, sinus congestion, sinus drainage, sinus infection, sneezing, sputum, wheezing, chest tightness, bronchospasm, dyspnea, head stuffiness, nasal irritation, pleurisy, pneumonia, sinus discomfort

Skin and Appendages: eczema, pruritus, acne, urticaria

Special Senses: loss of smell, loss of taste, ear infection, blurred vision, eye discomfort, eye infection

Hemic and Lymph: capillary fragility, enlarged lymph nodes

Mouth and Throat: sore throat, dry throat, glossitis, mouth irritation, phlegm, throat irritation

Read the entire FDA prescribing information for Aerospan HFA (Flunisolide Hemihydrate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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