Aerospan

Name: Aerospan

Manufacturer

  • Forest Pharmaceuticals, Inc.

Side Effects of Aerospan

Common side effects of Aerospan include:

  • headache
  • sore throat
  • cough
  • sneezing
  • fever
  • vomiting

This is not a complete list of Aerospan side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Aerospan (flunisolide inhalation)?

Flunisolide is a steroid that prevents the release of substances in the body that cause inflammation.

Flunisolide inhalation is used to prevent asthma attacks in adults and children who are at least 6 years old.

This medicine will not treat an asthma attack that has already begun.

Flunisolide inhalation may also be used for purposes not listed in this medication guide.

What should I avoid while using Aerospan (flunisolide inhalation)?

Avoid being near people who are sick or have infections. Steroid medicine can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Introduction

Synthetic fluorinated glucocorticoid.105

Aerospan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Body aches or pain
  • congestion
  • cough
  • dryness or soreness of the throat
  • fever
  • headache
  • hoarseness
  • pain or tenderness around the eyes and cheekbones
  • shortness of breath or troubled breathing
  • sneezing
  • stuffy or runny nose
  • tender, swollen glands in the neck
  • tightness of the chest or wheezing
  • trouble with swallowing
  • voice changes
Less common
  • Bladder pain
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody nose
  • bloody or cloudy urine
  • blurred vision
  • chest pain
  • chills
  • cough producing mucus
  • diarrhea
  • difficult, burning, or painful urination
  • dizziness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • hives
  • itching
  • joint or muscle pain
  • lower back or side pain
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • red, irritated eyes
  • skin rash
  • slow heartbeat
  • sore mouth or tongue
  • sores, ulcers, or white spots in the mouth or on the lips
  • sweating
  • swelling
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
Incidence not known
  • Creamy white, curd-like patches in the mouth or throat
  • darkening of the skin
  • discouragement
  • fainting
  • feeling sad or empty
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • loss of strength or energy
  • muscle weakness
  • nausea
  • pain when eating or swallowing
  • trouble concentrating
  • trouble sleeping
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Abdominal or stomach fullness
  • acid or sour stomach
  • appetite changes
  • bad, unusual, or unpleasant (after) taste
  • belching
  • blemishes on the skin
  • burning, dry, or itching eyes
  • change in taste
  • constipation
  • cramps
  • difficulty with moving
  • discharge or excessive tearing
  • dizziness or lightheadedness
  • ear pain
  • fear
  • feeling of constant movement of self or surroundings
  • gas
  • headache, severe and throbbing
  • heartburn
  • heavy bleeding
  • indigestion
  • irritability
  • itching of the vagina or genital area
  • loss of smell or taste
  • muscle aching or cramping
  • muscle stiffness
  • pain during sexual intercourse
  • pain in the neck
  • pimples
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • sensation of spinning
  • shakiness
  • skin rash, encrusted, scaly, and oozing
  • stomach discomfort, upset, or pain
  • swollen joints
  • thick, white vaginal discharge with no odor or with a mild odor
  • trouble sitting still
  • trouble sleeping
  • upset stomach

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Uses of Aerospan

  • It is used to treat asthma.
  • Do not use Aerospan (flunisolide (oral inhalation)) to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

How is this medicine (Aerospan) best taken?

Use Aerospan as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Follow how to use as you have been told by the doctor or read the package insert.
  • To gain the most benefit, do not miss doses.
  • Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • For breathing in only.
  • Shake well before use.
  • Prime puffer (inhaler) before first use or if not used for more than 2 weeks by spraying it 2 times.
  • Rinse out mouth after each use. Do not swallow the rinse water. Spit it out.
  • Do not use near an open flame or while smoking. It may burst.
  • Put the cap back on after you are done using your dose.
  • Do not use a spacer with the puffer (inhaler).
  • Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not use 2 doses at the same time or extra doses.

Indications and Usage for Aerospan

Aerospan inhalation aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older.

Important Limitations of Use

• Aerospan is NOT indicated for the relief of acute bronchospasm. • Aerospan is NOT indicated in children less than 6 years of age.

Aerospan Dosage and Administration

Administration Information

Aerospan should be administered by the orally inhaled route in patients aged 6 years and older. Shake well prior to each inhalation. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

Patients should be instructed on the proper use of their inhaler. Aerospan contains a built-in spacer. Do not use with any external spacer or holding chamber devices. Instruct patients to prepare the inhaler for use by pulling the built-in purple actuator out from the gray spacer and snapping into an "L" shape prior to use. Pediatric patients should administer Aerospan under adult supervision.

Recommended Dosage

Adults and Adolescents 12 Years of Age and Older

The starting dosage is based on previous asthma therapy and disease severity, including consideration of the patients’ current control of asthma symptoms and risk of future exacerbation. The recommended starting dosage for patients aged 12 years and older who are not on an inhaled corticosteroid is 160 mcg twice daily, approximately 12 hours apart. For other patients, and for patients who do not respond adequately to Aerospan 160 mcg after 2 weeks of therapy, increasing the dosage may provide additional asthma control. The maximum recommended dosage is 320 mcg twice daily.

Pediatric Patients 6 to 11 Years

The starting dosage is based on previous asthma therapy and disease severity, including consideration of the patients’ current control of asthma symptoms and risk of future exacerbation. The recommended starting dosage for patients aged 6 to 11 years who are not on an inhaled corticosteroid is 80 mcg twice daily, approximately 12 hours apart. For other patients, and for patients who do not respond adequately to Aerospan 80 mcg after 2 weeks of therapy, increasing the dosage may provide additional asthma control. The maximum recommended dosage for patients 6 to 11 years of age is 160 mcg twice daily.

General Dosing Recommendations

If symptoms arise between doses, an inhaled short-acting beta2-agonist should be used for immediate relief.

The onset and degree of symptom relief with orally inhaled corticosteroids is usually apparent within 2-4 weeks after the start of treatment, and varies with individual patients. The time to improvement in asthma control was not evaluated in clinical studies with Aerospan.

If a dosage regimen of Aerospan and additional therapeutic options, e.g., increasing the Aerospan dosage, initiating an inhaled corticosteroid and long-acting beta2-agonist (LABA) combination product, or initiating oral corticosteroids, should be considered.

After asthma stability has been achieved, titrate to the lowest effective dosage to reduce the possibility of side effects.

Warnings and Precautions

Local Infections

In clinical studies with flunisolide, localized infections with Candida albicans or Aspergillus niger have occurred in the mouth and pharynx and occasionally in the larynx. If oropharyngeal candidiasis develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with Aerospan therapy, but at times therapy with Aerospan may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised. [see Adverse Reactions (6.1)].

Acute Asthma Episodes

Aerospan is not a bronchodilator and is not indicated for rapid relief of bronchospasm. Instruct patients to contact their physician immediately when episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with Aerospan. During such episodes, patients may require therapy with systemic corticosteroids.

Immunosuppression

Patients who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Because of the potential for worsening infections, use inhaled corticosteroids 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.

Transfer from Systemic Corticosteroids

Particular care is needed in patients who are transferred from systemically active corticosteroids to Aerospan because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery or infections (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although Aerospan may provide control of asthmatic symptoms during these episodes, in recommended doses it supplies less than the physiologic amounts of glucocorticoid (cortisol) systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.

During periods of stress or a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume systemic steroids immediately and to contact their physician for further instruction. Instruct these patients to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack.

Wean patients requiring oral corticosteroids slowly from systemic corticosteroid use after transferring to Aerospan. Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg/day on a weekly basis [see Dosage and Administration (2)]. Lung function (forced expiratory volume in one second [FEV1] or morning peak expiratory flow rate [AM PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma signs and symptoms, observe patients for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to Aerospan may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g. rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.

During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint or muscular pain, lassitude and depression, despite maintenance or even improvement of respiratory function.

Hypercorticism and Adrenal Suppression

In responsive patients, flunisolide may permit control of asthmatic symptoms with less suppression of HPA axis function than therapeutically equivalent oral doses of prednisone. Since flunisolide is absorbed into the circulation and can be systemically active, the beneficial effects of Aerospan in minimizing or preventing HPA axis dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing Aerospan.

Because of the possibility of systemic absorption of inhaled corticosteroids, observe patients treated with Aerospan carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients post-operatively or during periods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses. If such changes occur, reduce the Aerospan dose slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic corticosteroids.

Reduction in Bone Mineral Density

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids, including flunisolide. The clinical significance of small changes in BMD with regard to long-term outcomes is unknown. Monitor patients with major risk factors for decreased bone mineral content, 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 (e.g., anticonvulsants and corticosteroids) and treat with established standards of care.

Effects on Growth

Orally inhaled corticosteroids, including flunisolide, may cause a reduction in growth velocity when administered to pediatric patients [see Use in Specific Populations (8.4)]. Monitor the growth of children and adolescents receiving Aerospan. To minimize the systemic effects of orally inhaled corticosteroids, including Aerospan, titrate each patient to his/her lowest effective dose [see Dosage and Administration (2)].

Glaucoma and Cataracts

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids, including flunisolide. Monitor patients closely, especially patients with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts.

Paradoxical Bronchospasm

As with other inhaled asthma medications, bronchospasm may occur with an immediate increase in wheezing after dosing. If bronchospasm occurs following dosing with Aerospan, treat immediately with a fast-acting inhaled bronchodilator. Discontinue treatment with Aerospan immediately and institute alternative therapy.

For the Consumer

Applies to flunisolide: inhalation aerosol liquid, inhalation aerosol powder

Along with its needed effects, flunisolide (the active ingredient contained in Aerospan HFA) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking flunisolide:

More common
  • Body aches or pain
  • congestion
  • cough
  • dryness or soreness of the throat
  • fever
  • headache
  • hoarseness
  • pain or tenderness around the eyes and cheekbones
  • shortness of breath or troubled breathing
  • sneezing
  • stuffy or runny nose
  • tender, swollen glands in the neck
  • tightness of the chest or wheezing
  • trouble with swallowing
  • voice changes
Less common
  • Bladder pain
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody nose
  • bloody or cloudy urine
  • blurred vision
  • chest pain
  • chills
  • cough producing mucus
  • diarrhea
  • difficult, burning, or painful urination
  • dizziness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • hives
  • itching
  • joint or muscle pain
  • lower back or side pain
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • red, irritated eyes
  • skin rash
  • slow heartbeat
  • sore mouth or tongue
  • sores, ulcers, or white spots in the mouth or on the lips
  • sweating
  • swelling
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
Incidence not known
  • Creamy white, curd-like patches in the mouth or throat
  • darkening of the skin
  • discouragement
  • fainting
  • feeling sad or empty
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • loss of strength or energy
  • muscle weakness
  • nausea
  • pain when eating or swallowing
  • trouble concentrating
  • trouble sleeping
  • vomiting

Some side effects of flunisolide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Abdominal or stomach fullness
  • acid or sour stomach
  • appetite changes
  • bad, unusual, or unpleasant (after) taste
  • belching
  • blemishes on the skin
  • burning, dry, or itching eyes
  • change in taste
  • constipation
  • cramps
  • difficulty with moving
  • discharge or excessive tearing
  • dizziness or lightheadedness
  • ear pain
  • fear
  • feeling of constant movement of self or surroundings
  • gas
  • headache, severe and throbbing
  • heartburn
  • heavy bleeding
  • indigestion
  • irritability
  • itching of the vagina or genital area
  • loss of smell or taste
  • muscle aching or cramping
  • muscle stiffness
  • pain during sexual intercourse
  • pain in the neck
  • pimples
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • sensation of spinning
  • shakiness
  • skin rash, encrusted, scaly, and oozing
  • stomach discomfort, upset, or pain
  • swollen joints
  • thick, white vaginal discharge with no odor or with a mild odor
  • trouble sitting still
  • trouble sleeping
  • upset stomach

For Healthcare Professionals

Applies to flunisolide: compounding powder, inhalation aerosol, inhalation aerosol with adapter

General

The most commonly reported adverse reactions include pharyngitis, rhinitis, headache, sinusitis, and increased cough.[Ref]

Respiratory

Very common (10% or more): Pharyngitis (up to 17.5%), rhinitis (up to 15.7%)
Common (1% to 10%): Increased cough, sinusitis, epistaxis, bronchitis, laryngitis, voice alteration, cold symptoms, nasal congestion, sinus drainage, sinus infection, sneezing, sputum, wheezing, bronchospasm, dyspnea, head stuffiness, nasal irritation, sinus discomfort, sore throat, dry throat[Ref]

Gastrointestinal

Common (1% to 10%): Vomiting, dyspepsia, abdominal pain, diarrhea, gastroenteritis, nausea, oral moniliasis, upset stomach, heartburn, constipation, gas, abdominal fullness, glossitis, mouth irritation, phlegm[Ref]

Nervous system

Very common (10% or more): Headache (up to 13.8%)
Common (1% to 10%): Migraine, taste perversion, weakness, numbness, hyperactivity[Ref]

Musculoskeletal

Common (1% to 10%): Neck pain, myalgia
Frequency not reported: Decreased bone mineral density; reduction in growth velocity[Ref]

Ocular

Common (1% to 10%): Blurred vision, eye discomfort, eye infection
Frequency not reported: Glaucoma, increased intraocular pressure, cataracts[Ref]

Dermatologic

Common (1% to 10%): Erythema multiforme, sweating, eczema, pruritus, acne, urticaria

Cardiovascular

Common (1% to 10%): Chest pain, edema, palpitations, tachycardia, hypertension[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, dysmenorrhea, vaginitis[Ref]

Hematologic

Common (1% to 10%): Enlarged lymph nodes, capillary fragility[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction[Ref]

Metabolic

Common (1% to 10%): Decreased appetite, increased appetite, weight gain[Ref]

Other

Common (1% to 10%): Ear pain, chills, malaise, vertigo, fatigue, loss of smell, ear infection[Ref]

Psychiatric

Common (1% to 10%): Insomnia, irritability, shakiness, anxiety, depression, moodiness, hypoactivity[Ref]

Some side effects of Aerospan HFA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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