Alvesco

What is Alvesco?

• Alvesco (ciclesonide) an inhaled corticosteroid maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

Ciclesonide

Ciclesonide ball-and-stick animation

What are the uses of this medicine?

• Alvesco (ciclesonide) Inhalation Aerosol is a prescription medicine used for the control and prevention of asthma in adults and children 12 years of age and older.
• ALVESCO Inhalation Aerosol contains ciclesonide, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body and reduce inflammation.
• When you inhale ALVESCO Inhalation Aerosol it may help to control and prevent your symptoms of asthma by reducing your airway inflammation.

Limitations of use:

• ALVESCO Inhalation Aerosol is not for the relief of acute bronchospasm.
• ALVESCO Inhalation Aerosol is not a bronchodilator and does not treat sudden symptoms of an asthma attack such as wheezing, cough, shortness of breath, and chest pain or tightness.
• Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.

How does this medicine work?

• ALVESCO Inhalation Aerosol is not for the relief of acute bronchospasm. ALVESCO Inhalation Aerosol is not a bronchodilator and does not treat sudden symptoms of an asthma attack such as wheezing, cough, shortness of breath, and chest pain or tightness. Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.
• Ciclesonide is a pro-drug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application.
• Des-ciclesonide has anti-inflammatory activity with affinity for the glucocorticoid receptor that is 120 times higher than the parent compound.
• The precise mechanisms of corticosteroid action in asthma are unknown.
• Inflammation is recognized as an important component in the pathogenesis of asthma.
• Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in the asthmatic response.
• These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Who Should Not Use this medicine ?

This medicine cannot be used with:

• to treat status asthmaticus or other sudden symptoms of asthma. ALVESCO Inhalation Aerosol is not a rescue inhaler and should not be used to give you fast relief from your asthma attack.
• are allergic to ciclesonide or any of the ingredients in ALVESCO Inhalation Aerosol.

What drug interactions can this medicine cause?

• Co-administration of orally inhaled ciclesonide and oral ketoconazole, a potent inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of des-ciclesonide by approximately 3.6-fold at steady state, while levels of ciclesonide remained unchanged.

Is this medicine FDA approved?

• It was patented in 1990 and approved for medical use in 2005.
• The drug was approved for adults and children 12 and over by the US Food and Drug Administration in October 2006.

How should this medicine be used?

Recommended dosage: Patients ≥ 12 years who received bronchodilators alone:

• The recommended Starting Dose is 80 mcg twice daily.
• The Highest Recommended Dose is 160 mcg twice daily.

Patients ≥ 12 years who received inhaled corticosteroids:

• The recommended Starting Dose is 80 mcg twice daily.
• The Highest Recommended Dose is 320 mcg twice daily.

Patients ≥ 12 years who received oral corticosteroids:

• The recommended Starting Dose is 320 mcg twice daily
• The Highest Recommended Dose is 320 mcg twice daily

Administration:

• Use ALVESCO Inhalation Aerosol exactly as your healthcare provider tells you to use it. Do not take more of your medicine, or take it more often than your healthcare provider tells you.
• You must use ALVESCO Inhalation Aerosol regularly. It may take 4 weeks or longer after you start using ALVESCO Inhalation Aerosol for your asthma symptoms to get better. Do not stop using ALVESCO Inhalation Aerosol even if you are feeling better, unless your healthcare provider tells you to.
• If your symptoms do not improve or get worse, call your healthcare provider.
• Your healthcare provider may prescribe a rescue inhaler for emergency relief of sudden asthma attacks. Call your healthcare provider if you have:
• an asthma attack that does not respond to your rescue inhaler or
• you need more of your rescue inhaler than usual.
• If you use another inhaled medicine, ask your healthcare provider for instructions on how to use it while you use ALVESCO Inhalation Aerosol.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation Aerosol 80 mcg/actuation or 160 mcg/actuation

This medicine is available in fallowing brand namesː

• ALVESCO

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• swelling of nose and throat (nasopharyngitis)
• swelling of the sinuses (sinusitis)
• throat pain
• upper respiratory infection
• joint pain (arthralgia)
• nasal congestion
• pain in arms, legs, and back

What special precautions should I follow?

• Candida albicans infection of the mouth and pharynx. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse mouth following inhalation.
• ALVESCO is not a bronchodilator and is not indicated for rapid relief of bronchospasm or other acute episodes of asthma. During such episodes, patients may require therapy with oral corticosteroids.
• Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
• Risk of impaired adrenal function when transferring from oral steroids to inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to ALVESCO.
• Hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue ALVESCO slowly.
• Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor growth routinely in pediatric patients receiving ALVESCO.
• Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of inhaled corticosteroids including ALVESCO. Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely.
• As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with ALVESCO, it should be treated immediately with a fast-acting inhaled bronchodilator.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypercorticism

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• ALVESCO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of ALVESCO in children under 12 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ciclesonide
• Inactive ingredients: propellant HFA-134a and ethanol

Who manufactures and distributes this medicine?

Manufactured for:

• Covis Pharma
• Zug, 6300 Switzerland
• Made in United Kingdom

What should I know about storage and disposal of this medication?

• Store ALVESCO Inhalation Aerosol at room temperature between 59°F to 86°F (15°C to 30°C)
• Do not puncture the ALVESCO Inhalation Aerosol canister
• Do not store the ALVESCO Inhalation Aerosol canister near heat or a flame. Temperatures above 120°F (49°C) may cause the canister to burst.
• Do not throw the ALVESCO Inhalation Aerosol canister into a fire or an incinerator.
• Safely throw away medicine that is out of date or no longer needed.
• Keep ALVESCO Inhalation Aerosol clean and dry at all times.

• Dailymed label info on Alvesco
• FDA Alvesco

Alvesco Resources
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