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This document outlines crucial safety information regarding the use of Alvesco (ciclesonide). It is essential to understand these warnings to ensure safe and effective use of this medication. Consult your healthcare provider if you have any concerns or questions.

• Fungal Infection in the Mouth: Inhaling Alvesco (ciclesonide) can lead to a fungal infection known as thrush in your mouth and throat. To minimize this risk, rinse your mouth with water and spit after each use. Notify your healthcare provider if you experience symptoms such as white patches, a cotton-like feeling in your mouth, pain while eating or swallowing, or loss of taste. Treatment may be necessary if thrush develops.

• Bronchospasm (Narrowing of Airways): Alvesco (ciclesonide) may cause bronchospasm, a condition that involves tightening of the muscles in your lungs, resulting in breathing difficulties, wheezing, coughing, and chest discomfort. If you experience difficulty breathing after use, utilize your rescue inhaler and seek immediate medical attention.

• Increased Risk of Infections: As a corticosteroid, Alvesco (ciclesonide) can weaken your immune response, increasing susceptibility to infections. This risk is heightened if you are on other immune-suppressing medications. Inform your healthcare provider if you are being treated for infections like tuberculosis, as alternative treatments may be necessary. Report symptoms of infection such as fever, chills, and body aches promptly.

• Altered Stress Hormone Levels: Prolonged or excessive use of Alvesco (ciclesonide) can lead to an increase in absorbed medication, affecting cortisol levels. Symptoms resembling Cushing's disease, such as weight gain, facial puffiness, and muscle weakness, may occur. Use the medication as prescribed to avoid these effects.

• Delayed Growth in Children: Long-term use of Alvesco (ciclesonide) in children may result in growth delays. The lowest effective dose should be used for the shortest duration necessary. Discuss any concerns regarding your child's growth with their healthcare provider to determine the appropriateness of this medication.

• Eye and Vision Problems: Though rare, increased eye pressure, glaucoma, and cataracts have been reported with Alvesco (ciclesonide) use. If you have a history of these conditions, frequent eye exams may be recommended. Report any vision changes to your eye care provider immediately.

Contraindications:

• Sudden Asthma Attacks: Alvesco (ciclesonide) is not suitable for the treatment of sudden asthma attacks. Consult your healthcare provider for appropriate emergency treatment options.

When taking this medication, some common side effects may include dry or irritated throat, hoarseness, a bad taste in the mouth, coughing, stuffy or runny nose, headache, and symptoms resembling an upper respiratory tract infection, such as sore throat and cough. These effects are generally mild, but if they persist or worsen, it is advisable to consult a healthcare provider for guidance.

In addition to these, some individuals may experience dry mouth, joint pain, back pain, pain in the hands and feet, or nausea. Fungal infections in the mouth have also been reported. Although these side effects can be concerning, they are generally manageable with medical advice.

There are also more serious side effects that, although rare, require immediate medical attention. These include sudden worsening of breathing problems, characterized by difficulty breathing, wheezing, or chest pain. A serious allergic reaction could occur, presenting symptoms such as rash, hives, swelling of the face, tongue, or throat, severe dizziness, and trouble breathing. Changes in stress hormone levels may lead to unexpected weight gain, puffiness of the face, muscle weakness, mood changes, and other symptoms. If you experience any of these severe reactions, seek urgent medical care promptly.

It is important to monitor any side effects you experience and consult a healthcare provider for personalized advice and assistance.

Ciclesonide, also known as Alvesco, can interact with various medications, which may impact its effectiveness or increase the risk of side effects. It is important to inform your healthcare provider about all other medications you are taking, including prescription, over-the-counter, vitamins, and herbal supplements.

Certain drugs, such as Desmopressin, are generally not recommended to be used with ciclesonide. Your doctor might opt for alternative treatments or adjust your medication regimen if you are on both.

Other medications, like Ritonavir and some azole antifungals (e.g., Ketoconazole), can affect how ciclesonide is processed in your body, potentially altering its effectiveness. In some cases, using these drugs together might be necessary, but your doctor will likely adjust dosages to manage any interaction.

Lastly, using ciclesonide with medications such as auranofin may increase the likelihood of side effects. However, if both drugs are deemed necessary, your healthcare provider will carefully monitor and adjust your treatment plan as needed. Always consult with your doctor before making any changes to your medication regimen.