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The following safety information outlines important considerations and potential risks associated with the use of this medication. Patients and healthcare providers should review these carefully to ensure safe usage and address any concerns.

• Not for Immediate Relief of Asthma Attacks: Dulera (mometasone/formoterol) is not suitable for treating sudden asthma attacks or acute breathing difficulties. For rapid relief, use a rescue inhaler like albuterol (Ventolin).

• Risk of Oral Thrush: The steroid component in Dulera can cause a fungal infection in the mouth and throat, known as thrush. To minimize this risk, rinse your mouth with water and spit after each use. Those with weakened immune systems should be especially cautious.

• Bronchospasm Warning: Inhaled medications like Dulera may lead to bronchospasm, causing immediate breathing difficulties. If this occurs, use a rescue inhaler and seek medical assistance immediately.

• Increased Infection Risk: Corticosteroids in Dulera can compromise the immune system, heightening the risk of infections such as respiratory infections and pneumonia. The risk is increased if you're also taking other immune-suppressing drugs.

• Caution with Steroid Transition: Transitioning from oral to inhaled steroids can cause a sudden drop in cortisol levels, leading to withdrawal symptoms. Patients should be monitored closely, especially if they have used oral steroids long-term.

• Stress Hormone Imbalance: Adhering to the prescribed dosage is crucial, as excessive use can lead to side effects from high cortisol levels, such as weight gain and elevated blood pressure.

• Heart-Related Side Effects: Formoterol in Dulera can affect heart rate and rhythm. These side effects are rare when taken as directed, but any symptoms like dizziness or a rapid heartbeat should be reported to a healthcare provider.

• Growth Concerns in Children: Inhaled steroids may delay growth in pediatric patients. Healthcare providers will prescribe the minimal effective dose to mitigate this risk.

• Eye Health Considerations: Long-term use may increase the risk of glaucoma or cataracts. Patients with a history of these conditions should have regular eye examinations and report any vision changes.

• Low Potassium Levels: Formoterol may cause a decrease in blood potassium levels, especially if overused, leading to symptoms like weakness or muscle cramps. Report any such symptoms to your healthcare provider.

Contraindications include:

• Current severe asthma attacks.
• Known allergies to mometasone or formoterol.

Discuss these concerns with your healthcare provider to ensure Dulera is appropriate for your condition.

When taking this medication, some common side effects may include a stuffy nose, sore throat, dry mouth, hoarseness, and symptoms similar to a common cold, such as sinus pressure. These effects are usually mild, but if they persist or worsen, it's advisable to consult a healthcare provider. Headaches and sinus-related symptoms are also possible, typically affecting a small percentage of users.

There are other side effects that, although less common, may still occur. These include chest pain and blurred vision. If you experience these symptoms, especially if they become severe, your healthcare provider should be contacted promptly.

In rare cases, more serious side effects can occur and require immediate medical attention. These include sudden worsening of breathing problems, which may indicate severe asthma or airway narrowing, and serious allergic reactions characterized by rash, hives, swelling, or difficulty breathing. Additionally, changes in stress hormone levels can cause symptoms such as weight gain, facial puffiness, muscle weakness, and mood changes. Heart-related issues like dizziness, fatigue, a rapid or irregular heartbeat, and fainting are also serious and necessitate urgent care.

If you notice any unusual effects not listed here, it is important to reach out to your healthcare provider for guidance. Your health and safety are paramount, and timely medical advice can help manage any adverse effects effectively.