Dulera 200-5mcg Oral Inhaler 120inh

Dulera contains mometasone furoate and formoterol fumarate. Mometasone furoate is a corticosteroid that exhibits potent anti-inflammatory activity. It reduces inflammation in the airways, decreasing hyperresponsiveness. Formoterol fumarate is a long-acting beta2-adrenergic agonist (LABA) that acts locally in the lung as a bronchodilator. It stimulates beta2-adrenergic receptors in the bronchial smooth muscle, leading to relaxation of the smooth muscle and bronchodilation.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of a weak adrenal gland: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision.
Chest pain or pressure.
Rapid or abnormal heartbeat.
Feeling anxious or jittery.
Shakiness.
Seizures.
Sleep disturbances.
Severe nausea or vomiting.
Redness or white patches in the mouth or throat.
Changes in vision, eye pain, or severe eye irritation.
Feeling tired or weak.
Flushing.

Important Respiratory Warning

This medication can cause severe breathing problems, which may be life-threatening, shortly after taking a dose. If you experience difficulty breathing, worsening breathing, wheezing, or coughing after using this medication, use a rescue inhaler and seek immediate medical attention.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you're bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:

Headache.
Nose or throat irritation.
Common cold symptoms.
* Flu-like symptoms.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.

To ensure your safety, it is crucial to disclose all of your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor. This will help prevent potential interactions and ensure your safety while taking this medication.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have diabetes (high blood sugar), consult with your doctor, as this drug may increase your blood sugar levels.

You may not experience the full effects of this medication for a few weeks. If your breathing problems worsen, your rescue inhaler is less effective, or you need to use it more frequently, contact your doctor immediately.

Do not exceed the recommended dose or frequency of this medication, as overdoses of this type of drug have been fatal. Consult with your doctor if you have any concerns.

If you have been taking this medication for an extended period, consult with your doctor before stopping, as you may need to gradually taper off the medication to avoid potential side effects.

When transitioning from an oral steroid to another form of steroid, you may be at risk for severe and potentially life-threatening side effects, including weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, contact your doctor immediately.

In the event of a severe injury, surgery, or infection, you may require additional doses of oral steroids to help your body cope with the stress. Carry a warning card indicating that you may need extra steroids in these situations.

Long-term use of this medication may increase your risk of developing cataracts or glaucoma. Consult with your doctor and undergo regular eye exams as recommended.

Prolonged use of this medication may also lead to osteoporosis (weak bones). Discuss your risk factors with your doctor and ask about any concerns you may have.

You may be more susceptible to infections while taking this medication. To minimize your risk, wash your hands frequently and avoid close contact with people who have infections, colds, or flu.

If you have not had chickenpox or measles before, avoid exposure to these illnesses, as they can be severe or even fatal in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, consult with your doctor.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so consult with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Beta-blockers (especially non-selective): May block the bronchodilatory effect of formoterol and cause severe bronchospasm in asthma patients. Avoid concomitant use.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): May increase systemic exposure to mometasone, leading to increased risk of systemic corticosteroid effects.
• Other long-acting beta2-adrenergic agonists (LABAs): Concomitant use is not recommended as it may lead to overdose of LABA.
• Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the effect of formoterol on the cardiovascular system, leading to QT prolongation and ventricular arrhythmias. Use with extreme caution.

• Diuretics (loop or thiazide): May potentiate hypokalemia and/or ECG changes associated with beta-agonists, especially at high doses.
• QT-prolonging drugs (e.g., antiarrhythmics, certain antihistamines, macrolides): Increased risk of ventricular arrhythmias with formoterol.
• Other sympathomimetic agents: May potentiate adverse cardiovascular effects of formoterol.
• Xanthine derivatives (e.g., theophylline): May potentiate hypokalemia.

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, chest tightness)
• Increased need for rescue inhaler (short-acting beta-agonist)
• Paradoxical bronchospasm (immediate worsening of breathing after inhalation)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, muscle weakness)
• Signs of infection (e.g., fever, chills, increased cough, changes in sputum color)
• Cardiovascular symptoms (e.g., palpitations, chest pain, rapid heart rate, tremors)

Dulera is Pregnancy Category C. There are no adequate and well-controlled studies of Dulera in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids should be used at the lowest effective dose.

It is not known whether mometasone furoate or formoterol fumarate are excreted in human milk. Caution should be exercised when Dulera is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dulera and any potential adverse effects on the breastfed infant from Dulera or from the underlying maternal condition.

Approved for asthma in patients 12 years of age and older. Safety and effectiveness in children younger than 12 years have not been established. Monitor growth in pediatric patients receiving corticosteroids, as they may cause a reduction in growth velocity.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, caution should be exercised when using Dulera in elderly patients due to the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

• Dulera is a maintenance therapy and should not be used for acute bronchospasm. Patients should have a short-acting beta-agonist (SABA) available for rescue.
• Patients should be instructed on proper inhaler technique and to rinse their mouth with water and spit after each dose to minimize the risk of oral candidiasis (thrush) and systemic corticosteroid absorption.
• The black box warning for LABAs regarding increased risk of asthma-related death applies to Dulera. It should only be used in asthma patients not adequately controlled on an ICS alone or whose disease severity clearly warrants both ICS and LABA therapy.
• Regular monitoring of asthma control, pulmonary function, and potential side effects (e.g., growth in children, signs of systemic corticosteroid effects) is important.
• Do not stop Dulera abruptly, especially if on high doses for prolonged periods, as this can precipitate adrenal insufficiency.

• Inhaled Corticosteroid (ICS) monotherapy (e.g., mometasone furoate, fluticasone propionate, budesonide)
• Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
• Long-acting Muscarinic Antagonists (LAMAs) (e.g., tiotropium, umeclidinium) - for COPD, sometimes add-on for severe asthma
• Oral corticosteroids (for severe exacerbations or refractory asthma)
• Biologic therapies (e.g., omalizumab, mepolizumab, benralizumab, dupilumab) for severe asthma

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take medication prescribed to someone else. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.