Dulera 50mcg/5mcg Aerosol

Mometasone furoate is a corticosteroid that exhibits potent anti-inflammatory activity. It inhibits multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in allergic and non-allergic mediated inflammation. Formoterol fumarate is a long-acting selective beta2-adrenergic agonist (LABA) that stimulates adenyl cyclase, an enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of the release of mediators of immediate hypersensitivity from cells, especially from mast cells.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of high blood sugar, such as:
+ Confusion
+ Drowsiness
+ Excessive thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of a weak adrenal gland, such as:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Chest pain or pressure
Rapid or abnormal heartbeat
Feeling nervous or excitable
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
Fatigue or weakness
Flushing

Breathing Problems: A Life-Threatening Condition

This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:

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, contact 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, any of 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 that is similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.

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, discuss tapering off the medication with your doctor before stopping, as abrupt cessation may be harmful.

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 such 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 and any concerns with your doctor.

You may be more susceptible to infections while taking this medication. To minimize this risk, practice good hygiene by washing your hands frequently and avoiding close contact with individuals 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 individuals 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 adolescents. Regular growth checks may be necessary, so discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to weigh the benefits and risks of this medication for both you and your baby.

• Other long-acting beta2-adrenergic agonists (LABAs)
• Use as monotherapy for asthma (LABA component)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole, cobicistat-containing products) - may increase systemic exposure to mometasone, leading to increased risk of systemic corticosteroid effects.
• Beta-adrenergic blockers (especially non-selective) - may block the pulmonary effect of formoterol and produce severe bronchospasm, particularly in patients with asthma. Should not be used concurrently.
• Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs) - may potentiate the effect of formoterol on the cardiovascular system, increasing the risk of arrhythmias.
• QT-prolonging drugs (e.g., quinidine, disopyramide, procainamide, phenothiazines, antihistamines, macrolides) - increased risk of ventricular arrhythmias with formoterol.

• Non-potassium-sparing diuretics (e.g., loop or thiazide diuretics) - may potentiate the hypokalemic effect of beta-agonists.
• Xanthine derivatives (e.g., theophylline) and other sympathomimetics - may potentiate adverse cardiovascular effects.
• Other inhaled corticosteroids - additive systemic effects.

• Not available

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
• Increased need for rescue inhaler (short-acting beta-agonist)
• Signs of oral candidiasis (white patches in mouth/throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, adrenal insufficiency symptoms like fatigue, weakness, nausea, vomiting)
• Cardiovascular symptoms (e.g., palpitations, chest pain, rapid heart rate)
• Muscle cramps or weakness (hypokalemia)

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. Monitor neonates of mothers receiving corticosteroids during pregnancy for signs of hypoadrenalism.

Mometasone and formoterol are excreted in the milk of lactating animals. It is not known whether Dulera is excreted in human milk. 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. Caution should be exercised when Dulera is administered to a nursing woman.

Approved for patients 12 years of age and older. Safety and effectiveness have not been established in children younger than 12 years of age. Monitor growth in pediatric patients receiving corticosteroids, as growth suppression has been observed.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, caution should be exercised 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 inhaler and should be used consistently twice daily, not as a rescue inhaler for acute symptoms.
• Patients should be instructed to rinse their mouth with water and spit after each use to minimize the risk of oral candidiasis (thrush).
• Due to the LABA component, Dulera carries a Black Box Warning regarding increased risk of asthma-related death when used as monotherapy in asthma. It should only be used in asthma as combination therapy with an ICS.
• Regular follow-up is crucial to assess asthma control, adherence, and monitor for adverse effects.
• Patients should be advised to contact their healthcare provider if their asthma symptoms worsen or if they need to use their rescue inhaler more frequently.

• Inhaled corticosteroids (e.g., fluticasone, budesonide, mometasone monotherapy)
• Long-acting beta2-agonists (e.g., salmeterol, formoterol monotherapy - generally not recommended for asthma without ICS)
• Leukotriene receptor antagonists (e.g., montelukast)
• Oral corticosteroids (for severe exacerbations)
• 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 your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. 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 name of the medication taken, the amount consumed, and the time it occurred.