Dulera 100-5mcg Oral Inhaler 120inh

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 intracellular adenyl cyclase, an enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels cause relaxation of bronchial smooth muscle and inhibition of mediator release from mast cells in the airway.

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, difficulty 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.
Difficulty sleeping.
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

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, 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, 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 similar to this one. If you are unsure, consult your doctor or pharmacist to determine if there are any potential interactions.

This list is not exhaustive, and it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure that it is safe for you to take this medication in conjunction with your other medications and health conditions.

To avoid any potential interactions or complications, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all of your other medications and health problems.

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 becomes 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 such situations.

Long-term use of this medication may increase your risk of developing cataracts or glaucoma. Consult with your doctor and schedule 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 immediately.

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.

• Other long-acting beta2-adrenergic agonists (LABAs) (e.g., salmeterol, arformoterol, indacaterol, olodaterol)
• Non-selective beta-blockers (e.g., propranolol, carvedilol) in patients with asthma

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole, cobicistat-containing products) - may increase systemic exposure to mometasone
• QT-prolonging drugs (e.g., quinidine, disopyramide, sotalol, phenothiazines, tricyclic antidepressants, macrolide antibiotics) - may potentiate formoterol's effect on the cardiovascular system
• Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs) - within 2 weeks of use, may potentiate formoterol's effect on the cardiovascular system

• Diuretics (e.g., loop or thiazide diuretics) - may potentiate hypokalemia and/or ECG changes associated with beta-agonists
• Other sympathomimetic agents - may potentiate adverse cardiovascular effects
• Xanthine derivatives (e.g., theophylline) - may potentiate hypokalemia

• Not specifically identified for minor interactions with Dulera

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
• Increased need for rescue inhaler (e.g., albuterol)
• Decreased peak expiratory flow (PEF) readings
• Signs of oral candidiasis (white patches in mouth or throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, vision changes)
• Palpitations, tremor, chest pain (potential beta-agonist effects)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies of Dulera in pregnant women. Animal studies have shown teratogenic effects with mometasone and formoterol.

Caution should be exercised when Dulera is administered to a nursing woman. It is not known whether mometasone furoate or formoterol fumarate are 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.

Safety and effectiveness have not been established in children younger than 12 years of age. Monitor growth velocity 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, but greater sensitivity of some older individuals cannot be ruled out. Monitor for cardiovascular effects due to formoterol and potential for increased susceptibility to systemic corticosteroid effects.

• Dulera is a maintenance medication and should not be used for acute asthma attacks or sudden shortness of breath. Patients should always have a rescue inhaler available.
• Proper inhaler technique is crucial for effective drug delivery. Educate patients on how to use the inhaler correctly and to rinse their mouth after each use to prevent oral candidiasis.
• Due to the LABA component, Dulera should only be used in asthma patients who are not adequately controlled on an inhaled corticosteroid alone or whose disease severity clearly warrants initiation of treatment with both an ICS and a LABA.
• Monitor patients for signs of systemic corticosteroid effects, especially with prolonged use or higher doses, including adrenal suppression, bone mineral density changes, and ocular effects (glaucoma, cataracts).
• Patients should be advised to report any worsening of asthma symptoms, increased rescue inhaler use, or signs of infection immediately to their healthcare provider.

• Inhaled Corticosteroid (ICS) monotherapy (e.g., mometasone, fluticasone, budesonide)
• Long-Acting Muscarinic Antagonists (LAMAs) (e.g., tiotropium, umeclidinium)
• Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
• Oral corticosteroids (for severe exacerbations)
• Biologic therapies (e.g., omalizumab, mepolizumab, benralizumab, dupilumab) for severe asthma

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 details about the medication taken, the amount, and the time it happened.