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Dulera Inhaler

Generic name: formoterol and mometasone [for-MOE-ter-ol-and-moe-MET-a-sone]
Brand name: Dulera
Drug class: bronchodilator combinations

What is Dulera?

Inhalers containing dulera contain a mixture of formoterol and mometasone. Formoterol is a bronchodilator with a long-acting effect that relaxes the muscles of the airways in order to improve breathing. Mometasone is a corticosteroid. It stops the release of substances that cause inflammation in the body. Dulera helps control and prevent symptoms of asthma among adults and children older than 5 years. Dulera should not be used to treat asthma or bronchospasm attacks.

Warnings

The medicine Dulera will not treat asthma or bronchospasm attacks quickly enough. When used alone, formoterol can increase the risk of death among asthmatics. This risk does not increase when mometasone and formoterol are combined. If your breathing problems worsen quickly or you feel that your asthma medication is not working, seek medical attention.

Before you take this drug

Dulera should not be used if you have an allergy to mometasone or formoterol. Mometasone may weaken your immunity. Inform your doctor of any illnesses or infections you have had in the last few weeks.

Tell your doctor about any of the following to ensure that Dulera will be safe for you:

  • Heart disease High blood pressure

  • A seizure;

  • A weak immune system

  • Liver disease

  • Osteoporosis;

  • Glaucoma or other vision problems

  • Diabetes;

  • Drug allergy

  • Pheochromocytoma

  • A thyroid disorder

  • An aneurysm is a weak or damaged blood vessel that could rupture and cause severe bleeding.

Inform your doctor that you are expecting. Formoterol or mometasone may harm an unborn child. Untreated or uncontrolled pregnancy asthma can cause serious complications, such as premature birth or low birth weight. Treatment for asthma may prove beneficial to both mom and child. Breastfeeding may not be possible while taking this medication. You should consult your doctor if you are concerned about any risks. Dulera should not be used by children under 5 years of age.

Similar/related drugs

Prednisone, Symbicort, Ventolin, Breo Ellipta, Ventolin HFA, Dupixent, and Xopenex

What to take Dulera?

Inhalers Dulera come with instructions on safe and effective usage, as well as directions for priming. Please follow the instructions carefully. Follow the directions on how to use the medicine. Too much medicine can have life-threatening effects. If you have questions, don't hesitate to consult your physician or pharmacist. Do not use Dulera to treat asthma attacks. Only use fast-acting inhalation medicines for an attack. If your breathing problem gets worse or you suspect that your asthma medication is not working, seek medical attention. Always read and follow all instructions provided with your medication, whether they be from a pharmacist or doctor. If any part of it remains unclear to you, don't hesitate to seek clarification from either person. After each use, rinse your mouth with water, but do not swallow.

Never allow children under the age of 12 years old to use this medication without adult supervision. Your symptoms could improve within 1 or 2 weeks when taken as directed; inform your physician if symptoms continue to worsen after that point. Once your asthma has been successfully controlled, your physician may advise discontinuing use of Dulera. Dosage needs may change due to surgery, illness or stressors such as an asthma attack; before making changes on your own without consulting with your healthcare provider first. Notify your doctor immediately if your peak flow meters are not performing as they should be; check both vision and bone mineral density regularly, store away from moisture or high heat and away from moisture inhalers that might burst due to overheating as these could release potentially hazardous gasses that are dangerous for health or could trigger explosions - never burn or puncture an empty inhaler in order to preserve its effectiveness!

Dulera 120-inhalation inhalers do not require a specific orientation for storage. After priming the Dulera 60 inhaler, place the inhaler on its side or with the mouthpiece facing down. Keep the medicine canister out of reach of open flames or high temperatures, like in a hot car. If the canister gets too warm, it may explode. You should not burn or puncture an empty inhaler. Your doctor may ask you to stop taking this medication once your asthma has been controlled. Do not stop taking the medicine until your doctor says so.

Details on dosage

Adult Dosage of Dulera for Asthma: Maintenance:

Orally, inhale two inhalations twice daily, morning and evening.

Each inhalation contains 100 mcg, 200 mcg, or 300 mcg of mometasone and 5 mcg of formoterol.

Maximum Daily Dose: 800 mg of mometasone, 20 mg of formoterol

Comments:

The starting dose is determined by the patient's prior asthma treatment.

Patients who have previously been on medium-dose corticosteroids inhaled should start on 100 mcg/5 mcg.

Patients who have previously been on high-dose inhaled corticosteroids should start on 200 mcg/5 mcg.

Not for the treatment of acute bronchospasm.

Maintenance dose for asthma in children:

Children 12 years of age and older should use this product.

Orally, inhale two inhalations twice daily, morning and evening.

Each inhalation contains 100 mcg, 200 mcg, or 300 mcg of mometasone and 5 mcg of formoterol.

Maximum Daily Dose: 800 mg of mometasone, 20 mg of formoterol

Comments:

The starting dose is determined by the patient's prior asthma treatment.

Patients who have previously been on medium-dose corticosteroids inhaled should start on 100 mcg/5 mcg.

Patients who have previously been on high-dose inhaled corticosteroids should start on 200 mcg/5 mcg.

Not for the treatment of acute bronchospasm.

Use: For patients aged 12 and older with inadequate control of their asthma on long-term medication, or for those whose disease is severe enough to require an inhaled beta2-adrenergic antagonist and corticosteroid.

What happens if I miss the dose?

Do not take the missed dose. Use your next dose as usual.Do not take two doses at the same time.

What happens if I overdose?

Call 1-800-222-1222 immediately if you suspect being poisoned and seek immediate medical advice or call 911 immediately for an ambulance response. The symptoms of an overdose include a rapid heart rate and chest pain.

What should be avoided?

Avoid using a second inhaled medicine that contains formoterol (or a similar medication, such as arformoterol, indacaterol, olodaterol, salmeterol, or vilanterol).Avoid being around people who are ill or infected. If you have been exposed to measles or chickenpox, call your doctor immediately for treatment. If you are taking a medication that contains mometasone, a steroid, these conditions can be fatal or very serious.

Side effects of Dulera

If you experience signs and symptoms indicative of an allergic reaction such as hives, difficulty breathing or swelling to lips, face, tongue or throat - seek emergency medical assistance immediately!

If you experience:

  • Asthma symptoms are getting worse.

  • Tremors, nervousness, chest pain or rapid or rapid-fire heartbeats;

  • Feeling short of breath, fever, chills, and a cough with mucus;

  • If you experience wheezing or other breathing problems, discontinue use of this medication.

  • Blurred vision, redness or pain in the eyes, or seeing halos around lights

  • Signs of Thrush (a Fungal Infection): sores in the mouth or throat or white patches; difficulty swallowing

  • High blood sugar: increased thirst, frequent urination and fruity breath odor;

  • Low sodium level: cramping, constipation, numbness, tingling or fluttering, muscle weakness, or limp feeling.

  • Signs and symptoms of hormonal disorders: fatigue or weakness, feeling weak-headed, nausea. Vomiting.

Mometasone can affect the growth of children. If your child's growth isn't normal while taking this medicine, tell your doctor.

Dulera may cause side effects such as:

  • Runny or stuffy nasal congestion, sinus pain

  • Headache;

  • Cough, sore throat.

There may be other side effects.Call your physician immediately if experiencing side effects; otherwise contact the FDA's 800-FDA-1088 number to report side effects.

Interaction with other drug

Sometimes taking multiple medications at the same time may not be safe; certain medicines could interfere with one another and increase side effects or make them less effective than intended.

Tell your doctor about your other medications, including:

  • Antifungal medicines such as ketoconazole.

  • Medicine to treat HIV.

This list is incomplete. There are other drugs that may interact with mometasone and formoterol, such as prescription and over-the-counter medicines, vitamins, and herbal products. This list does not cover every possible drug interaction.