Brand Names: Dulera
Generic Name: formoterol and mometasone
- What is formoterol and mometasone (Dulera)?
- What are the possible side effects of formoterol and mometasone (Dulera)?
- What is the most important information I should know about formoterol and mometasone (Dulera)?
- What should I discuss with my healthcare provider before using formoterol and mometasone (Dulera)?
- How should I use formoterol and mometasone (Dulera)?
- What happens if I miss a dose (Dulera)?
- What happens if I overdose (Dulera)?
- What should I avoid while using formoterol and mometasone (Dulera)?
- What other drugs will affect formoterol and mometasone (Dulera)?
- Where can I get more information (Dulera)?
What is formoterol and mometasone (Dulera)?
Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.
Mometasone is a steroid. It prevents the release of substances in the body that cause inflammation.
Formoterol and mometasone is a combination medicine used as a maintenance treatment for asthma in adults and children who are at least 12 years old. This medicine is not for use in treating an asthma or bronchospasm attack.
Formoterol when used alone may increase the risk of death in people with asthma. However, this risk is not increased when formoterol and mometasone are used together as a combination product.
Formoterol and mometasone may also be used for purposes not listed in this medication guide.
What are the possible side effects of formoterol and mometasone (Dulera)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- sores or white patches in your mouth or throat;
- wheezing, choking, or other breathing problems after using this medication;
- blurred vision, eye pain, or seeing halos around lights;
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
- chest pain, fast or pounding heartbeats, tremors, restless feeling, seizure;
- low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
- high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;
- signs of infection--fever, chills, body aches, tiredness, nausea, vomiting; or
- worsening asthma symptoms.
Mometasone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about formoterol and mometasone (Dulera)?
Formoterol and mometasone is not a rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.
What should I discuss with my healthcare provider before using formoterol and mometasone (Dulera)?
Mometasone can weaken your immune system. Tell your doctor about any illness or infection you've had within the past several weeks.
Tell your doctor if you have ever had:
- heart disease, high blood pressure;
- liver disease;
- low bone mineral density;
- glaucoma or cataracts;
- a weak immune system;
- a drug allergy;
- pheochromocytoma (tumor of the adrenal gland);
- a thyroid disorder; or
- an aneurysm (a weakened or damaged blood vessel that could tear and cause severe bleeding).
Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you don't get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.
Formoterol and mometasone is not approved for use by anyone younger than 12 years old.
How should I use formoterol and mometasone (Dulera)?
Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.
Formoterol and mometasone is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an asthma attack. Seek medical attention if your fast-acting medicine does not work.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Rinse your mouth with water after each use of your inhaler.
It may take up to 1 week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve. Your doctor may tell you to stop using formoterol and mometasone once your asthma is well controlled.
Asthma is often treated with a combination of drugs. Use all medications as directed. Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your dose or dosing schedule without your doctor's advice. Tell your doctor if any of your medicines seem to stop working.
Store at room temperature away from moisture and high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.
Store the 60-inhalation canister on its side, or with the mouthpiece down.
What happens if I miss a dose (Dulera)?
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.
What happens if I overdose (Dulera)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.
What should I avoid while using formoterol and mometasone (Dulera)?
Do not use a second form of formoterol (Bevespi, Perforomist, Symbicort) or other long-acting inhaled bronchodilator unless your doctor tells you to.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a steroid such as mometasone.
What other drugs will affect formoterol and mometasone (Dulera)?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Tell your doctor about all your other medicines, especially:
This list is not complete. Other drugs may affect formoterol and mometasone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information (Dulera)?
Your pharmacist can provide more information about formoterol and mometasone.
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