Formoterol oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

Formoterol oral inhalation comes as a solution (liquid) to inhale by mouth using a nebulizer (machine that turns medication into a mist that can be inhaled). It is usually inhaled twice a day in the morning and the evening about 12 hours after you inhaled your last dose. Inhale formoterol at about the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use formoterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not use formoterol to treat sudden attacks of COPD. Your doctor will prescribe a short-acting beta agonist medication such as albuterol (Accuneb, Proair, Proventil, Ventolin) to use during attacks. If you were using this type of medication on a regular basis before you began treatment with formoterol, your doctor will probably tell you to stop using it regularly, but to continue to use it to treat attacks.

Formoterol inhalation should not be used to treat COPD that is quickly getting worse. Call your doctor or get emergency medical help if your breathing problems worsen, if you have to use your short-acting inhaler to treat attacks of COPD more often, or if your short-acting inhaler does not relieve your symptoms.

Formoterol inhalation may help control your symptoms but will not cure your condition. Do not stop using formoterol without talking to your doctor. If you suddenly stop using formoterol, your symptoms may worsen.

To inhale the solution using a nebulizer, follow these steps:

1. Remove one vial of formoterol inhalation solution from the foil pouch.
2. Look at the liquid in the vial. It should be clear and colorless. Do not use the vial if the liquid is cloudy or discolored.
3. Twist off the top of the vial and squeeze all of the liquid into the nebulizer reservoir. Do not mix other medications with formoterol in the reservoir.
4. Connect the nebulizer reservoir to the mouthpiece or face mask.
5. Connect the nebulizer to the compressor.
6. Place the mouthpiece in your mouth or put on the face mask. Sit in an upright, comfortable position and turn on the compressor.
7. Breathe in calmly, deeply, and evenly for about 9 minutes until mist stops forming in the nebulizer chamber.
8. Dispose of the empty vial and its top safely, so that they are out of the reach of children.

Clean your nebulizer regularly. Follow the manufacturer’s directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your nebulizer.

Do not mix the formoterol solution with other inhalation solutions in your nebulizer.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using formoterol oral inhalation,

• Tell your doctor and pharmacist if you are allergic to formoterol, any other medications, or any of the ingredients in formoterol nebulizer solution. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• Tell your doctor if you use another LABA such as such as arformoterol (Brovana), indacaterol (Arcapta), olodaterol (Striverdi Respimat, in Stiolto Respimat), salmeterol (Serevent, in Advair), or vilanterol (in Anoro Ellipta, Breo Ellipta, Trelegy Ellipta). Your doctor will tell you which medication you should use and which medication you should stop using.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminophylline; amiodarone (Nexterone, Pacerone); antidepressant such as amitriptyline, desipramine (Norpramin), clomipramine (Anafranil), imipramine (Tofranil), nortriptyline, or trimipramine (Surmontil); beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, others), nadolol (Corgard), propranolol (Inderal, Innopran), and sotalol (Betapace, Sorine); clonidine (Catapres); diet pills; disopyramide (Norpace); diuretics (‘water pills’); dofetilide (Tikosyn); epinephrine (Primatene Mist); erythromycin (E.E.S, E-Mycin, Erythrocin); medications for colds such as phenylephrine (Sudafed PE), and pseudophedrine (Sudafed); monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate); moxifloxacin (Avelox); pimozide (Orap); procainamide; quinidine (in Nuedexta);steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); theophylline (Theochron, Theo-24); and thioridazine. Many other medications may also interact with formoterol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have asthma. Your doctor will tell you not to use formoterol inhalation unless you are using it along with an inhaled steroid medication.
• Tell your doctor if you have or have ever had an irregular heartbeat; QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death); high blood pressure; seizures; diabetes; or heart, liver, or thyroid disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using formoterol, call your doctor.
• You should know that formoterol inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, call your doctor right away. Do not use formoterol inhalation again unless your doctor tells you that you should.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Formoterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Nervousness
• Headache
• Uncontrollable shaking of a part of the body
• Dry mouth
• Muscle cramps
• Nausea
• Vomiting
• Diarrhea
• Extreme tiredness
• Dizziness
• Difficulty falling asleep or staying asleep
• Stuffed or runny nose
• Sore throat

Some side effects can be serious. If you experience any of the following symptoms, stop using formoterol inhalation and call your doctor immediately or get emergency medical treatment:

• Swelling of the face, throat, tongue, lips, or eyes
• Difficulty swallowing or breathing
• Hives
• Rash
• Itching
• Fast, pounding, or irregular heartbeat
• Chest pain
• Fainting

Formoterol may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep formoterol vials of nebulizer solution sealed in their foil pouches and away from light and excess heat and until you are ready to use them. Store the nebulizer solution in the refrigerator. You can also store it at room temperature for up to 3 months. Keep this medication out of reach of children.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• Chest pain
• Fainting
• Fast, pounding, or irregular heartbeat
• Nervousness
• Headache
• Uncontrollable shaking of a part of the body
• Seizures
• Muscle cramps
• Dry mouth
• Nausea
• Dizziness
• Excessive tiredness
• Difficulty falling asleep or staying asleep
• Thirst
• Trouble breathing

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using formoterol.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.