Olodaterol (inhalation)

Olodaterol (inhalation) is used to manage the symptoms of chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema.

Olodaterol may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Using too much of olodaterol can cause life-threatening side effects.

Use olodaterol at the same time each day, even if you feel well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Use only the inhaler device provided with your medicine or you may not get the correct dose. Use the new inhaler each time you get your prescription refilled.

Olodaterol is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Do not change your dose or stop using your medicine without your doctor's advice.

Store at room temperature away from moisture and heat. Do not freeze.

Olodaterol (inhalation) is for people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

Olodaterol (inhalation) is not a rescue medicine. It will not work quickly enough to treat a bronchospasm attack.

Seek medical help if your breathing problems get worse quickly, or if you believe your medications are not working as well.

You should not use olodaterol if you are allergic to it. Olodaterol is only for people with COPD and should not be used to treat asthma.

Tell your doctor if you have ever had:

• heart problems, high blood pressure;
• diabetes;
• a seizure; or
• a thyroid disorder.

Tell your doctor if you are pregnant or breastfeeding.

Olodaterol is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Olodaterol may cause serious side effects. Call your doctor right away if you experience:

• tremors, nervousness, chest pain, fast or pounding heartbeats;
• wheezing, choking, or other breathing problems after using olodaterol;
• worsening breathing problems;
• high blood sugar—signs include increased thirst, increased urination, dry mouth, fruity breath odor; or
• low potassium level—signs include leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or a feeling of being limp.

Common side effects of olodaterol may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• cough, shortness of breath, chest discomfort;
• diarrhea;
• dizziness;
• pain or burning when you urinate;
• back pain, joint pain; or
• rash.

This is not a full list of side effects, and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease:

-5 mcg (2 inhalations) orally once a dayUse: Maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

Use the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not use two doses at the same time.

Do not use the medicine more than once in a 24-hour period.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much olodaterol can be deadly.

Signs of an overdose may include chest pain, fast or uneven heartbeats, feeling anxious, shaking, muscle cramps, feeling dizzy, and fainting.

Keep olodaterol away from your eyes.

Do not use another inhaled bronchodilator that has olodaterol or a similar medicine (like formoterol, arformoterol, indacaterol, salmeterol, or vilanterol).

If you also use a short-acting bronchodilator, do not use it every day while you are using olodaterol. Use the short-acting bronchodilator only for a sudden bronchospasm attack.

Other drugs may affect olodaterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.