Olodaterol

Olodaterol is a prescription medication used for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Olodaterol belongs to a group of drugs called long-acting beta2-adrenergic agonists. These work by relaxing the airways.

This medication is available as a spray for inhalation and is taken once daily.

Common side effects of olodaterol include upper respiratory tract infections, inflammation of the nasal passages and throat, bronchitis, urinary tract infections, cough, rash, diarrhea, back pain, and joint pain.

Olodaterol can also cause dizziness. Do not drive or operate heavy machinery until you know how olodaterol affects you.

Olodaterol is a prescription medication used for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is not used to treat asthma or acute exacerbations or deteriorations of COPD.

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

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the condition being treated.

The recommended dose/dose range of olodaterol for the maintenance treatment of airway obstruction in chronic obstructive pulmonary disease is 2 inhalations once daily, at the same time each day. The dose is equivalent to 5 micrograms of olodaterol.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large, placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including olodaterol, the active ingredient in olodaterol. The safety and efficacy of olodaterol in patients with asthma have not been established. Olodaterol is not indicated for the treatment of asthma.

Serious side effects have been reported with olodaterol including the following:

Common side effects of olodaterol include

• upper respiratory tract infections
• inflammation of the nasal passages and throat
• bronchitis
• urinary tract infections
• cough
• rash
• diarrhea
• back pain
• joint pain

Olodaterol can also cause dizziness. Do not drive or operate heavy machinery until you know how olodaterol affects you.

Do not take olodaterol if you:

• are allergic to olodaterol or to any of its ingredients
• have asthma

Serious side effects have been reported with olodaterol. See the “Olodaterol Precautions” section.

Common side effects of olodaterol include

• upper respiratory tract infections
• inflammation of the nasal passages and throat
• bronchitis
• urinary tract infections
• cough
• rash
• diarrhea
• back pain
• joint pain

Olodaterol can also cause dizziness. Do not drive or operate heavy machinery until you know how olodaterol affects you.

This is not a complete list of olodaterol side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other beta2-adrenergic agonists such as formoterol (Foradil, in Symbicort) and salmeterol (Serevent, in Advair)
• diuretics such as hydrochlorothiazide (Microzide), furosemide (Lasix), and torsemide (Demadex)
• steroids such as hydrocortisone (Cortef), prednisone (Prednisone Intensol), prednisolone (Orapred, Prelone), and methylprednisolone (Medrol, Depo-Medrol)
• monoamine oxidase inhibitors such as phenelzine (Nardil, Nardelzine), tranylcypromine (Parnate), and selegiline (Deprenyl, Eldepryl)
• beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), metoprolol (Lopressor), and propranolol (Inderal)

This is not a complete list of olodaterol drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Olodaterol falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if olodaterol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using olodaterol.

This medication should not be used by people with asthma. Asthma-related deaths have been reported with other medications in this class.

This medication is for long-term maintenance treatment of airway obstruction, not acute deteriorations of chronic obstructive pulmonary disease.