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.

Olodaterol may be found in some form under the following brand names:

• Striverdi Respimat

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.

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of olodaterol, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking olodaterol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to olodaterol or to any of its ingredients
• have heart problems
• have kidney problems
• have liver problems
• have diabetes mellitus
• are pregnant or breastfeeding

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

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.

Take olodaterol exactly as prescribed.

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

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of olodaterol at the same time.

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.

If you take too much olodaterol, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store olodaterol at room temperature.

Keep this and all medicines out of the reach of children.

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.