Olodaterol inhalation

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Avoid getting this medicine in your eyes.

Do not use a second long-acting inhaled bronchodilator such as arformoterol (Brovana), albuterol (Combivent, DuoNeb), formoterol (Foradil, Perforomist, Symbicort), olodaterol (Striverdi), or salmeterol (Serevent, Advair) unless your doctor has told you to.

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

Call your doctor at once if you have:

• new or worsening COPD symptoms;

• wheezing, choking, or other breathing problems after using this medicine;

• pounding heartbeats or fluttering in your chest;

• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

• low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or

• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats, seizure.

Common side effects may include:

• runny or stuffy nose, sinus pain, sneezing;

• cough, sore throat;

• diarrhea;

• dizziness;

• painful or difficult urination;

• rash; or

• back pain, joint pain.

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.

In the U.S.

• Striverdi Respimat

Available Dosage Forms:

• Spray

Therapeutic Class: Bronchodilator

Pharmacologic Class: Beta-2 Adrenergic Agonist

Nervousness, shaking (tremor), and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: pounding heartbeat, muscle cramps/weakness, increased thirst/urination, joint pain.

Get medical help right away if you have any very serious side effects, including: chest pain, rapid breathing, fast/irregular heartbeat, severe dizziness, fainting.

Rarely, this medication has caused severe (possibly fatal), sudden worsening of breathing problems (paradoxical bronchospasm). If you have trouble breathing or sudden wheezing, use your quick-relief inhaler and get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Applies to olodaterol: inhalation aerosol

General

-The most common adverse effect leading to discontinuation was worsening COPD.
-The most common serious adverse events were COPD exacerbation, pneumonia, and atrial fibrillation.[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, constipation[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia[Ref]

Nervous system

Common (1% to 10%): Dizziness[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, bronchitis, cough, pneumonia[Ref]

Other

Common (1% to 10%): Pyrexia[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash[Ref]

Some side effects of olodaterol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Data not available

Data not available

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at maximum recommended human daily inhalation dose (MRHDID). No clinical data on exposed pregnancies are available. Clinical data on fertility are not available for this drug, and nonclinical studies performed with this drug showed no adverse effect on fertility. This drug and/or its metabolites crossed the placenta in rats. Enlarged or small heart atria or ventricles, eye abnormalities, and split or distorted sternum have been shown in rats at inhalation doses approximately 7,130 times the MRDHID: The inhibitory effect of beta-adrenergic agonists on uterine contraction should be taken into account. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

UK: Use should be avoided. AU, US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C