Pronunciation:

oh-loe-DA-ter-ol

Brand Names:

• Striverdi Respimat

Dosage Forms:

• Spray

Classifications:

Therapeutic—

Bronchodilator

Pharmacologic—

Beta-2 Adrenergic Agonist

Uses of This Medicine:

Olodaterol is used for the long-term maintenance treatment of air flow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing).

Olodaterol belongs to the family of medicines known as adrenergic bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Olodaterol is not for use in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olodaterol in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Arotinolol
• Atenolol
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Bupranolol
• Carteolol
• Carvedilol
• Celiprolol
• Dilevalol
• Esmolol
• Labetalol
• Landiolol
• Levobunolol
• Mepindolol
• Methacholine
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Sotalol
• Talinolol
• Tertatolol
• Timolol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma—Use is not recommended in patients with this condition without an inhaled steroid medicine.

• COPD attack, severe—Should not be used if you are having a severe COPD attack or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack.

• Diabetes or
• Heart or blood vessel disease (eg, coronary insufficiency, obstructive cardiomyopathy) or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hypokalemia (low potassium levels in the blood) or
• Seizures or
• Thyroid problems (eg, thyrotoxicosis)—Use with caution. May make these conditions worse.

• Liver disease, severe—Use has not been studied in patients with this condition.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance of breathing problems.

This medicine is used with a special inhaler and usually comes with a patient information leaflet or patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

Use this medicine at the same time each day to prevent COPD attacks.

Do not stop using this medicine or other breathing medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by pressing the dose-release button until you see a mist, then press the button 3 more times. If you have not used the inhaler for more than 3 days, prime it once before use. If you have not used it for more than 21 days, press the dose-release button until you see a mist, then press it 3 more times.

To use the inhaler:

• Take the inhaler and cartridge out of the carton before you use it for the first time.
• Do not use the inhaler for this medicine with any other medicine.
• Push the narrow end of the cartridge into the inhaler. About 1/8 of an inch will remain visible when the cartridge is correctly inserted.
• Do not turn the clear base before inserting the cartridge.
• Do not remove the cartridge once it has been inserted in the inhaler.
• Flip the yellow cap until it snaps fully open. Turn the clear base in the direction of the black arrows on the label until it clicks (half a turn).
• Prime the inhaler before use by releasing 4 test sprays.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it without closing the air vents. Do not block the mouthpiece with your teeth or tongue. Point the inhaler to the back of your throat.
• While pressing down firmly and fully on the dose release button of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Hold your breath for about 10 seconds or for as long as you can, then breathe out. Repeat these steps for the next puff.
• Close the yellow cap after taking your medicine.
• Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least once a week.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (spray):
  • For maintenance treatment of COPD:
    • Adults—Two puffs once a day. Do not use more than 2 puffs every 24 hours.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away the inhaler 3 months after its first use, or when the inhaler is locked, or when it expires.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

This medicine should not be used together with similar inhaled medicines, such as albuterol (Proventil®, Ventolin®), isoproterenol (Isuprel®), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Bricanyl®).

Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

This medicine should not be used if you are having a severe asthma or COPD attack, or if symptoms of an asthma or COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

Talk with your doctor or get medical care right away if:

• Your symptoms do not improve after using this medicine or if they become worse.
• Your short-acting inhaler does not seem to work as well as it used to and you need it more often than normal.
• You have a big decrease in your peak flow when measured as directed by your doctor.

This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Olodaterol may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: convulsions (seizures), decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, shortness of breath, or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing, or chest tightness while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chills

cough

difficulty in breathing

ear congestion

fever

headache

loss of voice

runny or stuffy nose

sneezing

sore throat

unusual tiredness or weakness

Less common

Bladder pain

bloody or cloudy urine

chest pain

cough producing mucus

difficult, burning, or painful urination

frequent urge to urinate

lower back or side pain

skin rash

tightness in the chest

Rare

Cough that does not go away or gets worse

coughing up blood

hoarseness

loss of appetite

weight loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

chest pain or discomfort

confusion

decreased urine

dizziness

drowsiness

dry mouth

fast, pounding, or irregular heartbeat or pulse

flushed, dry skin

fruit-like breath odor

general feeling of discomfort or illness

headache

increased hunger

increased thirst

increased urination

irregular heartbeat

mood changes

muscle spasm or tremors

nausea

nervousness

numbness or tingling in the hands, feet, or lips

pain or discomfort in the arms, jaw, back, or neck

pounding in the ears

rapid, deep breathing

restlessness

seizures

slow heartbeat

stomach cramps

troubled breathing

unexplained weight loss

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Muscle aches

Less common

Back or joint pain

constipation

diarrhea

difficulty in moving

dizziness

joint pain

muscle stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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