Indacaterol inhalation

Indacaterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Indacaterol is used to prevent bronchospasm in people with chronic obstructive pulmonary disease (COPD), including bronchitis or emphysema. Indacaterol will not treat a bronchospasm attack that has already begun.

Indacaterol is not for use in treating asthma.

Indacaterol may also be used for purposes not listed in this medication guide.

Use indacaterol only as directed by your doctor. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. Using the medicine more often may increase the chance of serious unwanted effects.

In order for indacaterol to help prevent COPD attacks, it must be used once a day at the same time each day as ordered by your doctor.

Indacaterol inhalation powder is used with a special inhaler (Neohaler™) and usually comes with a Medication Guide and patient directions. Read the directions carefully before using indacaterol. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor 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.

To use indacaterol inhalation powder with the Neohaler™:

• Dry your hands before handling indacaterol.
• Open a blister card of capsules. Do not remove a capsule until you are ready for a dose.
• Open the base of inhaler firmly and tilt the mouthpiece to open the inhaler.
• Place the capsule only in the capsule-chamber in the base of the inhaler. Do not swallow the capsule and do not place a capsule directly into the mouthpiece.
• Hold the mouthpiece of the inhaler upright and press both buttons at the same time. Press the buttons only once. You should hear a click as the capsule is being pierced.
• Breathe out fully. Do not exhale into the mouthpiece.
• Place the mouthpiece in your mouth then close your lips around the mouthpiece.
• Breathe in quickly and deeply.
• Remove the inhaler from your mouth. Hold your breath as long as you can and then exhale.
• Open the inhaler after using it, and remove and discard the empty capsule. Do not leave the used capsule inside the chamber.
• Close the mouthpiece and then replace the cover.
• Do not wash the inhaler. Keep it dry.
• You may reuse your inhaler. But use a new inhaler with each refill of your medicine.
• Do not use the inhaler for indacaterol with any other medicine.

Dosing

The dose of indacaterol 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 indacaterol. 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 powder dosage form (used with Neohaler™):
  • For maintenance treatment of COPD:
    • Adults—75 micrograms (mcg) (1 capsule) by oral inhalation once a day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of indacaterol, 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.

Do not use indacaterol more than one time every 24 hours.

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.

If you will be using indacaterol for a long time, it is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

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

indacaterol should not be used if you are having a severe COPD attack, or if symptoms of 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 to your doctor or get medical care right away:

• Your symptoms do not improve after using indacaterol within a few days or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.

indacaterol should not be used together with similar inhaled medicines such as arformoterol (Brovana™), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist™), salmeterol (Serevent®), or salmeterol/fluticasone (Advair®).

indacaterol may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using indacaterol and check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing after using indacaterol.

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

indacaterol 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.

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.

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:

• Arm, back, or jaw pain
• chest pain or discomfort
• chest tightness or heaviness
• cough
• dizziness
• fainting
• fast or irregular heartbeat
• fever or chills
• nausea
• shortness of breath
• sneezing
• sore throat
• sweating
• tightness in the chest
• troubled breathing
• wheezing

• Abdominal or stomach pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• body aches or pain
• dry mouth
• ear congestion
• fainting
• flushed, dry skin
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased urination
• loss of consciousness
• loss of voice
• rapid weight gain
• runny or stuffy nose
• stomachache
• sweating
• tingling of the hands or feet
• unexplained weight loss
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

• Fast, irregular, pounding, or racing heartbeat or pulse

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:

• Muscle or bone pain
• muscle spasm
• pain or tenderness around the eyes and cheekbones

• Itching skin
• rash

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.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Mild to moderate liver dysfunction: No adjustment recommended

Severe liver dysfunction: No data available

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Data not available