Indacaterol (Inhalation route)
- Arcapta Neohaler
Indacaterol maleate is not indicated for the treatment of asthma. Long-acting beta-2-adrenergic agonists (LABAs), such as indacaterol, increase the risk of asthma-related death .
Beta-2 Adrenergic Agonist
Uses of This Medicine:
Indacaterol is used to treat air flow blockage and prevent worsening of 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).
Indacaterol is a long-acting bronchodilator. 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:
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.
Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indacaterol in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Allergy to milk proteins Use with caution. This medicine contains lactose (milk sugar) and milk proteins.
- Asthma Do not use this medicine if you have this condition. Some people with asthma have had more severe asthma attacks when they used this medicine.
- COPD attack, severe 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.
- Diabetes or
- Heart or blood vessel disease or
- Heart rhythm problems (e.g., QT prolongation) or
- Hypertension (high blood pressure) or
- Hyperthyroidism (overactive thyroid) or
- Hypokalemia (low potassium in the blood) or
- Ketoacidosis (high ketones in the blood) or
- Seizures, history of Use with caution. May make these conditions worse.
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 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 this medicine 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 this medicine. 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 this medicine.
- 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 this medicine with any other medicine.
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 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.
- For maintenance treatment of COPD:
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.
Do not use this medicine more than one time every 24 hours.
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.
Precautions While Using This Medicine:
If you will be using this medicine 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.
This medicine 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 this medicine 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.
This medicine 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®).
This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine.
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: 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.
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.
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:
- More common
- Arm, back, or jaw pain
- chest pain or discomfort
- chest tightness or heaviness
- fast or irregular heartbeat
- fever or chills
- shortness of breath
- sore throat
- tightness in the chest
- troubled breathing
- Less common
- 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
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- loss of consciousness
- loss of voice
- rapid weight gain
- runny or stuffy nose
- tingling of the hands or feet
- unexplained weight loss
- unusual tiredness or weakness
- unusual weight gain or loss
- Incidence not known
- Fast, irregular, pounding, or racing heartbeat or pulse
- Less common
- Muscle or bone pain
- muscle spasm
- pain or tenderness around the eyes and cheekbones
- Incidence not known
- Itching skin
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:
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:
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.
Last Updated: 9/15/2016