Indacaterol Inhalation Powder

ARCAPTA NEOHALER consists of a dry powder formulation of indacaterol maleate for oral inhalation only with the NEOHALER inhaler. The inhalation powder is packaged in clear gelatin capsules.

Each clear, hard gelatin capsule contains a dry powder blend of 75 mcg of indacaterol (equivalent to 97 mcg of indacaterol maleate) with approximately 25 mg of lactose monohydrate (which contains trace levels of milk protein) as the carrier.

The active component of ARCAPTA NEOHALER is indacaterol maleate, a (R) enantiomer. Indacaterol maleate is a selective beta2-adrenergic agonist. Its chemical name is (R)-5-[2-(5,6-Diethylindan-2-ylamino)-1-hydroxyethyl]-8hydroxy-1H-quinolin-2-one maleate; its structural formula is

Indacaterol maleate has a molecular weight of 508.56, and its empirical formula is C24H28N2O3 • C4H4O4. Indacaterol maleate is a white to very slightly grayish or very slightly yellowish powder. Indacaterol maleate is freely soluble in Nmethylpyrrolidone and dimethylformamide, slightly soluble in methanol, ethanol, propylene glycol and polyethylene glycol 400, very slightly soluble in water, isopropyl alcohol and practically insoluble in 0.9% sodium chloride in water, ethyl acetate and n-octanol.

The NEOHALER inhaler is a plastic device used for inhaling ARCAPTA. The amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow rate and inspiratory time. Under standardized in vitro testing at a fixed flow rate of 60 L/min for 2 seconds, the NEOHALER inhaler delivered 57 mcg for the 75 mcg dose strength (equivalent to 73.9 mcg of indacaterol maleate) from the mouthpiece. Peak inspiratory flow rates (PIFR) achievable through the NEOHALER inhaler were evaluated in 26 adult patients with COPD of varying severity. Mean PIFR was 95 L/min (range 52-133 L/min) for adult patients. Approximately ninety-five percent of the population studied generated a PIFR through the device exceeding 60 L/min.

No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.

Your pharmacist can provide more information about indacaterol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Indacaterol is a long-acting bronchodilator that opens up the airways in your lungs. It’s used to treat chronic obstructive pulmonary disease (COPD). This condition causes symptoms such as wheezing, cough, chest tightness, and shortness of breath.

This drug is available as an inhalation powder in capsules you take by mouth.

Indacaterol isn’t available as a generic drug. It’s only available as brand-named drug Arcapta Neohaler.

More common side effects of taking this drug include runny nose, cough, sore throat, headache, and nausea.

This drug shouldn’t be used to treat sudden symptoms of COPD. Always have your rescue inhaler, such as albuterol, with you to treat sudden symptoms. If you don’t have a rescue inhaler, ask your doctor to prescribe one to you.

IMPORTANT INFORMATION

• FDA warning See Details

• For inhalation only See Details

• Milk allergy See Details

• When to seek emergency help See Details

What is indacaterol?

This drug is a prescription drug. It’s available as inhalation powder in capsules. The capsules should only be used with the Neohaler inhaler that comes with the drug.

Arcapta is a brand-name drug. It isn’t available as a generic drug.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

This drug is used to treat chronic obstructive pulmonary disease (COPD). This causes symptoms such as wheezing, cough, chest tightness, and shortness of breath.

How it works

This drug belongs to a class of drugs called long acting beta2-adrenergic agonists (LABA). A class of drugs is a group of medications that work in a similar way.

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More Common Side Effects

Some of the more common side effects of indacaterol include:

• runny nose

• cough

• sore throat

• headache

• nausea

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious Side Effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• worsening symptoms of chronic obstructive pulmonary disease (COPD). Symptoms include:

  • wheezing
  • cough
  • chest tightness
  • shortness of breath

• serious allergic reactions. Symptoms include:

  • skin rash
  • hives
  • swelling of your tongue, lips, and face
  • trouble breathing or swallowing 

• sudden shortness of breath

• fast or irregular heartbeat (palpitations)

• increased blood pressure

• heart problems. Symptoms include:

  • chest pain
  • muscle spasms
  • muscle weakness
  • abnormal heart rhythm

• high blood sugar. Symptoms include:

  • frequent urination
  • intense thirst
  • blurred vision
  • headache

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

All possible dosages and forms may not be included here. Your doctor will tell you what dosage is right for you. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

What are you taking this medication for?

Chronic obstructive pulmonary disease (COPD)

Brand: Arcapta Neohaler

Form: Inhalation powder in capsules Strengths: 75 mcg Adult dosage (ages 18 years and older)

Inhale the contents of one 75 mcg indacaterol capsule using the Neohaler inhaler. Take this drug at the same time each day. Don’t swallow the capsules. If you swallow them, this drug won’t work the way it’s supposed to in your lungs.

Child dosage (ages 0–17 years)

This medication hasn’t been studied in children. It shouldn’t be used in people younger than 18 years. This disease doesn’t normally occur in children.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you. Important considerations for taking this drug

You can take this drug with or without food

Take this drug at the same time each day

Don’t cut, crush, or puncture the capsule

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Store this drug at room temperature

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A prescription for this medication is refillable

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Travel

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Self-management

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Clinical monitoring

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Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead

Insurance

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Are there any alternatives?