Arcapta Neohaler

Name: Arcapta Neohaler

What Is Indacaterol?

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

Indacaterol is used as an inhaled medication to prevent bronchospasm in people with chronic obstructive pulmonary disease (COPD), including bronchitis or emphysema. Indacaterol is not for use in treating asthma.

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

This medication may increase the risk of asthma-related death. It is critical that you use only the prescribed dose of this medicine and follow all patient instructions for safe use of the medication.

Before you use this medicine, tell your doctor if you have heart disease, high blood pressure, coronary artery disease, a heart rhythm disorder, seizures, diabetes, a thyroid disorder, or lactose intolerance.

Do not take an indacaterol capsule by mouth. It is for use only in the Neohaler device.

Call your doctor right away if your symptoms do not improve, or if they get worse while using indacaterol. Tell your doctor if any of your medications do not seem to work as well in preventing attacks.

Do not stop using indacaterol without your doctor's advice. Your asthma symptoms may get worse after you stop using the medication.

You should not use this medication if you are allergic to indacaterol or any food products, or if you have asthma.

Indacaterol may contain lactose. Before taking this medication, tell your doctor if you have a hereditary form of galactose intolerance, severe lactase deficiency, or glucose galactose malabsorption.

To make sure you can safely use indacaterol, tell your doctor if you have any of these other conditions:

  • heart disease, high blood pressure, coronary artery disease;
  • a heart rhythm disorder;
  • a seizure disorder such as epilepsy;
  • diabetes; or
  • a thyroid disorder.

FDA pregnancy category C. It is not known whether indacaterol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether indacaterol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without medical advice.

Introduction

Bronchodilator; a relatively selective, long-acting β2-agonist.1 14 15 16 17

Stability

Storage

Oral Inhalation

Powder

25°C (may be exposed to 15–30°C) in a dry place; protect from light and moisture.1

Store dry-powder capsules in foil-sealed blisters until immediately before use.1 2 Do not store used or unused capsules in inhaler device.2 Remove only one capsule immediately before use or effectiveness of drug may be reduced.1 2 Discard additional capsules if opened and exposed to air (i.e., not intended for immediate use).1

Before Using Arcapta Neohaler

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.

Pediatric

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

Geriatric

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

Pregnancy

Pregnancy Category Explanation
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.

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.

Interactions with 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.

  • Carteolol
  • Carvedilol
  • Labetalol
  • Levobunolol
  • Metipranolol
  • Nadolol
  • Oxprenolol
  • Penbutolol
  • Pindolol
  • Practolol
  • Propranolol
  • Sotalol
  • Timolol

Interactions with Food/Tobacco/Alcohol

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.

What are some other side effects of Arcapta Neohaler?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Runny nose.
  • Cough.
  • Sore throat.
  • Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Arcapta Neohaler Description

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]-8-hydroxy-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 N-methylpyrrolidone 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.

How Supplied/Storage and Handling

How Supplied

75 mcg Arcapta Neohaler contains ARCAPTA (indacaterol inhalation powder) capsules packaged in aluminum blister cards, one NEOHALER inhaler, and an FDA approved Medication Guide.

Unit Dose (blister pack), Box of 30 (5 blister cards with 6 capsules each) NDC 63402-675-30.

The NEOHALER inhaler consists of a white protective cap and a base with mouthpiece, capsule chamber and two translucent red push buttons.

Storage and Handling

Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature].

75 mcg: Protect capsule from light and moisture.

  • ARCAPTA capsules should be used with the NEOHALER inhaler only. The NEOHALER inhaler should not be used with any other capsules.
  • Capsules should always be stored in the blister and only removed from the blister immediately before use.
  • Always use the new NEOHALER inhaler provided with each new prescription.

Keep out of the reach of children.

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