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Foradil

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Foradil Aerolizer

FORADIL AEROLIZER
(formoterol fumarate) Inhalation Powder

WARNING

ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as formoterol the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death. Data from a large placebo controlled US study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol [see WARNINGS AND PRECAUTIONS].

Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.

Because of this risk, use of FORADIL AEROLIZER for the treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use FORADIL AEROLIZER only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue FORADIL AEROLIZER) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use FORADIL AEROLIZER for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Pediatric and Adolescent Patients

Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be considered to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g. inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.

DRUG DESCRIPTION

FORADIL AEROLIZER consists of a dry powder formulation of formoterol fumarate intended for oral inhalation only with the AEROLIZER Inhaler. The inhalation powder is packaged in clear hard gelatin capsules.

Each capsule contains a dry powder blend of 12 mcg of formoterol fumarate and 25 mg of lactose (which contains trace levels of milk proteins) as a carrier.

The active component of FORADIL is formoterol fumarate, a racemate. Formoterol fumarate is a selective beta2adrenergic agonist. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is

FORADIL AEROLIZER (formoterol fumarate) Structural Formula Illustration

Formoterol fumarate has a molecular weight of 840.9, and its empirical formula is (C19H24N2O4)2•C4H4O4•2H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether.

The AEROLIZER Inhaler is a plastic device used for inhaling FORADIL. 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 AEROLIZER Inhaler delivered 10 mcg of formoterol fumarate from the mouthpiece. Peak inspiratory flow rates (PIFR) achievable through the AEROLIZER Inhaler were evaluated in 33 adult and adolescent patients and 32 pediatric patients with mild-to-moderate asthma. Mean PIFR was 117.82 L/min (range 34188 L/min) for adult and adolescent patients, and 99.66 L/min (range 43-187 L/min) for pediatric patients. Approximately ninety percent of each population studied generated a PIFR through the device exceeding 60 L/min.

To use the delivery system, a FORADIL capsule is placed in the well of the AEROLIZER Inhaler, and the capsule is pierced by pressing and releasing the buttons on the side of the device. The formoterol fumarate formulation is dispersed into the air stream when the patient inhales rapidly and deeply through the mouthpiece.

What are the possible side effects of formoterol inhalation (Foradil Aerolizer, Perforomist)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain, fast or pounding heartbeats, tremors, shaking, or restless feeling;
  • wheezing, choking, or other breathing problems after using this medication;
  • increased thirst or hunger, urinating more than usual; or
  • worsening asthma symptoms.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Foradil Aerolizer »

What are the precautions when taking formoterol fumarate inhalation powder (Foradil Aerolizer)?

Before taking formoterol, tell your doctor or pharmacist if you are allergic to it; or to similar bronchodilators (e.g., albuterol, metaproterenol, salmeterol); or to sympathomimetic drugs (e.g., epinephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., irregular heartbeat, angina), high blood pressure, overactive thyroid (hyperthyroidism), seizures, diabetes, metabolism problems (e.g., ketoacidosis), swelling of an artery (aneurysm), a certain tumor of the adrenal gland (pheochromocytoma).

Formoterol may...

Read All Potential Precautions of Foradil Aerolizer »

Last reviewed on RxList: 4/2/2012
This monograph has been modified to include the generic and brand name in many instances.

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