Foradil Aerolizer

DRUG DESCRIPTION

FORADIL® AEROLIZER® (formoterol fumarate inhalation powder) consists of a capsule dosage form containing a dry powder formulation of FORADIL (formoterol fumarate) intended for oral inhalation only with the AEROLIZER Inhaler.

Each clear, hard gelatin 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 beta2-adrenergic bronchodilator. 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 inhalation powder) 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 34-188 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...

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).

Formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can...

Read All Potential Precautions of Foradil Aerolizer »


Foradil Aerolizer Consumer (continued)

SIDE EFFECTS: Shakiness (tremor), nausea, headache, dizziness, nervousness, dry mouth, stomach upset, tiredness, trouble sleeping, or hoarseness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips; chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast breathing, muscle weakness/cramping, fast/pounding/irregular heartbeat, increased thirst/urination.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: dizziness, rash, itching/swelling (especially of the face/tongue/throat), trouble breathing.

Rarely, formoterol can cause a worsening of breathing problems (paradoxical bronchospasm) that may be life-threatening. If this occurs, immediately seek medical attention.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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).

Formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using formoterol, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using formoterol safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.


Foradil Aerolizer Patient Information Including Side Effects

Brand Names: Foradil Aerolizer, Perforomist

Generic Name: formoterol (Pronunciation: for MOE ter all)

  • What is formoterol inhalation (Foradil Aerolizer)?
  • What are the possible side effects of formoterol inhalation (Foradil Aerolizer)?
  • What is the most important information I should know about formoterol inhalation (Foradil Aerolizer)?
  • What should I discuss with my healthcare provider before using formoterol inhalation (Foradil Aerolizer)?
  • How should I use formoterol inhalation (Foradil Aerolizer)?
  • What happens if I miss a dose (Foradil Aerolizer)?
  • What happens if I overdose (Foradil Aerolizer)?
  • What should I avoid while using formoterol inhalation (Foradil Aerolizer)?
  • What other drugs will affect formoterol (Foradil Aerolizer)?
  • Where can I get more information?

What is formoterol inhalation (Foradil Aerolizer)?

Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.

Formoterol inhalation is used to prevent bronchospasm in people with reversible obstructive airways disease, including symptoms of night-time asthma. It is also used in people with chronic obstructive pulmonary disease (COPD) such as emphysema and chronic bronchitis.

Formoterol inhalation may also be used for other purposed not listed in this medication guide.

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

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 include:

  • dizziness, anxiety, headache;
  • sleep problems (insomnia);
  • back pain, muscle cramps;
  • sore throat, dry mouth, cough, stuffy nose;
  • skin rash, itching; or
  • changes in your voice.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about formoterol inhalation (Foradil Aerolizer)?

Formoterol capsules are for use only in the Foradil Aerolizer device. Use only one capsule at a time. Do not take the capsules by mouth. Never place a capsule in the mouthpiece of the inhaler.

Do not use formoterol inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, short-acting inhalation medication to treat an asthma attack.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Formoterol inhalation 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. Talk with your doctor about your individual risks and benefits in using formoterol inhalation.

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