Perforomist

DRUG DESCRIPTION

PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate.

The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is:

PERFOROMIST® (formoterol fumarate) Structural Formula Illustration

Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2•C4H4O4•2H2O. Formoterol fumarate dihydrate, USP 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.

PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or 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 Perforomist »

What are the precautions when taking formoterol fumarate inhalation solution (Perforomist)?

Before using formoterol, tell your doctor or pharmacist if you are allergic to it; 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: diabetes, heart problems (e.g., irregular heartbeat, angina), high blood pressure, liver problems, overactive thyroid (hyperthyroidism), seizures.

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...

Read All Potential Precautions of Perforomist »


Perforomist Consumer (continued)

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

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: muscle weakness/cramps, increased thirst/urination.

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

Rarely, this medication has caused severe (possibly fatal), sudden worsening of breathing problems (paradoxical bronchospasm). If you have trouble breathing or experience sudden wheezing, use your quick-relief inhaler and seek immediate medical attention.

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: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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 using formoterol, tell your doctor or pharmacist if you are allergic to it; 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: diabetes, heart problems (e.g., irregular heartbeat, angina), high blood pressure, liver problems, overactive thyroid (hyperthyroidism), seizures.

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.

Before having surgery, tell your doctor or dentist that you are using this medication.

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.

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.


Perforomist Patient Information Including Side Effects

Brand Names: Foradil Aerolizer, Perforomist

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

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

What is formoterol inhalation (Perforomist)?

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 (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 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 (Perforomist)?

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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