Formoterol Fumarate Inhalation Solution (Perforomist)
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Formoterol Fumarate Inhalation Solution (Perforomist)

PERFOROMIST®
(formoterol fumarate)

WARNING

ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (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, the active ingredient in PERFOROMIST Inhalation Solution. The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication [see CONTRAINDICATION, WARNINGS AND PRECAUTIONS].

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 symptoms.

Less serious side effects may...

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 »

Last reviewed on RxList: 6/20/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Maintenance Treatment of COPD

PERFOROMIST (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Important Limitations of Use

PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS].

PERFOROMIST Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma have not been established.

DOSAGE AND ADMINISTRATION

The recommended dose of PERFOROMIST (formoterol fumarate) Inhalation Solution is one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg is not recommended.

PERFOROMIST Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. The safety and efficacy of PERFOROMIST Inhalation Solution have been established in clinical trials when administered using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) and the PRONEB® Ultra compressor. The safety and efficacy of PERFOROMIST Inhalation Solution delivered from non-compressor based nebulizer systems have not been established.

PERFOROMIST Inhalation Solution should always be stored in the foil pouch, and only removed IMMEDIATELY BEFORE USE. Contents of any partially used container should be discarded.

If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered.

The drug compatibility (physical and chemical), efficacy, and safety of PERFOROMIST Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

HOW SUPPLIED

Dosage Forms And Strengths

PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each vial contains formoterol fumarate dihydrate, USP equivalent to 20 mcg/2 mL of formoterol fumarate.

PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as a 2 mL sterile solution for nebulization in 2.5 mL low-density polyethylene unit dose vials. Each vial is overwrapped in a foil pouch and supplied in cartons as listed below. Carton of 60 individually wrapped unit dose vials, NDC 49502-605-61

Storage and Handling

Prior to dispensing to the patient: Store in a refrigerator, 2°C to 8°C (36°F to 46°F)

After dispensing to the patient: Store at 2°C to 25°C (36°F to 77°F) for up to 3 months. Protect pouch from heat.

  • PERFOROMIST Inhalation Solution should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow and equipped with a facemask or mouthpiece.
  • Vial should always be stored in the foil pouch, and only removed IMMEDIATELY before use.
  • Do not take by mouth.
  • Contents of any partially used container should be discarded.
  • Discard the container and top after use.
  • Keep out of the reach of children

Dey Pharma, L.P. Napa, CA 94558

Last reviewed on RxList: 6/20/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Long acting beta2-adrenergic agonists such as formoterol increase the risk of asthma-related death [See BOXED WARNING and WARNINGS AND PRECAUTIONS].

Beta2-Agonist Adverse Reaction Profile

Adverse reactions to PERFOROMIST Inhalation Solution are expected to be similar in nature to other beta2-adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, muscle cramps, palpitations, nausea, dizziness, fatigue, malaise, insomnia, hypokalemia, hyperglycemia, and metabolic acidosis.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults with COPD

The data described below reflect exposure to PERFOROMIST Inhalation Solution 20 mcg twice daily by oral inhalation in 586 patients, including 232 exposed for 6 months and 155 exposed for at least 1 year. PERFOROMIST Inhalation Solution was studied in a 12-week, placebo-and active-controlled trial (123 subjects treated with PERFOROMIST Inhalation Solution) and a 52-week, active-controlled trial (463 subjects treated with PERFOROMIST Inhalation Solution). Patients were mostly Caucasians (88%) between 40-90 years old (mean, 64 years old) and had COPD, with a mean FEV1 of 1.33 L. Patients with significant concurrent cardiac and other medical diseases were excluded from the trials.

Table 1 shows adverse reactions from the 12-week, double-blind, placebo-controlled trial where the frequency was greater than or equal to 2% in the PERFOROMIST Inhalation Solution group and where the rate in the PERFOROMIST Inhalation Solution group exceeded the rate in the placebo group. In this trial, the frequency of patients experiencing cardiovascular adverse events was 4.1% for PERFOROMIST Inhalation Solution and 4.4% for placebo. There were no frequently occurring specific cardiovascular adverse events for PERFOROMIST Inhalation Solution (frequency greater than or equal to 1% and greater than placebo). The rate of COPD exacerbations was 4.1% for PERFOROMIST Inhalation Solution and 7.9% for placebo.

TABLE 1 : Number of patients with adverse reactions in the 12-week multiple-dose controlled clinical trial

Adverse Reaction PERFOROMIST Placebo
Inhalation Solution 20 mcg
n (%) N (%)
Total Patients 123 (100) 114 (100)
Diarrhea 6 (4.9) 4 (3.5)
Nausea 6 (4.9) 3 (2.6)
Nasopharyngitis 4 (3.3) 2 (1.8)
Dry Mouth 4 (3.3) 2 (1.8)
Vomiting 3 (2.4) 2 (1.8)
Dizziness 3 (2.4) 1 (0.9)
Insomnia 3 (2.4) 0 0

Patients treated with PERFOROMIST Inhalation Solution 20 mcg twice daily in the 52-week open-label trial did not experience an increase in specific clinically significant adverse events above the number expected based on the medical condition and age of the patients.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of PERFOROMIST. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylactic reactions, urticaria, angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema), rash, and bronchospasm.

Read the Perforomist (formoterol fumarate inhalation solution) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Adrenergic Drugs

If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of formoterol may be potentiated [see WARNINGS AND PRECAUTIONS].

Xanthine Derivatives, Steroids, or Diuretics

Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists [see WARNINGS AND PRECAUTIONS].

Non-potassium Sparing Diuretics

The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics.

MAO Inhibitors, Tricyclic Antidepressants, QTc Prolonging Drugs

Formoterol, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.

Beta-blockers

Beta-adrenergic receptor antagonists (beta-blockers) and formoterol may inhibit the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

Last reviewed on RxList: 6/20/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Asthma-Related Deaths

[See BOXED WARNING]

Data from a large placebo-controlled study in asthma patients showed that long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Data are not available to determine whether the rate of death in patients with COPD is increased by long-acting beta2-adrenergic agonists.

A 28-week, placebo-controlled US study comparing the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. 3/13,179 in patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34). The increased risk of asthma-related death is considered a class effect of the long-acting beta2-adrenergic agonists, including PERFOROMIST Inhalation Solution. No study adequate to determine whether the rate of asthma related death is increased in patients treated with PERFOROMIST Inhalation Solution has been conducted. The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication. [see CONTRAINDICATIONS].

Clinical studies with formoterol fumarate administered as a dry powder inhaler suggested a higher incidence of serious asthma exacerbations in patients who received formoterol than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups.

Deterioration of Disease and Acute Episodes

PERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. PERFOROMIST Inhalation Solution has not been studied in patients with acutely deteriorating COPD. The use of PERFOROMIST Inhalation Solution in this setting is inappropriate.

PERFOROMIST Inhalation Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. PERFOROMIST Inhalation Solution has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

When beginning PERFOROMIST Inhalation Solution, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. When prescribing PERFOROMIST Inhalation Solution, the healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct the patient how it should be used. Increasing inhaled beta2-agonist use is a signal of deteriorating disease for which prompt medical attention is indicated. COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If PERFOROMIST Inhalation Solution no longer controls the symptoms of bronchoconstriction, or the patient's inhaled, short-acting beta2-agonist becomes less effective or the patient needs more inhalation of short-acting beta2-agonist than usual, these may be markers of deterioration of disease. In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dosage of PERFOROMIST Inhalation Solution beyond the recommended 20 mcg twice daily dose is not appropriate in this situation.

Excessive Use and Use with Other Long-Acting Beta2-Agonists

As with other inhaled beta2-adrenergic drugs, PERFOROMIST Inhalation Solution should not be used more often, at higher doses than recommended, or in conjunction with other medications containing long-acting beta2-agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

Paradoxical Bronchospasm

As with other inhaled beta2-agonists, PERFOROMIST Inhalation Solution can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, PERFOROMIST Inhalation Solution should be discontinued immediately and alternative therapy instituted.

Cardiovascular Effects

PERFOROMIST Inhalation Solution, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms. If such effects occur, PERFOROMIST Inhalation Solution may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, PERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Coexisting Conditions

PERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines. Doses of the related beta2- agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Hypokalemia and Hyperglycemia

Beta-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see CLINICAL PHARMACOLOGY]. The decrease in serum potassium is usually transient, not requiring supplementation. Beta-agonist medications may produce transient hyperglycemia in some patients. Clinically significant changes in serum potassium and blood glucose were infrequent during clinical studies with long-term administration of PERFOROMIST Inhalation Solution at the recommended dose.

Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of PERFOROMIST Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria, angiodema, rash, and bronchospasm.

Patient Counseling Information

Asthma-Related Death

Patients should be informed that long acting beta agonist, such as PERFOROMIST, increase the risk of asthma-related death. All LABA, including PERFOROMIST, should not be used in patients with asthma without use of a long-term asthma control medication.

Acute Exacerbations or Deteriorations

PERFOROMIST Inhalation Solution is not indicated for relief of acute symptoms, and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist (the healthcare provider should provide the patient with such medication and instruct the patient in how it should be used). Patients should be instructed to seek medical attention if their symptoms worsen despite recommended doses of PERFOROMIST Inhalation Solution, if PERFOROMIST Inhalation Solution treatment becomes less effective, or if they need more inhalations of a short-acting beta2-agonist than usual.

Appropriate Dosing

Patients should not stop using PERFOROMIST Inhalation Solution unless told to do so by a healthcare provider because symptoms may get worse. Patients should not inhale more than the prescribed number of vials at any one time. The daily dosage of PERFOROMIST Inhalation Solution should not exceed one vial twice daily (40 mcg total daily dose). Excessive use of sympathomimetics may cause significant cardiovascular effects, and may be fatal.

Concomitant Therapy

Patients who have been taking inhaled, short-acting beta2-agonists (e.g., albuterol) on a regular basis should be instructed to discontinue the regular use of these products and use them only for symptomatic relief of acute symptoms. PERFOROMIST Inhalation Solution should not be used in conjunction with other inhaled medications containing long-acting beta2-agonists. Patients should be warned not to stop or change the dose of other concomitant COPD therapy without medical advice, even if symptoms improve after initiating treatment with PERFOROMIST Inhalation Solution.

Common Adverse Reactions with Beta2-agonists

Patients should be informed that treatment with beta2-agonists may lead to adverse reactions that include palpitations, chest pain, rapid heart rate, increased or decreased blood pressure, headache, tremor, nervousness, dry mouth, muscle cramps, nausea, dizziness, fatigue, malaise, low blood potassium, high blood sugar, high blood acid, or trouble sleeping [see ADVERSE REACTIONS].

Instructions for Administration

It is important that patients understand how to use PERFOROMIST Inhalation Solution with a nebulizer appropriately [see the accompanying Medication Guide]. Patients should be instructed not to mix other medications with PERFOROMIST Inhalation Solution or ingest PERFOROMIST Inhalation Solution. Patients should throw the plastic dispensing container away immediately after use. Due to their small size, the container and top pose a danger of choking to young children.

FDA-Approved Medication Guide

See the accompanying Medication Guide.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of formoterol fumarate has been evaluated in 2-year drinking water and dietary studies in both rats and mice. In rats, the incidence of ovarian leiomyomas was increased at doses of 15 mg/kg and above in the drinking water study and at 20 mg/kg in the dietary study (AUC exposure approximately 2300 times human exposure at the maximum recommended daily inhalation dose), but not at dietary doses up to 5 mg/kg (AUC exposure approximately 570 times human exposure at the maximum recommended daily inhalation dose). In the dietary study, the incidence of benign ovarian theca-cell tumors was increased at doses of 0.5 mg/kg (AUC exposure was approximately 57 times human exposure at the maximum recommended daily inhalation dose) and above. This finding was not observed in the drinking water study, nor was it seen in mice (see below). In mice, the incidence of adrenal subcapsular adenomas and carcinomas was increased in males at doses of 69 mg/kg (AUC exposure approximately 1000 times human exposure at the maximum recommended daily inhalation dose) and above in the drinking water study, but not at doses up to 50 mg/kg (AUC exposure approximately 750 times human exposure at the maximum recommended daily inhalation dose) in the dietary study. The incidence of hepatocarcinomas was increased in the dietary study at doses of 20 and 50 mg/kg in females (AUC exposures approximately 300 and 750 times human exposure at the maximum recommended daily inhalation dose, respectively) and 50 mg/kg in males, but not at doses up to 5 mg/kg (AUC exposure approximately 75 times human exposure at the maximum recommended daily inhalation dose). Also in the dietary study, the incidence of uterine leiomyomas and leiomyosarcomas was increased at doses of 2 mg/kg (AUC exposure was approximately 30 times human exposure at the maximum recommended daily inhalation dose) and above. Increases in leiomyomas of the rodent female genital tract have been similarly demonstrated with other beta-agonist drugs. Formoterol fumarate was not mutagenic or clastogenic in the following tests: mutagenicity tests in bacterial and mammalian cells, chromosomal analyses in mammalian cells, unscheduled DNA synthesis repair tests in rat hepatocytes and human fibroblasts, transformation assay in mammalian fibroblasts and micronucleus tests in mice and rats. Reproduction studies in rats revealed no impairment of fertility at oral doses up to 3 mg/kg (approximately 600 times the maximum recommended daily inhalation powder dose in humans on a mg/m² basis).

Animal Pharmacology

Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. The clinical significance of these findings is unknown. [See DRUG INTERACTIONS, Xanthine Derivatives, Steroids, or Diuretics]

Use In Specific Populations

Pregnancy

Teratogenic Effects: Pregnancy Category C

Formoterol fumarate administered throughout organogenesis did not cause malformations in rats or rabbits following oral administration. However, formoterol fumarate was found to be teratogenic in rats and rabbits in other testing laboratories. When given to rats throughout organogenesis, oral doses of 0.2 mg/kg (approximately 40 times the maximum recommended daily inhalation dose in humans on a mg/m² basis) and above delayed ossification of the fetus, and doses of 6 mg/kg (approximately 1200 times the maximum recommended daily inhalation dose in humans on a mg/m²basis) and above decreased fetal weight. Formoterol fumarate has been shown to cause stillbirth and neonatal mortality at oral doses of 6 mg/kg and above in rats receiving the drug during the late stage of pregnancy. These effects, however, were not produced at a dose of 0.2 mg/kg. Because there are no adequate and well-controlled studies in pregnant women, PERFOROMIST Inhalation Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women should be advised to contact their physician if they become pregnant while taking PERFOROMIST Inhalation Solution.

Labor and Delivery

There are no adequate and well-controlled human studies that have investigated the effects of PERFOROMIST Inhalation Solution during labor and delivery.

Because beta-agonists may potentially interfere with uterine contractility, PERFOROMIST Inhalation Solution should be used during labor only if the potential benefit justifies the potential risk.

Nursing Mothers

In reproductive studies in rats, formoterol was excreted in the milk. It is not known whether formoterol is excreted in human milk, but because many drugs are excreted in human milk, caution should be exercised if PERFOROMIST Inhalation Solution is administered to nursing women. There are no well-controlled human studies of the use of PERFOROMIST Inhalation Solution in nursing mothers. Women should be advised to contact their physician if they are nursing while taking PERFOROMIST Inhalation Solution.

Pediatric Use

PERFOROMIST Inhalation Solution is not indicated for use in children. The safety and effectiveness of PERFOROMIST Inhalation Solution in pediatric patients have not been established. The pharmacokinetics of formoterol fumarate has not been studied in pediatric patients.

Geriatric Use

Of the 586 subjects who received PERFOROMIST Inhalation Solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over. Of the 123 subjects who received PERFOROMIST Inhalation Solution in the 12-week safety and efficacy trial, 48 (39%) were 65 years of age or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. The pharmacokinetics of PERFOROMIST Inhalation Solution has not been studied in elderly subjects.

Last reviewed on RxList: 6/20/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

The expected signs and symptoms with overdosage of PERFOROMIST Inhalation Solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms listed under ADVERSE REACTIONS. Signs and symptoms may include angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, and metabolic acidosis. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of PERFOROMIST Inhalation Solution.

Treatment of overdosage consists of discontinuation of PERFOROMIST Inhalation Solution together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of PERFOROMIST Inhalation Solution. Cardiac monitoring is recommended in cases of overdosage.

The minimum lethal inhalation dose of formoterol fumarate in rats is 156 mg/kg (approximately 32,000 times the maximum recommended daily inhalation dose in humans on a mg/m² basis). The median lethal oral doses in Chinese hamsters, rats, and mice provide even higher multiples of the maximum recommended daily inhalation dose in humans.

For additional information about overdose treatment, call a poison control center (1-800-222-1222).

CONTRAINDICATIONS

All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication. [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 6/20/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Formoterol fumarate is a long-acting, beta2-adrenergic receptor agonist (beta2-agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. In vitro studies have shown that formoterol has more than 200-fold greater agonist activity at beta2-receptors than at beta1-receptors. Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1receptors are the predominant receptors in the heart, there are also beta2-receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects.

The pharmacologic effects of beta2-adrenoceptor agonist drugs, including formoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

In vitro tests show that formoterol is an inhibitor of the release of mast cell mediators, such as histamine and leukotrienes, from the human lung. Formoterol also inhibits histamine-induced plasma albumin extravasation in anesthetized guinea pigs and inhibits allergen-induced eosinophil influx in dogs with airway hyper-responsiveness. The relevance of these in vitro and animal findings to humans with COPD is unknown.

Pharmacodynamics

Systemic Safety and Pharmacokinetic / Pharmacodynamic Relationships

The major adverse effects of inhaled beta2-agonists occur as a result of excessive activation of the systemic beta-adrenergic receptors. The most common adverse effects in adults include skeletal muscle tremor and cramps, insomnia, tachycardia, decreases in plasma potassium, and increases in plasma glucose.

Changes in serum potassium and serum glucose were evaluated in 12 COPD patients following inhalation of single doses of PERFOROMIST Inhalation Solution containing 10, 20 and 244 mcg of formoterol fumarate (calculated on an anhydrous basis) in a crossover study. At 1 hour after treatment with formoterol fumarate inhalation solution, mean (± standard deviation) serum glucose rose 26 ± 30, 29 ± 28, and 38 ± 44 mg/dL, respectively, and was not significantly different from baseline or trough level at 24 hours post-dose. At 1 hour after dosing with formoterol fumarate inhalation solution 244 mcg, serum potassium fell by 0.68 ± 0.4 mEq/L, and was not different from baseline or trough level at 24 hours post-dose.

Linear pharmacokinetic/pharmacodynamic (PK/PD) relationships between urinary formoterol excretion and decreases in serum potassium, increases in plasma glucose, and increases in heart rate were generally observed with another inhalation formulation of formoterol fumarate and hence would be expected with PERFOROMIST Inhalation Solution also. Following single dose administration of 10-fold the recommended clinical dose of the other formoterol fumarate inhalation formulation having comparable exposure to single dose of 244 mcg of PERFOROMIST Inhalation Solution (approximately 12-fold the recommended clinical dose) in healthy subjects, the formoterol plasma concentration was found to be highly correlated with the reduction in plasma potassium concentration. Data from this study showed that maximum reductions from baseline in plasma potassium ranged from 0.55 to 1.52 mmol/L with a median maximum reduction of 1.01 mmol/L. Generally, the maximum effect on plasma potassium was noted 1 to 3 hours after peak formoterol plasma concentrations were achieved.

Electrophysiology

In the dose-ranging study of PERFOROMIST Inhalation Solution, ECG-determined heart rate increased by a mean of 6 ±3 beats per minute at 6 hours after a single dose of 244 mcg, but was back to predose level at 16-24 hours.

The effect of PERFOROMIST Inhalation Solution on heart rate and cardiac rhythm was studied in a 12-week clinical trial comparing PERFOROMIST Inhalation Solution to placebo and an active control treatment. COPD patients, including 105 patients exposed to PERFOROMIST Inhalation Solution, underwent continuous electrocardiographic (Holter) monitoring during two 24-hour periods (study baseline and after 8-12 weeks of treatment). ECGs were performed pre-dose and at 2 to 3 hours post-dose at study baseline (prior to dosing) and after 4, 8 and 12 weeks of treatment. Bazett's and Fridericia's methods were used to correct the QT interval for heart rate (QTcB and QTcF, respectively). The mean increase from baseline in QTcB interval over the 12-week treatment period was ≤ 4.8 msec for PERFOROMIST Inhalation Solution and ≤ 4.6 msec for placebo. The percent of patients who experienced a maximum change in QTc greater than 60 msec at any time during the 12-week treatment period was 0% and 1.8% for PERFOROMIST Inhalation Solution and placebo, respectively, based on Bazett's correction, and 1.6% and 0.9%, respectively, based on Fridericia's correction. Prolonged QT was reported as an adverse event in 1 (0.8%) patient treated with PERFOROMIST Inhalation Solution and 2 (1.8%) placebo patients. No occurrences of atrial fibrillation or ventricular tachycardia were observed during 24-hour Holter monitoring or reported as adverse events in patients treated with PERFOROMIST Inhalation Solution after the start of dosing. No increase in supraventricular tachycardia over placebo-treated subjects was observed. The mean increase in maximum heart rate from baseline to 8-12 weeks after the start of dosing was 0.6 beats per minute (bpm) for patients treated with PERFOROMIST Inhalation Solution twice daily compared to 1.2 bpm for placebo patients. There were no clinically meaningful differences from placebo in acute or chronic effects on heart rate, including QTcB and QTcF, or cardiac rhythm resulting from treatment with PERFOROMIST Inhalation Solution.

At an exposure from formoterol fumarate dry powder formulation comparable to approximately 12-fold the recommended dose of PERFOROMIST Inhalation Solution, a mean maximum increase of pulse rate of 26 bpm was observed 6 hours post dose in healthy subjects. This study showed that the maximum increase of mean corrected QT interval (QTc) was 25 msec when calculated using Bazett's correction and was 8 msec when calculated using Fridericia's correction. The QTc returned to baseline within 12 to 24 hours post-dose. Formoterol plasma concentrations were weakly correlated with pulse rate and increase of QTc duration. The effects on pulse rate and QTc interval are known pharmacological effects of this class of study drug and were not unexpected at this supratherapeutic formoterol fumarate inhalation dose.

Tachyphylaxis / Tolerance

Tolerance to the effects of inhaled beta-agonists can occur with regularly-scheduled, chronic use. In a placebo-controlled clinical trial in 351 adult patients with COPD, the bronchodilating effect of PERFOROMIST Inhalation Solution was determined by the FEV1 area under the curve over 12 hours following dosing on Day 1 and after 12 weeks of treatment. The effect of PERFOROMIST Inhalation Solution did not decrease after 12 weeks of twice-daily treatment (Figures 1 and 2).

Pharmacokinetics

Information on the pharmacokinetics of formoterol (dry powder and/or inhalation solution) in plasma and/or urine is available in healthy subjects as well as patients with chronic obstructive pulmonary disease after oral inhalation of doses at and above the therapeutic dose.

Urinary excretion of unchanged formoterol was used as an indirect measure of systemic exposure. Plasma drug disposition data parallel urinary excretion, and the elimination half-lives calculated for urine and plasma are similar.

Absorption

Pharmacokinetic properties of formoterol fumarate were evaluated in 12 COPD patients following inhalation of single doses of PERFOROMIST Inhalation Solution containing 10, 20 and 244 mcg of formoterol fumarate (calculated on an anhydrous basis) and 12 mcg formoterol fumarate dry powder, through 36 hours after single-dose administration. Formoterol fumarate concentrations in plasma following the 10 and 20 mcg doses of PERFOROMIST Inhalation Solution and the 12 mcg dose of formoterol fumarate dry powder were undetectable or only detected sporadically at very low concentrations. Following a single 244 mcg dose of PERFOROMIST Inhalation Solution (approximately 12 times the recommended clinical dose), formoterol fumarate concentrations were readily measurable in plasma, exhibiting rapid absorption into plasma, and reaching a maximum drug concentration of 72 pg/mL within approximately 12 minutes of dosing.

The mean amount of formoterol excreted unchanged in 24 hour urine following single oral inhalation doses of 10, 20, and 244 mcg PERFOROMIST Inhalation Solution were found to be 109.7 ng, 349.6 ng, and 3317.5 ng, respectively. These findings indicate a near dose proportional increase in systemic exposure within the dose range tested.

When 12 mcg of a dry powder formulation of formoterol fumarate was given twice daily to COPD patients by oral inhalation for 12 weeks, the accumulation index, based on the urinary excretion of unchanged formoterol was 1.19 to 1.38. This suggests some accumulation of formoterol in plasma with multiple dosing. Although multiple-dose pharmacokinetic data is unavailable from PERFOROMIST Inhalation Solution, assumption of linear pharmacokinetics allows a reasonable prediction of minimal accumulation based on single-dose pharmacokinetics. As with many drug products for oral inhalation, it is likely that the majority of the inhaled formoterol fumarate delivered is swallowed and then absorbed from the gastrointestinal tract.

Distribution

The binding of formoterol to human plasma proteins in vitro was 61% to 64% at concentrations from 0.1 to 100 ng/mL. Binding to human serum albumin in vitro was 31% to 38% over a range of 5 to 500 ng/mL. The concentrations of formoterol used to assess the plasma protein binding were higher than those achieved in plasma following inhalation of a single 244 mcg dose of PERFOROMIST Inhalation Solution.

Metabolism

Formoterol is metabolized primarily by direct glucuronidation at either the phenolic or aliphatic hydroxyl group and O-demethylation followed by glucuronide conjugation at either phenolic hydroxyl groups. Minor pathways involve sulfate conjugation of formoterol and deformylation followed by sulfate conjugation. The most prominent pathway involves direct conjugation at the phenolic hydroxyl group. The second major pathway involves O-demethylation followed by conjugation at the phenolic 2'-hydroxyl group. In vitro studies showed that multiple drug-metabolizing enzymes catalyze glucuronidation (UGT1A1, 1A8, 1A9, 2B7 and 2B15 were the most predominant enzymes) and O-demethylation (CYP2D6, CYP2C19, CYP2C9 and CYP2A6) of formoterol. Formoterol did not inhibit CYP450 enzymes at therapeutically relevant concentrations. Some patients may be deficient in CYP2D6 or 2C19 or both. Whether a deficiency in one or both of these isozymes results in elevated systemic exposure to formoterol or systemic adverse effects has not been adequately explored.

Excretion

Following administration of single 10, 20, and 244 mcg PERFOROMIST Inhalation Solution doses (calculated on an anhydrous basis) delivered via nebulizer in 12 COPD patients, on average, about 1.1% to 1.7% of the dose was excreted in the urine as unchanged formoterol as compared to about 3.4% excreted unchanged following inhalation administration of 12 mcg of formoterol fumarate dry powder. Renal clearance of formoterol following inhalation administration of PERFOROMIST Inhalation Solution in these subjects was about 157 mL/min. Based on plasma concentrations measured following the 244 mcg dose, the mean terminal elimination half-life was determined to be 7 hours.

Gender

As reported for another formoterol fumarate inhalation formulation, upon correction for body weight, pharmacokinetics of formoterol fumarate did not differ significantly between males and females.

Geriatric, Pediatric, Hepatic/Renal Impairment

The pharmacokinetics of formoterol fumarate has not been studied in elderly and pediatric patient populations. The pharmacokinetics of formoterol fumarate has not been studied in subjects with hepatic or renal impairment.

Clinical Studies

Adult COPD Trial

PERFOROMIST (formoterol fumarate) Inhalation Solution was evaluated in a 12-week, double-blind, placebo-and active-controlled, randomized, parallel-group, multicenter trial conducted in the United States. Of a total enrollment of 351 adults (age range: 40 to 86 years; mean age: 63 years) with COPD who had a mean pre-bronchodilator FEV1 of 1.34 liters (44% of predicted), 237 patients were randomized to PERFOROMIST Inhalation Solution 20 mcg or placebo, administered twice daily via a PARI-LC Plus® nebulizer with a PRONEB® Ultra compressor. The diagnosis of COPD was based upon a prior clinical diagnosis of COPD, a smoking history (at least 10 pack-years), age (at least 40 years), and spirometry results (pre-bronchodilator baseline FEV1 at least 30% and less than 70% of the predicted value, and the FEV1/FVC less than 70%). About 58% of patients had bronchodilator reversibility, defined as a 10% or greater increase in FEV1 after inhalation of 2 actuations (180 mcg) of albuterol from a metered dose inhaler. About 86% (106) of patients treated with PERFOROMIST Inhalation Solution and 74% (84) of placebo patients completed the trial. PERFOROMIST Inhalation Solution 20 mcg twice daily resulted in significantly greater post-dose bronchodilation (as measured by serial FEV1 for 12 hours post-dose; the primary efficacy analysis) compared to placebo when evaluated at endpoint (week 12 for completers and last observation for dropouts). Similar results were seen on Day 1 and at subsequent timepoints during the trial. Mean FEV1 measurements at Day 1 (Figure 1) and at endpoint (Figure 2) are shown below.

Figure 1 : Mean1 FEV1 at Day 1

Mean FEV1 at Day 1 - Illustration

Figure 2 : Mean1 FEV1 at Endpoint after 12 Weeks of Treatment

Mean FEV1 at Endpoint after 12 Weeks - Illustration

Patients treated with PERFOROMIST Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo.

Examination of age ( ≥ 65 or younger) and gender subgroups did not identify differences in response to PERFOROMIST Inhalation Solution. There were too few non-Caucasian subjects to assess differences in populations defined by race adequately. In the 12 week study, 78% of subjects achieved a 15% increase from baseline FEV1 following the first dose of PERFOROMIST Inhalation Solution 20 mcg. In these subjects, the median time to onset of bronchodilation, defined as 15% increase in FEV1, was 11.7 minutes. When defined as an increase in FEV1 of 12% and 200 mL, the time to onset of bronchodilation was 13.1 minutes after dosing. The median time to peak bronchodilator effect was 2 hours after dosing.

1Figures show least-squares means adjusted for baseline FEV1

Last reviewed on RxList: 6/20/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

MEDICATION GUIDE

PERFOROMIST®
(Per-FOR-o-mist)
(formoterol fumarate)

Inhalation Solution PERFOROMIST Inhalation Solution is only for use with a nebulizer.

Read the Medication Guide that comes with PERFOROMIST Inhalation Solution before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about PERFOROMIST Inhalation Solution?

PERFOROMIST Inhalation Solution can cause serious side effects including:

  • People with asthma who take long-acting beta2 adrenergic agonist (LABA) medicines such as PERFOROMIST Inhalation Solution have an increased risk of death from asthma problems.
  • It is not known if LABA medicines, such as PERFOROMIST Inhalation Solution, increase the risk of death in people with chronic obstructive pulmonary disease (COPD).
  • Get emergency medical care if:
  • breathing problems worsen quickly
  • you use your rescue inhaler medicine, but it does not relieve your breathing problems

What is PERFOROMIST Inhalation Solution?

PERFOROMIST Inhalation Solution is used long term, 2 times a day (morning and evening), in controlling symptoms of chronic obstructive pulmonary disease (COPD) in adults with COPD.

PERFOROMIST Inhalation Solution is only for use with a nebulizer. LABA medicines such as PERFOROMIST Inhalation Solution help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

PERFOROMIST Inhalation Solution is not for use to treat sudden symptoms of COPD.

PERFOROMIST Inhalation Solution should not be used in children. It is not known if PERFOROMIST Inhalation Solution is safe and effective in children.

It is not known if PERFOROMIST Inhalation Solution is safe and effective in people with asthma.

Who should not use PERFOROMIST Inhalation Solution?

Do not use PERFOROMIST Inhalation Solution if you have asthma without using a long-term asthma control medicine. What should I tell my healthcare provider before using PERFOROMIST Inhalation Solution? Tell your healthcare provider about all of your health conditions, including if you:

  • have heart problems
  • have high blood pressure
  • have diabetes
  • have seizures
  • have thyroid problems
  • have liver problems
  • are pregnant or planning to become pregnant. It is not known if PERFOROMIST Inhalation Solution can harm an unborn baby.
  • are breastfeeding. It is not known if PERFOROMIST Inhalation Solution passes into breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. PERFOROMIST Inhalation Solution and certain other medicines may interact with each other. This may cause serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use PERFOROMIST Inhalation Solution?

Read the step-by-step instructions for using PERFOROMIST Inhalation Solution at the end of this Medication Guide.

  • Use PERFOROMIST Inhalation Solution exactly as prescribed. One ready-to-use vial of PERFOROMIST Inhalation Solution is one dose. The usual dose of PERFOROMIST Inhalation Solution is one ready-to-use vial, twice a day (morning and evening) breathed in through your nebulizer machine. The 2 doses should be about 12 hours apart. Do not use more than 2 vials of PERFOROMIST Inhalation Solution a day.
  • Do not mix other medicines with PERFOROMIST Inhalation Solution in your nebulizer machine.
  • If you miss a dose of PERFOROMIST Inhalation Solution, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at one time.
  • While you are using PERFOROMIST Inhalation Solution 2 times each day:
  • do not use other medicines that contain a long-acting beta2-agonist (LABA) for any reason.
  • do not use your short-acting beta2-agonist medicine on a regular basis (four times a day).
  • PERFOROMIST Inhalation Solution does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have one prescribed for you.
  • Do not stop using PERFOROMIST Inhalation Solution or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse.Your healthcare provider will change your medicines as needed.
  • Do not use PERFOROMIST Inhalation Solution:
  • more often than prescribed,
  • more medicine than prescribed for you, or
  • with other LABA medicines

Call your healthcare provider or get emergency medical care right away if:

  • your breathing problems worsen with PERFOROMIST Inhalation Solution
  • you need to use your rescue inhaler medicine more often than usual
  • your rescue inhaler medicine does not work as well for you at relieving symptoms

What are the possible side effects of PERFOROMIST Inhalation Solution?

PERFOROMIST Inhalation Solution can cause serious side effects, including:

  • See “What is the most important information I should know about PERFOROMIST Inhalation Solution?”
  • Sudden shortness of breath immediately after use of PERFOROMIST Inhalation Solution.
  • Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
  • chest pain
  • increased or decreased blood pressure
  • a fast and irregular heartbeat
  • low blood potassium
  • high blood sugar
  • high blood acid

Common side effects of PERFOROMIST Inhalation Solution include:

  • headache
  • tremor
  • nervousness
  • dry mouth
  • muscle cramps
  • nausea, vomiting
  • diarrhea
  • dizziness
  • tiredness
  • trouble sleeping
  • If your COPD symptoms worsen over time do not increase your dose of PERFOROMIST Inhalation Solution, instead call your healthcare provider.

Tell your healthcare provider if you get any side effect that bothers you or that does not go away. These are not all the side effects with PERFOROMIST Inhalation Solution. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store PERFOROMIST Inhalation Solution?

  • Store PERFOROMIST Inhalation Solution in a refrigerator between 36° to 46°F (2° to 8°C) in the protective foil pouch. Protect from light and heat. Do not open a sealed pouch until you are ready to use a dose of PERFOROMIST Inhalation Solution. Once a sealed pouch is opened, PERFOROMIST Inhalation Solution must be used right away. PERFOROMIST Inhalation Solution may be used directly from the refrigerator.
  • PERFOROMIST Inhalation Solution may also be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 3 months (90 days). If stored at room temperature, discard PERFOROMIST Inhalation Solution if it is not used after 3 months or if past the expiration date, whichever is sooner. Space is provided on the packaging to record dispense date and use by date.
  • Do not use PERFOROMIST Inhalation Solution after the expiration date provided on the foil pouch and vial.
  • PERFOROMIST Inhalation Solution should be colorless. Discard PERFOROMIST Inhalation Solution if it is not colorless.
  • Keep PERFOROMIST Inhalation Solution and all medicines out of the reach of children.

General Information about PERFOROMIST Inhalation Solution

Medicines are sometimes prescribed for purposes that are not mentioned in a Medication Guide. Do not use PERFOROMIST Inhalation Solution for a condition for which it was not prescribed. Do not give PERFOROMIST Inhalation Solution to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about PERFOROMIST Inhalation Solution. If you would like more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about PERFOROMIST Inhalation Solution that was written for healthcare professionals.

  • For customer service, call 1-800-395-3376
  • To report side effects, call (1-877-446-3679)
  • For medical information, call 1-800-429-7751

Instructions for Using PERFOROMIST (formoterol fumarate) Inhalation Solution

PERFOROMIST Inhalation Solution is used only in a standard jet nebulizer machine connected to an air compressor. Make sure you know how to use your nebulizer machine before you use it to breathe in PERFOROMIST Inhalation Solution or other medicines.

Do not mix PERFOROMIST Inhalation Solution with other medicines in your nebulizer machine.

PERFOROMIST Inhalation Solution comes sealed in a foil pouch. Do not open a sealed pouch until you are ready to use a dose of PERFOROMIST Inhalation Solution.

1. Remove vial from the foil pouch.

2. Twist the cap completely off the vial and squeeze all the medicine into the nebulizer medicine cup (reservoir) (Figure 1).

Figure 1

Filling up the nebulizer - Illustration

3. Connect the nebulizer reservoir to the mouthpiece or facemask (Figure 2).

Figure 2

Connect the nebulizer reservoir to the mouthpiece - Illustration

4. Connect the nebulizer to the compressor.

5. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (Figure 3) or put on the facemask (Figure 4); and turn on the compressor.

Figure 3 and Figure 4

PERFOROMIST® (Per-FOR-o-mist) (formoterol fumarate) Figure 3 & 4 Illustration

6. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer reservoir. The average nebulization time is 9 minutes. At this point, the treatment is finished.

7. Discard the PERFOROMIST Inhalation Solution container and top after use.

8. Clean the nebulizer (see manufacturer's instructions).

Last reviewed on RxList: 6/20/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

MEDICATION GUIDE

PERFOROMIST®
(Per-FOR-o-mist)
(formoterol fumarate)

Inhalation Solution PERFOROMIST Inhalation Solution is only for use with a nebulizer.

Read the Medication Guide that comes with PERFOROMIST Inhalation Solution before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about PERFOROMIST Inhalation Solution?

PERFOROMIST Inhalation Solution can cause serious side effects including:

  • People with asthma who take long-acting beta2 adrenergic agonist (LABA) medicines such as PERFOROMIST Inhalation Solution have an increased risk of death from asthma problems.
  • It is not known if LABA medicines, such as PERFOROMIST Inhalation Solution, increase the risk of death in people with chronic obstructive pulmonary disease (COPD).
  • Get emergency medical care if:
  • breathing problems worsen quickly
  • you use your rescue inhaler medicine, but it does not relieve your breathing problems

What is PERFOROMIST Inhalation Solution?

PERFOROMIST Inhalation Solution is used long term, 2 times a day (morning and evening), in controlling symptoms of chronic obstructive pulmonary disease (COPD) in adults with COPD.

PERFOROMIST Inhalation Solution is only for use with a nebulizer. LABA medicines such as PERFOROMIST Inhalation Solution help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

PERFOROMIST Inhalation Solution is not for use to treat sudden symptoms of COPD.

PERFOROMIST Inhalation Solution should not be used in children. It is not known if PERFOROMIST Inhalation Solution is safe and effective in children.

It is not known if PERFOROMIST Inhalation Solution is safe and effective in people with asthma.

Who should not use PERFOROMIST Inhalation Solution?

Do not use PERFOROMIST Inhalation Solution if you have asthma without using a long-term asthma control medicine. What should I tell my healthcare provider before using PERFOROMIST Inhalation Solution? Tell your healthcare provider about all of your health conditions, including if you:

  • have heart problems
  • have high blood pressure
  • have diabetes
  • have seizures
  • have thyroid problems
  • have liver problems
  • are pregnant or planning to become pregnant. It is not known if PERFOROMIST Inhalation Solution can harm an unborn baby.
  • are breastfeeding. It is not known if PERFOROMIST Inhalation Solution passes into breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. PERFOROMIST Inhalation Solution and certain other medicines may interact with each other. This may cause serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use PERFOROMIST Inhalation Solution?

Read the step-by-step instructions for using PERFOROMIST Inhalation Solution at the end of this Medication Guide.

  • Use PERFOROMIST Inhalation Solution exactly as prescribed. One ready-to-use vial of PERFOROMIST Inhalation Solution is one dose. The usual dose of PERFOROMIST Inhalation Solution is one ready-to-use vial, twice a day (morning and evening) breathed in through your nebulizer machine. The 2 doses should be about 12 hours apart. Do not use more than 2 vials of PERFOROMIST Inhalation Solution a day.
  • Do not mix other medicines with PERFOROMIST Inhalation Solution in your nebulizer machine.
  • If you miss a dose of PERFOROMIST Inhalation Solution, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at one time.
  • While you are using PERFOROMIST Inhalation Solution 2 times each day:
  • do not use other medicines that contain a long-acting beta2-agonist (LABA) for any reason.
  • do not use your short-acting beta2-agonist medicine on a regular basis (four times a day).
  • PERFOROMIST Inhalation Solution does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have one prescribed for you.
  • Do not stop using PERFOROMIST Inhalation Solution or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse.Your healthcare provider will change your medicines as needed.
  • Do not use PERFOROMIST Inhalation Solution:
  • more often than prescribed,
  • more medicine than prescribed for you, or
  • with other LABA medicines

Call your healthcare provider or get emergency medical care right away if:

  • your breathing problems worsen with PERFOROMIST Inhalation Solution
  • you need to use your rescue inhaler medicine more often than usual
  • your rescue inhaler medicine does not work as well for you at relieving symptoms

What are the possible side effects of PERFOROMIST Inhalation Solution?

PERFOROMIST Inhalation Solution can cause serious side effects, including:

  • See “What is the most important information I should know about PERFOROMIST Inhalation Solution?”
  • Sudden shortness of breath immediately after use of PERFOROMIST Inhalation Solution.
  • Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
  • chest pain
  • increased or decreased blood pressure
  • a fast and irregular heartbeat
  • low blood potassium
  • high blood sugar
  • high blood acid

Common side effects of PERFOROMIST Inhalation Solution include:

  • headache
  • tremor
  • nervousness
  • dry mouth
  • muscle cramps
  • nausea, vomiting
  • diarrhea
  • dizziness
  • tiredness
  • trouble sleeping
  • If your COPD symptoms worsen over time do not increase your dose of PERFOROMIST Inhalation Solution, instead call your healthcare provider.

Tell your healthcare provider if you get any side effect that bothers you or that does not go away. These are not all the side effects with PERFOROMIST Inhalation Solution. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store PERFOROMIST Inhalation Solution?

  • Store PERFOROMIST Inhalation Solution in a refrigerator between 36° to 46°F (2° to 8°C) in the protective foil pouch. Protect from light and heat. Do not open a sealed pouch until you are ready to use a dose of PERFOROMIST Inhalation Solution. Once a sealed pouch is opened, PERFOROMIST Inhalation Solution must be used right away. PERFOROMIST Inhalation Solution may be used directly from the refrigerator.
  • PERFOROMIST Inhalation Solution may also be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 3 months (90 days). If stored at room temperature, discard PERFOROMIST Inhalation Solution if it is not used after 3 months or if past the expiration date, whichever is sooner. Space is provided on the packaging to record dispense date and use by date.
  • Do not use PERFOROMIST Inhalation Solution after the expiration date provided on the foil pouch and vial.
  • PERFOROMIST Inhalation Solution should be colorless. Discard PERFOROMIST Inhalation Solution if it is not colorless.
  • Keep PERFOROMIST Inhalation Solution and all medicines out of the reach of children.

General Information about PERFOROMIST Inhalation Solution

Medicines are sometimes prescribed for purposes that are not mentioned in a Medication Guide. Do not use PERFOROMIST Inhalation Solution for a condition for which it was not prescribed. Do not give PERFOROMIST Inhalation Solution to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about PERFOROMIST Inhalation Solution. If you would like more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about PERFOROMIST Inhalation Solution that was written for healthcare professionals.

  • For customer service, call 1-800-395-3376
  • To report side effects, call (1-877-446-3679)
  • For medical information, call 1-800-429-7751

Instructions for Using PERFOROMIST (formoterol fumarate) Inhalation Solution

PERFOROMIST Inhalation Solution is used only in a standard jet nebulizer machine connected to an air compressor. Make sure you know how to use your nebulizer machine before you use it to breathe in PERFOROMIST Inhalation Solution or other medicines.

Do not mix PERFOROMIST Inhalation Solution with other medicines in your nebulizer machine.

PERFOROMIST Inhalation Solution comes sealed in a foil pouch. Do not open a sealed pouch until you are ready to use a dose of PERFOROMIST Inhalation Solution.

1. Remove vial from the foil pouch.

2. Twist the cap completely off the vial and squeeze all the medicine into the nebulizer medicine cup (reservoir) (Figure 1).

Figure 1

Filling up the nebulizer - Illustration

3. Connect the nebulizer reservoir to the mouthpiece or facemask (Figure 2).

Figure 2

Connect the nebulizer reservoir to the mouthpiece - Illustration

4. Connect the nebulizer to the compressor.

5. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (Figure 3) or put on the facemask (Figure 4); and turn on the compressor.

Figure 3 and Figure 4

PERFOROMIST® (Per-FOR-o-mist) (formoterol fumarate) Figure 3 & 4 Illustration

6. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer reservoir. The average nebulization time is 9 minutes. At this point, the treatment is finished.

7. Discard the PERFOROMIST Inhalation Solution container and top after use.

8. Clean the nebulizer (see manufacturer's instructions).

Last reviewed on RxList: 6/20/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Perforomist Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FORMOTEROL SOLUTION - INHALATION

(for-MOW-ter-all)

COMMON BRAND NAME(S): Perforomist

WARNING: Rarely, in patients treated for asthma, serious (sometimes fatal) asthma-related breathing problems have occurred with the use of long-acting inhaled beta agonists (e.g., salmeterol). Because formoterol is similar to salmeterol, it may also cause these problems. This form of formoterol is not approved to treat asthma. Consult your doctor or pharmacist for more details.

USES: Formoterol is used as a long-term (maintenance) treatment to prevent or decrease breathing problems caused by ongoing lung diseases (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). Formoterol belongs to the class of drugs known as long-acting inhaled beta-agonists. It works by opening air passages in the lungs to make breathing easier. This effect helps to reduce wheezing, coughing, and shortness of breath.

This medication does not work immediately and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief inhaler (e.g., albuterol, also called salbutamol in some countries) for sudden shortness of breath while you are using formoterol. You should always have a quick-relief inhaler with you.

Formoterol is usually used with other medications such as corticosteroids (inhaled or taken by mouth). However, it should not be used with other long-acting inhaled beta agonists (e.g., salmeterol) because doing so may increase your risk for side effects.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. This medication is used with a special machine called a nebulizer that changes the solution to a fine mist that you inhale. Learn all instructions for the use of this medication and the nebulizer equipment. Do not use the solution if it is discolored. If you have any questions, consult your doctor or pharmacist.

This medication does not require any mixing before use. Using a mouthpiece or face mask with the nebulizer, inhale the prescribed dose of medication into your lungs, usually twice daily (morning and evening) or as directed by your doctor. The two doses should be about 12 hours apart. Each treatment usually takes about 9 minutes. Give this medication only through a nebulizer. Do not swallow the solution. Do not mix with other medicines in your nebulizer.

Use this medication regularly to receive the most benefit from it. To help you remember, use it at the same times each day. To prevent infections, clean the nebulizer and mouthpiece/face mask according to the manufacturer's directions.

Do not use more of this medication or use it more often than prescribed because doing so may cause serious side effects. The manufacturer recommends that you do not use more than 2 vials a day.

Do not stop using this medication or change your dose without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

If you have been using a quick-relief inhaler (e.g., albuterol, salbutamol) on a regular daily schedule (such as 4 times daily), your doctor will direct you to stop this schedule and use the quick-relief inhaler only as needed for sudden shortness of breath. Consult your doctor for details.

Seek immediate medical attention if your breathing suddenly worsens, if this medication or your quick-relief inhaler stop working well, or if you need to use the quick-relief inhaler more often than usual (4 or more puffs daily or more than 1 inhaler every 8 weeks). Do not increase your dose of formoterol unless your doctor directs you to do so.

Disclaimer

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.

Read the Perforomist (formoterol fumarate inhalation solution) Side Effects Center for a complete guide to possible side effects »

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.

Disclaimer

Perforomist Consumer (continued)

DRUG INTERACTIONS: See also Uses section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: beta blockers (e.g., propranolol, sotalol).

Many drugs besides formoterol may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using formoterol, report all medications you are currently using to your doctor or pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: chest pain, fast/irregular heartbeat, severe dizziness, fainting.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood pressure, heart rate, lung function) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Avoid smoking and other factors that make breathing worse.

Ask your doctor or pharmacist whether you should have an annual flu shot.

MISSED DOSE: If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C) in the sealed protective pouch. Protect from light and heat.

Unopened pouches of medication may also be stored at room temperature between 68-77 degrees F (20-25 degrees C) for up to 3 months. Discard the medication if it is not used within 3 months or after its expiration date, whichever is sooner. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised January 2011. Copyright(c) 2011 First Databank, Inc.

Perforomist Patient Information Including Side Effects

Brand Names: Foradil Aerolizer, Perforomist

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

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

Read the Perforomist (formoterol fumarate inhalation solution) Side Effects Center for a complete guide to possible side effects »

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

Formoterol may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using formoterol inhalation.

Asthma is often treated with a combination of different drugs. If you use formoterol inhalation to treat asthma, you must use it together with another asthma control medication. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

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.

Side Effects Centers

Perforomist Patient Information including How Should I Take

What should I discuss with my healthcare provider before using formoterol inhalation (Perforomist)?

You should not use this medication if you are allergic to formoterol. If you have asthma, formoterol inhalation should not be your only asthma medication. You must use it together with at least one other asthma control medication.

If you have any of these other conditions, you may need a dose adjustment or special tests:

  • a food or drug allergy;
  • heart disease or high blood pressure;
  • epilepsy or other seizure disorder;
  • diabetes; or
  • a thyroid disorder.

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

Do not give this medication to a child younger than 5 years old.

How should I use formoterol inhalation (Perforomist)?

Formoterol may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using formoterol inhalation.

Asthma is often treated with a combination of different drugs. If you use formoterol inhalation to treat asthma, you must use it together with another asthma control medication. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. This device is not to be used with a spacer. Ask your doctor or pharmacist if you have any questions.

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.

If you are using formoterol inhalation to prevent exercise-induced asthma, use the medicine 15 minutes before exercising, or as directed by your doctor. Allow at least 12 hours to pass before you use the medicine again.

Use formoterol inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature, away from moisture, light, and heat. Keep each capsule in the blister pack until you are ready to use one. Be sure your hands are dry when handling a formoterol capsule.

Do not try to clean or take apart the Aerolizer device. Throw it away when your capsules run out. Always use the new device provided with the medication when you get your prescription refilled.

Side Effects Centers

Perforomist Patient Information including If I Miss a Dose

What happens if I miss a dose (Perforomist)?

Use the medication as soon as you remember, then wait 12 hours before using the medication again. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Perforomist)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest pain, nervousness, dry mouth, nausea, sleep problems (insomnia), tremors, chest pain, fast or irregular heartbeats, feeling weak or light-headed, fainting, or seizure (convulsions).

What should I avoid while using formoterol inhalation (Perforomist)?

Do not use a second form of formoterol (such as Symbicort) or use a similar other long-acting inhaled bronchodilator such as salmeterol (Advair, Serevent) or arformoterol (Brovana) unless your doctor has told you to.

What other drugs will affect formoterol (Perforomist)?

Before using formoterol inhalation tell your doctor if you are taking any of the following medicines:

  • cisapride (Propulsid);
  • droperidol (Inapsine);
  • methadone (Methadose);
  • pentamidine (NebuPent, Pentam);
  • a diuretic (water pill);
  • caffeine, diet pills, cold medicine, or a stimulant medication;
  • an antibiotic such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek);
  • medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), or thioridazine (Mellaril);
  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan), quinidine (Cardioquin, Quinaglute), or sotalol (Betapace);
  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
  • an antidepressant such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil); or
  • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

This list is not complete and other drugs may interact with formoterol inhalation. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about formoterol inhalation.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision date: 12/15/2010.

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