Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 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 30 individually wrapped unit dose vials, NDC 49502-605-30 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). Protect pouch from light and heat. After dispensing to the patient: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and 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; PRINCIPAL DISPLAY PANEL – 20 mcg/2 mL NDC 49502-605-30 Perforomist ® (formoterol fumarate) INHALATION SOLUTION 20 mcg/2 mL vial Patient Information for Patients Enclosed Sterile Unit Dose Vials - Individually Wrapped - For Oral Inhalation Only EACH 2 mL VIAL CONTAINS: ACTIVE: Formoterol fumarate, USP. INACTIVES: Citric acid, sodium citrate, sodium chloride, and water. CARTON CONTAINS: 30 individually wrapped 2 mL vials Discard three months after dispense date. Use by: ________ STORAGE CONDITIONS: PRIOR TO DISPENSING TO THE PATIENT: Store refrigerated, 2°C to 8°C (36°F to 46°F). Protect pouch from light and heat. AFTER DISPENSING TO THE PATIENT: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and heat. VIAL SHOULD ALWAYS BE STORED IN THE FOIL POUCH, AND ONLY REMOVED IMMEDIATELY BEFORE USE. Keep out of reach of children. FOR THE HEALTHCARE PROVIDER: When Perforomist ® Inhalation Solution is dispensed to the patient, inform the patient to discard the product at the expiration date on the product if storing in a refrigerator or if the patient plans on storing the drug at room temperature, write an expiration date in the “Use by” box on the carton or dispensing container. The “Use by” date should not exceed 3 months from date dispensed. Protect pouch from light and heat. FOR THE PATIENT: Use Perforomist ® Inhalation Solution prior to the “Use by” date if stored at room temperature; otherwise, discard when the product expires. Rx only Manufactured for: Mylan Specialty L.P. Morgantown, WV 26505 U.S.A. Manufactured by: The Ritedose Corporation Columbia, SC 29203 U.S.A. U.S. Pat. Nos. 6,667,344, 6,814,953, 7,348,362, 7,462,645, 8,623,922, and 9,730,890 Mylan Specialty L.P., Morgantown, WV 26505 MS:605:30C:R3 RPSC0340 Perforomist 20 mcg/2 mL Carton Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING 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 30 individually wrapped unit dose vials, NDC 49502-605-30 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). Protect pouch from light and heat. After dispensing to the patient: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and 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
- PRINCIPAL DISPLAY PANEL – 20 mcg/2 mL NDC 49502-605-30 Perforomist ® (formoterol fumarate) INHALATION SOLUTION 20 mcg/2 mL vial Patient Information for Patients Enclosed Sterile Unit Dose Vials - Individually Wrapped - For Oral Inhalation Only EACH 2 mL VIAL CONTAINS: ACTIVE: Formoterol fumarate, USP. INACTIVES: Citric acid, sodium citrate, sodium chloride, and water. CARTON CONTAINS: 30 individually wrapped 2 mL vials Discard three months after dispense date. Use by: ________ STORAGE CONDITIONS: PRIOR TO DISPENSING TO THE PATIENT: Store refrigerated, 2°C to 8°C (36°F to 46°F). Protect pouch from light and heat. AFTER DISPENSING TO THE PATIENT: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and heat. VIAL SHOULD ALWAYS BE STORED IN THE FOIL POUCH, AND ONLY REMOVED IMMEDIATELY BEFORE USE. Keep out of reach of children. FOR THE HEALTHCARE PROVIDER: When Perforomist ® Inhalation Solution is dispensed to the patient, inform the patient to discard the product at the expiration date on the product if storing in a refrigerator or if the patient plans on storing the drug at room temperature, write an expiration date in the “Use by” box on the carton or dispensing container. The “Use by” date should not exceed 3 months from date dispensed. Protect pouch from light and heat. FOR THE PATIENT: Use Perforomist ® Inhalation Solution prior to the “Use by” date if stored at room temperature; otherwise, discard when the product expires. Rx only Manufactured for: Mylan Specialty L.P. Morgantown, WV 26505 U.S.A. Manufactured by: The Ritedose Corporation Columbia, SC 29203 U.S.A. U.S. Pat. Nos. 6,667,344, 6,814,953, 7,348,362, 7,462,645, 8,623,922, and 9,730,890 Mylan Specialty L.P., Morgantown, WV 26505 MS:605:30C:R3 RPSC0340 Perforomist 20 mcg/2 mL Carton Label
Overview
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 beta 2 -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: Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C 19 H 24 N 2 O 4 ) 2 •C 4 H 4 O 4 •2H 2 O. 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. Structural Formula
Indications & Usage
PERFOROMIST Inhalation Solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: • 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. ( 1.1 ) Important limitations of use: • PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) • PERFOROMIST Inhalation Solution is not indicated to treat asthma. ( 1.2 ) 1.1 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. 1.2 Important Limitations of Use PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2) ]. PERFOROMIST Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma have not been established.
Dosage & 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. For oral inhalation only. • One 20 mcg/2 mL vial every 12 hours ( 2 ) • For use with a standard jet nebulizer (with a facemask or mouthpiece) connected to an air compressor ( 2 )
Warnings & Precautions
• LABA as monotherapy (without inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) • Do not initiate PERFOROMIST Inhalation Solution in acutely deteriorating patients. ( 5.2 ) • Do not use for relief of acute symptoms. Concomitant short-acting beta 2 -agonists can be used as needed for acute relief. ( 5.2 ) • Do not exceed the recommended dose. Excessive use of PERFOROMIST Inhalation Solution or use in conjunction with other medications containing long-acting beta 2 -agonists, can result in clinically significant cardiovascular effects, and may be fatal. ( 5.3 , 5.5 ) • Life-threatening paradoxical bronchospasm can occur. Discontinue PERFOROMIST Inhalation Solution immediately. ( 5.4 ) • Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or with sensitivity to sympathomimetic drugs. ( 5.6 , 5.7 ) 5.1 Serious Asthma-Related Events – Hospitalizations, Intubations, Death • The safety and efficacy of PERFOROMIST in patients with asthma have not been established. PERFOROMIST is not indicated for the treatment of asthma [see CONTRAINDICATIONS (4) ] . • Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed ‑ dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. • A 28-week, placebo-controlled US study comparing the safety of another LABA (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. 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. • Available data do not suggest an increased risk of death with use of LABA in patients with COPD. 5.2 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 beta 2 -agonist. When beginning PERFOROMIST Inhalation Solution, patients who have been taking inhaled, short-acting beta 2 -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 beta 2 -agonist and instruct the patient how it should be used. Increasing inhaled beta 2 -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 beta 2 -agonist becomes less effective or the patient needs more inhalation of short-acting beta 2 -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. 5.3 Excessive Use and Use with Other Long-Acting Beta 2 -Agonists As with other inhaled beta 2 -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 beta 2 -agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. 5.4 Paradoxical Bronchospasm As with other inhaled beta 2 -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. 5.5 Cardiovascular Effects PERFOROMIST Inhalation Solution, like other beta 2 -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. 5.6 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 beta 2 -agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. 5.7 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 (12.2) ]. 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. 5.8 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of PERFOROMIST Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.
Contraindications
Use of a LABA, including PERFOROMIST, without an inhaled corticosteroid is contraindicated in patients with asthma [see WARNINGS and PRECAUTIONS (5.1) ] . PERFOROMIST is not indicated for the treatment of asthma. • Use of a LABA, including PERFOROMIST, without an inhaled corticosteroid is contraindicated in patients with asthma. ( 4 )
Adverse Reactions
Long-acting beta 2 -adrenergic agonists, such as PERFOROMIST, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events. PERFOROMIST is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS (5.1) ] . Most common adverse reactions ( > 2% and more common than placebo) are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Beta 2 -Agonist Adverse Reaction Profile Adverse reactions to PERFOROMIST Inhalation Solution are expected to be similar in nature to other beta 2 -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. 6.2 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 FEV 1 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 Inhalation Solution 20 mcg Placebo 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. 6.3 Postmarketing Experience The following adverse reactions have been reported during post-approval use of PERFOROMIST Inhalation Solution. 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
Drug Interactions
• Other adrenergic drugs may potentiate effect. Use with caution. ( 5.3 , 7.1 ) • Xanthine derivatives, steroids, diuretics, or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. ( 5.7 , 7.2 , 7.3 ) • MAO inhibitors, tricyclic antidepressants and drugs that prolong QTc interval may potentiate effect on the cardiovascular system. Use with extreme caution. ( 7.4 ) • Beta-blockers may decrease effectiveness. Use with caution and only when medically necessary. ( 7.5 ) 7.1 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 (5.3 , 5.5 , 5.6 , 5.7) ]. 7.2 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 (5.7) ]. 7.3 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. 7.4 MAO Inhibitors, Tricyclic Antidepressants, QTc Prolonging Drugs Formoterol, as with other beta 2 -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. 7.5 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.
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