inhalation solution has not been studied in patients with acutely deteriorating COPD; use of inhalation solution in this setting is inappropriate Not for use in relief of acute symptoms, ie, as rescue therapy for treatment of acute episodes of bronchospasm; inhalation solution not studied in 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 therapy, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (eg, four times a day) should be instructed to discontinue regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms When prescribing inhalation solution, healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct 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 inhalation solution no longer controls symptoms of bronchoconstriction, or 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, undertake a re-evaluation of patient and the COPD treatment regimen at once Increasing daily dosage of inhalation solution beyond recommended 20 mcg twice daily dose is not appropriate in this situation Pregnancy Category: C Lactation: not known if excreted in breast milk, use cautionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Long-acting selective beta-2 agonist Bronchial smooth muscle relaxation Absorption Peak Plasma Time: 5 min Peak Plasma Concentration: 92 pg/mL Distribution Protein Bound: 61-64% Metabolism Metabolized by CYP2D6, CYP2C19, CYP2C9, CYP2A6 Elimination Half-Life: 10 hr Clearance: 150 mL/min Excretion: Urine 66%; feces 33% BRAND FORM. UNIT PRICE PILL IMAGE formoterol fumarate inhalation- 20 mcg/2 mL nebulizer solnPerforomist inhalation- 20 mcg/2 mL nebulizer solnPerforomist inhalation- 20 mcg/2 mL nebulizer solnCopyright © 2010 First DataBank, Inc.Print Patient Educationformoterol fumarate inhalation FORMOTEROL SOLUTION - INHALATION (for-MOW-ter-all) COMMON BRAND NAME(S): Perforomist 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 (LABAs). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This effect helps to reduce wheezing, coughing, and shortness of breath.This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief inhaler (such as 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.This form of formoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as formoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems. HOW TO USE: Read the Patient Information Leaflet 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 as directed by your doctor, usually twice daily (morning and evening). 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 (such as 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.Learn which of your medications/inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.Tell your doctor if your symptoms do not improve or if they worsen. SIDE EFFECTS: Shakiness (tremor), nausea, headache, nervousness, dizziness, dry mouth, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: muscle weakness/cramps, increased thirst/urination.Get medical help right away if you have any very serious side effects, including: 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 get medical help right away.A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before using formoterol, tell your doctor or pharmacist if you are allergic to it; or to arformoterol; 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 (such as irregular heartbeat, angina), high blood pressure, liver problems, overactive thyroid (hyperthyroidism), seizures, swelling of an artery (aneurysm), a certain tumor of the adrenal gland (pheochromocytoma).Formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using formoterol, tell your doctor or pharmacist of all the drugs you take and 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 about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding. DRUG INTERACTIONS: 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.Do not use other LABA drugs (such as arformoterol, salmeterol) while using this medication. OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center 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.Lab and/or medical tests (such as blood pressure, heart rate, lung function) may be done while you are using this medication. Keep all medical and lab appointments. 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. Use your next dose at the regular time. Do not double the dose to catch up. STORAGE: Store in the refrigerator in the sealed protective pouch. Protect from light and heat.Unopened pouches of medication may also be stored at room temperature 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 medications 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. MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). Information last revised May 2023. Copyright(c) 2023 First Databank, Inc. 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