Formoterol

Formoterol is a prescription medicine used for the long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

• Formoterol is available under the following different brand names: Perforomist

Adult dosage

Solution for inhalation

• 20mcg/2mL

Chronic Obstructive Pulmonary Disease (COPD)

Adult dosage

• Perforomist: 20 mcg inhaled via nebulizer every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Formoterol include:

• nausea, 
• vomiting, 
• diarrhea,
• nervousness, 
• trouble sleeping,
• headache,
• dizziness,
• tremor,
• tiredness,
• muscle cramps, and 
• dry mouth.

Serious side effects of Formoterol include:

• tremors, 
• nervousness, 
• chest pain, 
• fast or pounding heartbeats,
• wheezing, choking, or other breathing problems,
• worsening breathing problems,
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor, and
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in the chest, numbness or tingling, muscle weakness, or limp feeling.

Rare side effects of Formoterol include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Formoterol has severe interactions with no other drugs.
• Formoterol has serious interactions with at least 69 other drugs.
• Formoterol has moderate interactions with at least 282 other drugs.
• Formoterol has minor interactions with the following drugs: 
  • bendroflumethiazide
  • bumetanide
  • chloroquine
  • chlorothiazide
  • chlorthalidone
  • cyclopenthiazide
  • ethacrynic acid
  • eucalyptus
  • furosemide
  • green tea
  • hydrochlorothiazide
  • indapamide
  • methyclothiazide
  • metolazone
  • noni juice
  • sage
  • torsemide

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Asthma treatment without an inhaled corticosteroid

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Formoterol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Formoterol?”

Cautions

• Coexisting conditions include cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertension, aneurysm, and pheochromocytoma
• Life-threatening paradoxical bronchospasm can occur; discontinue immediately
• Immediate hypersensitivity reactions may occur (eg, anaphylactic reactions, urticaria, angioedema, rash, bronchospasm)
• Available data do not suggest an increased risk of death with the use of LABA in patients with COPD
• As with other inhaled beta2-adrenergic drugs, inhalation solution should not be used more often, at higher doses than recommended, or in conjunction with other medications containing long-acting beta2-agonists; an overdose may result; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs
• Beta-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects; 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 inhalation solution at the recommended dose
• Cardiovascular effects
  • 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, inhalation solution may need to be discontinued
  • Beta-agonists have been reported to produce ECG changes, such as flattening of T wave, prolongation of QTc interval, and ST-segment depression; the clinical significance of these findings is unknown
  • 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 related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis
• Serious asthma-related events
  • Safety and efficacy in patients with asthma are not established; not indicated for the treatment of asthma; 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
  • LABA as monotherapy also increases the risk of asthma-related hospitalization in pediatric and adolescent patients; these findings are considered a class effect of LABA monotherapy; when LABA is 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
  • Available data do not suggest an increased risk of death with the use of LABA in patients with COPD
• Acute COPD episodes
  • Inhalation solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition; 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 the relief of acute symptoms, ie, as rescue therapy for the 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 regularly (eg, 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 inhalation solution, a healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct the patient on 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 hours or chronically over several days or longer; if inhalation solution no longer controls 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, undertake a re-evaluation of the patient and the COPD treatment regimen at once
  • Increasing the daily dosage of inhalation solution beyond recommended 20 mcg twice daily dose is not appropriate in this situation

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy.
• Lactation
  • Not known if excreted in breast milk, use caution