Glycopyrrolate Inhaled Formoterol

Glycopyrrolate Inhaled-Formoterol is a combination medication indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 

• Glycopyrrolate Inhaled-Formoterol is available under the following different brand names: Bevespi Aerosphere.

Common side effects of Glycopyrrolate Inhaled-Formoterol include:

• urinary tract infection
• cough

Serious side effects of Glycopyrrolate Inhaled-Formoterol include:

• hives
• difficult breathing
• swelling of the face, lips, tongue, or throat
• difficult/painful urination 
• muscle cramps/weakness 
• increased thirst/urination
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in the chest, numbness or tingling, muscle weakness, or limp feeling

Rare side effects of Glycopyrrolate Inhaled-Formoterol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because 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.

Adult dosage

Inhalation aerosol

• (9 mcg/4.8 mcg)/inhalation

Chronic obstructive pulmonary disease

Adult dosage

• 2 inhalations (ie, 18 mcg/9.6 mcg) orally two times a day (morning and evening)
• Do not exceed 2 inhalations two times a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

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, healthcare provider, or pharmacist first.

• Glycopyrrolate Inhaled-Formoterol has severe interactions with the following drug:
  • umeclidinium bromide/vilanterol inhaled
• Glycopyrrolate Inhaled-Formoterol has serious interactions with at least 67 other drugs
• Glycopyrrolate Inhaled-Formoterol has moderate interactions with at least 349 other drugs
• Glycopyrrolate Inhaled-Formoterol has minor interactions with at least 28 other drugs

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 healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• All LABAs are contraindicated in patients with asthma without the use of a long-term asthma control medication; not indicated for the treatment of asthma

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Do not use more often than recommended, at higher doses than recommended, or in combination with additional therapy containing a LABA because of the risk of overdose; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic medicines; patients using the drug should not use another medicine containing a LABA for any reason
• Can produce paradoxical bronchospasm that may be life-threatening; treat immediately with an inhaled, short-acting bronchodilator, discontinue therapy, and institute alternative therapy
• Immediate hypersensitivity reactions have been reported after administration of formoterol or glycopyrrolate; if signs suggesting allergic reactions occur angioedema (including difficulties in breathing or swallowing, swelling of tongue, lips, and face), urticaria, or skin rash, therapy should be stopped at once and alternative treatment considered
• Therapy should be used with caution in patients with narrow-angle glaucoma; prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (. eg, eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion and corneal edema); instruct patients to consult a physician immediately should any of these signs or symptoms develop
• Therapy should be used with caution in patients with urinary retention; prescribers and patients should be alert for signs and symptoms of urinary retention (eg, difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder neck obstruction; instruct patients to consult a physician immediately should any of these signs or symptoms develop
• Like all medications containing sympathomimetic amines, this medication should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines
• Beta2-agonist medicines may produce transient hyperglycemia in some patients; the clinical significance is unknown
• LABAs can produce clinically significant cardiovascular effects, including increases in pulse rate or systolic or diastolic blood pressure; if such effects occur, therapy may need to be discontinued; beta-agonists have also been reported to produce electrocardiographic changes, such as flattening of the T wave, prolongation of the QTc interval, and ST-segment depression; clinical significance of these findings is unknown; the drug should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
• Doses of the related beta2-agonist albuterol, when administered IV, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis owing to transient hyperglycemia; use caution
• LABAs may produce significant hypokalemia, which has the potential to produce adverse cardiovascular effects; in patients with severe COPD, hypokalemia may be potentiated by hypoxia and concomitant treatment, which may increase the susceptibility for cardiac arrhythmias; the decrease in serum potassium is usually transient, not requiring supplementation
• Asthma-related events
  • The safety and efficacy in patients with asthma are not established; not indicated for the treatment of asthma
  • Use of LABA as monotherapy, without inhaled corticosteroids (ICS), for asthma associated with increased risk of asthma-related death
  • Available data from controlled clinical trials also suggest that the 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 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
  • No trial adequate to determine whether the rate of asthma-related deaths is increased in patients treated with this drug combination has been conducted
  • Available data do not suggest an increased risk of death with the use of LABA in patients with COPD
• Deterioration of disease and acute episodes
  • Therapy should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition; this drug has not been studied in patients with acutely deteriorating COPD; using the drug in this setting is inappropriate
  • Therapy should not be used for the relief of acute symptoms, (eg, as rescue therapy for the treatment of acute episodes of bronchospasm; the drug 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 initiating 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 medicines and use them only for symptomatic relief of acute respiratory symptoms
  • When prescribing the drug, the 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 a period of hours or chronically over several days or longer; if the drug no longer controls the symptoms of bronchoconstriction or the patient’s inhaled, short-acting beta2-agonist becomes less effective, or the patient needs more inhalations 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 beyond the recommended dose is not appropriate in this situation

Pregnancy and Lactation

• There are no well-controlled human trials that have investigated the effects on preterm labor or labor at term; because beta 2 agonists may potentially interfere with uterine contractility, the drug should be used during labor only if the potential benefit justifies the potential risk
• Single-dose studies in humans found that a very small amount of glycopyrrolate passed the placental barrier
• Lactation
  • There are no available data on the effects of glycopyrrolate, or formoterol fumarate on breastfed children or milk production
  • There are no available data on the presence of glycopyrrolate or formoterol fumarate in human milk
  • Formoterol fumarate and glycopyrrolate have been detected in the plasma of undoped rat pups suckling from exposed dams; the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for therapy and any potential adverse effects on the breastfed child from the drug or underlying maternal condition