Budesonide Inhaled-Formoterol-Glycopyrrolate Inhaled

Budesonide Inhaled-Formoterol-Glycopyrrolate Inhaled is a prescription medication used for maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD).

• Budesonide Inhaled-Formoterol-Glycopyrrolate Inhaled is available under the following different brand names: Breztri

Common side effects of Budesonide Inhaled-Formoterol-Glycopyrrolate Inhaled include:

• Throat pain or irritation.
• White patches in the mouth or throat.
• Headache, joint pain, and muscle spasms.
• Pounding heartbeats, feeling anxious.
• High blood sugar levels.
• Painful or difficult urination.
• Nausea,
• Diarrhea.
• Cough, hoarse voice.
• Flu symptoms; or
• Cold symptoms such as stuffy or runny nose, sneezing, sinus pain, and sore throat.

Serious side effects of Budesonide Inhaled-Formoterol-Glycopyrrolate Inhaled include:

• Hives. 
• Difficulty breathing. 
• Swelling of the face, lips, tongue, or throat.
• Worsened breathing problems.
• Wheezing, choking, or other breathing problems after using this medication.
• Tremors, nervousness, chest pain, fast or pounding heartbeats.
• Sores or white patches in your mouth and throat, pain when swallowing.
• Flu symptoms, body aches, and unusual tiredness.
• Painful or burning when you urinate, little or no urination.
• Blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights.
• Low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in the chest, increased thirst or urination, numbness or tingling, muscle weakness, or limp feeling.
• Signs of a lung infection--fever, chills, cough with mucus, chest pain, feeling short of breath; or
• Signs of a hormonal disorder--tiredness or weakness, feeling light-headed, nausea, vomiting.

Rare side effects of Budesonide Inhaled-Formoterol-Glycopyrrolate Inhaled 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, loss of coordination, feeling 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

• 160 mcg/9 mcg/4.8 mcg per inhalation

Chronic Obstructive Pulmonary Disease

Adult dosage

• 2 oral 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, health care provider, or pharmacist first.

• Budesonide Inhaled-Formoterol-Glycopyrrolate Inhaled has severe interactions with the following drug
  • umeclidinium bromide/vilanterol inhaled
• Budesonide Inhaled-Formoterol-Glycopyrrolate Inhaled has serious interactions with at least 68 other drugs.
• Budesonide Inhaled-Formoterol-Glycopyrrolate Inhaled has moderate interactions with at least 322 other drugs.
• Budesonide Inhaled-Formoterol-Glycopyrrolate Inhaled 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 your products. 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, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Safety and efficacy not established for asthma; use of long-acting beta2-adrenergic agonists (LABAs) as monotherapy (. e, without inhaled corticosteroids) for asthma is associated with increased risk of asthma-related death; data do not suggest an increased risk of death with LABAs in patients with COPD
• Do not initiate in patients with acutely deteriorating COPD, which may be a life-threatening condition; use only for maintenance and not as a rescue therapy
• Patients who have been taking inhaled, short-acting beta2 agonists regularly should discontinue these drugs when budesonide/formoterol/glycopyrrolate inhaled is initiated
• Excess use or use with other long-acting beta2 agonists may result in overdose, clinically significant cardiovascular effects, and fatalities
• Oropharyngeal candidiasis is associated with orally inhaled corticosteroids; advised patients to rinse their mouth with water and without swallowing
• Lower respiratory tract infections, including pneumonia, were reported following inhaled corticosteroids
• Immunosuppressive drugs (.g, corticosteroids) use increases susceptibility to infection; some infections may be more serious or fatal compared with others not taking corticosteroids
• Caution if patients are being transferred from systemic corticosteroids; monitor for adrenal insufficiency, particularly for patients maintained on physiologic doses (.g, above 20 mg/day of prednisone, or equivalent)
• Hypercriticism and adrenal suppression may occur if the dose is exceeded
• Oral inhaled therapies can produce paradoxical bronchospasm, which may be life-threatening; if this occurs, permanently discontinue, and treat immediately with an inhaled, short-acting bronchodilator
• Hypersensitivity, including anaphylaxis, reported; allergic reactions including angioedema, urticaria, or rash may occur; discontinue the drug
• Beta2 agonists can produce clinically significant cardiovascular effects (. g, increased heart rate, and blood pressure, arrhythmias, ECG changes)
• Decreased bone mineral density observed with long-term administration of corticosteroids
• Use of long-term corticosteroids or inhaled anticholinergics associated with glaucoma, cataracts, or worsening of narrow-angle glaucoma
• Caution in patients with urinary retention (. g, prostatic hyperplasia, bladder-neck obstruction)
• Caution with sympathomimetic use in patients with convulsive disorders or thyrotoxicosis; beta2 agonists may aggravate preexisting diabetes mellitus and ketoacidosis
• Beta-agonists may produce significant hypokalemia and transient hyperglycemia
• Drug interaction overview
  • Strong CYP3A4 inhibitors
    • Exercise caution
    • Coadministration with strong CYP3A4 inhibitors may increase budesonide systemic exposure
  • Adrenergic drugs
    • Exercise caution
    • Coadministration of formoterol with other adrenergic drugs may cause additive sympathetic effects
    • Xanthine derivatives, corticosteroids, or diuretics
  • Monitor for hypokalemia
    • Coadministration of beta2 agonists (. g, formoterol) with xanthine derivatives, corticosteroids, or diuretics may potentiate the risk of hypokalemia
    • The hypokalemia and/or ECG changes that may result from nonpotassium-sparing diuretics may be worsened by beta2 agonists, especially if the beta2 agonist dose exceeded
  • MAOIs, TCAs, or QTc prolonging drugs
    • Use extreme caution with beta2 agonists in patients treated with MAOIs, TCAs, or other drugs known to prolong QTc interval owing to the additive action of adrenergic agonists on the cardiovascular system
  • Beta-blockers
    • Beta-blockers inhibit the therapeutic effect of beta2 agonists and may also produce severe bronchospasm
    • Patients with COPD should normally not use beta blockers, except under certain circumstances (. g, prophylaxis after MI); consider cardioselective beta blockers when necessary
  • Anticholinergics
  • Monitor
    • Coadministration of glycopyrrolate with anticholinergic medications may cause additive effects

Pregnancy and Lactation

• Data are not available for glycopyrrolate or formoterol fumarate in pregnant women; however, studies are available for budesonide
• Studies (Swedish registries) of pregnant women who received inhaled budesonide alone during pregnancy did not show an increased risk of abnormalities
• Clinical considerations
• Labor or delivery: No well-controlled human trials; because of the potential for beta-agonists interfering with uterine contractility, restrict use during labor to patients in whom benefits outweigh risks
• Lactation
  • Data are not available for glycopyrrolate or formoterol fumarate in lactating women; however, studies are available for budesonide
  • Budesonide dry powder inhalation shows the total daily oral dose of budesonide available in breast milk to the infant is approximately 0.3-1% of the maternal inhaled dose