Budesonide Formoterol Glycopyrrolate

Budesonide, Formoterol, and Glycopyrrolate are prescription medications used in adults to help control the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 

• Budesonide, Formoterol, and Glycopyrrolate are available under various brand names: Breztri Aerosphere

Common side effects of Budesonide, Formoterol, and Glycopyrrolate 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, Formoterol, and Glycopyrrolate 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, Formoterol, and Glycopyrrolate 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 such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, 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

• Metered-dose inhaler (budesonide 160 mcg/glycopyrrolate 9 mcg/formoterol 4.8 mcg per actuation):
• Oral inhalation: 2 inhalations twice daily; maximum dose: 2 inhalations twice daily.

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, Formoterol, and Glycopyrrolate have severe interactions with the following drugs:
  • umeclidinium bromide/vilanterol inhaled
• Budesonide, Formoterol, and Glycopyrrolate have serious interactions with at least 67 other drugs.
• Budesonide, Formoterol, and Glycopyrrolate have moderate interactions with at least 321 other drugs.
• Budesonide, Formoterol, and Glycopyrrolate have 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 health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to Budesonide, Formoterol, and Glycopyrrolate

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Budesonide, Formoterol, and Glycopyrrolate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Budesonide, Formoterol, and Glycopyrrolate?”

Cautions

• Budesonide can weaken your immune system. Tell your doctor about any illness or infection you've had within the past several weeks.
• Budesonide, formoterol, and glycopyrrolate are not rescued medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.
• If this medication gets in your eyes, rinse with water and call your doctor if you have severe eye redness.
• Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a steroid such as budesonide.
• Ask your doctor before using a second inhaled bronchodilator that contains formoterol or a similar medicine (such as arformoterol, formoterol, indacaterol, olodaterol, salmeterol, or vilanterol).

Pregnancy and Lactation

• Tell your doctor if you are pregnant.
• 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

• Tell your doctor if you are breastfeeding.
• 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 ~0.3-1% of the maternal inhaled dose