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Budesonide/Glycopyrrolate/Formoterol Fumarate is available as a metered dose inhaler containing a combination of budesonide (160 mcg), glycopyrrolate (9 mcg), and formoterol fumarate (4.8 mcg) per inhalation.

Budesonide/Glycopyrrolate/Formoterol Fumarate is a IC/ LAMA/LABA that is used to treat chronic obstructive pulmonary disease (COPD).

Budesonide/Glycopyrrolate/Formoterol Fumarate is a combination of three medications used for COPD that work together to relax and open up the airways in your lungs so you can breathe more easily.

• Budesonide is an inhaled corticosteroid (IC). It lowers inflammation (swelling) in your lungs, which helps control COPD symptoms
• Glycopyrrolate is a long-acting muscarinic antagonist (LAMA). In your lungs, the medication blocks the activity of a natural chemical in your body called acetylcholine. This helps open up your airways, which helps you breathe easier
• Formoterol is a long-acting beta-2 agonist (LABA). It helps relax the muscles in your airways and make it easier to breathe

The typical dose of Budesonide/Glycopyrrolate/Formoterol Fumarate is 2 inhalations (or puffs) by mouth twice daily (taken as 2 puffs in the morning and 2 puffs in the evening).

Budesonide/Glycopyrrolate/Formoterol Fumarate is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or to any
of the excipients.

Common side effects of Budesonide/Glycopyrrolate/Formoterol Fumarate:

• Upper respiratory tract infection (common cold, runny nose)
• Pneumonia
• Back pain
• Oral thrush
• Flu
• Muscle spasms
• Urinary tract infection (UTI)
• Cough
• Sinus infection
• Diarrhea

Serious side effects are rare with Budesonide/Glycopyrrolate/Formoterol Fumarate. Contact your healthcare provider immediately if you experience any of the following.

• Breathing problems: sudden shortness of breath, difficulty breathing, coughing, wheezing
• Overdose: heart attack, chest pain, fast or abnormal heart rate, dizziness, anxiety, headache, tremor, dry mouth, muscle spasms, nausea, tiredness, hard time sleeping (insomnia)
• Allergic reactions: hives, swelling of the lips, tongue, or throat, rash, difficulty breathing, anaphylaxis (type of allergic reaction)

The following medications may interact with Budesonide/Glycopyrrolate/Formoterol Fumarate:

• Strong cytochrome P450 3A4 inhibitors (e.g. ritonavir): Use with caution
• May cause systemic corticosteroid effects
• Other adrenergic drugs may potentiate effect: Use with caution
• Diuretics, xanthine derivatives or steroids may potentiate hypokalemia or ECG changes. Use with caution
• Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system
• Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm
• Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of Budesonide/Glycopyrrolate/Formoterol Fumarate with other anticholinergic-containing drugs

Various FDA-approved generic manufacturers

It is not known if Budesonide/Glycopyrrolate/Formoterol Fumarate can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Budesonide/Glycopyrrolate/Formoterol Fumarate. You and your healthcare provider will decide if you should take Budesonide/Glycopyrrolate/Formoterol Fumarate while you are pregnant.

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