Budesonide / Formoterol

Budesonide/formoterol is a combination inhaler used to manage chronic breathing conditions. It is available under the brand names Symbicort and Breyna, as well as the generic budesonide and formoterol fumarate dihydrate inhalation aerosol.

• Treats asthma in patients 6 years of age and older (all available strengths)
• Intended for asthma patients not adequately controlled on an inhaled corticosteroid alone, or who need both an inhaled corticosteroid and a long-acting bronchodilator
• Symbicort 160/4.5 mcg and Breyna 160 mcg/4.5 mcg: maintenance treatment to improve airflow in COPD, including chronic bronchitis and/or emphysema (this strength only)
• Symbicort 160/4.5 mcg and Breyna 160 mcg/4.5 mcg: reduce the frequency of COPD flare-ups (exacerbations)
• Not indicated for the relief of sudden, acute breathing attacks — a separate rescue inhaler is needed

This inhaler contains two active ingredients that target different aspects of lung disease. Budesonide is a potent anti-inflammatory corticosteroid — it dials down the immune cells and chemical signals (such as histamine, leukotrienes, and cytokines) that cause airway swelling and irritation. Formoterol is a long-acting beta-2 adrenergic agonist — it binds to receptors on the muscles surrounding the airways, causing them to relax and widen so air can flow more freely. The anti-inflammatory action helps control the underlying disease over time, while the bronchodilating action helps keep airways open on a day-to-day basis.

Because budesonide is delivered directly to the lungs and is rapidly broken down in the liver when any is swallowed, most of its activity stays local in the airway — this limits the amount that gets into the rest of the body and reduces systemic steroid side effects.

These inhalers are taken by mouth inhalation only, twice a day — once in the morning and once in the evening, roughly 12 hours apart. The strength used depends on whether you are being treated for asthma or COPD, and your age and disease severity — follow your prescriber's instructions exactly. Do not take more than 2 inhalations of your prescribed strength twice daily.

• Shake the inhaler well before each use
• Prime it with 2 test sprays before first use, and re-prime after 7 or more days of non-use or if it has been dropped
• Rinse your mouth with water after each use — spit it out, do not swallow
• If you miss a dose, take it as soon as you remember; if it is almost time for your next dose, skip the missed one and continue your regular schedule — do not double up

The most commonly reported side effects include:

• Nasopharyngitis (cold-like symptoms — runny nose, sore throat)
• Headache
• Upper respiratory tract infections
• Pharyngolaryngeal pain (sore or irritated throat)
• Sinusitis
• Oral candidiasis (yeast infection in the mouth or throat — rinsing after use helps prevent this)
• Nausea or stomach discomfort
• Bronchitis (more common in COPD patients)

More serious reactions to watch for include sudden worsening of breathing, fast or irregular heartbeat, chest pain, signs of severe allergic reaction (swelling, hives, trouble breathing), vision changes, or white patches in the mouth. Contact your doctor or seek emergency care right away if these occur.

• LABA risk in asthma: Long-acting bronchodilators like formoterol can increase the risk of serious asthma-related events when used alone. In this fixed combination with budesonide, clinical data do not show a significant added risk — but do not use any other long-acting bronchodilator at the same time.
• Not a rescue inhaler: This medication cannot treat sudden breathing attacks. Always have a separate short-acting rescue inhaler available.
• Mouth and throat yeast infections: Oral candidiasis (thrush) can develop — rinse your mouth with water after every dose and do not swallow the water.
• Increased infection risk: Inhaled corticosteroids can suppress the immune system. Chickenpox and measles can be more serious in people using corticosteroids. Avoid exposure and tell your doctor if you are exposed.
• Pneumonia (COPD patients): Symptoms of pneumonia and COPD flare-ups can overlap — see your doctor if your breathing worsens or you develop a fever.
• Adrenal suppression: Long-term use or high doses may affect your body's natural steroid production; do not stop suddenly if you have been on high doses — taper as directed.
• Bone, eye, and growth effects: Long-term use may lower bone density, increase the risk of glaucoma or cataracts, and slow growth in children. Regular monitoring is recommended.
• Heart and metabolic effects: This inhaler can raise blood sugar and lower potassium; use with caution if you have diabetes, a heart condition, or a seizure disorder.

Tell your doctor and pharmacist about all medications you take — several drug classes interact with budesonide/formoterol:

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, clarithromycin, itraconazole): slow the breakdown of budesonide, raising steroid levels in the blood and the risk of systemic steroid side effects
• MAO inhibitors and tricyclic antidepressants (e.g., phenelzine, amitriptyline): amplify formoterol's cardiovascular effects — use with extreme caution and within 2 weeks of stopping these drugs
• Beta-blockers (including eye drops, e.g., propranolol, timolol): can block formoterol's bronchodilating effect and may trigger severe airway tightening, especially in asthma
• Non-potassium-sparing diuretics (loop or thiazide diuretics, e.g., furosemide, hydrochlorothiazide): combined with formoterol, can worsen low blood potassium and abnormal heart rhythms
• Other long-acting beta-2 agonists (LABAs): must not be used together with this inhaler — doing so increases the risk of overdose and serious cardiovascular side effects

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Do not use if you are allergic to budesonide, formoterol, or any other ingredient in this inhaler
• This inhaler must not be used as the primary treatment for a severe, sudden asthma or COPD attack requiring emergency care
• Tell your doctor if you have a heart condition, high blood pressure, or irregular heartbeat — formoterol can affect the heart
• Tell your doctor if you have diabetes — this medicine can raise blood sugar levels
• Tell your doctor if you have a seizure disorder, an overactive thyroid (thyrotoxicosis), or osteoporosis
• Tell your doctor if you have glaucoma or cataracts — the medication requires eye monitoring
• Tell your doctor if you have active tuberculosis, a fungal, bacterial, or viral infection, or herpes of the eye
• Pregnant women: poorly controlled asthma carries its own risks to the pregnancy; discuss the benefit-risk balance with your doctor; inhaled budesonide has not been shown to increase the risk of birth defects in human studies
• Breastfeeding: budesonide passes into breast milk; discuss with your doctor before using
• Children 6 to under 12 years: growth should be monitored regularly during treatment
• Liver disease: patients with hepatic impairment should be monitored for increased drug exposure and related side effects

Taking too much of this inhaler — particularly the formoterol component — can cause an exaggeration of its usual effects: rapid or irregular heartbeat, chest pain, tremor, headache, dizziness, low blood potassium, high blood sugar, nausea, and in severe cases, seizures or cardiac arrest. Too much budesonide over a long period can cause adrenal suppression (the body's own cortisol production is reduced). If an overdose is suspected, stop using the inhaler and seek medical care immediately; cardiac monitoring is recommended. There is not enough evidence to say whether dialysis helps with formoterol overdose.

In clinical studies, budesonide/formoterol inhalers improved lung function (measured as FEV1 — the amount of air exhaled forcefully in one second) compared to budesonide alone. At higher doses of formoterol, small increases in heart rate and blood sugar, and small decreases in blood potassium, were observed — but no clinically significant abnormal heart rhythms were detected in studies of asthma or COPD patients. In COPD patients on long-term treatment, urinary cortisol measurements showed approximately 30% lower levels compared to placebo, indicating some effect on the body's natural cortisol (stress hormone) production.

After inhalation, budesonide is rapidly absorbed from the lungs, reaching peak blood levels in about 20 minutes, with a half-life of roughly 4.7 hours. A significant portion of any budesonide that is swallowed is broken down in the liver before it reaches the bloodstream (85–95% first-pass metabolism), which limits systemic steroid exposure. Formoterol is also rapidly absorbed after inhalation, with peak blood levels reached within 5–10 minutes; much of the inhaled dose that reaches the throat is swallowed and absorbed from the gut. Both medicines accumulate modestly with twice-daily dosing and reach steady-state levels within a few days of regular use.

Store at controlled room temperature 20°C to 25°C (68°F to 77°F) . Store the inhaler with the mouthpiece down. Keep out of the reach of children.