What you need to know about symbicort (budesonide and formoterol)

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Symbicort is a combination inhaler used to fight asthma and maintain airflow in people with chronic obstructive pulmonary disease (COPD) . It contains an inhaled corticosteroid called budesonide, which helps relieve airway inflammation, and a long-acting bronchodilator called formoterol fumarate dihydrate, which helps keep the airways open.

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Symbicort is not used as a life- saving inhaler , but provides long-term treatment for obstructive airway diseases such as asthma and COPD. While Symbicort is safe, convenient, and effective, it is not for everyone.

The first generic symbicort, simply called a budesonide / formoterol inhaler, was approved by the Food and Drug Administration (FDA) in February 2020 and costs about half the cost of symbicort.

Applications

Symbicort is approved for adults and children ages 6 and up.

Symbicort was approved by the FDA for asthma in 2006; was licensed for the treatment of COPD in 2009. The combination drug is used to provide long-term control of persistent asthma symptoms and to maintain airflow in people with COPD, including chronic bronchitis or emphysema .

Each of the drugs contained in Symbicort has a different effect on the respiratory tract:

  • Budesonide , also found in the Pulmicort one- way inhaler , is a corticosteroid (steroid) drug that blunts an overactive immune response that causes inflammation. Corticosteroids are synthetic medications that mimic the natural hormone cortisol produced by the adrenal glands.
  • Formoterol is a long-acting beta-agonist (LABA) that relaxes the smooth muscles of the airways so that they expand and remain open.

These effects are beneficial for people with reversible obstructive airway disease by reducing hyperresponsiveness that causes airway spasms and reducing bronchospasm , making it difficult for air to leave the lungs.

Asthma is considered a reversible obstructive disease because symptoms can be relieved and breathing can normalize with little long-term damage to the airways.

COPD is only partially reversible because airway damage tends to progress even after treatment. However, combination inhalers like Symbicort can slow the progression of the disease, even in those in an advanced stage.

Use not indicated on the label

On rare occasions, healthcare professionals have been known to prescribe combination inhalers such as Symbicort for the treatment of severe or recurrent bronchitis not associated with COPD.

This practice is not only undesirable, but also extremely harmful. Because inhaled corticosteroids suppress the immune system, they can prolong respiratory infections or promote secondary infections, increasing the risk of pneumonia .

Before using

Symbicort is generally prescribed when more conservative treatments fail to cure asthma or COPD. The indications for each disease are different.

In asthma, this is usually a lack of symptom control, generally defined as the need to use an emergency inhaler more than twice a week. In such cases, a daily inhaled corticosteroid on its own may be prescribed, followed by the addition of LABA as needed. LABA is never used alone to treat asthma.

Many public health authorities, including the Global Asthma Initiative (GINA), recommend combining inhaled corticosteroids and LABAs first rather than taking a gradual approach to asthma management .

In COPD, the indications are slightly different. According to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) , the combined use of inhaled corticosteroids and LABA is intended for people with severe COPD (defined as two or more exacerbations or one or more hospitalizations per year). Inhaled corticosteroids are rarely, if ever, used alone to treat COPD .

Although pulmonary function tests may be ordered to assess lung function, it is the frequency of exacerbations (called "seizures") that will ultimately determine whether Symbicort is appropriate.

Precautions and considerations

Symbicort should never be used by people with a known or suspected allergy to budesonide or formoterol.

Since cross-allergy between corticosteroids is common, Symbicort should be used with caution if you have ever had an allergic reaction to other inhaled steroids, such as:

People with certain pre-existing medical conditions should also use caution when taking Symbicort, as long-term use of corticosteroids can affect the eyes, decrease bone mineralization, and affect adrenal function. The benefits and risks of treatment for people with:

Symbicort is not contraindicated for these conditions, but it can aggravate them. See your doctor regularly to monitor the progression of these pre-existing conditions if you are using Symbicort.

Any child who has not been vaccinated against measles or chickenpox or who has not previously had this infection should be vaccinated before starting treatment. Due to its immunosuppressive action, Symbicort can aggravate these childhood infections and, in some cases, be fatal. If an unvaccinated child got measles or chickenpox while taking Symbicort, tell your doctor.

Symbicort may also be unacceptable if you have a pre-existing serious infection that has not been cured, including tuberculosis , shingles , and other serious bacterial, fungal, viral, or parasitic infections. Due to the immunosuppressive effect of Symbicort, its use may be postponed until the infection is completely cured.

Animal studies suggest a potential risk of fetal harm with Symbicort, but there are no well-controlled human studies. In some cases, the benefits of treatment may outweigh the risks.

If you are pregnant, planning to become pregnant, or breastfeeding, talk to your doctor before using Symbicort to fully understand the benefits and risks of the treatment for you.

Dose

Symbicort is available as a metered dose inhaler (MDI) , a type of inhaler that uses an aerosol propellant to deliver the drug deep into the lungs.

It has two different strengths:

  • 80 micrograms (mcg) of budesonide and 4.5 mcg of formoterol, 60 inhalations per canister
  • 160 mcg budesonide and 4.5 mcg formoterol, 120 puffs per balloon

The recommended dose depends on the age, the type of disease and the severity of the disease. In some cases, a lower starting dose may be recommended and only increased if control is not achieved. The maximum daily dose should never be exceeded.

Symbicort Recommended Dosage
Use for Age Dose
Asthma 6-11 years 2 puffs 80 / 4.5 mcg every 12 hours
Asthma 12 years and up 2 inhalations 80 / 4.5 mcg or 160 / 4.5 mcg every 12 hours
COPD Adults 2 inhalations of 160 / 4.5 mcg every 12 hours

Symbicort can provide relief in 15 minutes, but the full benefits of the medication can only be felt after two or more weeks of continuous use.

Call your healthcare provider if your condition has not improved after a week of use, your symptoms get worse, you need to use the emergency inhaler for two or more days in a row, or your peak flow meter reading is getting worse.

Symbicort is not intended to be used permanently by everyone. Once symptoms are under control, treatment can be reduced to low to moderate doses of inhaled corticosteroids, if necessary.

How to take and store

People who have had asthma for some time are often familiar with DIs like Symbicort. The devices are relatively easy to use, but require coordination of hand movements and breathing to ensure that the correct amount of medicine reaches the lungs.

The Symbicort MDI inhaler is used as follows:

  1. If you are using the inhaler for the first time (or have not used it for more than seven days), you will need to prime the device by shaking it for five seconds and releasing the test spray. Do this twice. If you have used the inhaler in the past seven days, shake it for five seconds and skip the test sprays.
  2. Remove the cap from the mouthpiece. Attach a spacer if desired.
  3. Exhale fully to empty your lungs.
  4. While holding the balloon upright, place the mouthpiece (or spacer) in your mouth and close your lips to snuggle up tightly.
  5. When you squeeze the trigger, inhale hard and deeply through your mouth only. (Some people pinch their nostrils or use a nose clip to stop breathing through their nose.)
  6. Hold your breath for 10 seconds.
  7. Breathe out slowly.
  8. Shake the can again for five seconds and repeat steps 3 through 7.
  9. When done, replace the mouthpiece cap.
  10. Rinse your mouth well with water and spit it out. Do not drink water.

Each time you press the inhaler, a built-in counter will tell you how many doses are left. Remember to fill in the recipe when the counter approaches 20.

You will need to clean the inhaler every seven days by wiping the inside and outside of the mouthpiece with a clean, dry cloth or cloth. Do not disassemble the inhaler or immerse it in water. (You can remove and wash the spacer with soap and water, but remember to dry it completely before use.)

MDI Symbicort inhalers can be stored at room temperature, ideally between 68 and 77 degrees F. Store the inhaler with the mouthpiece down. Do not pierce the container or place it near a heat source, as this may cause an explosion.

Never use an expired inhaler. Keep out of the reach of children and pets.

Side effects

Like all medicines, Symbicort can cause side effects. If they do occur, they are usually mild and generally improve as your body adjusts to the treatment. If symptoms persist or worsen, inform your doctor.

general

The side effects of both Symbicort drugs are similar, although people tend to have more gastrointestinal side effects when taking higher doses of the drug. For this reason, whenever possible, the lowest possible dose should be used.

However, the frequency of symptoms varies with the Symbicort 80 / 4.5 μg inhaler and the Symbicort 160 / 4.5 μg inhaler.

Among the side effects that affect at least 1% of Symbicort users, in order of frequency of occurrence :

Symbicort 80 / 4.5 mcg
Symbicort 160 / 4.5 mcg

One of the most common symptoms of using inhaled corticosteroids is oral yeast infection (thrush) . Rinsing your mouth well after each treatment and using a spacer can go a long way in avoiding this common fungal infection.

Severe form

People with asthma who take inhaled corticosteroids are at increased risk for pneumonia due to the immunosuppressive effects of the drug. If you develop pneumonia or a severe lower respiratory infection, you may need to temporarily stop taking Symbicort to prevent symptoms from getting worse .

People with COPD who take inhaled corticosteroids are also at increased risk for pneumonia. But interestingly, budenoside was found to be the only steroid that does not increase risk in these people .

In rare cases, Symbicort can cause a reaction known as paradoxical bronchospasm, in which respiratory symptoms worsen rather than improve after use. While this is more common with emergency inhalers than LABA-containing inhalers, it can still happen .

Equally rare is a life-threatening allergy known as anaphylaxis , in which exposure to budesonide or formoterol can cause serious bodily reactions. If left untreated, anaphylaxis can lead to shock, coma, heart or respiratory failure, and death.

When used in people with pre-existing adrenal insufficiency, Symbicort can further suppress cortisol production to the point of causing an adrenal crisis . This can cause shock and death, especially in young children .

All conditions should be considered a medical emergency.

When to seek emergency help
Signs and symptoms Can indicate
Fever, chills, extreme fatigue, shortness of breath, shallow breathing, bloody or green phlegm, and sharp chest pain when inhaling or coughing Pneumonia
Wheezing, shortness of breath, cough, and chest pain after using an asthma inhaler Paradoxical bronchospasm
Rash or hives, shortness of breath, wheezing, heart palpitations, flushing, dizziness, confusion, clammy skin, swelling of the face or tongue, and "feeling of impending doom" Anaphylaxis
Pain in the abdomen or side, dizziness, fatigue, fever, nausea, vomiting, confusion, profuse sweating, heart palpitations, and rapid breathing. Adrenal crisis

Warnings and interactions

Corticosteroid / LABA combination inhalers have long had a black box warning informing consumers that this class of drugs may increase the risk of asthma-related death. The warning was based on a 28-week trial in 2006 in which a related LABA called salmeterol caused 13 deaths among 13,179 users .

Subsequent studies have shown that while a single dose of LABA can be harmful, combination inhalers like Symbicort do not pose such a risk because the dose of LABA is so small. In 2017, the FDA approved the removal of the black box warning from all combination steroid / LABA inhalers .

Taking higher doses of Symbicort will not improve your asthma or COPD symptoms. It can cause tremors, tremors, chest pain, fast or irregular heartbeats, nausea, vomiting, and seizures. Severe overdose may require hospitalization with cardiac monitoring and intravenous beta -blockers to counteract the effects of LABAs .

Do not take beta blockers if you have signs of an overdose. Treatment must be done under medical supervision and some beta-blockers can cause asthma attacks if used incorrectly.

About combinations

Symbicort may interact with certain medications that use the same liver enzyme cytochrome P450 (CYP450) for metabolism. Competition for CYP450 can cause adverse changes in the blood concentrations of one or both drugs.

Among the drugs of greatest concern are those that strongly inhibit CYP450, including:

  • Azole antifungals such as Nizoral (ketoconazole) and Sporanox (itraconazole)
  • HIV protease inhibitors such as Norvir (ritonavir), Kaletra (ritonavir / lopinavir), Reyataz (atazanavir), Crixivan (indinavir), and Invirase (saquinavir)
  • Macrolide antibiotics such as clarithromycin and zithromax (azithromycin)
  • Ketolide antibiotics such as Ketek (telithromycin)
  • Serzon (nefazodone) , a type of antidepressant

Other medications can cause side effects and should be used with extreme caution, including:

  • Beta- blockers , including beta-blocker eye drops, can cause bronchospasm in some people with asthma who take Symbicort.
  • Diuretics ("water pills") can cause heart abnormalities and hypokalemia when used with Symbicort.
  • Antidepressants that are monoamine oxidase inhibitors (MAOIs) can cause heart symptoms when used with Symbicort.

In some cases, dose adjustments or dividing doses by one or more hours may be all that is needed to mitigate interactions. In other cases, the drug may need to be replaced.

To avoid interactions, tell your doctor about all the medications you take, including prescription, over-the-counter, herbal, or recreational medications.

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