Symbicort

Asthma Management

Symbicort is prescribed as a maintenance treatment for asthma in adults and children aged 6 years and older. It is used to help control and prevent symptoms such as:

• Wheezing
• Shortness of breath
• Coughing
• Chest tightness

This medication is typically used for patients whose asthma is not well-controlled on a long-term asthma-control medication or whose disease severity warrants treatment with two maintenance therapies.

Chronic Obstructive Pulmonary Disease (COPD)

In adults, Symbicort is used for the maintenance treatment of airflow obstruction caused by COPD. This includes conditions such as:

• Chronic bronchitis
• Emphysema

Regular use helps to improve lung function and may reduce the frequency of flare-ups or worsening symptoms over time.

Important Usage Information

Symbicort is a maintenance medication and should be used every day as directed by a healthcare provider. It is not a rescue inhaler and will not work fast enough to treat a sudden asthma attack or a sudden worsening of COPD symptoms. A separate fast-acting rescue inhaler is typically required for emergency situations.

How Symbicort Works

Symbicort is a combination inhaler that uses two different types of medicine to help manage lung conditions like asthma and chronic obstructive pulmonary disease (COPD).

Reducing Swelling

One part of the medication is budesonide, which is a corticosteroid. It works by targeting inflammation in the lungs. By reducing the swelling and irritation in the airways, it helps prevent the lungs from overreacting to triggers, which reduces the frequency of symptoms.

Relaxing Airway Muscles

The other part is formoterol, a long-acting bronchodilator. This ingredient works by relaxing the muscles that surround the breathing tubes in the lungs. When these muscles are relaxed, the airways stay open wider, allowing air to move more freely.

Together, these two ingredients provide a dual approach: one treats the underlying inflammation while the other keeps the physical passages open. This combination helps prevent symptoms such as wheezing, coughing, and shortness of breath throughout the day and night.

Common Side Effects

Many people using this medication do not experience serious side effects. Common symptoms may include:

• Headache
• Throat irritation or soreness
• Hoarseness or voice changes
• Coughing
• Stuffy or runny nose and sinus pain
• Nausea, vomiting, or stomach pain
• Back pain
• Muscle or bone pain
• Shaking (tremors) or nervousness
• Dizziness

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious side effects:

• Oral thrush: White patches in the mouth or on the tongue, or pain when swallowing.
• Signs of infection: Fever, chills, body aches, or persistent sore throat.
• Pneumonia: Increased mucus production, change in mucus color, fever, chills, increased cough, or difficulty breathing.
• Breathing problems: Sudden wheezing or chest tightness immediately after using the inhaler (paradoxical bronchospasm).
• Heart issues: Fast, pounding, or irregular heartbeat, chest pain, or high blood pressure.
• Vision changes: Blurred vision, eye pain, or seeing halos around lights.
• Low potassium levels: Muscle cramps, weakness, or irregular heart rhythms.
• High blood sugar: Increased thirst or frequent urination.
• Allergic reactions: Severe rash, hives, or swelling of the face, lips, or tongue.

To help prevent oral thrush, it is recommended to rinse your mouth with water and spit it out after each dose of the medication.

Not for Acute Symptoms

Symbicort is intended for maintenance treatment and should not be used to treat sudden, severe breathing problems. A separate rescue inhaler is required for acute attacks.

Infection Risks

Inhaled corticosteroids can lead to a fungal infection in the mouth or throat known as thrush. Rinsing the mouth with water and spitting it out after each dose is recommended to lower this risk. Patients with COPD may also face an increased risk of pneumonia while using this medication.

Adrenal and Systemic Concerns

Transitioning from oral corticosteroids to inhaled versions can lead to adrenal insufficiency, which can be serious. Long-term use of high doses may also cause systemic effects such as adrenal suppression or Cushing's syndrome.

Additional Precautions

• Cardiovascular Effects: The medication may affect heart rate and blood pressure. It should be used with caution in individuals with existing heart conditions.
• Bone and Eye Health: Long-term use may contribute to decreased bone mineral density or the development of glaucoma and cataracts.
• Paradoxical Bronchospasm: Some individuals may experience a sudden worsening of breathing immediately after use. If this occurs, the medication should be stopped.
• Immune System Suppression: This drug may make it harder for the body to fight infections. Exposure to chickenpox or measles should be avoided.
• Pediatric Growth: Children using inhaled corticosteroids may experience slower growth rates, requiring regular monitoring by a healthcare provider.

Pregnancy

There are no adequate and well-controlled studies of Symbicort in pregnant women. However, it is known that poorly controlled asthma during pregnancy can increase the risk of complications such as preeclampsia, low birth weight, and preterm delivery. Healthcare providers typically weigh the benefits of maintaining asthma control against the potential risks of the medication to the fetus.

One of the active ingredients, budesonide, has been used extensively in pregnant women with asthma, and data from these cases have generally not shown an increased risk of major birth defects. The other ingredient, formoterol, may potentially interfere with uterine contractions during labor and delivery.

Breastfeeding

It is known that budesonide is excreted in human breast milk. It is currently unknown whether formoterol passes into breast milk. Because many drugs are excreted in human milk, caution is advised when using Symbicort while breastfeeding. A healthcare provider can help determine if the benefits of the medication outweigh the potential risks to the nursing infant.

Available Forms

Symbicort is supplied as a pressurized metered-dose inhaler (MDI). This device is used for oral inhalation and delivers the medication as an aerosol spray.

The inhaler consists of a pressurized canister and a plastic actuator with a mouthpiece. Each device is designed to deliver a set number of sprays before it needs to be replaced.

FDA Approval and Indications

Symbicort was initially approved by the U.S. Food and Drug Administration (FDA) in 2006. It is currently approved for the following indications:

• Asthma: For the treatment of asthma in patients 6 years of age and older. It is intended for patients whose condition is not adequately controlled on a long-term asthma-control medication or whose disease severity warrants treatment with both an inhaled corticosteroid and a long-acting beta2-adrenergic agonist (LABA).
• COPD: For the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Regulatory History and Safety Updates

Previously, the FDA required a Boxed Warning for all medications containing a LABA due to concerns regarding an increased risk of asthma-related death. However, after reviewing extensive safety data from clinical trials, the FDA determined that when a LABA is used in combination with an inhaled corticosteroid (ICS), as it is in Symbicort, there is no significant increase in the risk of serious asthma-related events compared to using an ICS alone. As a result, the Boxed Warning was removed from the labeling for ICS/LABA combination products.

Symbicort is not approved for the treatment of acute bronchospasm or as a rescue medication for sudden breathing problems.

Generic Availability

The FDA has approved generic versions of budesonide and formoterol fumarate dihydrate inhalation aerosol. These generic alternatives are required to meet the same rigorous standards for quality, strength, and purity as the brand-name medication.

How Symbicort Manages Asthma

Symbicort is prescribed for the long-term treatment of asthma. It combines an inhaled corticosteroid, which targets the underlying inflammation in the airways, with a long-acting beta-agonist (LABA) that helps keep the airway muscles relaxed for at least 12 hours.

Daily Maintenance

For asthma management, Symbicort is used as a maintenance medication, meaning it must be taken every day to be effective. Regular use helps to:

• Prevent symptoms such as wheezing, coughing, and chest tightness.
• Reduce the risk of asthma flare-ups or exacerbations.
• Improve daily lung function and breathing capacity.

Rescue Use vs. Maintenance

While Symbicort is primarily a maintenance medication, it is not typically used to treat a sudden asthma attack that has already started. Patients should usually have a separate rescue inhaler available for quick relief of acute symptoms. However, you should follow the specific asthma action plan provided by your healthcare professional regarding when and how to use your inhalers.

Treatment Requirements

This medication is generally used for patients whose asthma is not well-controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid alone. It is intended to provide better control of symptoms and reduce the frequency of attacks when single-therapy treatments are insufficient.