Symbicort 80/4.5mcg (120 Oral Inh)

Budesonide is a potent glucocorticoid with anti-inflammatory properties. It reduces inflammation in the airways, decreasing bronchial hyperreactivity and mucus production. Formoterol is a long-acting selective beta2-adrenergic agonist (LABA) that stimulates beta2-receptors in the bronchial smooth muscle, leading to bronchodilation and relaxation of the airways. The combination provides both anti-inflammatory and bronchodilator effects.

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of high blood sugar, such as:
+ Confusion
+ Drowsiness
+ Excessive thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of a weak adrenal gland, such as:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Chest pain or pressure
Rapid or irregular heartbeat
Shakiness
Nervousness or excitability
Bone pain
Dizziness or fainting
Seizures
Severe nausea or vomiting
Fatigue or weakness
Sleep disturbances
Abnormal sensations, such as burning, numbness, or tingling
Flu-like symptoms
Sinus pain
Changes in vision, eye pain, or severe eye irritation
Redness or white patches in the mouth or throat
Mouth irritation or sores

Breathing Problems: A Life-Threatening Side Effect

This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:

Headache
Stomach pain
Nose or throat irritation
Common cold symptoms
Back pain
Nausea or vomiting

These are not all the possible side effects that may occur. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.

To ensure your safety, it is crucial to disclose all of your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.

Remember, this is not an exhaustive list of potential interactions. Therefore, it is vital to verify the safety of taking this medication with all of your medications and health problems. Never start, stop, or modify the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.

If you have diabetes (high blood sugar), consult your doctor, as this medication may increase your blood sugar levels. It may take up to 2 weeks to experience the full effects of this medication.

Monitoring and Emergency Situations

Immediately contact your doctor if your breathing problems worsen, your rescue inhaler becomes less effective, or you need to use it more frequently. Do not exceed the prescribed dose or frequency, as overdosing on this type of medication can be fatal. Consult your doctor if you have any concerns.

Transitioning from Oral Steroids

When switching from an oral steroid to another form of steroid, you may be at risk for severe and potentially life-threatening side effects. Be aware of symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and seek medical attention immediately if you experience any of these.

In cases of injury, surgery, or infection, you may require additional oral steroid doses to help your body cope with stress. Carry a warning card indicating that you may need extra steroids in certain situations.

Long-term Use and Potential Side Effects

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Schedule regular eye exams as recommended by your doctor.

Long-term use may also lead to osteoporosis (weak bones). Discuss your risk factors and any concerns with your doctor.

You may be more susceptible to infections; therefore, practice good hygiene by washing your hands frequently and avoiding close contact with people who have infections, colds, or flu.

Special Precautions

If you have not had chickenpox or measles before, avoid exposure to these illnesses, as they can be severe or even fatal in people taking steroid medications like this one. If you have been exposed, consult your doctor promptly.

If you are 65 or older, use this medication with caution, as you may be more prone to side effects.

In children and teenagers, this medication may affect growth in some cases. Regular growth checks may be necessary; consult your doctor for guidance.

Pregnancy, Breastfeeding, and COPD

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.

If you have chronic obstructive pulmonary disease (COPD), be aware that your risk of developing pneumonia is higher. This medication may further increase this risk; consult your doctor to discuss the potential risks and benefits.

• Acute bronchospasm or status asthmaticus (Symbicort is not a rescue inhaler)
• Primary treatment of severe acute attacks of asthma or COPD

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) - may increase systemic exposure to budesonide
• Other long-acting beta2-agonists (LABAs) - additive effects, increased risk of adverse cardiovascular events
• Non-selective beta-blockers (e.g., propranolol) - may antagonize the effect of formoterol and cause severe bronchospasm

• Diuretics (e.g., loop or thiazide diuretics) - may potentiate hypokalemia and/or ECG changes associated with beta-agonists
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs) - may potentiate the cardiovascular effects of formoterol
• QTc-prolonging drugs (e.g., quinidine, disopyramide, procainamide, phenothiazines, antihistamines) - increased risk of ventricular arrhythmias

• Not typically listed as clinically significant for this combination

• Worsening asthma or COPD symptoms (e.g., increased shortness of breath, wheezing, cough)
• Increased need for rescue inhaler (short-acting beta2-agonist)
• Oral candidiasis (white patches in mouth or throat)
• Hoarseness or dysphonia
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, mood changes)
• Signs of paradoxical bronchospasm (immediate worsening of breathing after inhalation)
• Cardiovascular symptoms (e.g., palpitations, chest pain, rapid heart rate, tremor)
• Vision changes (e.g., blurred vision, halos around lights)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is generally considered safer than other inhaled corticosteroids during pregnancy (Category B for budesonide alone), while formoterol is Category C. The combination is typically classified as Category C.

Budesonide is excreted in breast milk but is considered compatible with breastfeeding due to low systemic absorption and low infant exposure. Formoterol excretion into human milk is unknown, but systemic levels are low. Use with caution; weigh benefits of breastfeeding against potential risks to the infant.

Approved for asthma in patients 6 years of age and older. Monitor growth velocity regularly, as inhaled corticosteroids can affect growth. The lowest effective dose should be used.

No specific dose adjustment is required. However, elderly patients may be more susceptible to the cardiovascular effects of formoterol or systemic corticosteroid effects of budesonide due to comorbidities or polypharmacy. Monitor for adverse effects.

• Symbicort is a maintenance medication and should not be used for acute relief of bronchospasm. Patients should have a short-acting beta2-agonist (SABA) for rescue.
• Proper inhaler technique is crucial for efficacy. Patients should be instructed on how to use the inhaler correctly and to rinse their mouth after each dose to prevent oral candidiasis.
• The black box warning for LABAs regarding increased risk of asthma-related death applies to Symbicort. It should only be used in asthma patients for whom the benefits of an ICS/LABA combination outweigh the risks, or who are not adequately controlled on an ICS alone.
• Patients should be advised not to stop Symbicort abruptly, especially if on high doses, due to the risk of adrenal insufficiency.
• Monitor for signs of systemic corticosteroid effects, especially in children (growth) and patients on high doses or with predisposing factors (e.g., osteoporosis, glaucoma, cataracts, diabetes).

• Inhaled Corticosteroids (ICS) monotherapy (e.g., Pulmicort Flexhaler, Flovent HFA/Diskus)
• Long-Acting Beta2-Agonists (LABA) monotherapy (e.g., Serevent Diskus, Arcapta Neohaler) - generally not recommended for asthma without an ICS
• Long-Acting Muscarinic Antagonists (LAMA) (e.g., Spiriva HandiHaler/Respimat)
• Oral corticosteroids (for severe exacerbations)
• Leukotriene receptor antagonists (e.g., montelukast)
• Biologic therapies (e.g., omalizumab, mepolizumab, benralizumab, dupilumab) for severe asthma

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.