Symbicort 160/4.5mcg (120 Oral Inh)

Budesonide is an inhaled corticosteroid (ICS) that exerts potent anti-inflammatory effects by binding to glucocorticoid receptors, inhibiting inflammatory cells (e.g., mast cells, eosinophils, lymphocytes, macrophages, neutrophils) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines). This reduces bronchial hyperreactivity and inflammation. Formoterol is a long-acting beta2-adrenergic agonist (LABA) that selectively stimulates beta2-adrenergic receptors in the lung, leading to relaxation of bronchial smooth muscle and bronchodilation. It also inhibits the release of mediators from mast cells.

Urgent 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 immediate medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of a weak adrenal gland: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision.
Chest pain or pressure.
Rapid or abnormal heartbeat.
Shakiness.
Feeling nervous or excitable.
Bone pain.
Dizziness or fainting.
Seizures.
Severe nausea or vomiting.
Extreme fatigue or weakness.
Difficulty sleeping.
Abnormal burning, numbness, or tingling sensations.
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 mouth sores.

Important Warning: This medication can cause severe breathing problems, which may be life-threatening. If you experience difficulty breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek immediate medical attention.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Headache.
Stomach pain.
Nose or throat irritation.
Signs of a common cold.
Back pain.
Nausea or vomiting.

This is not an exhaustive list of possible side effects. 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.

Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose of any medication without first consulting your doctor.

Important Warnings and Cautions

When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.

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. If your breathing problems worsen, your rescue inhaler is less effective, or you need to use it more frequently, contact your doctor immediately.

Do not exceed the recommended dose or frequency of this medication, as overdoses have been fatal. Consult your doctor if you have any concerns.

When transitioning from an oral steroid to another form of steroid, you may be at risk for severe and potentially life-threatening side effects, including weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, contact your doctor right away.

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

Long-term use of this medication may increase the risk of cataracts or glaucoma. Consult your doctor and undergo regular eye exams as recommended.

Prolonged use may also lead to osteoporosis (weak bones). Discuss your risk factors and concerns with your doctor.

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

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.

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.

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

Specific Warning for COPD Patients

If you have Chronic Obstructive Pulmonary Disease (COPD), you are at a higher risk of developing pneumonia. This medication may further increase this risk; consult your doctor to discuss the potential risks and benefits.

• Other long-acting beta2-adrenergic agonists (LABAs) - increased risk of cardiovascular adverse effects.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) - significantly increase systemic exposure to budesonide, leading to potential for Cushing's syndrome and adrenal suppression.
• Beta-adrenergic blockers (including ophthalmic) - may antagonize the bronchodilating effect of formoterol and produce severe bronchospasm, especially in patients with asthma.
• QT-prolonging drugs (e.g., quinidine, disopyramide, procainamide, phenothiazines, tricyclic antidepressants) - additive effect on QT interval, increasing risk of ventricular arrhythmias.
• Diuretics (e.g., loop or thiazide diuretics) - may potentiate hypokalemia and/or ECG changes associated with beta-agonists, especially at high doses.

• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs) - may potentiate the cardiovascular effects of formoterol (e.g., hypertension, tachycardia). Use with extreme caution.
• Other sympathomimetic agents - additive effects on cardiovascular system; use with caution.
• Non-potassium-sparing diuretics - increased risk of hypokalemia.

• Not specifically categorized as minor; most interactions are significant due to the nature of the active ingredients.

• Worsening asthma or COPD symptoms (e.g., increased shortness of breath, wheezing, cough)
• Increased need for rescue inhaler (short-acting beta-agonist)
• Chest pain or discomfort
• Palpitations or rapid heart rate
• Tremor or nervousness
• Signs of oral candidiasis (white patches in mouth or throat)
• Hoarseness or dysphonia
• Signs of infection (e.g., fever, increased sputum, change in sputum color)
• Allergic reactions (e.g., rash, hives, swelling of face/mouth/tongue, severe bronchospasm)

Symbicort is classified as Pregnancy Category C. There are no adequate and well-controlled studies of Symbicort in pregnant women. Budesonide is generally considered one of the preferred inhaled corticosteroids for asthma management during pregnancy due to extensive human data suggesting low risk. Formoterol has shown reproductive toxicity in animal studies. Symbicort should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Budesonide is excreted into human milk, but at therapeutic doses, the amount is considered negligible and unlikely to harm a breastfed infant. Formoterol is also excreted into human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Symbicort and any potential adverse effects on the breastfed infant from Symbicort or from the underlying maternal condition. Use with caution.

Approved for asthma in patients 6 years of age and older. Not approved for COPD in pediatric patients. Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth velocity. The lowest effective dose should be used.

No specific dosage adjustment is required based on age. However, elderly patients may be more susceptible to the cardiovascular effects of beta-agonists (e.g., tremor, palpitations, increased heart rate, blood pressure changes) and may have comorbidities (e.g., cardiovascular disease, diabetes, osteoporosis, glaucoma) that require careful monitoring or dose adjustment of concomitant medications. Use with caution and monitor for adverse effects.

• Symbicort is a maintenance medication and should be used consistently, twice daily, not as a rescue inhaler for acute symptoms.
• Proper inhaler technique is crucial for effective drug delivery. Patients should be instructed and re-instructed on how to use the inhaler correctly.
• Rinsing the mouth with water and spitting it out after each dose helps prevent oral candidiasis (thrush) and dysphonia.
• Patients should always have a short-acting beta-agonist (SABA) rescue inhaler available for acute bronchospasm.
• The Black Box Warning for LABAs applies to the formoterol component, emphasizing that LABAs should not be used as monotherapy for asthma and that Symbicort is not for acute relief.
• Monitor for systemic corticosteroid effects, especially with high doses or prolonged use, such as adrenal suppression, bone density changes, and ocular effects (cataracts, glaucoma).

• Inhaled Corticosteroid (ICS) monotherapy (e.g., budesonide, fluticasone, mometasone)
• Long-Acting Beta2-Adrenergic Agonist (LABA) monotherapy (not for asthma, e.g., formoterol, salmeterol)
• Long-Acting Muscarinic Antagonist (LAMA) (e.g., tiotropium, umeclidinium)
• Short-Acting Beta2-Adrenergic Agonist (SABA) (e.g., albuterol, levalbuterol)
• Oral corticosteroids (for exacerbations or severe disease)
• Leukotriene receptor antagonists (e.g., montelukast)
• Phosphodiesterase-4 inhibitors (e.g., roflumilast - for severe COPD)
• Biologic therapies (e.g., omalizumab, mepolizumab, benralizumab, dupilumab - for severe asthma)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.