Symbicort: Advanced Control for Asthma and COPD
| Product dosage: 100 mcg + 6 mcg | |||
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| Product dosage: 200 mcg + 6 mcg | |||
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| Product dosage: 400 mcg + 6 mcg | |||
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Synonyms | |||
Symbicort (budesonide/formoterol fumarate dihydrate) is a combination maintenance inhaler prescribed for the long-term management of asthma in patients 6 years and older and for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It functions as both an inhaled corticosteroid (ICS) to reduce inflammation and a long-acting beta2-adrenergic agonist (LABA) to relax airway muscles. This dual mechanism provides comprehensive control, helping to prevent symptoms and exacerbations. It is not indicated for the relief of acute bronchospasm.
Features
- Active Ingredients: Contains budesonide (an inhaled corticosteroid) and formoterol (a long-acting bronchodilator).
- Delivery System: Utilizes a pressurized metered-dose inhaler (pMDI) with an integrated dose counter.
- Available Strengths: Comes in two dosage formulations: 80/4.5 mcg and 160/4.5 mcg (budesonide/formoterol per inhalation).
- Mechanism: Combines anti-inflammatory action with sustained bronchodilation.
- Dose Counter: Features an integrated counter to track remaining inhalations for adherence management.
Benefits
- Provides dual therapy in a single inhaler, simplifying treatment regimens and improving compliance.
- Effectively reduces airway inflammation, decreasing the frequency and severity of asthma exacerbations.
- Offers sustained bronchodilation, improving lung function and exercise tolerance in COPD patients.
- Helps achieve better overall symptom control, leading to improved quality of life and reduced rescue inhaler use.
- May reduce the need for oral corticosteroids in some patients with severe asthma.
- Supports long-term management with a well-established safety and efficacy profile.
Common use
Symbicort is commonly used for the maintenance treatment of asthma in patients whose disease is not adequately controlled with inhaled corticosteroids alone or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting beta2-agonist. In COPD, it is indicated for the long-term maintenance treatment of airflow obstruction, including to reduce exacerbations in patients with a history of exacerbations.
Dosage and direction
For asthma maintenance in patients 12 years and older, the recommended dosage is 2 inhalations twice daily (morning and evening, approximately 12 hours apart). The strength (80/4.5 mcg or 160/4.5 mcg) is determined based on disease severity and prior therapy. For patients 6 to under 12 years, the recommended dosage is 2 inhalations of Symbicort 80/4.5 mcg twice daily. For COPD, the recommended dosage is 2 inhalations of Symbicort 160/4.5 mcg twice daily. The mouth should be rinsed with water without swallowing after each dose to reduce the risk of oropharyngeal candidiasis. Shake well before each inhalation. The inhaler must be primized before first use or if not used for more than 7 days.
Precautions
Patients should be instructed that Symbicort is not to be used for the relief of acute symptoms. An acute exacerbation may require a course of oral corticosteroids. There is an increased risk of pneumonia in patients with COPD; patients should be monitored for signs and symptoms of pneumonia. Systemic and local corticosteroid effects, such as adrenal suppression, may occur, particularly at higher doses over prolonged periods. A reduction in bone mineral density may be seen with long-term administration of inhaled corticosteroids. There is also a risk of increased intraocular pressure, glaucoma, and cataracts. Patients may experience cardiovascular effects, such as increases in pulse rate or blood pressure. Hypersensitivity reactions, including anaphylaxis, may occur. Paradoxical bronchospasm may occur immediately after dosing, requiring alternative therapy. Patients should be cautioned regarding the avoidance of cytochrome P450 3A4 inhibitors. Hypokalemia and hyperglycemia may occur.
Contraindications
Symbicort is contraindicated in patients with a known hypersensitivity to budesonide, formoterol, or any ingredient in the formulation. Its primary use to treat acute symptoms or acute exacerbations is not recommended and it is not a substitute for rescue medication. It should not be initiated in patients with significantly worsening or acutely deteriorating asthma or COPD.
Possible side effect
Common side effects (≥5% incidence) include nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis. Serious side effects can include pneumonia (in COPD patients), cardiovascular effects (chest pain, hypertension, tachycardia, arrhythmias), paradoxical bronchospasm, immunosuppression and increased risk of infections, adrenal insufficiency, hypercorticism, reduction in bone mineral density, growth suppression in children and adolescents, glaucoma and cataracts, and hypersensitivity reactions (including rash, urticaria, and anaphylaxis).
Drug interaction
Concomitant use with other adrenergic drugs (e.g., other LABAs) may potentiate sympathetic effects and increase the risk of cardiovascular toxicity. Use with strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) may increase budesonide systemic exposure and increase the risk of systemic corticosteroid effects. Diuretics, xanthine derivatives, or steroids may potentiate hypokalemia or ECG changes. Beta-blockers (including eye drops) may antagonize the effects of formoterol and may produce severe bronchospasm in patients with asthma or COPD. Monoamine oxidase inhibitors and tricyclic antidepressants may potentiate the vascular effects of sympathomimetics.
Missed dose
If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take two doses at one time to make up for a missed dose.
Overdose
Overdosage may potentiate the effects of both components. Symptoms may include tachycardia, arrhythmias, tremor, headache, muscle cramps, dry mouth, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, and convulsions. Cardiac arrest and even death may occur. Supportive measures are indicated, with attention to cardiac and respiratory status. There is no specific antidote. Treatment should be symptomatic and supportive.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Do not freeze. Keep the canister away from heat and open flame. Store with the mouthpiece down. Keep out of reach of children. Discard the inhaler when the counter reads “0” or 3 months after removal from the foil pouch, whichever comes first.
Disclaimer
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here.
Reviews
(Clinical summary based on prescribing information and studies) Symbicort has demonstrated significant efficacy in numerous large-scale clinical trials. In asthma, it has been shown to provide superior asthma control compared to monotherapy with its individual components, significantly improving lung function (FEV1), reducing symptom days, and decreasing the rate of severe exacerbations. In COPD, studies have shown it improves lung function, health status, and reduces the rate of moderate and severe exacerbations compared to placebo and monocomponents. Its safety profile is well-characterized, with the most common adverse events being mild and local in nature. It is considered a cornerstone of maintenance therapy for appropriate patients within its indicated populations.