Monograph Details
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Respiratory Tract
> Asthma/COPD
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SYMBICORT 80/4.5 |
| Manufacturer |
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AstraZeneca Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Corticosteroid + long-acting β2-agonist. |
| Generic Name |
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Budesonide 80mcg, formoterol fumarate dihydrate 4.5mcg; per inh; pressurized metered-dose inhaler. |
| Also |
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• SYMBICORT 160/4.5
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| Indications |
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Long-term maintenance treatment of asthma in patients ≥12yrs old not adequately controlled on other asthma-controller medications (eg, low-medium dose inhaled corticosteroids) or those whose disease severity clearly warrants starting treatment with two maintenance therapies. |
| Children |
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Not established (see literature). |
| Adults |
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Not adequately controlled on low-medium dose inhaled steroids: start with 80/4.5 strength. Not adequately controlled on medium-high dose inhaled steroids: start with 160/4.5 strength. If not currently on inhaled steroids: choose strength depending on asthma severity. If insufficient response after 1–2 weeks using 80/4.5 strength, may switch to 160/4.5 strength. For all: 2 inh twice daily (AM & PM). Rinse mouth after use. |
| Contraindications |
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Not for acute relief of bronchospasm. Do not initiate in significantly or acutely deteriorating asthma. |
| Precautions |
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Reevaluate periodically. Do not exceed recommended dose. Not for use with other long-acting β2-agonists or for transferring from oral steroids. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Hypokalemia. Severe hepatic impairment. Hyperresponsiveness to sympathomimetics. Diabetes. Hyperthyroidism. Ketoacidosis. Immunosuppressed. Tuberculosis. Untreated infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider anti-infective prophylactic therapies. If adrenal insufficiency exists following systemic corticosteroid therapy, replacement with inhaled corticosteroids may exacerbate symptoms of adrenal insufficiency (eg, lassitude). Prescribe a short-acting β2-agonist for acute symptoms; monitor for increased need. Monitor potassium, intraocular pressure, bone mineral density if other osteoporosis risk factors exist; and for growth suppression in adolescents; hypercorticism and HPA axis suppression. Pregnancy (Cat.C). Labor & delivery. Nursing mothers. |
| Interactions |
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Caution with MAOIs, tricyclic antidepressants, β-blockers, K+-depleting diuretics, long-term ketoconazole, other potent CYP3A4 inhibitors. |
| Adverse Reactions |
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Nasopharyngitis, pharyngolaryngeal pain, sinusitis, congestion, oral candidiasis, headache, upper respiratory infection, flu, back pain, GI upset; rarely: paradoxical bronchospasm, hypersensitivity reactions; severe asthma episodes; increased risk of asthma-related death. |
| How Supplied |
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Inhaler—10.2g (120 inh) |
| Additional Resources |
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• Related Prescribing Note |
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