Company:

AstraZeneca

Antiasthmatic (corticosteroid + long-acting β₂-agonist)

Budesonide 160mcg, formoterol fumarate dihydrate 4.5mcg; per inh; pressurized metered-dose inhaler.

SYMBICORT 80/4.5

Budesonide 80mcg, formoterol fumarate dihydrate 4.5mcg; per inh; pressurized metered-dose inhaler.

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.

Symbicort combines the antiinflammatory agent, budesonide, with the long-acting selective β₂-agonist, formoterol, in a single metered-dose oral inhaler.

Improvements in efficacy endpoints (eg, 12-hour-average post-dose FEV₁ at week 2, and pre-dose FEV₁ over the course of the study) were greater with Symbicort than with budesonide or formoterol given alone. Significant improvement in FEV₁ occurred within 15 minutes of beginning therapy with Symbicort. Improvement in asthma control occurred within one day.

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.

Not established (see literature).

Not for acute relief of bronchospasm. Do not initiate in significantly or acutely deteriorating asthma.

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.

Caution with MAOIs, tricyclic antidepressants, β-blockers, K+-depleting diuretics, long-term ketoconazole, other potent CYP3A4 inhibitors.

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.

Inhaler—10.2g (120 inh)

For more information visit www.Symbicort.com.

6/27/07