SYMBICORT 80/4.5 Rx

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SYMBICORT 80/4.5

Asthma/COPD
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Generic Name and Formulations:

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

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Indications for SYMBICORT 80/4.5:

Treatment of asthma in patients ≥6yrs old not adequately controlled on long-term asthma-control medications (eg, inhaled corticosteroids) or those whose disease severity clearly warrants starting treatment with both an inhaled corticosteroid and LABA.

Limitations Of use:

Not for relief of acute bronchospasm.

Adult:

Allow approximately 12hrs between doses. Asthma: Base initial dose on asthma severity. 2 inh of 80/4.5 or 160/4.5 twice daily (AM & PM). If insufficient response after 1–2 weeks using 80/4.5 strength, may switch to 160/4.5 strength. Max 2 inh of 160/4.5 twice daily. Titrate to lowest effective strength after adequate response. COPD: 2 inh of 160/4.5 twice daily. Rinse mouth after use.

Children:

Allow approximately 12hrs between doses. Asthma: <6yrs: not established. 6–<12yrs: 2 inh of 80/4.5 twice daily (AM & PM). Rinse mouth after use. COPD: not indicated.

Contraindications:

Primary treatment of status asthmaticus or acute attacks of asthma or COPD where intensive measures required.

Warnings/Precautions:

Increased risk of asthma-related deaths and hospitalizations. Do not initiate in rapidly or acutely deteriorating COPD or asthma. Not for use with other long-acting β2-agonists. Do not exceed recommended dose. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral ­prophylactic therapies. Monitor for adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress, a severe COPD exacerbation, or a severe asthma attack. May unmask previously suppressed allergic conditions. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), growth in children, intraocular pressure, glaucoma, or cataracts. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Eosinophilic conditions. Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Hepatic impairment; monitor. Assess bone mineral density if risk factors exist (eg, osteoporosis, postmenopausal). Labor & delivery. Pregnancy. Nursing mothers.

Interactions:

Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin), during or within 2 weeks of discontinuing MAOIs or tricyclic antidepressants, β-blockers (consider cardioselective), K+-depleting diuretics.

See Also:

SYMBICORT 160/4.5

Pharmacological Class:

Corticosteroid + long-acting beta-2 agonist (LABA).

Adverse Reactions:

Nasopharyngitis, pharyngolaryngeal pain, sinusitis, congestion, oral candidiasis, headache, upper respiratory infection, flu, back pain, GI upset; hypersensitivity reactions, risk of asthma-related death. COPD: bronchitis.

How Supplied:

Inhaler—10.2g (120 inh)