Symbicort

FDA label

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Titration Asthma: if inadequate response after 1-2 weeks on 80/4.5, replace with 160/4.5

Renal Undefined

Hepatic No formal PK studies in hepatic impairment; both components are predominantly cleared by hepatic metabolism and may accumulate in plasma - closely monitor patients with hepatic disease

Exceeding 2 inhalations BID or combining with another LABA risks formoterol overdose (cardiovascular effects, fatalities reported with excess sympathomimetics)

Instructions

• Oral inhalation only; doses morning and evening ~12 h apart, every day
• Rinse mouth with water WITHOUT swallowing after each dose (reduces oral candidiasis)
• Prime before first use, if unused >7 days, or if dropped: shake well 5 s, release 2 test sprays away from face
• Do not use more than 2 inhalations BID and do not use any additional LABA
• Use an inhaled short-acting beta2-agonist for acute symptoms between doses; stop regular SABA use when starting
• Not for acute bronchospasm or rapidly deteriorating asthma/COPD

Available strengths

• inhaler 80/4.5, 160/4.5 mcg

Contraindications

• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD requiring intensive measures

Cautions

• LABA monotherapy increases asthma-related death risk (SMART); ICS/LABA fixed-dose combos showed no significant increase vs ICS alone - always used here with ICS
• Not for acute symptoms or acutely deteriorating disease
• Do not use more often or at higher doses than recommended, and do not use with another LABA - excessive sympathomimetic use has caused clinically significant cardiovascular effects and fatalities
• Oropharyngeal candidiasis - rinse mouth after use
• Pneumonia and lower respiratory infection risk in COPD
• Immunosuppression: worsening of TB/fungal/bacterial/viral/parasitic infection, ocular herpes; severe chickenpox/measles in susceptible patients
• Adrenal suppression/hypercorticism; taper slowly when transferring from systemic corticosteroids and watch for adrenal insufficiency during stress or severe asthma exacerbation
• Caution with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole) - increased systemic corticosteroid exposure
• Paradoxical bronchospasm and upper airway symptoms - discontinue if they occur
• Immediate hypersensitivity reactions: urticaria, angioedema, rash, bronchospasm
• Excessive beta-adrenergic stimulation: seizures, angina, hyper/hypotension, tachycardia up to 200 bpm, arrhythmias, tremor, palpitation, nervousness, insomnia
• Reduction in bone mineral density; reduced growth velocity in pediatric patients - monitor growth and titrate to the lowest effective strength
• Glaucoma, increased intraocular pressure and cataracts - consider periodic eye examinations
• Rare systemic eosinophilic conditions/Churg-Strauss syndrome, usually on reduction or withdrawal of oral corticosteroids
• Caution in convulsive disorders, thyrotoxicosis, unusual responsiveness to sympathomimetic amines, and in patients with cardiovascular disorders or diabetes/ketoacidosis
• Hypokalemia and hyperglycemia from beta-agonist effect

Adverse reactions

• Asthma (>=3%): nasopharyngitis, headache, URTI, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, oral candidiasis
• COPD (>=3%): nasopharyngitis, oral candidiasis, bronchitis, sinusitis, viral URTI
• Postmarketing: tachyarrhythmias/palpitations, hypercorticism, growth velocity reduction (peds), cataract/glaucoma, anaphylaxis/angioedema, hyperglycemia, hypokalemia, tremor, behavior/sleep disturbances, dysphonia

Pregnancy No adequate human studies of the combination; human data with inhaled budesonide alone show no increased malformation risk; poorly controlled asthma itself raises perinatal risk — maintain asthma control

Lactation Budesonide present in human milk (~0.3-1% of maternal inhaled dose reaches infant); no data for formoterol in human milk; weigh benefit vs risk