 budesonide and formoterol fumarate |
| Symbicort |
Pharmaceutical
company:
AstraZeneca International
www.astrazeneca.com |
Pharmacologic classification: steroid, beta adrenergic agonist
Therapeutic classification: antiasthmatic
Pregnancy risk category: C
AVAILABLE FORMS
Inhalation aerosol: 80 mcg budesonide and 4.5 mcg formoterol/metered spray; 160 mcg budesonide and 4.5 mcg formoterol/metered spray
INDICATIONS AND DOSAGES
Long-term treatment of asthma--
Adults and children age 12 years and older: Two inhalations b.i.d. (morning and evening) by oral inhalation; dosage should be based on severity of asthma and patient response; maximum daily dose 640 mcg budesonide/18 mcg formoterol.
CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients with known hypersensitivity to any component of the drug, with acute asthma attack, with concurrent use of inhaled long-acting beta agonist, and in breast-feeding women.
Use cautiously in patients with history of CV disease or hypertension, and during pregnancy.
INTERACTIONS
Drug-drug.
Diuretics: May increase risk of hypokalemia. Use together cautiously.
Potent CYP enzyme inhibitors such as ketoconazole: May increase serum budesonide levels. Use together cautiously.
ADVERSE REACTIONS
CNS: dizziness, headache, nervousness, pyrexia, tremors.
CV: palpitations.
GI: diarrhea, viral gastroenteritis, nausea, vomiting, stomach discomfort, oral candidiasis.
Musculoskeletal: back pain.
Respiratory: asthma, nasopharyngitis, URI, pharyngo-laryngeal pain, sinusitis, nasal congestion.
Other: back pain, dysphonia, influenza.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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