Symbicort (budesonide/formoterol fumarate) — ASTRAZENECA

Maintenance therapy for asthma
Bronchospasm prevention with COPD
Maintenance therapy for asthma
Prevention of bronchospasm with chronic bronchitis
Prevention of bronchospasms with emphysema
160 mcg-4.5 mcg/actuation HFA aerosol inhaler
Inhale 2 puffs by inhalation route 2 times per day in the morning andevening

80 mcg-4.5 mcg/actuation HFA aerosol inhaler
Inhale 2 puffs by inhalation route 2 times per day in the morning andevening

Maintenance therapy for asthma
Dosage Type: Hfa aerosol with adapter (gram)
Inhale 2 puffs by inhalation route 2 times per day in the morning andevening
Inhale 2 puffs by inhalation route 2 times per day in the morning andevening

Prevention of bronchospasms with emphysema
Inhale 2 puffs by inhalation route 2 times per day in the morning andevening
Severe Warnings
Congenital long QT syndrome
Herpes simplex infection
Hypokalemia
Inactive tuberculosis
Ocular herpes simplex
Ocular hypertension
Parasitic infection
Prolonged QT interval
Pulmonary tuberculosis
Varicella contact
Varicella zoster virus infection
Contraindicated
Acutely deteriorating asthma
Moderate Warnings
Cardiac arrhythmia
Cataracts
Chronic myocardial ischemia
Diabetes mellitus
Glaucoma
Hypercortisolism
Hypertension
Oropharyngeal candidiasis
Osteopenia
Osteoporosis
Seizure disorder
Thyrotoxicosis
Less Frequent
Severe
Chest pain
Tremor

Less Severe
Abdominal pain with cramps
Acute bacterial otitis media
Bronchitis
Bruising
Cramps
Dysgeusia
Dyspnea
Ecchymosis
Fever
General weakness
Headache disorder
Insomnia
Nausea
Pain
Skin rash
Syncope
Vomiting
Xerostomia
More Frequent
Severe
None

Less Severe
Allergic rhinitis
Cough
Diarrhea
Dizziness
Dyspepsia
Gastroenteritis
Headache disorder
Insomnia
Nasal congestion
Nausea
Oral candidiasis
Pharyngitis
Sinusitis
Sore throat
Upper respiratory infection
Voice change
Vomiting
Xerostomia
Rare / Very Rare
Severe
Adrenal cortical insufficiency
Anaphylaxis
Angina
Angioedema
Asthma exacerbation
Atrial fibrillation
Cardiac arrhythmia
Cataracts
Drug-induced psychosis
Eosinophilic granulomatosis with polyangiitis
Glaucoma
Hypercortisolism
Hyperglycemia
Hypertension
Hypokalemia
Hypotension
Immunosuppression
Malaise
Metabolic acidosis
Ocular hypertension
Osteopenia
Paradoxical bronchospasm
Tachycardia
Urticaria
Ventricular premature beats

Less Severe
Aggressive behavior
Arthralgias
Contact dermatitis
Cough
Depression
Esophageal candidiasis
Fatigue
Flu-like symptoms
Irritability
Nervousness
Palpitations
Pruritus of skin
Skin rash
Symptoms of anxiety
Urticaria
More information
Contraindicated
None

Severe Precaution
Budesonide_Formoterol (low dose)
1 Day – 6 Years
Risk of decreased growth rate. Safety and efficacy not established age<6 years.
Glucocorticoid_LA-Beta Agonist
1 Day – 12 Years
Safety and efficacy not established age<12 years. Do not use for acute asthma. Risk of decreased growth rate.

Management or Monitoring Precaution
Budesonide (Aerosol Pwder_Misc)
6 Years – 18 Years
May reduce growth rate; monitor growth and use lowest effective dose.
Glucocorticoid_Formoterol
12 Years – 18 Years
May reduce growth velocity, monitor growth rate. Not for acute asthma event. Titrate to lowest effective dose.
Budesonide (inhal, Nasal)
Severity Level: 2
Additional Notes: Current evidence supports use of inhaled corticosteroids for asthma tx in preg

Formoterol Fumarate
Severity Level: 2
Additional Notes: Insufficient human data available

More information
Contraindicated
None

Precaution Exists
Budesonide
GeneralExcretion PotentialEffect on InfantNotes
Evaluate use carefullyExcretedNot known; no or inclusive dataReported amount in breastmilk < 1% of maternal dose w/ inhalation.
Formoterol
GeneralExcretion PotentialEffect on InfantNotes
Evaluate use carefullyUnknownNot known; no or inclusive dataExcret in rat studies;Low plasma levels,amt excret unlikely to be clin signif

No Known Risk
None
More information
Contraindicated
None

Precaution Exists
Formoterol
Cardiovascular-Use caution in severe cardiovascular diseases (e.g. coronary insufficiency, aneurysm) since beta-agonists increase heart rate and blood pressure. Endocrine-Use caution in poorly controlled hyperthyroidism or diabetes.
Organ / SystemHEPRENCARDENDONEURO / PSYCHPULM
Increased Risk / Adverse EffectsNNYYNN
BEERS: N   HEDIS: N   STOPP: N

No Known Risk
None
Bronchospasm prevention with COPD
J44Other chronic obstructive pulmonary disease
J44.9Chronic obstructive pulmonary disease, unspecified
Maintenance therapy for asthma
J45Asthma
J45.2Mild intermittent asthma
J45.20Mild intermittent asthma, uncomplicated
J45.3Mild persistent asthma
J45.30Mild persistent asthma, uncomplicated
J45.4Moderate persistent asthma
J45.40Moderate persistent asthma, uncomplicated
J45.5Severe persistent asthma
J45.50Severe persistent asthma, uncomplicated
J45.9Other and unspecified asthma
J45.90Unspecified asthma
J45.909Unspecified asthma, uncomplicated
Prevention of bronchospasm with chronic bronchitis
J41Simple and mucopurulent chronic bronchitis
J41.0Simple chronic bronchitis
J41.1Mucopurulent chronic bronchitis
J41.8Mixed simple and mucopurulent chronic bronchitis
J42Unspecified chronic bronchitis
J44Other chronic obstructive pulmonary disease
J44.9Chronic obstructive pulmonary disease, unspecified
Prevention of bronchospasms with emphysema
J43Emphysema
J43.0Unilateral pulmonary emphysema [macleod's syndrome]
J43.1Panlobular emphysema
J43.2Centrilobular emphysema
J43.8Other emphysema
J43.9Emphysema, unspecified
J44Other chronic obstructive pulmonary disease
J44.9Chronic obstructive pulmonary disease, unspecified
0-9 A-Z
J41 Simple and mucopurulent chronic bronchitis
J41.0 Simple chronic bronchitis
J41.1 Mucopurulent chronic bronchitis
J41.8 Mixed simple and mucopurulent chronic bronchitis
J42 Unspecified chronic bronchitis
J43 Emphysema
J43.0 Unilateral pulmonary emphysema [macleod's syndrome]
J43.1 Panlobular emphysema
J43.2 Centrilobular emphysema
J43.8 Other emphysema
J43.9 Emphysema, unspecified
J44 Other chronic obstructive pulmonary disease
J44 Other chronic obstructive pulmonary disease
J44 Other chronic obstructive pulmonary disease
J44.9 Chronic obstructive pulmonary disease, unspecified
J44.9 Chronic obstructive pulmonary disease, unspecified
J44.9 Chronic obstructive pulmonary disease, unspecified
J45 Asthma
J45.2 Mild intermittent asthma
J45.20 Mild intermittent asthma, uncomplicated
J45.3 Mild persistent asthma
J45.30 Mild persistent asthma, uncomplicated
J45.4 Moderate persistent asthma
J45.40 Moderate persistent asthma, uncomplicated
J45.5 Severe persistent asthma
J45.50 Severe persistent asthma, uncomplicated
J45.9 Other and unspecified asthma
J45.90 Unspecified asthma
J45.909 Unspecified asthma, uncomplicated

Data included with permission and copyrighted by First DataBank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgement of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Diagnosis codes are provided for reference only. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatement.