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BREYNA (budesonide/formoterol fumarate)
- controller medication for asthma
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
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
Default screening record
- Inhale 2 puffs by inhalation route 2 times per day in the morning andevening
- None
Contraindicated
- boceprevir
- bromocriptine
- cabergoline
- Cafergot
- Compound 347
- Cycloset
- D.h.e.45
- dihydroergotamine
- elvitegr-cobicist-emtric-tenof
- enflurane
- ergoloid
- Ergomar
- ergotamine tartrate
- ergotamine-caffeine
- Forane
- Incivek
- isoflurane
- Kaletra
- Korlym
- lopinavir-ritonavir
- methylergonovine
- Mifeprex
- mifepristone
- Migergot
- Migranal
- Norvir
- Norvir Soft Gelatin
- Parlodel
- ritonavir
- sevoflurane
- Sojourn
- Stribild
- telaprevir
- Terrell
- Ultane
- Victrelis
Severe
Moderate
- amoxicil-clarithromy-lansopraz
- Avelox
- Avelox Abc Pack
- Avelox In Nacl (iso-osmotic)
- Biaxin
- Biaxin Xl
- Biaxin Xl Pak
- Cipro
- Cipro In D5W
- Cipro Xr
- ciprofloxacin
- ciprofloxacin (mixture)
- ciprofloxacin in D5W
- clarithromycin
- Erythrocin
- erythromycin
- erythromycin-sulfisoxazole
- itraconazole
- ketoconazole
- Levaquin
- Levaquin In 5 % Dextrose
- levofloxacin
- levofloxacin in D5W
- moxifloxacin
- moxifloxacin in NaCl (iso-osm)
- norfloxacin
- Noroxin
- ofloxacin
- Omeclamox-pak
- omeprazole-clarith-amoxicillin
- Onmel
- Prevpac
- Sporanox
- Sporanox Pulsepak
- None
Contraindicated
- Fungal infection
- Ocular hypertension
- Osteoporosis
- Parasitic infection
Severe
Moderate
- Active tuberculosis
- Cardiac arrhythmia
- Cataracts
- Chickenpox
- Chronic myocardial ischemia
- Diabetes mellitus
- Disease of liver
- Glaucoma
- Hypertension
- Hypokalemia
- Hypothalamic-pituitary insufficiency
- Immunosuppression
- Measles
- Osteopenia
- Pheochromocytoma
- Seizure disorder
- Thyrotoxicosis
BREYNA (budesonide/formoterol fumarate)
- controller medication for asthma
- None
- 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
More Frequent
Severe
Less Severe
- Chest pain
- Tremor
- Abdominal pain with cramps
- Acute bacterial otitis media
- Bronchitis
- Bruising
- Cough
- Cramps
- Dysgeusia
- Dyspnea
- Ecchymosis
- Fever
- General weakness
- Headache disorder
- Insomnia
- Nausea
- Pain
- Skin rash
- Syncope
- Vomiting
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Adrenocortical 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
- Arthralgia
- Contact dermatitis
- Depression
- Esophageal candidiasis
- Fatigue
- Flu-like symptoms
- Irritability
- Nervousness
- Palpitations
- Pruritus of skin
- Skin rash
- Symptoms of anxiety
- Urticaria
Contraindicated
None
Severe Precaution
Budesonide_Formoterol (low dose)
Risk of decreased growth rate. Safety and efficacy not established age<6 years.
Safety and efficacy not established age<12 years. Do not use for acute asthma. Risk of decreased growth rate.
- 1 Day – 6 Years
- Risk of decreased growth rate. Safety and efficacy not established age<6 years.
- 1 Day – 12 Years
- Risk of decreased growth rate. Safety and efficacy not established age<6 years.
Glucocorticoid_LA-Beta Agonist
Risk of decreased growth rate. Safety and efficacy not established age<6 years.
Safety and efficacy not established age<12 years. Do not use for acute asthma. Risk of decreased growth rate.
- 1 Day – 6 Years
- Safety and efficacy not established age<12 years. Do not use for acute asthma. Risk of decreased growth rate.
- 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)
May reduce growth rate; monitor growth and use lowest effective dose.
May reduce growth velocity, monitor growth rate. Not for acute asthma event. Titrate to lowest effective dose.
- 6 Years – 18 Years
- May reduce growth rate; monitor growth and use lowest effective dose.
- 12 Years – 18 Years
- May reduce growth rate; monitor growth and use lowest effective dose.
Glucocorticoid_Formoterol
May reduce growth rate; monitor growth and use lowest effective dose.
May reduce growth velocity, monitor growth rate. Not for acute asthma event. Titrate to lowest effective dose.
- 6 Years – 18 Years
- May reduce growth velocity, monitor growth rate. Not for acute asthma event. Titrate to lowest effective dose.
- 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 and animal data available
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Budesonide
Reported amount in breastmilk < 1% of maternal dose w/ inhalation.
Insuff human data avail;Low plasma levels,amt excret unlikely to be clin sig
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Excreted | Not known; no or inclusive data | Reported amount in breastmilk < 1% of maternal dose w/ inhalation. |
Formoterol
Reported amount in breastmilk < 1% of maternal dose w/ inhalation.
Insuff human data avail;Low plasma levels,amt excret unlikely to be clin sig
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insuff human data avail;Low plasma levels,amt excret unlikely to be clin sig |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Bronchospasm prevention with COPD | |
| J44 | Other chronic obstructive pulmonary disease |
| J44.8 | Other specified chronic obstructive pulmonary disease |
| J44.89 | Other specified chronic obstructive pulmonary disease |
| J44.9 | Chronic obstructive pulmonary disease, unspecified |
| Maintenance therapy for asthma | |
| 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 |
| 0-9 | A-Z |
|---|---|
| J44 | Other chronic obstructive pulmonary disease |
| J44.8 | Other specified chronic obstructive pulmonary disease |
| J44.89 | Other specified chronic obstructive pulmonary disease |
| 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 |
Formulary Reference Tool