BREYNA 160 ug/1

Budesonide and Formoterol Fumarate · AEROSOL, METERED · Mylan Pharmaceuticals Inc.

No Recall History

Plain English

BREYNA is a aerosol, metered containing budesonide and formoterol fumarate at 160 ug/1, taken respiratory (inhalation). Manufactured by Mylan Pharmaceuticals Inc..

Key Facts

Brand Name: BREYNA
Generic Name: Budesonide and Formoterol Fumarate
NDC Code (Product): 0378-7503
Manufacturer: Mylan Pharmaceuticals Inc.
Strength: 160 ug/1
Dosage Form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: ANDA211699
Drug Class: Corticosteroid [EPC]
Marketing Start: 07/31/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

device delivery system issue195 reports

wrong technique in product usage process144 reports

device malfunction131 reports

dyspnoea108 reports

device issue93 reports

cough87 reports

product substitution issue87 reports

off label use80 reports

drug ineffective79 reports

wrong technique in device usage process70 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE BREYNA is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: • Treatment of asthma in patients 6 years of age and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. ( 1.2 ) Important limitations: • Not indicated for the relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma BREYNA is indicated for the treatment of asthma in patients 6 years of age and older. BREYNA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta 2 -adrenergic agonist (LABA). Important Limitations of Use: • BREYNA is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease BREYNA 160 mcg/4.5 mcg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) inclu…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For oral inhalation only. • Treatment of asthma in patients 12 years and older: 2 inhalations of BREYNA 80 mcg/4.5 mcg or 160 mcg/4.5 mcg twice daily. Starting dosage is based on asthma severity. ( 2.2 ) • Treatment of asthma in patients aged 6 to less than 12 years: 2 inhalations of BREYNA 80 mcg/4.5 mcg twice daily. ( 2.2 ) • Maintenance treatment in COPD: 2 inhalations of BREYNA 160 mcg/4.5 mcg twice daily. ( 2.3 ) 2.1 Administration Information BREYNA should be administered as 2 inhalations twice daily (morning and evening, approximately 12 hours apart), every day by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing. Prime BREYNA before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well before each spray and releasing two test sprays into the air away from the face. More frequent administration or a higher number of inhalations (more than 2 inhalations twice daily) of the pr…

Contraindications

4 CONTRAINDICATIONS The use of BREYNA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required. • Hypersensitivity to any of the ingredients in BREYNA. • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures ( 4 ) • Hypersensitivity to any of the ingredients in BREYNA ( 4 )

Drug Interactions

7 DRUG INTERACTIONS In clinical studies, concurrent administration of budesonide and formoterol fumarate dihydrate inhalation aerosol and other drugs, such as short-acting beta 2 -agonists, intranasal corticosteroids, and antihistamines/decongestants has not resulted in an increased frequency of adverse reactions. No formal drug interaction studies have been performed with budesonide and formoterol fumarate dihydrate inhalation aerosol. • Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. ( 7.1 ) • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol on vascular system. ( 7.2 ) • Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.3 ) • Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non-potassium-sparing diuretics may worsen with concomitant beta-agonists. ( 7.4 ) 7.1 Inhibitors of Cytochrome P4503A4 The main route of metabolism of corticosteroids, including budesonide, a component of BREYNA, is via cytochrome P450 (CYP) isoe…

Adverse Reactions

6 ADVERSE REACTIONS LABA use may result in the following: • Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1) ] . • Cardiovascular and central nervous system effects [see Warnings and Precautions (5.12) ] . Systemic and inhaled corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions (5.4) ] • Pneumonia or lower respiratory tract infections in patients with COPD [see Warnings and Precautions (5.5) ] • Immunosuppression [see Warnings and Precautions (5.6) ] • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8) ] • Growth effects in pediatric patients [see Warnings and Precautions (5.14) ] • Glaucoma and cataracts [see Warnings and Precautions (5.15) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (incidence ≥ 3%) are: • Asthma: nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, s…

Frequently Asked Questions

What is BREYNA used for?

BREYNA contains Budesonide and Formoterol Fumarate. It is a aerosol, metered taken respiratory (inhalation). Consult your doctor for specific uses.

Is BREYNA a controlled substance?

BREYNA is not classified as a controlled substance by the DEA.

What is the generic name for BREYNA?

The generic name for BREYNA is Budesonide and Formoterol Fumarate. There are 11 other brand versions of Budesonide and Formoterol Fumarate.

What is the NDC code for BREYNA 160 ug/1?

The NDC (National Drug Code) for BREYNA 160 ug/1 is 0378-7503, listed by Mylan Pharmaceuticals Inc..

Product NDC

0378-7503

Package NDC

0378-7503-32

Other Budesonide Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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