Drugplain

Budesonide and Formoterol Fumarate Dihydrate 160 ug/1

Budesonide and Formoterol Fumarate Dihydrate · AEROSOL · Sportpharm LLC

1 Recall on Record
Plain English

Budesonide and Formoterol Fumarate Dihydrate is a aerosol containing budesonide and formoterol fumarate dihydrate at 160 ug/1, taken respiratory (inhalation). Manufactured by Sportpharm LLC.

Key Facts

Brand Name
Budesonide and Formoterol Fumarate Dihydrate
Generic Name
Budesonide and Formoterol Fumarate Dihydrate
NDC Code (Product)
85766-114
Manufacturer
Sportpharm LLC
Strength
160 ug/1
Dosage Form
AEROSOL
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
NDA021929
Drug Class
Corticosteroid [EPC]
Marketing Start
01/03/2020

Recall History

1 Recall on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

asthma6 reports
dyspnoea5 reports
dizziness4 reports
asthenia3 reports
fall3 reports
headache3 reports
hypertension3 reports
lower respiratory tract infection3 reports
nausea3 reports
abdominal pain upper2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 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 BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is indicated for the treatment of asthma in patients 6 years of age and older. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 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 beta2-adrenergic agonist (LABA). Important Limitations of Use: • BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is NOT indicated for the relief of acute bronchospas…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For oral inhalation only. • Treatment of asthma in patients 12 years and older: 2 inhalations of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 or 160/4.5 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 BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 twice daily. ( 2.2 ) • Maintenance treatment in COPD: 2 inhalations of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 twice daily. ( 2.3 ) 2.1 Administration Information BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 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 BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 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…

Contraindications

4 CONTRAINDICATIONS The use of budesonide and formoterol fumarate dihydrate 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 BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. ( 4 ) • Hypersensitivity to any of the ingredients in BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS In clinical studies, concurrent administration of budesonide and formoterol fumarate dihydrate 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. • 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 budesonide and formoterol fumarate dihydrate, is via cytochrome P450 (CYP) isoenzyme 3A…

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, sin…

Frequently Asked Questions

What is Budesonide and Formoterol Fumarate Dihydrate used for?

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

Is Budesonide and Formoterol Fumarate Dihydrate a controlled substance?

Budesonide and Formoterol Fumarate Dihydrate is not classified as a controlled substance by the DEA.

What is the generic name for Budesonide and Formoterol Fumarate Dihydrate?

The generic name for Budesonide and Formoterol Fumarate Dihydrate is Budesonide and Formoterol Fumarate Dihydrate. There are 6 other brand versions of Budesonide and Formoterol Fumarate Dihydrate.

What is the NDC code for Budesonide and Formoterol Fumarate Dihydrate 160 ug/1?

The NDC (National Drug Code) for Budesonide and Formoterol Fumarate Dihydrate 160 ug/1 is 85766-114, listed by Sportpharm LLC.

Product NDC

85766-114

Package NDC

85766-114-12

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

Data from openFDA · Public domain (CC0 1.0)