Budesonide And Formoterol Fumarate Dihydrate
Generic Name: budesonide and formoterol fumarate dihydrate
Brand Names:
Budesonide And Formoterol Fumarate Dihydrate
11 DESCRIPTION BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only.
Overview
11 DESCRIPTION BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only.
Uses
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.
Dosage
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.
Side Effects
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 con...
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.
Warnings
5 WARNINGS AND PRECAUTIONS Serious asthma-related events: Long-acting beta2-adrenergic agonists as monotherapy increase the risk. ( 5.1 ) Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or COPD or to treat acute symptoms. ( 5.2 ) Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose. ( 5.3 ) Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ( 5.4 ) Pneumonia: Increased risk in patients with COPD. 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.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of budesonide and formoterol fumarate dihydrate or one of its individual components, formoterol fumarate, in pregnant women; however studies are available for the other component budesonide. In animal reproduction studies, budesonide and formoterol fumarate dihydrate, administered by the inhalation route, was teratogenic, embryocidal, and reduced fetal weights in rats at less than the maximum recommended human daily inhalation dose (MRHDID) on a mcg/m 2 basis.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is available in two strengths and is supplied in the following package sizes: Dosage Forms and Strengths Package Size NDC BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 120 Inhalations NDC 85766-113-12 (relabeled from NDC 0310-7372-20) BUDESONIDE AND FORMOTEROL FUMARATE DIHY...
Frequently Asked Questions
What is Budesonide And Formoterol Fumarate Dihydrate used for?▼
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.
What are the side effects of Budesonide And Formoterol Fumarate Dihydrate?▼
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 con...
Can I take Budesonide And Formoterol Fumarate Dihydrate during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of budesonide and formoterol fumarate dihydrate or one of its individual components, formoterol fumarate, in pregnant women; however studies are available for the other component budesonide. In animal reproduction studies, budesonide and formoterol fumarate dihydrate, administered by the inhalation route, was teratogenic, embryocidal, and reduced fetal weights in rats at less than the maximum recommended human daily inhalation dose (MRHDID) on a mcg/m 2 basis.
What are the important warnings for Budesonide And Formoterol Fumarate Dihydrate?▼
5 WARNINGS AND PRECAUTIONS Serious asthma-related events: Long-acting beta2-adrenergic agonists as monotherapy increase the risk. ( 5.1 ) Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or COPD or to treat acute symptoms. ( 5.2 ) Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose. ( 5.3 ) Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ( 5.4 ) Pneumonia: Increased risk in patients with COPD. 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.