Drugplain

SYMBICORT 160 ug/1

Budesonide and Formoterol Fumarate Dihydrate · AEROSOL · A-S Medication Solutions

No Recall History
Plain English

SYMBICORT is a aerosol containing budesonide and formoterol fumarate dihydrate at 160 ug/1, taken respiratory (inhalation). Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
SYMBICORT
Generic Name
Budesonide and Formoterol Fumarate Dihydrate
NDC Code (Product)
50090-4509
Manufacturer
A-S Medication Solutions
Strength
160 ug/1
Dosage Form
AEROSOL
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
NDA021929
Drug Class
Corticosteroid [EPC]
Marketing Start
05/29/2007

Recall History

No Recall History

Side Effects Reported to FDA

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

dyspnoea17,587 reports
asthma11,965 reports
cough7,829 reports
drug ineffective6,734 reports
off label use5,866 reports
pneumonia5,750 reports
wheezing5,696 reports
fatigue5,337 reports
malaise4,563 reports
headache4,498 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE SYMBICORT 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 SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older. SYMBICORT 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: • SYMBICORT is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) …

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For oral inhalation only. • Treatment of asthma in patients 12 years and older: 2 inhalations of SYMBICORT 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 SYMBICORT 80/4.5 twice daily. ( 2.2 ) • Maintenance treatment in COPD: 2 inhalations of SYMBICORT 160/4.5 twice daily. ( 2.3 ) 2.1 Administration Information SYMBICORT 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 SYMBICORT 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 prescribed strength…

Contraindications

4 CONTRAINDICATIONS The use of SYMBICORT 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 SYMBICORT. • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. ( 4 ) • Hypersensitivity to any of the ingredients in SYMBICORT. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS In clinical studies, concurrent administration of SYMBICORT 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 SYMBICORT. • 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 SYMBICORT, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma conc…

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 SYMBICORT used for?

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

Is SYMBICORT a controlled substance?

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

What is the generic name for SYMBICORT?

The generic name for SYMBICORT is Budesonide and Formoterol Fumarate Dihydrate. There are 7 other brand versions of Budesonide and Formoterol Fumarate Dihydrate.

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

The NDC (National Drug Code) for SYMBICORT 160 ug/1 is 50090-4509, listed by A-S Medication Solutions.

Product NDC

50090-4509

Package NDC

50090-4509-0

Other Budesonide Brands

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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)