Hormones / EndoRESPIRATORY (INHALATION)High Alert

SYMBICORT

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE

Standard Dose

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 of SYMBICORT is not recommended as some patients are more likely to experience adverse effects with higher doses of formoterol. Patients using SYMBICORT should not use additional LABA for any reason [see Warnings and Precautions (5.3 , 5.12 ) ]. 2.2 Asthma If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief. Adult and Adolescent Patients 12 Years of Age and Older For patients 12 years of age and older, the dosage is 2 inhalations of SYMBICORT 80/4.5 or SYMBICORT 160/4.5 twice daily. The recommended starting dosages for SYMBICORT for patients 12 years of age and older are based upon patients' asthma severity or level of control of asthma symptoms, and risk of exacerbations on current inhaled corticosteroids. The maximum recommended dosage in adult and adolescent patients 12 years and older is SYMBICORT 160/4.5, two inhalations twice daily. Improvement in asthma control following inhaled administration of SYMBICORT can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief. For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with SYMBICORT 80/4.5, replacement with SYMBICORT 160/4.5 may provide additional asthma control. If a previously effective dosage regimen of SYMBICORT fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, (e.g., replacing the lower strength of SYMBICORT with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered. Pediatric Patients Aged 6 to Less than 12 Years For patients 6 to less than 12 years of age, the dosage is 2 inhalations of SYMBICORT 80/4.5 twice daily. 2.3 Chronic Obstructive Pulmonary Disease For patients with COPD the recommended dose is SYMBICORT 160/4.5, two inhalations twice daily. If shortness of breath occurs in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief.

Max Dose

See official label

Primary Use

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.

Summary

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).

Structured Monograph

Clinical summary

Indications and 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) including chronic bronchitis and/or emphysema. SYMBICORT 160/4.5 is also indicated to reduce exacerbations of COPD. SYMBICORT 160/4.5 is the only strength indicated for the treatment of COPD. Important Limitations of Use: SYMBICORT is NOT indicated for the relief of acute bronchospasm. Dosage and 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 of SYMBICORT is not recommended as some patients are more likely to experience adverse effects with higher doses of formoterol. Patients using SYMBICORT should not use additional LABA for any reason [see Warnings and Precautions (5.3 , 5.12 ) ]. 2.2 Asthma If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief. Adult and Adolescent Patients 12 Years of Age and Older For patients 12 years of age and older, the dosage is 2 inhalations of SYMBICORT 80/4.5 or SYMBICORT 160/4.5 twice daily. The recommended starting dosages for SYMBICORT for patients 12 years of age and older are based upon patients' asthma severity or level of control of asthma symptoms, and risk of exacerbations on current inhaled corticosteroids. The maximum recommended dosage in adult and adolescent patients 12 years and older is SYMBICORT 160/4.5, two inhalations twice daily. Improvement in asthma control following inhaled administration of SYMBICORT can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief. For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with SYMBICORT 80/4.5, replacement with SYMBICORT 160/4.5 may provide additional asthma control. If a previously effective dosage regimen of SYMBICORT fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, (e.g., replacing the lower strength of SYMBICORT with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered. Pediatric Patients Aged 6 to Less than 12 Years For patients 6 to less than 12 years of age, the dosage is 2 inhalations of SYMBICORT 80/4.5 twice daily. 2.3 Chronic Obstructive Pulmonary Disease For patients with COPD the recommended dose is SYMBICORT 160/4.5, two inhalations twice daily. If shortness of breath occurs in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Serious a

Monitoring

• 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.

Interaction Notes

• 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.