Adult Dosing

Asthma

• Recommended dose: Two inhalations of 80/4.5 or 160/4.5 mcg (budesonide/formoterol) twice daily, approximately 12 hrs apart, depending on asthma severity
• May increase to 160/4.5 mcg two inhalations twice daily for patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with 80/4.5 mcg
• Max: 160/4.5 mcg twice daily
• Max: If using turbuhaler, 2 puffs bid of 200/6 mcg formulation
• Note that the 200/6 mcg turbuhaler delivers 160/4.5 mcg per puff

Chronic Obstructive Pulmonary Disease

• Recommended dose: Two inhalations of 160/4.5 mcg (budesonide/formoterol) twice daily
• If shortness of breath occurs between doses, an inhaled short-acting beta-2 agonist should be taken for immediate relief

Note:

• Rinse mouth with water without swallowing after inhalation

Pediatric Dosing

Asthma

Children >12 yrs

• Recommended dose: Two inhalations of 80/4.5 or 160/4.5 mcg (budesonide/formoterol) twice daily, approximately 12 hrs apart, depending on asthma severity
• May increase to 160/4.5 mcg two inhalations twice daily for patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with 80/4.5 mcg
• Max: 160/4.5 mcg twice daily
• Max: If using turbuhaler, 2 puffs bid of 200/6 mcg formulation
• Note that the 200/6 mcg turbuhaler delivers 160/4.5 mcg per puff

Note:

• Safety and effectiveness have not been established in children <12 yrs of age

[Outline]

• Adult Dosing
• Pediatric Dosing

• Long-term maintenance treatment of asthma in patients 12 yrs of age
• Maintenance treatment of airflow obstruction in patients with COPD

• Hypersensitivity to any of the ingredients of the product
• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD requiring intensive measures

• Formoterol increases the risk of asthma-related death. It has been proved from controlled clinical trials that long-acting beta2-adrenergic agonists (LABA), such as formoterol, increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigate the increased risk of asthma-related death from LABA
• Prescribe therapy only for patients not adequately controlled on a long-term asthma-control medication, when treating patients with asthma. Maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid, once asthma control is achieved and maintained. Assess the patient at regular intervals and step down therapy if possible without loss of asthma control
• Therapy is not recommended for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment:

• Severe hepatic impairment: Dose adjustments not defined; caution advised

See Supplemental Patient Information

• Long-acting beta2-adrenergic agonists (LABA), such as formoterol, may increase the risk of asthma-related death [US Black Box Warning]
• When treating patients with asthma, prescribe this drug only for patients not adequately controlled with other long-term asthma-control medications or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA [US Black Box Warning]
• Do not use therapy in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids [US Black Box Warning]
• As therapy has not been studied in patients with acutely deteriorating asthma or COPD, do not initiate in patients with acutely deteriorating asthma or to treat acute symptoms
• Do not use at higher doses than recommended, more often than recommended, or in combination with other inhaled drugs containing long-acting beta2-adrenergic agonists because of the risk of overdose
• Monitor patients periodically for signs of adverse effects in the oral cavity because localized infections of the mouth and pharynx with Candida albicans may occur during therapy. Advise patients to rinse the mouth following therapy inhalation
• Monitor patients with COPD for signs and symptoms of pneumonia and other potential lung infections during therapy
• Patients who are on immunosuppressant drugs may experience potential worsening of infections including existing tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible children or adults using corticosteroids
• Carefully monitor patients who have been transferred from systemically active corticosteroids to inhaled corticosteroid therapy because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to inhaled corticosteroids
• Discontinue therapy if hypercorticism and adrenal suppression occur with very high dosages or at the regular dosage in susceptible individuals
• Administer cautiously if used concomitantly with strong cytochrome P450 3A4 inhibitors because adverse effects related to increased systemic exposure to budesonide may occur
• Discontinue therapy and institute alternative therapy if paradoxical bronchospasm occurs following therapy initiation
• Immediate hypersensitivity reactions may occur during therapy, manifested by urticaria, angioedema, rash, and bronchospasm
• Use with caution in patients with cardiovascular or central nervous system disorders because of excessive beta-adrenergic stimulation
• Assess bone mineral density initially and periodically thereafter during therapy because decreases in bone mineral density (BMD) have been observed with long-term administration of inhaled corticosteroids
• Routinely monitor growth of pediatric patients receiving therapy because orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients
• Long-term administration of inhaled corticosteroids may cause glaucoma, increased intraocular pressure, and cataracts in patients with asthma and COPD
• Monitor for metabolic adverse effects like eosinophilia, hypokalemia, and hyperglycemia during therapy
• Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis

Cautions: Use cautiously in

• Arrhythmias

Supplemental Patient Information

• Instruct patients to promptly report to their physician if they experience decreased effectiveness of inhaled, short-acting beta2-agonists or a significant decline in their lung functions

Pregnancy Category:C

Breastfeeding: The amounts of inhaled budesonide excreted into breastmilk are minute and infant exposure is negligible. Therefore, inhaled budesonide is considered to be acceptable during breastfeeding.No published data exist on the use of formoterol by inhaler during lactation; however, data from the related drug indicate that very little is expected to be excreted into breastmilk. Therefore, it is acceptable during breastfeeding because of the low bioavailability and maternal serum levels after use. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 03 January 2011).Manufacturer recommends to discontinue nursing or to discontinue treatment, taking into account the importance of the drug to the mother.

• RESP: Paradoxical bronchospasm, exacerbation of asthma, asthma-related death, pneumonia, cough, bronchitis, upper respiratory infections
• CV: Arrhythmias, hypertensive crisis, BP changes, chest pain, palpitations, tachycardia
• CNS: Headache, tremor, nervousness, insomnia
• PSYCHIATRY: Psychosis, behavioral disturbances
• EENT: Glaucoma, increased IOP, cataracts, nasopharyngitis, pharyngolaryngeal pain, sinusitis, nasal congestion
• GI: Dyspepsia, nausea, vomiting, oral candidiasis
• METABOLIC: Hypokalemia, growth suppression (pediatric patients)
• ENDO: Adrenal insufficiency, hyperglycemia
• GU: URI symptoms
• MUSC: Muscle cramps, osteoporosis (long-term use), back pain
• HYPERSENSITIVITY: Anaphylaxis
• MISC: Angioedema, influenza

Budesonide

• Anti-inflammatory corticosteroid; inhibits multiple inflammatory cytokines, exhibits potent glucocorticoid activity and weak mineralocorticoid activity
• Extensively metabolized by liver; CYP450: 3A4 substrate
• Absolute bioavailability: 39%
• Renally excreted: 60% (none unchanged); feces
• Half-life: 2-3 hrs

Formoterol

• Beta2-adrenergic agonist; relaxes bronchial smooth muscles by producing accumulation of cyclic adenosine monophosphate (cAMP) at beta-adrenergic receptors
• Extensively metabolized by liver; CYP450: 2A6, 2C9/19, 2D6 substrate
• Minimal systemic absorption
• Excretion: Urine 59-62% (10% unchanged); feces: 32-34%
• Half-life: 10 hrs

US Trade Name(s)

• Symbicort

US Availability

Symbicort (budesonide/formoterol)

• MDI
• 80 mcg/4.5 mcg/INH
• 160 mcg/4.5 mcg/INH

Canadian Trade Name(s)

• Symbicort Turbuhaler

Canadian Availability

Symbicort Turbuhaler (budesonide/formoterol)

• MDI
• 100 mcg/6 mcg/INH
• 200 mcg/6 mcg/INH

UK Trade Name(s)

• Symbicort Turbohaler

UK Availability

Symbicort Turbohaler (budesonide/formoterol)

• MDI
• 100 mcg/6 mcg/INH
• 200 mcg/6 mcg/INH
• 400 mcg/12 mcg/INH

Australian Trade Name(s)

• Symbicort Turbuhaler

Australian Availability

Symbicort Turbuhaler (budesonide/eformoterol)

• MDI
• 100 mcg/6 mcg/INH
• 200 mcg/6 mcg/INH
• 400 mcg/12 mcg/INH

[Outline]

Pulmonary

Respiratory Agents; Inhaled

Pricing data from www.DrugStore.com in U.S.A.

• Symbicort 80-4.5 MCG/ACT AERO [Inhaler] (ASTRAZENECA LP)
  10.2 act = $204.98
  30.6 act = $591.99
• Symbicort 160-4.5 MCG/ACT AERO [Inhaler] (ASTRAZENECA LP)
  10.2 act = $232.99
  30.6 act = $666.99

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.