Usual Adult Dose for Asthma - Maintenance

Budesonide-formoterol 80/4.5 mcg and 160/4.5 mcg:

• Recommended dose: 2 inhalations orally twice daily
• Maximum dose: 2 inhalations twice daily

Budesonide-formoterol 100/6 mcg and 200/6 mcg:

• ASTHMA MAINTENANCE: 1 to 2 inhalations orally once or twice daily. Dose can temporarily be increased up to 4 inhalations twice daily.
• ASTHMA MAINTENANCE AND RELIEVER THERAPY: 1 to 2 inhalations orally twice daily, or 2 inhalations once daily. 1 additional inhalation can be used as needed in response to symptoms. No more than 6 inhalations should be taken on any single occasion. The maximum total daily dose is 8 inhalations.

Comments:

• If asthma symptoms arise between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief.
• The recommended starting dosage is based on asthma severity.
• Improvement in asthma control can occur within 15 minutes of beginning treatment; however, the maximum benefit may take 2 weeks or longer after beginning treatment.
• If there is not adequate response to the starting dose after 1 to 2 weeks of therapy with budesonide 80 mg-formoterol 4.5 mg, replacement with budesonide 160 mg-formoterol 4.5 mg may provide additional asthma control.
• If a previously effective dosage fails to provide adequate control of asthma, reevaluate the therapy and consider additional therapeutic options (e.g., replacing the lower strength of this combination drug with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids).

Use: For patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

Budesonide-formoterol 160/4.5, 200/6 mcg:
2 inhalations orally twice daily
Maximum dose: 4 inhalations

Comments:

• Budesonide-formoterol 160/4.5 mcg and 200/6 mcg are the only strengths indicated for the treatment of COPD.
• If shortness of breath occurs between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief.

Uses:

• Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
• To reduce exacerbations of COPD

Usual Pediatric Dose for Asthma - Maintenance

6 to less than 12 years:
Budesonide-formoterol 80/4.5 mcg: 2 inhalations orally twice daily

12 years or older:
Budesonide-formoterol 80/4.5 mcg and 160/4.5 mcg:

• Recommended dose: 2 inhalations orally twice daily
• Maximum dose: 2 inhalations twice daily

Budesonide-formoterol 100/6 mcg and 200/6 mcg:

• ASTHMA MAINTENANCE: 1 to 2 inhalations orally once or twice daily. Dose can temporarily be increased up to 4 inhalations twice daily.
• ASTHMA MAINTENANCE AND RELIEVER THERAPY: 1 to 2 inhalations orally twice daily, or 2 inhalations once daily. 1 additional inhalation can be used as needed in response to symptoms. No more than 6 inhalations should be taken on any single occasion. The maximum total daily dose is 8 inhalations.

Comments:

• If asthma symptoms arise between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief.
• The recommended starting dosage is based on asthma severity.
• Improvement in asthma control can occur within 15 minutes of beginning treatment; however, the maximum benefit may take 2 weeks or longer after beginning treatment.
• If a previously effective dosage fails to provide adequate control of asthma, reevaluate the therapy and consider additional therapeutic options (e.g., replacing the lower strength of this combination drug with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids).

Use: For patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA

Renal Dose Adjustments

Studies have not been conducted in patients with renal impairment.

Liver Dose Adjustments

Monitor closely patients with hepatic disease.

Precautions

ASTHMA: Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For oral inhalation only.
• Rinse the mouth with water without swallowing after inhalation to help reduce the risk of infections in the mouth or throat.
• Prime the inhaler before using for the first time by releasing two test sprays into the air away from the face, and shaking well for 5 seconds before each spray.
• If the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again.
• More frequent administration or a higher number of inhalations (more than 2 inhalations twice daily) is not recommended; additional LABA should not be used for any reason.
• Discard the inhaler when the labeled number of inhalations have been used or within 3 months after removal from the foil pouch. Never immerse the canister into water to determine the amount remaining in the canister.
• Consult the manufacturer product information for instructions on how to use the inhaler.

Storage requirements:

• Store at room temperature 20C to 25C (68F to 77F).
• Store the inhaler with the mouthpiece down.
• For best results, the canister should be at room temperature before use. Shake well for 5 seconds before using.

General:

• Acute symptoms of asthma or COPD should be treated with an inhaled, short-acting beta2-agonist.
• Use with additional long-acting beta 2-agonist: Do not use in combination with additional LABAs because of risk of overdose.

Limitations of Use: This combination drug is NOT indicated for the relief of acute bronchospasm.

Monitoring:

• Respiratory: Monitor signs and symptoms of pneumonia other potential lung infections
• Endocrine: Monitor growth of pediatric patients
• Ocular: Monitor signs and symptoms of glaucoma and cataracts

Patient advice:

• Read the patient's labeling (Medication Guide) for additional information about this combination drug.
• Seek medical advice if the treatment is ineffective or if the prescribed dose for inhalation has been exceeded.

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