Usual Adult Dose for Asthma - Maintenance

5 to 11 years: 2 inhalations of 50 mcg mometasone/5 mcg formoterol twice a day
Maximum dose: 200 mcg mometasone/20 mcg formoterol per day

12 years and older: Two inhalations twice daily (morning and evening).

• Each inhalation contains either 100 mcg or 200 mcg of mometasone with 5 mcg of formoterol.

Maximum Dose: 800 mcg of mometasone/20 mcg of formoterol per day

Comments:

• The starting dose should be determined based on patient's previous asthma therapy.
• Patients previously on inhaled medium dose corticosteroids should be started on the 100 mcg/5 mcg strength.
• Patients previously on inhaled high dose corticosteroids should be started on the 200 mcg/5 mcg strength.
• Not for use in treatment of acute bronchospasm.

Usual Pediatric Dose for Asthma - Maintenance

For children 12 years of age and older:
Two inhalations inhaled orally twice daily (morning and evening).

Each inhalation contains either 100 mcg or 200 mcg of mometasone with 5 mcg of formoterol.

Maximum Daily Dose: 800 mcg of mometasone; 20 mcg of formoterol

Comments:

• The starting dose should be determined based on patient's previous asthma therapy.
• Patients previously on inhaled medium dose corticosteroids should be started on the 100 mcg/5 mcg strength.
• Patients previously on inhaled high dose corticosteroids should be started on the 200 mcg/5 mcg strength.
• Not for use in treatment of acute bronchospasm.

Use: Indicated for patients 12 years of age and older who have inadequate control on a long-term asthma control medication or whose disease severity requires initiation of an inhaled corticosteroid and long-acting beta2-adrenergic agonist

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Status asthmaticus or other acute asthma episodes requiring intensive measures
• Hypersensitivity to any of the ingredients

Safety and efficacy have not been established in patients younger than 5 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Rinse mouth with water without swallowing after use.
• The inhaler should be primed before using for the first time and/or if not used for more than 5 days by releasing 4 test sprays into the air, away from the face, and shaking well before each spray.
• Shake well prior to each inhalation.
• Remove the cap from the mouthpiece of the actuator before using.

Storage requirements:

• Canister should remain in actuator to ensure delivery of correct amount of medication and proper functioning of the dose counter.
• Store the 60-inhalation inhaler with mouthpiece down or in a horizontal position.

Monitoring:

• Hepatic: Monitor patients for signs of increased drug exposure.
• Immunologic: Monitor for signs of development of oral candidiasis.
• Musculoskeletal: Monitor bone mineral density (BMD) in patients at higher risk for decreased BMD.
• Musculoskeletal: Monitor growth of pediatric patients.