DUAKLIR PRESSAIR

ACLIDINIUM BROMIDE AND FORMOTEROL FUMARATE

Manufacturer: Covis Pharma US, Inc

Score: 141.0

Quick Summary

DUAKLIR PRESSAIR is a combination of aclidinium bromide and formoterol fumarate indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It is not indicated for the relief of acute bronchospasm or for the treatment of asthma. The recommended dose is one oral inhalation of 400 mcg/12 mcg, twice daily. The most common adverse reactions include upper respiratory tract infection, headache, and back pain. DUAKLIR PRESSAIR is contraindicated in patients with severe hypersensitivity to milk proteins, hypersensitivity to aclidinium bromide, formoterol fumarate, or to any component of the product, and in patients with asthma without an inhaled corticosteroid.

Key Clinical Findings and Indications

DUAKLIR PRESSAIR is a combination of aclidinium bromide and formoterol fumarate
Indicated for the maintenance treatment of patients with COPD
Not indicated for the relief of acute bronchospasm or for the treatment of asthma

Important Safety Information

Warning

LABAs, such as formoterol fumarate, increase the risk of asthma-related death

Contraindications

Severe hypersensitivity to milk proteins
Hypersensitivity to aclidinium bromide, formoterol fumarate, or to any component of the product
Asthma without an inhaled corticosteroid

Adverse Reactions

Upper respiratory tract infection
Headache
Back pain

Dosing Recommendations

General Guidance

No dose adjustment is necessary in elderly patients or in patients with renal impairment

COPD

Adult Dose

One oral inhalation of 400 mcg/12 mcg, twice daily

Pediatric Dose

Special Population Considerations

Pregnancy

There are no adequate and well-controlled studies of DUAKLIR PRESSAIR in pregnant women
Use during labor should be restricted to those patients in whom the benefits clearly outweigh the risk

Nursing Mothers

Pediatric Use

DUAKLIR PRESSAIR is not indicated for use in children
The safety and effectiveness of DUAKLIR PRESSAIR in the pediatric population have not been established

Geriatric Use

No overall differences in safety or effectiveness were observed between geriatric patients and younger patients
Greater sensitivity of some older individuals cannot be ruled out