May 25, 2017
Recommended Topic Related To:

AirDuo RespiClick

"The US Food and Drug Administration has approved AstraZeneca's Symbicort inhalation aerosol (80/4.5 mcg) for children aged 6 to 12 years with asthma that is not well controlled with an inhaled corticosteroid, the company has announced.

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AirDuo RespiClick Inhalation Powder

AIRDUO RESPICLICK
(fluticasone propionate and salmeterol) Inhalation Powder

WARNING

ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in AIRDUO RESPICLICK, increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 subjects on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

Therefore, when treating patients with asthma, physicians should only prescribe AIRDUO RESPICLICK 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 a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue AIRDUO RESPICLICK) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use AIRDUO RESPICLICK for patients whose asthma is adequately controlled on low-or medium-dose inhaled corticosteroids [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

AIRDUO RESPICLICK 55/14 mcg, AIRDUO RESPICLICK 113/14 mcg and AIRDUO RESPICLICK 232/14 mcg are combinations of fluticasone propionate and salmeterol xinafoate.

One active component of AIRDUO RESPICLICK is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11,17-dihydroxy-16α-methyl-3oxoandrosta-1,4-diene-17-carbothioate, 17-propionate, and the following chemical structure:

Fluticasone propionate - Structural Formula Illustration

Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.

The other active component of AIRDUO RESPICLICK is salmeterol xinafoate, a beta2- adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2naphthalenecarboxylate and the following chemical structure:

Salmeterol xinafoate - Structural Formula Illustration

Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4•C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water.

AIRDUO RESPICLICK is a white multidose dry powder inhaler (MDPI) for oral inhalation only. It contains a formulation blend of fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base, equivalent to 20.3 mcg of salmeterol xinafoate. Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream.

Under standardized in vitro test conditions, the AIRDUO RESPICLICK inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base, equivalent to 18.5 mcg of salmeterol xinafoate, with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds.

The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 106.72 L/min (range: 73.64 to 125.51 L/min).

Last reviewed on RxList: 2/8/2017
This monograph has been modified to include the generic and brand name in many instances.

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