Duaklir Pressair (aclidinium bromide/formoterol fumarate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Formoterol fumarate, a synthetic sympathomimetic amine, is a relatively selective, long-acting beta2-agonist.
Aclidinium bromide, a synthetic quaternary ammonium antimuscarinic agent, is a long-acting orally inhaled bronchodilator.
Formoterol fumarate is a synthetic sympathomimetic amine. Like salmeterol, formoterol is a long-acting, selective beta2-receptor agonist, and is structurally and pharmacologically similar to other selective beta2-adrenergic receptor agonists (e.g., albuterol, salmeterol). Formoterol occurs as a racemic mixture; only the R,R -enantiomer is active.
Formoterol stimulates beta2-adrenergic receptors and apparently has little or no effect on beta1- or alpha-adrenergic receptors. The drug's beta-adrenergic effects appear to result from stimulation of the production of cyclic adenosine-3',5'-monophosphate (cAMP) by activation of adenyl cyclase. Cyclic AMP mediates numerous cellular responses, and increased concentrations of cAMP are associated with relaxation of bronchial smooth muscle and suppression of some aspects of inflammation, such as inhibition of release of proinflammatory mast-cell mediators (e.g., histamine, leukotrienes).
Some studies in patients with mild asthma and in animals suggest that formoterol inhibits allergen-induced infiltration of eosinophils into airways, and reduces extravasation of plasma proteins (e.g., albumin). However, current evidence indicates that formoterol, like salmeterol, does not possess clinically important anti-inflammatory effects.
Tolerance to the bronchoprotective effects of formoterol (diminished effect on FEV1) has been reported after prolonged (2 weeks) dosing at twice the recommended dose (24 mcg), with loss of protection at the end of the 12-hour dosing period.
Limited data suggest that formoterol has a more rapid onset of action than salmeterol but a similar duration of action and similar bronchodilatory effects.
Aclidinium bromide is a synthetic quaternary ammonium antimuscarinic agent for use as a long-acting, orally inhaled bronchodilator. The drug is a nonselective competitive antagonist at muscarinic (M1-M5) receptors. Aclidinium competitively and reversibly inhibits the actions of acetylcholine and other cholinergic stimuli at M3 receptors in the smooth muscle of the respiratory tract leading to bronchodilation.
Most of a dose of orally inhaled aclidinium bromide is deposited in the oropharynx and swallowed. Aclidinium is expected to be minimally absorbed into systemic circulation whether the dose is deposited in the lungs or swallowed, since the drug undergoes rapid and extensive hydrolysis that occurs both chemically and enzymatically via esterases to inactive metabolites. Aclidinium and its metabolites are not expected to affect drugs metabolized by cytochrome P-450 isoenzymes at plasma concentrations achieved clinically.
Approximately 0.1% of a dose is excreted in urine following oral inhalation. The effective half-life of aclidinium bromide is 5-8 hours following oral inhalation.
USES: This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: aclidinium and formoterol.
Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Aclidinium belongs to a class of drugs known as anticholinergics, and formoterol belongs to a class of drugs known as long-acting beta agonists (LABAs). Both drugs are also known as bronchodilators.
This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed.
This medication is not approved to treat asthma.
Generic name: aclidinium bromide/formoterol fumarate
Pronunciation: (A-kli-DIN-ee-um/for-MOE-ter-ol)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Duaklir Pressair
Indications
The following indications are listed for Duaklir Pressair:
- Bronchospasm Prevention With Copd
Also known as: Copd With Bronchospasms Prophylaxis.
Dosing
Each 2-mL single-dose vial of formoterol fumarate oral inhalation solution contains 20 mcg of formoterol fumarate. The oral inhalation solution does not require dilution prior to administration by nebulization. The actual amount of drug delivered to the lungs will depend on patient factors and the type of nebulization system used and its performance.
Each actuation of the oral aerosol inhaler containing the fixed combination of formoterol fumarate dihydrate and budesonide delivers 5.1 mcg of formoterol fumarate dihydrate and 91 or 181 mcg of budesonide from the valve and delivers 4.5 mcg of formoterol fumarate dihydrate and 80 or 160 mcg of budesonide from the actuator per metered spray, depending on the preparation used. The strength of formoterol/budesonide preparations and dosage of the fixed combination are expressed in terms of drug delivered from the mouthpiece of the actuator. The actual amount of drug delivered to the lungs depends on factors such as the patient's coordination between the actuation of the inhaler and inspiration through the delivery system. The commercially available formoterol/budesonide aerosol inhaler delivers 60 metered sprays per 6- or 6.9-g canister and 120 metered sprays per 10.2-g canister.
After priming of the oral aerosol inhaler containing the fixed combination of formoterol fumarate and glycopyrrolate, each actuation of the oral aerosol inhaler (Bevespi(R) Aerosphere(R)) delivers 5.5 mcg of formoterol fumarate and 10.4 mcg of glycopyrrolate (equivalent to 8.3 mcg of glycopyrronium) from the valve. Dosage is expressed in terms of drug delivered from the mouthpiece; each actuation of the inhaler delivers 4.8 mcg of formoterol fumarate and 9 mcg of glycopyrrolate (equivalent to 7.2 mcg of glycopyrronium) from the actuator. The actual amount of drug delivered to the lungs depends on factors such as the patient's coordination between actuation of the device and inspiration through the delivery system. Commercially available formoterol/glycopyrrolate aerosol inhaler delivers 28 or 120 metered sprays per 5.9- or 10.7-g canister, respectively.
Each actuation of the oral aerosol inhaler containing the fixed combination of formoterol fumarate dihydrate and mometasone furoate delivers 5.5 mcg of formoterol fumarate dihydrate and 115 or 225 mcg of mometasone furoate from the valve and delivers 5 mcg of formoterol fumarate dihydrate and 100 or 200 mcg of mometasone furoate from the actuator per metered spray, depending on the preparation used. The strength of formoterol/mometasone preparations and dosage of the fixed combination are expressed in terms of drug delivered from the mouthpiece of the actuator. The actual amount of drug delivered to the lungs may depend on factors such as the patient's coordination between actuation of the device and inspiration through the delivery system. Commercially available formoterol/mometasone aerosol inhaler delivers 60 or 120 metered sprays per 8.8- or 13-g canister, respectively.
For the long-term management of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD), the usual dosage of aclidinium bromide in adults is 400 mcg (one inhalation) twice daily via the Pressair(R) device. Orally inhaled aclidinium should not be used for the treatment of acute episodes of bronchospasm.
Aclidinium bromide is administered by oral inhalation only using a specific breath-actuated, oral inhalation device (Pressair(R)) that delivers powdered drug.
Prior to use, the inhaler should be removed from the sealed pouch. The protective cap should be removed from the inhaler by lightly squeezing the arrows marked on each side of the cap and pulling outward. The patient should then hold the inhaler with the mouthpiece toward the face, but not inside the mouth, with the green button facing straight up; the inhaler should not be tilted. Before placing the inhaler in the mouth, the patient should completely depress and then release the green button on the inhaler and then check the colored control window to ensure that it has changed from red to green, indicating that the dose is ready for inhalation.
Before inhaling the dose, the patient should exhale as completely as possible, being careful not to exhale into the Pressair(R) device. The patient should then place the mouthpiece of the inhaler tightly between the lips and inhale quickly and deeply through the mouth. The patient should hear a click (indicating that the inhaler is being used correctly) during the inhalation and should continue inhaling. The green button should not be pressed or held down during the inhalation. After a complete inhalation, the patient should remove the inhaler from the mouth and hold their breath for as long as comfortable, then exhale slowly through the nose. While some patients may taste the drug delivered from the Pressair(R) device, they should be instructed not to use another dose even if they do not taste the drug. The patient should check the control window to ensure that it has changed from green to red, indicating that the full dose has been inhaled. If the control window is still green, the patient should attempt to inhale through the device again. If the patient is unable to inhale correctly after several attempts, the patient should contact their clinician. After the control window has turned red, the protective cap should be pressed back onto the mouthpiece of the inhaler.
The inhaler does not need to be cleaned. However, if desired, the outside of the mouthpiece can be wiped with a dry tissue or paper towel; water should not be used to clean the inhaler. The inhaler should be discarded when the dose indicator (showing the number of doses remaining in intervals of ten) reads zero, when the device locks out (i.e., the green button stays depressed), or 45 days after removal of the inhaler from the sealed pouch, whichever comes first. The inhaler also should be discarded if the device appears damaged or the protective cap is lost.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
The following information addresses potential interactions with formoterol fumarate. When formoterol fumarate is used in fixed combination with budesonide, glycopyrrolate, or mometasone furoate, interactions associated with budesonide, glycopyrrolate, and mometasone also should be considered. No formal drug interaction studies have been performed to date with the fixed-combination preparations containing formoterol fumarate and budesonide, glycopyrrolate, or mometasone.
No formal drug interaction studies have been performed with aclidinium to date. Results of in vitro studies suggest that aclidinium has limited potential to cause metabolic interactions with cytochrome P-450 (CYP) isoenzymes at plasma concentrations achieved clinically.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Formoterol fumarate and fixed combinations containing formoterol fumarate are contraindicated in patients hypersensitive to the drug or any ingredient in the formulation.
Because of the risk of asthma-related death and hospitalization, use of formoterol for the treatment of asthma without concomitant use of long-term asthma controller therapy, such as inhaled corticosteroids, is contraindicated. (See Asthma-related Death and Serious Asthma-related Events under Warnings/Precautions: Warnings, in Cautions and also see Uses: Bronchospasm.)
Formoterol fumarate in fixed combination with budesonide (formoterol/budesonide; Symbicort(R)) and formoterol fumarate in fixed combination with mometasone furoate (formoterol/mometasone; Dulera(R)) are contraindicated as primary treatment of status asthmaticus or other acute episodes of asthma or chronic obstructive pulmonary disease (COPD) when intensive measures are required.
Formoterol fumarate in fixed combination with glycopyrrolate (formoterol/glycopyrrolate; Bevespi(R) Aerosphere(R)) is not indicated for the treatment of asthma.
The manufacturer states that there are no known contraindications to the use of aclidinium.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects occurring in 2% or more of adults in clinical trials receiving formoterol fumarate oral inhalation solution for the treatment of COPD include diarrhea, nausea, vomiting, nasopharyngitis, dry mouth, dizziness, and insomnia.
Adverse effects occurring in 3% or more of patients receiving formoterol fumarate in fixed combination with budesonide for the treatment of asthma include nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.
Adverse effects occurring in 3% or more of patients receiving formoterol fumarate in fixed combination with budesonide for the treatment of COPD include nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection.
Adverse effects occurring in 2% or more of patients receiving formoterol fumarate in fixed combination with glycopyrrolate for the treatment of COPD and more frequently than in those receiving placebo include urinary tract infection and cough.
Adverse effects occurring in 3% or more of patients receiving formoterol fumarate in fixed combination with mometasone furoate for the treatment of asthma and more frequently than in those receiving placebo include nasopharyngitis, sinusitis, and headache.
Adverse events occurring in at least 3% of patients receiving aclidinium and at an incidence greater than with placebo include headache, nasopharyngitis, and cough.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Formoterol fumarate oral inhalation solution (Perforomist(R)) and formoterol fumarate in fixed combination with glycopyrrolate (Bevespi(R) Aerosphere(R)) are not indicated for use in children. Safety and efficacy of these preparations in children have not been established.
Safety and efficacy of formoterol fumarate in fixed combination with budesonide (Symbicort(R)) in pediatric patients 12 years of age or older with asthma have been established in studies of up to 12 months' duration. Safety and efficacy of formoterol/budesonide in pediatric patients 6 to less than 12 years of age with asthma have been established in studies of up to 12 weeks' duration; however, the manufacturer states that safety and efficacy of the fixed-combination preparation in children younger than 6 years of age with asthma have not been established.
Safety and efficacy of formoterol fumarate in fixed combination with mometasone furoate (Dulera(R)) in pediatric patients 12 years of age or older with asthma have been established in studies of up to 12 months' duration.
Available data from controlled clinical trials suggest that monotherapy with long-acting beta2-adrenergic agonists increases the risk of asthma-related hospitalization in pediatric and adolescent patients. (See Asthma-related Death and Serious Asthma-related Events under Warnings/Precautions: Warnings, in Cautions.)
Safety and efficacy of oral inhalation of aclidinium have not been established in children. However, COPD does not generally occur in children.
Category C. (See Users Guide.) Formoterol may interfere with uterine contractility; carefully weigh benefit versus risk in labor.
There is an increased risk of adverse perinatal outcomes (e.g., preeclampsia, premature birth, low birth weight, and neonates small for gestational age) in women with poorly or moderately controlled asthma. Pregnant women with asthma should be closely monitored and therapy adjusted as necessary to maintain optimal asthma control.
The effects of formoterol fumarate in fixed combination with budesonide, glycopyrrolate, or mometasone furoate during labor and delivery are not known. Because of the potential for beta-agonist interference with uterine contractility, use of formoterol in fixed combination with budesonide, glycopyrrolate, or mometasone during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Category C. (See Users Guide.)
Formoterol is distributed into milk in rats; it is not known whether formoterol is distributed into human milk. Effects of formoterol fumarate on breast-fed infants or milk production also are not known.
The benefits of breast-feeding and the woman's clinical need for formoterol fumarate alone or in fixed combination with budesonide or mometasone should be considered along with any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
Because many drugs are distributed into human milk, caution should be exercised when formoterol fumarate in fixed combination with glycopyrrolate is administered to nursing women. Since there are no data from controlled clinical studies, the manufacturer of formoterol/glycopyrrolate states that a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Aclidinium is distributed into milk in rats; it is not known whether the drug is distributed into milk in humans. The manufacturer recommends that orally inhaled aclidinium be used with caution in nursing women.
The manufacturers of formoterol fumarate and formoterol fumarate in fixed combination with budesonide, glycopyrrolate, or mometasone furoate state that dosage adjustment is not required in geriatric patients.
No substantial differences in safety and efficacy of formoterol alone or in fixed combination with budesonide, glycopyrrolate, or mometasone furoate have been observed in geriatric patients relative to younger adults. However, the manufacturers state that the possibility that some geriatric patients may exhibit increased sensitivity to formoterol or fixed combinations containing formoterol cannot be ruled out. (See Dosage and Administration: Special Populations.)
No overall differences in safety and efficacy were observed in geriatric patients relative to younger adults, but increased sensitivity cannot be ruled out. Dosage adjustment is not necessary in geriatric patients.
ICD codes
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Last reviewed · Source: First Databank (FDB) drug data
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