Tudorza Pressair (aclidinium bromide)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Aclidinium bromide, a synthetic quaternary ammonium antimuscarinic agent, is a long-acting orally inhaled bronchodilator.
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: Aclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works 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.
Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems.
If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
Generic name: aclidinium bromide
Pronunciation: (A-kli-DIN-ee-um)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Tudorza Pressair
Indications
The following indications are listed for Tudorza Pressair:
- Bronchospasm Prevention With Copd
Also known as: Copd With Bronchospasms Prophylaxis.
Dosing
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
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
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 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
No enhanced messaging available.
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.)
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.
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
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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