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TUDORZA PRESSAIR
Classes
Respiratory Long-Acting Muscarinic Antagonists (LAMA)
Administration
The Tudorza Pressair inhaler is a breath-actuated multi-dose dry powder inhaler; each actuation delivers 375 mcg of aclidinium bromide from the mouthpiece.
Prior to initial use, remove the inhaler from the sealed bag and discard the bag.
The protective cap should be removed by lightly squeezing the arrows marked on each side of the cap and pulling outwards. Ensure that nothing is blocking the mouthpiece.
Instruct the patient to hold the inhaler with the mouthpiece facing them, but not inside their mouth. The green button should be facing straight up.
Before placing the inhaler into their mouth, they should press the green button all the way down and then release it; they should not continue to hold it down. Once the green button is pressed, the control window will change from red to green, indicating that the medication is ready for inhalation. If the control window remains red, repeat the press and release actions until the control window is green.
Before inhaling the dose, have the patient breathe out completely away from the inhaler; they should never breathe out into the inhaler.
Instruct the patient to put their lips tightly around the mouthpiece and to breathe in through the mouth quickly and deeply until a "click" sound is heard; this lets the patient know that they have inhaled the full dose. It is important that the patient does NOT hold down the green button while they are breathing in the dose.
The patient should remove the inhaler from their mouth and hold their breath for as long as is comfortable, then breathe out slowly through their nose.
Although some patients may taste the medication during their inhalation, they should not take an extra dose if they do not taste anything after inhaling.
The control window should turn red after the full dose has been inhaled. If it remains green after the dose is inhaled, the inhalation process should be repeated. If correct inhalation has not been achieved after several attempts, the doctor or healthcare professional should be contacted.
Once the window has turned red, the protective cap should be placed back onto the inhaler by pressing it back onto the mouthpiece.
The dose indicator displays how many doses are left. The first time the inhaler is used, the indicator will display the number 60. The indicator number will count down as the patient uses the inhaler; the indicator moves slowly, displaying intervals of 10 (60, 50, 40, 30, 20, 10, 0). As the patient is nearing their last dose, a red band begins to appear to warn that a new aclidinium inhaler is needed.
The inhaler should be discarded after one of the following occurs: the marking "0" with a red background shows in the middle of the dose indicator, or the device locks out, or after 45 days after the inhaler is removed from the sealed bag, whichever comes first.
The inhaler does not need to be cleaned; the mouthpiece can be wiped with a dry tissue or paper towel. Water should never be used as it may damage the inhaler.[51311]
Adverse Reactions
heart failure / Delayed / 0-1.0
AV block / Early / 0-1.0
cardiac arrest / Early / 0-1.0
anaphylactoid reactions / Rapid / Incidence not known
bronchospasm / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
visual impairment / Early / Incidence not known
ocular hypertension / Delayed / Incidence not known
prostatic hypertrophy / Delayed / Incidence not known
diabetes mellitus / Delayed / 0-1.0
corneal edema / Early / Incidence not known
blurred vision / Early / Incidence not known
urinary retention / Early / Incidence not known
dysuria / Early / Incidence not known
urethral pain / Early / Incidence not known
headache / Early / 6.6-6.6
pharyngitis / Delayed / 5.5-5.5
cough / Delayed / 3.0-3.0
diarrhea / Early / 2.7-2.7
sinusitis / Delayed / 1.7-1.7
rhinitis / Early / 1.6-1.6
vomiting / Early / 1.1-1.1
dental pain / Delayed / 1.1-1.1
xerostomia / Early / 0-1.0
rash / Early / Incidence not known
urticaria / Rapid / Incidence not known
ocular pain / Early / Incidence not known
Common Brand Names
TUDORZA PRESSAIR
Dea Class
Rx
Description
Inhaled long-acting muscarinic antagonist (LAMA); given twice daily
Used in adults for the maintenance treatment of COPD, including chronic bronchitis and/or emphysema
Not indicated for the treatment of acute bronchospasm or asthma
Dosage And Indications
400 mcg (1 actuation of 400 mcg/actuation) twice daily (approximately 12 hours apart) via oral inhalation is the usual and max dosage. Each inhalation delivers 375 mcg of aclidinium bromide from the mouthpiece. Not indicated for acute bronchospasm. Use an inhaled short-acting beta-2 agonist (SABA) for immediate relief of acute symptoms. Do not use other long-acting muscarinic antagonists (LAMAs) concurrently.[51311] According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, aclidinium may be used as initial monotherapy in all groups of COPD patients; however, combination therapy with a long-acting beta-agonist (LABA) or inhaled corticosteroid (ICS) may be needed in patients in Group D or those patients still experiencing dyspnea or exacerbations upon follow-up.[63765]
Dosing Considerations
No dosage adjustments are needed.
No dosage adjustments are needed.
Drug Interactions
Anticholinergics: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Atropine: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Atropine; Difenoxin: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Belladonna; Opium: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Benztropine: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Chlordiazepoxide; Clidinium: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Dicyclomine: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Diphenoxylate; Atropine: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Flavoxate: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Fluticasone; Umeclidinium; Vilanterol: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufaturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Glycopyrrolate: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Glycopyrrolate; Formoterol: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Homatropine; Hydrocodone: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Hyoscyamine: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Indacaterol; Glycopyrrolate: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Ipratropium: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufaturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Ipratropium; Albuterol: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufaturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Methacholine: (Major) Discontinue use of aclidinium 168 hours or more before a methacholine challenge test. Aclidinium inhibits the airway response to methacholine.
Methenamine; Sodium Acid Phosphate; Methylene Blue; Hyoscyamine: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Methscopolamine: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Neostigmine; Glycopyrrolate: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Oxybutynin: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Phenobarbital; Hyoscyamine; Atropine; Scopolamine: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Propantheline: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Scopolamine: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Tiotropium: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufaturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Tiotropium; Olodaterol: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufaturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Trihexyphenidyl: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufacturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Umeclidinium: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufaturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
Umeclidinium; Vilanterol: (Moderate) Although aclidinium is minimally absorbed into the systemic circulation after inhalation, there is the potential for aclidinium to have additive anticholinergic effects when administered with other anticholinergics or antimuscarinics. Per the manufaturer, avoid concomitant administration of aclidinium with other anticholinergic medications, when possible.
How Supplied
Aclidinium bromide/TUDORZA PRESSAIR Respiratory (Inhalation) Pwd Met: 400mcg
Maximum Dosage
800 mcg (2 actuations)/day via oral inhalation.
800 mcg (2 actuations)/day via oral inhalation.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Mechanism Of Action
Aclidinium is a respiratory antimuscarinic or long-acting antimuscarinic antagonist (LAMA), which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1—M5. Bronchodilation occurs through aclidinium's inhibition of the M3 receptor in the smooth muscle of the airways. The competitive and reversible nature of antagonism was exhibited with human and animal origin receptors and isolated organ preparations. Prevention of acetylcholine-induced bronchoconstriction was shown to be dose-dependent in preclinical in vitro and in vivo studies. The effect lasted longer than 24 hours. The clinical relevance of these findings is unknown. After inhalation of aclidinium, bronchodilation is predominantly a site-specific effect.
Pharmacokinetics
Aclidinium is administered as a dry-powder via oral inhalation. The volume of distribution following 400 mcg IV of aclidinium is approximately 300 L. The major route of metabolism is hydrolysis, which occurs both chemically and enzymatically by esterases. Aclidinium is rapidly and extensively hydrolyzed to its alcohol and dithienylglycolic acid derivatives, neither which binds to muscarinic receptors and are devoid of pharmacologic activity. Following an IV dose of aclidinium in young, healthy volunteers with an inter-individual variability of 36%, the total clearance was approximately 170 L/h. Radiolabelled aclidinium was administered intravenously to healthy volunteers and was extensively metabolized with 1% excreted as unchanged aclidinium. Approximately 54—65% of the radioactivity was excreted in urine and 20—33% of the dose was excreted in feces. Almost the entire dose was eliminated by hydrolysis. After dry powder inhalation, urinary excretion of aclidinium is about 0.09% of the dose and the estimated effective half-life is 5—8 hours.
Pharmacodynamically, improvement in lung function, as assessed by serial spirometry, persisted for up to 12 hours following a single dose in clinical studies. Onset of improvement was typically noted within 30 minutes of an oral inhalation during the first day of treatment.
Due to the low plasma levels achieved at the clinically relevant doses, aclidinium and its metabolites are not expected to alter the disposition of drugs metabolized by the human CYP450 enzyme system. In addition, in vitro studies using human liver microsomes indicated that aclidinium and its major metabolites do not inhibit CYP450, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5 or 4A9/11 at concentrations up to 1,000-fold higher than the maximum plasma concentration that would be expected to be achieved at the therapeutic dose. Therefore, it is unlikely that aclidinium causes CYP450 related drug interactions.
The absolute bioavailability of aclidinium is approximately 6% in healthy volunteers. Following twice-daily oral inhalation administration of 400 mcg aclidinium in healthy subjects, peak steady state plasma levels were observed within 10 minutes after inhalation.
Pregnancy And Lactation
There are no adequate and well controlled studies of aclidinium during human pregnancy to inform drug associated risks. No adverse developmental effects were seen with the administration of inhaled aclidinium to pregnant rats and rabbits during organogenesis at 15 or 20 times, respectively, the maximum recommended human daily inhaled dose (MRHDID). However, reduced pup weights were seen when pregnant rats continued inhalation administration through lactation at 5 times the MRHDID of aclidinium. Adverse developmental effects occurred when rabbits were orally dosed with aclidinium at approximately 1,400 times the MRHDID.
Use aclidinium with caution during breast-feeding. There are no available data on the effects of aclidinium on the breastfed child or on milk production or presence in human milk. Aclidinium is excreted into the milk of lactating female rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Decreased pup weights were observed from dams exposed during the lactation period. In a pharmacokinetic study, levels of radioactivity in milk and plasma in rats were measured after a single intravenous dose of 1 mg/kg of radiolabeled aclidinium on approximately post-natal day 14. The maximum concentration in milk was measured at 6 hours post-dose and was found to be 10 to 14 times higher than in plasma. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.[51311]