Brand and Other Names:Tudorza Pressair
- Classes: Anticholinergics, Respiratory
Dosing & Uses
Dosage Forms & Strengths
metered-dose inhaler (dry powder)
Breath-activated dry powder inhaler indicated for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema
400 mcg (1 actuation) inhaled PO BID
Renal & Hepatic Impairment
Renal impairment: No dosage adjustment required
Hepatic impairment: Not studied
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
1st degree AV block
Angioedema (including swelling of lips and tongue or throat)
Hypersensitivity to drug or formulation components or severe hypersensitivity to milk proteins
Not for acute episodes of bronchospasm (ie, not for rescue therapy)
May cause paradoxical bronchospasm; if this occurs, discontinue and consider other treatments
Worsening of narrow-angle glaucoma may occur; use with caution in patients with narrow-angle glaucoma; instruct patients to consult a physician immediately if it occurs
Worsening of urinary retention may occur (eg, prostatic hyperplasia, bladder-neck obstruction); use with caution in patients with prostatic hyperplasia or bladder-neck obstruction; instruct patients to consult a physician immediately if it occurs
Immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis, may occur after administration; if hypersensitivity occurs, discontinue immediately and consider alternate treatment
Coadministration with other anticholinergics may increase risk for adverse effects
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Distributed in human breast milk is probable
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Long-acting muscarinic antagonist (LAMA), often referred to as an anticholinergic; selective muscarinic antagonist with affinity for the M3 (subscript) receptor in the airways; produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle
~55% of administered dose is swallowed, but negligible oral absorption is observed; fraction of inhaled dose that reaches systemic circulation is low (<5%)
Peak Plasma Time: 10-15 minutes (in COPD)
Peak Plasma Concentration: 80 pg/mL (in COPD)
Whole lung deposition: 30% of the metered dose
Vd: 300 L (IV administration)
Aclidinium bromide is rapidly hydrolyzed in plasma into its alcohol (LAS34823) and acid (LAS34850) metabolites by both enzymatic and non-enzymatic cleavage; neither of these metabolites are active
Half-life: 5-8 hr following repeat BID administration
Renal clearance: Low
Total clearance: 170 L/hr (IV administration)
Excretion: Urine 0.1% (as aclidinium bromide), 65% (as metabolites); feces 33% (as metabolites)
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Select a box to add or remove a plan.
Select a class to view formulary status for similar drugs