Dosing and uses of Tudorza Pressair (aclidinium)
Adult dosage forms and strengths
metered-dose inhaler (dry powder)
- 400mcg/actuation
COPD
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
Pediatric dosage forms and strengths
Safety and efficacy not established
Tudorza Pressair (aclidinium) adverse (side) effects
1-10%
Headache (6.6%)
Nasopharyngitis (5.5%)
Cough (3%)
Diarrhea (2.7%)
Sinusitis (1.7%)
Rhinitis (1.6%)
Toothache (1.1%)
Fall (1.1%)
Vomiting (1.1%)
<1%
Diabetes mellitus
Dry mouth
1st degree AV block
Osteoarthritis
Cardiac failure
Cardiorespiratory arrest
Postmarketing reports
Anaphylaxis
Angioedema (including swelling of lips and tongue or throat)
Urticaria
Rash
Bronchospasm
Itching
Nausea
Dysphonia
Blurred vision
Urinary retention
Tachycardia
Stomatitis
Warnings
Contraindications
Hypersensitivity to drug or formulation components or severe hypersensitivity to milk proteins
Cautions
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 and lactation
Pregnancy category: C
Lactation: Distributed in human breast milk is probable
Pregnancy categories
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.
Pharmacology of Tudorza Pressair (aclidinium)
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
Absorption
~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)
Distribution
Whole lung deposition: 30% of the metered dose
Vd: 300 L (IV administration)
Metabolism
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
Elimination
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)
