DUAKLIR PRESSAIR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DUAKLIR PRESSAIR (DUAKLIR PRESSAIR).
Dual bronchodilator combining a long-acting muscarinic antagonist (aclidinium) and a long-acting beta2-agonist (formoterol). Aclidinium inhibits acetylcholine at M3 receptors, reducing bronchoconstriction; formoterol stimulates beta2-adrenergic receptors, relaxing airway smooth muscle.
| Metabolism | Aclidinium: Hydrolysis by esterases (major), minor CYP2D6 and CYP3A4. Formoterol: Extensive glucuronidation (UGT1A1, UGT2B7) and O-demethylation (CYP2D6, CYP2C19). |
| Excretion | Renal (55% as unchanged aclidinium; 20% as metabolites); biliary/fecal (33% as metabolites and parent) |
| Half-life | Terminal half-life 5.0–6.5 hours (aclidinium); steady-state reached within 2 days; no accumulation at therapeutic doses |
| Protein binding | ~30% bound to plasma albumin (aclidinium); formoterol ~46–58% to albumin |
| Volume of Distribution | Aclidinium: 200 L (≈2.9 L/kg); formoterol: ~150 L (≈2.1 L/kg); indicates extensive tissue distribution |
| Bioavailability | Inhalation: ~15% (aclidinium); formoterol ~30–40% of inhaled dose reaches systemic circulation |
| Onset of Action | Inhalation: 15 minutes (bronchodilation effect begins within 15 minutes, peak at 1–3 hours) |
| Duration of Action | 12 hours (twice-daily dosing maintains bronchodilation over 12-hour interval; no significant difference at end of dosing interval vs placebo) |
1 inhalation (aclidinium 400 mcg / formoterol 12 mcg) twice daily.
| Dosage form | POWDER, METERED |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. Use with caution in severe renal impairment (eGFR <30 mL/min) due to limited data. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Contraindicated in severe hepatic impairment (Child-Pugh C) due to lack of data. |
| Pediatric use | Not approved for use in pediatric patients (under 18 years). Safety and efficacy not established. |
| Geriatric use | No specific dose adjustment required. Monitor for anticholinergic and beta-agonist adverse effects, especially in patients with comorbidities (e.g., cardiovascular disease, glaucoma, urinary retention). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DUAKLIR PRESSAIR (DUAKLIR PRESSAIR).
| Breastfeeding | No data on excretion in human milk. Aclidinium: minimal excretion expected due to low oral bioavailability and molecular size. Formoterol: likely excreted in breast milk; M/P ratio unknown. Risk of infant beta-agonist effects (tachycardia, hypoglycemia). Decision: discontinue nursing or drug, considering importance to mother. |
| Teratogenic Risk | DUAKLIR PRESSAIR (aclidinium bromide/formoterol fumarate) is contraindicated in pregnancy. Aclidinium: No adequate human data; animal studies show increased resorptions and delayed ossification at maternal toxic doses. Formoterol: Animal studies show increased fetal death, umbilical hernia, and delayed ossification at high doses. First trimester: unknown risk; second/third trimesters: possible fetal tachycardia, hypoglycemia due to beta-agonist effects. Benefits must outweigh risks; use only if clearly needed. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
["Severe hypersensitivity to aclidinium, formoterol, or lactose","Asthma (without concomitant ICS)"]
| Precautions | ["Not for acute bronchospasm or asthma","Cardiovascular effects (increased pulse, BP, QT prolongation)","Paradoxical bronchospasm","Immediate hypersensitivity reactions","Worsening of urinary retention","Worsening of narrow-angle glaucoma"] |
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| Fetal Monitoring | Monitor fetal heart rate and growth if used long-term in pregnancy. Assess maternal heart rate, blood pressure, blood glucose due to formoterol beta-agonist effects. No specific antidote; monitor for signs of overdose (tremor, palpitations). |
| Fertility Effects | Animal studies: aclidinium reduced fertility indices (copulation, fertility, and conception indices) at high doses; formoterol did not affect fertility in rats. Human data: none. Potential for reversible impairment of fertility in both sexes based on animal findings. |