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) |
| Molecular Weight | 564.7 |
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 | Insufficient human data; animal studies show no teratogenicity at clinically relevant doses. Use only if benefit outweighs risk. |
| 2nd trimester | Insufficient human data; potential for beta-agonist effects on uterine contractility and fetal heart rate. Use only if benefit outweighs risk. |
| 3rd trimester | Insufficient human data; potential for beta-agonist effects on uterine contractility and fetal heart rate. Use only if benefit outweighs risk. |
Clinical note
Comprehensive clinical and safety monograph for DUAKLIR PRESSAIR (DUAKLIR PRESSAIR).
| Placental transfer | Unknown; based on molecular weight and lipophilicity, both components likely cross placenta. |
| Breastfeeding | Limited human data; aclidinium and formoterol are likely excreted into breast milk in small amounts. Caution in nursing mothers; consider risk-benefit. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
Hypersensitivity to aclidinium, formoterol, or any excipient
| 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 |
| Food/Dietary | No significant food interactions have been reported. However, avoid grapefruit juice if there is concurrent use of medications metabolized by CYP3A4 (though formoterol is not primarily CYP3A4 substrate). No dietary restrictions specific to Duaklir Pressair. |
| Clinical Pearls |
Loading safety data…
| Lactation Rating | L3 (Moderately Safe) |
| 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. |
| 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. |
| DUAKLIR PRESSAIR (aclidinium/formoterol) is a fixed-dose combination LAMA/LABA for maintenance treatment of COPD. It should not be used for acute bronchospasm. The Pressair inhaler has a dose counter and audible click; ensure patient inhales forcefully and deeply. Common adverse effects include headache, nasopharyngitis, and cough. Monitor for paradoxical bronchospasm, worsening of narrow-angle glaucoma, and urinary retention. |
| Patient Advice | Use exactly as prescribed; do not use for sudden breathing problems. · Rinse mouth with water after each dose to prevent oral thrush. · Keep the inhaler dry; do not wash or put in water. · Do not use with other LAMA or LABA medications. · Seek medical help if breathing worsens or you have signs of allergic reaction (rash, hives, swelling). · Inform your doctor if you have glaucoma, enlarged prostate, bladder problems, or liver disease. · Store at room temperature away from moisture and heat. |