aclidinium/formoterol

Aclidinium: Acts as an anticholinergic by inhibiting the M₃ receptor in bronchial smooth muscle. Formoterol: Beta₂-adrenergic agonist that stimulates adenyl cyclase, resulting in accumulation of cyclic adenosine monophosphate and subsequent bronchodilation.

Therapeutic effects:

Improved airflow and ↓ exacerbations in COPD.

Pharmacokinetics ⬆ ⬇

Absorption: Aclidinium: 6% systemically absorbed following inhalation; Formoterol: majority of inhaled drug is swallowed and absorbed.

Distribution: Unknown

Metabolism/Excretion: Aclidinium: Rapidly hydrolyzed; metabolites are not pharmacologically active. Metabolites are eliminated in urine (54–65%) and feces (20–33%); <1% excreted unchanged in urine. Formoterol: Mostly metabolized by the liver; 10–18% excreted unchanged in urine.

Half-Life: Aclidinium: 12 hr. Formoterol: 10 hr.

Time/Action Profile ⬆ ⬇

(bronchodilation)

ROUTE	ONSET	PEAK	DURATION
Inhalation	1 hr	2–4 hr	12 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Severe hypersensitivity to milk proteins;
Asthma;
Acutely deteriorating COPD or acute respiratory symptoms.

Use Cautiously in:

Narrow-angle glaucoma;
Prostatic hyperplasia or bladder neck obstruction;
Severe hypersensitivity to milk proteins;
History of hypersensitivity to atropine (cross-sensitivity may occur);
Cardiovascular disease (including angina, hypertension, and arrhythmias);
Diabetes;
Seizure disorders;
Glaucoma;
Hyperthyroidism;
Pheochromocytoma;
Excessive use (may lead to tolerance and paradoxical bronchospasm);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk; may inhibit contractions during labor;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: angina, arrhythmias, hypertension, hypotension, palpitations, tachycardia

EENT: worsening of narrow-angle glaucoma

F and E: hypokalemia

GI: dry mouth, nausea

GU: urinary retention

Metab: hyperglycemia

MS: arthralgia, muscle cramps

Neuro: dizziness, headache, insomnia, nervousness, tremor

Resp: cough, PARADOXICAL BRONCHOSPASM

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with MAO inhibitors, tricyclic antidepressants, or other QT interval prolonging agents may results in serious arrhythmias; use concurrently only with extreme caution.
↑risk of hypokalemia with theophylline, corticosteroids, loop diuretics, and thiazide diuretics.
Beta blockers may ↓ therapeutic effects.
↑adrenergic effects may occur with concurrent use of adrenergics.
May ↑ risk of anticholinergic effects with other anticholingerics.

Route/Dosage ⬆ ⬇

Inhaln
(Adults ): One inhalation (aclidinium 400 mcg/formoterol 12 mcg) twice daily.

Availability ⬆ ⬇

Powder for inhalation (contains lactose): aclidinium 400 mcg/formoterol 12 mcg/actuation

Assessment ⬆ ⬇

Assess lung sounds, pulse, and BP before administration and during peak of medication. Note amount, color, and character of sputum produced. Closely monitor patients on higher dose for adverse effects.
Monitor pulmonary function tests before initiating and periodically during therapy to determine effectiveness.
Observe for paradoxical bronchospasm (wheezing, dyspnea, tightness in chest) and hypersensitivity reaction (rash; urticaria; swelling of the face, lips, or eyelids). If condition occurs, withhold medication and notify health care professional immediately.
Monitor ECG periodically during therapy. May cause prolonged QTc interval.
Monitor patient for signs of hypersensitivity reactions (difficulties in breathing or swallowing, swelling of tongue, lips and face), urticaria, or skin rash during therapy. Discontinue therapy and consider alternative if reaction occurs.

Lab Test Considerations:

May cause ↑ serum glucose and decreased serum potassium.

Implementation ⬆ ⬇

Inhaln: Administer as 1 inhalation twice daily, morning and evening. Inhaler is breath-activated.

Patient/Family Teaching ⬆ ⬇

Instruct patient to use medication as directed. Do not discontinue therapy without discussing with health care professional, even if feeling better. If a dose is missed skip dose and take next dose at regularly scheduled time. Do not double doses. Use a rapid-acting bronchodilator if symptoms occur before next dose is due. Caution patient not to use more than 1 time a day; may cause adverse effects, paradoxical bronchospasm, or loss of effectiveness of medication. Instruct patient to review Patient Information before starting therapy and with each Rx refill in case of changes.
Caution patient not to use medication to treat acute symptoms. A rapid-acting inhaled beta-adrenergic bronchodilator should be used for relief of acute asthma attacks. Notify health care professional immediately if symptoms get worse or more inhalations than usual are needed from rescue inhaler.
Instruct patient to contact health care professional immediately if shortness of breath is not relieved by medication or nausea, vomiting, shakiness, headache, fast or irregular heartbeat, sleeplessness, or signs and symptoms of narrow angle glaucoma (eye pain or discomfort, blurred vision, visual halos or colored images, red eyes) or urinary retention (difficulty passing urine, painful urination) occur.
Advise patient to consult health care professional before taking any Rx, OTC, or herbal products or alcohol concurrently with this therapy. Caution patient also to avoid smoking and other respiratory irritants.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Bronchodilation with decreased airflow obstruction.

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Code ⬆

NDC Code

72124- Circassia Pharmaceuticals Inc.
- 72124-001- DUAKLIR PRESSAIR
  - 72124-001-01- 1 POUCH in 1 CARTON (72124-001-01) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER

72124- Circassia Pharmaceuticals Inc.
- 72124-001- DUAKLIR PRESSAIR
  - 72124-001-03- 1 POUCH in 1 CARTON (72124-001-03) > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇