aclidinium/formoterol

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;
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:

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 anticholinergics.

Availability ⬆ ⬇

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

Route/Dosage ⬆ ⬇

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

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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.

Classifications ⬆ ⬇

Therapeutic Classification: bronchodilators

Pharmacologic Classification: anticholinergics, adrenergics

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: Primarily metabolized by the liver; 10–18% excreted unchanged in urine.

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

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(bronchodilation)

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

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of aclidinium/formoterol. Instruct patient to use 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 once a day; using more frequently 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.
Explain need for pulmonary function tests prior to and periodically during therapy to determine effectiveness of medication.
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 notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and 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.

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Indications ⬇

Contraind./Precautions ⬆ ⬇