fluticasone/vilanterol

Contraindicated in:

Hypersensitivity to any components or severe hypersensitivity to milk proteins;
Acute attack of asthma or COPD (onset of action is delayed);
Patients not receiving a long-term asthma-control medication (e.g., inhaled corticosteroid);
Patients whose asthma is currently controlled on low- or medium-dose inhaled corticosteroid therapy.

Use Cautiously in:

Moderate to severe hepatic impairment (↑ fluticasone levels may lead to systemic corticosteroid effects);
Cardiovascular history;
Glaucoma or cataracts;
History of seizures, thyrotoxicosis, diabetes mellitus, or ketacidosis;
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit outweighs potential risk to infant;
Pedi: Safety and effectiveness not established in children <18 yr (COPD) or <5 yr (asthma);
Geri: Older adults may be more sensitive to effects.

Exercise Extreme Caution in:

Concurrent use of MAO inhibitors or tricyclic antidepressants.

Adv. Reactions/Side Effects ⬆ ⬇

EENT: cataracts, glaucoma, nasopharyngitis, oral candidiasis

Endo: adrenal suppression, ↓growth (in children), hyperglycemia

F and E: hypokalemia

MS: ↓bone mineral density

Neuro: headache

Resp: ↑risk of pneumonia, paradoxical bronchospasm, upper respiratory tract infection

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, AND URTICARIA)

Interactions ⬆ ⬇

Drug-drug:

↑risk of corticosteroid effects or adverse cardiovascular reactions with CYP3A4 inhibitors, including clarithromycin, conivaptan, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, or voriconazole; concurrent use should be undertaken with extreme caution.
Beta blockers may ↓ effectiveness of vilanterol and ↑ risk of severe bronchospasm.
↑risk of hypokalemia with non-potassium-sparing diuretics.

Availability ⬆ ⬇

Powder for inhalation (contains lactose): fluticasone 50 mcg/vilanterol 25 mcg/inhalation in a two-strip blister per dose; fluticasone 100 mcg/vilanterol 25 mcg/inhalation in a two-strip blister per dose; fluticasone 200 mcg/vilanterol 25 mcg/inhalation in a two-strip blister per dose

Route/Dosage ⬆ ⬇

COPD

Inhaln (Adults ): One inhalation (fluticasone 100 mcg/vilanterol 25 mcg) once daily.

Asthma

Inhaln (Adults ): One inhalation of either fluticasone 100 mcg/vilanterol 25 mcg or fluticasone 200 mcg/vilanterol 25 mcg once daily (base decision on severity of asthma); not to exceed dosage of one inhalation of fluticasone 200 mcg/vilanterol 25 mcg once daily.
Inhaln (Children 12–17 yr): One inhalation (fluticasone 100 mcg/vilanterol 25 mcg) once daily.
Inhaln (Children 5–11 yr): One inhalation (fluticasone 50 mcg/vilanterol 25 mcg) once daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Fluticasone: decreases airway inflammation.
Vilanterol: relaxes bronchial smooth muscle.

Therapeutic effects:

Improved airflow and ↓ exacerbations in COPD.
Reduction in asthma exacerbations.

Classifications ⬆ ⬇

Therapeutic Classification: bronchodilators

Pharmacologic Classification: corticosteroids, adrenergics

Pharmacokinetics ⬆ ⬇

Fluticasone

Absorption: 15.2% systemically absorbed from lungs following inhalation; minimal absorption from swallowing (swallowed drug undergoes extensive first-pass hepatic metabolism).

Distribution: Unknown.

Protein Binding: 99.6%.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A4 isoenzyme to inactive metabolites; primarily excreted in feces.

Half-Life: 24 hr.

Vilanterol

Absorption: 27.3% systemically absorbed from lungs following inhalation; minimal absorption from swallowing (swallowed drug undergoes extensive first-pass hepatic metabolism).

Distribution: Unknown.

Protein Binding: 93.9%.

Metabolism/Excretion: Primarily metabolized by the CYP3A4 isoenzyme to inactive metabolites. Primarily excreted in urine (70%), with 30% excreted in feces.

Half-Life: 21.3 hr.

Time/Action Profile ⬆ ⬇

(bronchodilation)

ROUTE	ONSET	PEAK	DURATION
Fluticasone/vilanterol (inhaln)	within 1 hr	1–2 hr	24 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy and to follow instructions in Medication Guide for use of inhaler.
Advise patient to take medication as directed. If a dose is missed, take as soon as remembered unless almost time for next dose. Advise patient not to discontinue medication without consulting a health care provider; gradual ↓ is required.
Advise patient to rinse mouth with water without swallowing after administration to ↓ risk of oropharyngeal candidiasis.
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 provider immediately if symptoms worsen or more inhalations than usual are needed from rescue inhaler.
Advise patient to stop using medication and notify health care provider immediately if signs and symptoms of hypersensitivity reaction occurs.
Instruct patient not to use additional long-acting beta₂ agonists.
Caution patient to avoid smoking, known allergens, and other respiratory irritants.
Advise patient to notify health care provider if signs and symptoms of pneumonia or sore throat or mouth occur.
Instruct patient to notify health care provider immediately if exposed to chickenpox or measles. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other Rx, OTC, or herbal products.
Advise patient to have regular eye examinations. Instruct patient to notify health care provider immediately if signs and symptoms of glaucoma (eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion corneal edema) occur.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.
Pedi: Advise caretakers to have a health care provider monitor growth regularly during therapy and to titrate to lowest effective dose.

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Indications ⬇

Contraind./Precautions ⬆ ⬇