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 (vilanterol);
Concurrent use of beta blockers;
Glaucoma or cataracts;
History of seizures, thyrotoxicosis, diabetes mellitus, or ketacidosis (vilanterol);
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, oral candidiasis

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

F and E: hypokalemia

MS: ↓bone mineral density (fluticasone)

Neuro: headache

Resp: nasopharyngitis, ↑risk of pneumonia (fluticasone), upper respiratory tract infection, paradoxical bronchospasm

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, AND URTICARIA), ↑risk of/worsening infections (fluticasone)

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.
Concurrent use of beta-blockers may ↓ effectiveness of vilanterol and ↑ risk of severe bronchospasm.
↑risk of hypokalemia with concurrent use of 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 ⬆ ⬇

Chronic Obstructive Pulmonary Disease

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 drugs undergo 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 ⬆ ⬇

Instruct patient in how to use inhaler, to use it once daily at the same time each day and not to stop taking medication without consulting health care professional. Advise patient to rinse mouth without swallowing to reduce risk of oropharyngeal candidiasis. Instruct patient to read Medication Guide prior to use of inhaler and with each Rx refill in case of changes.
Instruct patient in need for and use of rescue inhaler. Caution patient to notify health care professional if symptoms get worse, need more inhalations than usual from rescue inhaler, decrease in lung function as described by health care professional. Increased use of short-acting agent may signal disease deterioration.
Inform patient of increased risk of pneumonia. Advise patient to notify health care professional if fever, chills, change in sputum color, increased cough, or increase in breathing problems occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to have regular eye examinations; may increase risk of cataracts and glaucoma. Instruct patient to notify health care professional 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 females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇