• Maintenance treatment of asthma as prophylactic therapy.

Contraindicated in:

• Hypersensitivity (aerosol contains propellants; powder contains lactose [avoid in patients with severe milk protein allergy])
• Acute attack of asthma/status asthmaticus.

Use Cautiously in:

• Active untreated infections
• Diabetes
• Glaucoma or cataracts
• Underlying immunosuppression (due to disease or concurrent therapy)
• Systemic corticosteroid therapy (should not be abruptly discontinued when inhalable therapy is started; additional corticosteroids needed in stress or trauma)
• Hepatic impairment
• OB: Safety not established in pregnancy
• Lactation: Use while breastfeeding only if potential maternal benefit outweighs potential risk to infant
• Pedi: Children <5 yr (furoate) or <4 yr (propionate) (safety not established; prolonged or high-dose therapy may lead to complications).

CNS: headache, dizziness.

EENT: cataracts, dysphonia, glaucoma, hoarseness, oropharyngeal fungal infections, nasal stuffiness, rhinorrhea, sinusitis.

Endo: adrenal suppression (high-dose, long-term therapy only), ↓ bone mineral density, ↓ growth (in children), Cushing's syndrome.

GI: diarrhea.

MS: muscle pain.

Resp: bronchospasm, cough, upper respiratory tract infection, wheezing.
Misc: (INCLUDING ANAPHYLAXIS, LARYNGEAL EDEMA, BRONCHOSPASM, AND URTICARIA)HYPERSENSITIVITY REACTIONS , CHURG-STRAUSS SYNDROME, fever.

Drug-Drug:

• Strong CYP3A4 inhibitors, including ritonavir, atazanavir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, saquinavir, and voriconazole↓ metabolism and ↑ levels; concurrent use not recommended.

• Inhalation aerosol (propionate) (Flovent HFA): 44 mcg/metered inhalation in 10.6-g canisters (120 metered inhalations); 110 mcg/metered inhalation in 12-g canisters (120 metered inhalations); 220 mcg/metered inhalation in 12-g canisters (120 metered inhalations);
• Powder for inhalation (furoate) (Arnuity Ellipta): 50 mcg/blister; 100 mcg/blister; 200 mcg/blister;
• Powder for inhalation (propionate) (Armonair Respiclick): 55 mcg/inhalation; 113 mcg/inhalation; 232 mcg/inhalation;
• Powder for inhalation (propionate) (Flovent Diskus): 50 mcg/blister; 100 mcg/blister; 250 mcg/blister;
• In combination with: salmeterol (Advair Diskus, Advair HFA, AirDuo RespiClick, Wixhela Inhub), vilanterol (Breo Ellipta), umeclidinium and vilanterol (Trelegy Ellipta). See Appendix [not included in this PDA edition].

Aerosol for Oral Inhalation

• Inhaln (Adults and Children 12 yr): No prior treatment with inhaled corticosteroid — 88 mcg twice daily initially, may ↑ dose in 2 wk if not adequately responding (max dose = 880 mcg twice daily).
• Inhaln (Children 4–11 yr): 88 mcg twice daily (max dose = 88 mcg twice daily).

Powder for Oral Inhalation

• Inhaln (Adults and Children 12 yr): No prior treatment with inhaled corticosteroid — Propionate (Flovent Diskus): 100 mcg twice daily initially, may ↑ dose in 2 wk if not adequately responding (max dose = 1,000 mcg twice daily); Propionate (Armonair Respiclick): 55 mcg twice daily initially, may ↑ dose in 2 wk if not adequately responding (max dose = 232 mcg twice daily); Furoate: 100 mcg once daily, may ↑ dose in 2 wk to 200 mcg once daily if not adequately responding (max dose = 200 mcg once daily); Prior treatment with inhaled corticosteroid — Propionate (Armonair Respiclick): 55–232 mcg twice daily (starting dose should be based on dose of previous inhaled corticosteroid and disease severity) (max dose = 232 mcg twice daily); Furoate: 100–200 mcg once daily (max dose = 200 mcg once daily).
• Inhaln (Children 5–11 yr): Furoate: 50 mcg once daily.
• Inhaln (Children 4–11 yr): No prior treatment with inhaled corticosteroid — Propionate (Flovent Diskus): 50 mcg twice daily initially, may ↑ dose in 2 wk to 100 mcg twice daily if not adequately responding (max dose = 100 mcg twice daily).

Armonair Respiclick, Arnuity Ellipta, Flovent Diskus, Flovent HFA

• Potent, locally acting anti-inflammatory and immune modifier.

• Decreases frequency and severity of asthma attacks.

Therapeutic Classification: corticosteroids

Pharmacologic Classification: corticosteroids

Absorption: <1% (aerosol), 8–14% (powder). Action is primarily local after inhalation.

Distribution: 10–25% of inhaled corticosteroids is deposited in the airways if a spacer device is not used. With the use of a spacer, a greater percentage may reach the respiratory tract. Crosses the placenta and enters breast milk in small amounts.

Protein Binding: 91–99%.

Metabolism/Excretion: Metabolized by the liver primarily by the CYP3A4 isoenzyme after absorption from lungs; <5% excreted in urine; remainder excreted in feces.

Half-life: 7.8 hr (propionate); 24 hr (furoate).

(improvement in symptoms)

†Improvement in pulmonary function; decreased airway responsiveness may take longer.

• Advise patient to take medication as directed. If a dose is missed, take as soon as remembered unless almost time for next dose. Instruct patient to read the Patient Information and Instructions for Use before using and with each Rx refill, in case of new information. Advise patient not to discontinue medication without consulting health care professional; gradual decrease is required.
• Advise patients using inhalation corticosteroids and bronchodilator to use bronchodilator first and to allow 5 min to elapse before administering the corticosteroid, unless otherwise directed by health care professional.
• Advise patient that inhalation corticosteroids should not be used to treat an acute asthma attack but should be continued even if other inhalation agents are used.
• Patients using inhalation corticosteroids to control asthma may require systemic corticosteroids for acute attacks. Advise patient to use regular peak flow monitoring to determine respiratory status.
• Advise patient to stop using medication and notify health care professional immediately if signs and symptoms of hypersensitivity reactions occur.
• Caution patient to avoid smoking, known allergens, and other respiratory irritants.
• Advise patient to notify health care professional if sore throat or mouth occurs.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking other Rx, OTC, or herbal products.
• Advise patient to stop using medication and notify health care professional immediately if signs and symptoms of hypersensitivity reactions occur.
• Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Instruct patient whose systemic corticosteroids have been recently reduced or withdrawn to carry a warning card indicating the need for supplemental systemic corticosteroids in the event of stress or severe asthma attack unresponsive to bronchodilators.
• Aerosol for Oral Inhalation: Instruct patient in the proper use of the metered-dose inhaler. Inhaler should be primed before using for first time by releasing 4 sprays into air, away from face. When inhaler has not been used for more than 7 days, reprime unit by releasing 1 spray into air away from face. Shake inhaler well. Exhale completely and then close lips firmly around mouthpiece. While breathing in deeply and slowly, press down on canister. Hold breath for as long as possible to ensure deep instillation of medication. Remover inhaler from mouth and breathe out gently. Allow 1–2 min between inhalations. Rinse mouth with water or mouthwash after each use to minimize fungal infections, dry mouth and hoarseness. Wash inhalation assembly at least once weekly in warm running water (see Appendix F).
• Powder for Oral Inhalation: Do not use with a spacer. Exhale completely and then close lips firmly around mouthpiece. While breathing in deeply and slowly, press down on canister. Hold breath for as long as possible to ensure deep instillation of medication. Remover inhaler from mouth and breathe out gently. Allow 1–2 min between inhalations. After inhalation, rinse mouth with water and spit out (see Appendix F). Never wash the mouthpiece or any part of the Diskus inhaler. Discard Diskus inhaler device (Flovent Diskus) 6 wks (50-mcg strength) or 2 mo (100-mcg and 250-mcg strengths), (Armonair Respiclick) 30 days after opening, or blister tray (Arnuity Ellipta) 6 wks after removal from protective foil overwrap pouch or after all blisters have been used (whichever comes first).

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