- Asmanex HFA
- Asmanex Twisthaler
Maintenance treatment of asthma as prophylactic therapy.
Potent, locally acting anti-inflammatory and immune modifier.
- Decreased frequency and severity of asthma attacks.
- Improved asthma symptoms.
Absorption: <1%; action is primarily local after inhalation.
Distribution: 10–25% is deposited in airways if a spacer device is not used. All cross the placenta and enter breast milk in small amounts.
Metabolism and Excretion: Primarily metabolized by the liver via the CYP3A4 isoenzyme after absorption from lungs; 75% excreted in feces.
Half-life: 5 hr.
TIME/ACTION PROFILE (improvement in symptoms)
|Inhalation||within 24 hr||1–4 wk†||unknown|
- Hypersensitivity or intolerance to drug or milk proteins
- Acute attack of asthma/status asthmaticus.
Use Cautiously in:
- Active untreated infections
- Diabetes or glaucoma
- Underlying immunosuppression (due to disease or concurrent therapy)
- Systemic corticosteroid therapy (should not be abruptly discontinued when inhalation therapy is started; additional corticosteroids needed in stress or trauma)
- Pedi: Safety and effectiveness not established in children <12 yr (aerosol) and <4 yr (powder); prolonged or high-dose therapy in children may lead to complications.
Adverse Reactions/Side Effects
EENT: dysphonia, hoarseness, cataracts, glaucoma, nasal congestion, oropharyngeal candidiasis, pharyngitis, sinusitis
Endo: adrenal suppression (↑ dose, long-term therapy only), ↓ growth (children), ↓ bone mineral density
GI: diarrhea, dry mouth, dyspepsia, taste disturbances, nausea
MS: back pain
Neuro: headache, agitation, depression, dizziness, fatigue, insomnia, restlessness
Resp: bronchospasm, cough, wheezing
Misc: CHURG-STRAUSS SYNDROME, HYPERSENSITIVITY REACTIONS (including anaphylaxis, laryngeal edema, urticaria, and bronchospasm),
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Strong CYP3A4 inhibitors, including, atazanavir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, and saquinavir may ↓ metabolism and ↑ levels; use with caution.
Inhaln (Adults and Children ≥12 yr): Not on inhaled corticosteroids– Two 100–mcg inhalations twice daily; not to exceed 800 mcg/day; Currently on chronic oral corticosteroids– Two 200–mcg inhalations twice daily; not to exceed 800 mcg/day.
Inhaln (Children 5–11 yr): Two 50–mcg inhalations twice daily; not to exceed 200 mcg/day).
Inhaln (Adults and Children ≥12 yr): Previously on bronchodilators or other inhaled corticosteroids– 220 mcg (1 inhalation) once daily, up to 440 mcg/day as a single dose or 2 divided doses; Previously on oral corticosteroids– 440 mcg (2 inhalations) twice daily (not to exceed 880 mcg/day).
Inhaln (Children 4–11 yr): 110 mcg once daily in evening (not to exceed 110 mcg/day).
Inhalation aerosol (Asmanex HFA): 50 mcg/metered inhalation in 13-g canisters (120 metered inhalations), 100 mcg/metered inhalation in 13-g canisters (120 metered inhalations), 200 mcg/metered inhalation in 13-g canisters (120 metered inhalations)
Powder for inhalation (Asmanex Twisthaler): 110 mcg (delivers 100 mcg/metered inhalation; in packages of 7 and 30 inhalation units), 220 mcg (delivers 200 mcg/metered inhalation; in packages of 14, 30, 60, and 120 inhalation units)
In Combination with: formoterol (Dulera). See combination drugs.
- Monitor respiratory status and lung sounds. Assess pulmonary function tests periodically during and for several mo after a transfer from systemic to inhalation corticosteroids.
- Assess patients changing from systemic corticosteroids to inhalation corticosteroids for signs of adrenal insufficiency (anorexia, nausea, weakness, fatigue, hypotension, hypoglycemia) during initial therapy and periods of stress. If these signs appear, notify health care professional immediately; condition may be life-threatening.
- Monitor for withdrawal symptoms (joint or muscular pain, lassitude, depression) during withdrawal from oral corticosteroids.
- Monitor growth rate in children receiving chronic therapy; use lowest possible dose.
- May cause decreased bone mineral density during prolonged therapy. Monitor patients with increased risk (prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, chronic use of drugs that can reduce bone mass [anticonvulsants, oral corticosteroids]) for fractures.
- Monitor for signs and symptoms of hypersensitivity reactions (rash, pruritus, swelling of face and neck, dyspnea) periodically during therapy.
Lab Test Considerations:
Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal (HPA) axis suppression in chronic therapy. Children and patients using higher than recommended doses are at highest risk for HPA suppression.
- May cause ↑ serum and urine glucose concentrations if significant absorption occurs.
- After the desired clinical effect has been obtained, attempts should be made to decrease dose to lowest amount required to control symptoms. Gradually decrease dose every 2–4 wk as long as desired effect is maintained. If symptoms return, dose may briefly return to starting dose.
- Inhaln Allow at least 1 min between inhalations.
- Advise patient to take medication as directed. Take missed doses 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.
- Caution patient to avoid smoking, known allergens, and other respiratory irritants.
- Advise patient to notify health care professional if sore throat or sore mouth occurs.
- 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.
- Asmanex Twisthaler: Advise patient to remove cap while device is in upright position. To administer dose, exhale fully, then place mouthpiece between lips and inhale deeply and forcefully. Remove device from mouth and hold breath for 10 sec before exhaling (do not exhale into mouthpiece). Wipe the mouthpiece dry, if necessary, and replace the cap on the device. Rinse mouth with water; do not swallow, and spit out contents to help reduce risk of oropharyngeal candidiasis. Advise patient to discard twisthaler 45 days from opening or when dose counter reads "00", whichever comes first.
- Management of the symptoms of chronic asthma.
- Improvement in symptoms of asthma.