Dosing and uses of Asmanex Twisthaler, Asmanex HFA (mometasone inhaled)
Adult dosage forms and strengths
powder for inhalation (Asmanex Twisthaler)
- 110mcg/actuation
- 220mcg/actuation
metered dose inhaler (Asmanex HFA)
- 100mcg/actuation
- 200mcg/actuation
Asthma
Indicated for maintenance treatment of asthma as prophylactic therapy
Asmanex Twisthaler
- Received bronchodilators alone or inhaled corticosteroids: 220 mcg PO inhaled once daily in evening; may increase to 220 mcg q12hr if needed
- Received PO corticosteroids: 440 mcg PO inhaled q12hr; not to exceed 880 mcg/day
Asmanex HFA
- 2 inhalations PO q12hr (ie, 200-400 mcg q12hr); starting dose based on prior asthma therapy
- -Received inhaled medium-dose corticosteroids: 200 mcg inhaled PO q12hr (as 2 actuations of 100 mcg/actuation)
- -Received inhaled high-dose corticosteroids: 400 mcg inhaled PO q12hr (as 2 actuations of 200 mcg/actuation)
- -Received oral corticosteroids: 400 mcg inhaled PO q12hr (as 2 actuations of 200 mcg/actuation)
Pediatric dosage forms and strengths
powder for inhalation (Asmanex Twisthaler)
- 110mcg/actuation
- 220mcg/actuation
metered dose inhaler (Asmanex HFA)
- 100mcg/actuation
- 200mcg/actuation
Asthma
Indicated for maintenance treatment of asthma as prophylactic therapy
Asmanex Twisthaler
- <4 years: Safety and efficacy not established
- 4-11 years: 110 mcg PO inhaled once daily in evening; not to exceed 110 mcg/day
- ≥12 years (received bronchodilators alone or inhaled corticosteroids): 220 mcg PO inhaled once daily in evening; may increase to 220 mcg q12hr if needed
- ≥12 years (received PO corticosteroids): 440 mcg PO inhaled q12hr; not to exceed 880 mcg/day
Asmanex HFA
- <12 years: Safety and efficacy not established
- ≥12 years: 2 inhalations PO q12hr (ie, 200-400 mcg q12hr); starting dose based on prior asthma therapy
- -Received inhaled medium-dose corticosteroids: 200 mcg inhaled PO q12hr (as 2 actuations of 100 mcg/actuation)
- -Received inhaled high-dose corticosteroids: 400 mcg inhaled PO q12hr (as 2 actuations of 200 mcg/actuation)
- -Received oral corticosteroids: 400 mcg inhaled PO q12hr (as 2 actuations of 200 mcg/actuation)
Asmanex Twisthaler, Asmanex HFA (mometasone inhaled) adverse (side) effects
>10%
Headache (26%)
Viral infection (14%)
Pharyngitis (12%)
Epistaxis (11%)
1-10%
Cough (7%)
Upper respiratory tract infection (6%)
Dysmenorrhea (5%)
Frequency not defined
Loss of taste
Muscle soreness
Warnings
Contraindications
Hypersensitivity
Immunosuppressed patients
Tuberculosis
Status asthmaticus or other acute asthma episode necessitating intensive measures
Known hypersensitivity to milk proteins or any other ingredients
Cautions
Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex
Nasal septum perforation, epistaxis, wheezing
Cataracts, glaucoma, increased intraocular pressure
Risk of more serious or fatal course of chickenpox and measles in susceptible individuals; avoid use in unvaccinated or immunologically unexposed children or adults
Deaths from adrenal insufficiency have occurred after abrupt withdrawal of oral steroids; taper withdrawal gradually
May retard growth in children
Immunocompromised patients
Infections of nose and pharynx, including Candida albicans
Excessive use may suppress hypothalamic-pituitary-adrenal function
During periods of stress or severe status asthmaticus, patient may require supplementary systemic corticosteroids immediately; carry warning card to that effect
Long-term administration reduces bone mineral density
Pregnancy and lactation
Pregnancy: There are no randomized clinical studies in pregnant women; there are clinical considerations with use in pregnant women In women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma controL
Lactation: There are no available data on the presence of mometasone in human milk, the effects on the breastfed child, or the effects on milk production; other inhaled corticosteroids, similar to mometasone furoate, are present in human milk; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from drug or from underlying maternal condition
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Asmanex Twisthaler, Asmanex HFA (mometasone inhaled)
Mechanism of action
Corticosteroid with potent anti-inflammatory properties; exerts effects on various cells, including mast cells and eosinophils; also exerts effects on inflammatory mediators (eg, histamine, eicosanoids, leukotrienes, cytokines)
Absorption
Minimally absorbed
Onset: 1-3 days
Bioavailability: <0.1%
Distribution
Protein bound: 98-99%
Metabolism
Metabolized in liver by CYP3A4
Elimination
Half-life: 5.8 hr
Excretion: Urine, bile
