FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Mometasone: Glucocorticoid; elicits local anti-inflammatory effects on respiratory tract with minimal systemic absorption
Formoterol: Long-acting selective beta2-adrenergic agonist with rapid onset of action; acts locally as bronchodilator; stimulates intracellular adenyl cyclase, which results in increased cyclic adenosine monophosphate levels, causing relaxation of bronchial smooth muscle and inhibition of release of mast cell mediators
Interaction
Mometasone: Increased plasma concentration w/ strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products).
Formoterol: Enhanced hypokalaemic effect w/ xanthine derivatives, or non-potassium sparing diuretics. May prolong QTc-interval and increase the risk of ventricular arrhythmias when used w/ quinidine, terfenadine, astemizole, macrolides, disopyramide, procainamide, phenothiazines, MAOIs, and TCA. Decreased therapeutic effect w/ ?-adrenergic blockers. Increased risk of arrhythmias w/ halogenated hydrocarbons.
Pregnancy Category Note
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 furoate, or formoterol fumarate in human milk; the effects on the breastfed child, or the effects on milk production; 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 the drug or from the underlying maternal condition
Adult Dose
Inhalation/Respiratory
Indicated in the regular treatment of asthma, where use of a combination (LABA + Inhaled Corticosteroid) has been found to be appropriate.
Adult:
Initial: 2 puffs of 100 mcg/5 mcg inhaled twice daily; may increase to higher dose after 2 wks if inadequate response.
Severe asthma (initial) or inadequate response to lower dose (after 2 wk):
2 puffs of 200 mcg/5 mcg inhaled twice daily.
Maximum daily dose: 800 mcg/20 mcg daily
Child Dose
Child: >12 yr
Initial: 2 puffs of 100 mcg/5 mcg inhaled twice daily; may increase to higher dose after 2 wks if inadequate response.
Severe asthma (initial) or inadequate response to lower dose (after 2 wk):
2 puffs of 200 mcg/5 mcg inhaled twice daily.
Maximum daily dose: 800 mcg/20 mcg daily
Renal Dose
There are no data regarding the specific use of this combination in patients with renal impairment.
Administration
Oral Inhalation Preparation
Priming
Prime inhaler before first use or when inhaler is unused for >5 days
Release 4 test puffs into air, away from face
Remove cap; shake well for 5 sec before each test puff
Instructions
Check mouthpiece for objects before use
Make sure canister is fully inserted
Shake well before each use
Oral Inhalation Administration
For oral inhalation only
Remove cap; place middle or index finger on canister top while placing thumb underneath mouthpiece
Breathe out fully through your mouth, expelling as much air from lungs as possible; hold inhaler upright, placing the mouthpiece fully into the mouth, closing your lips around it
While pushing firmly on canister top, continue breathing in slowly until lungs are full; avoid breathing out
Hold breath as comfortably possible, up to 10 sec
Remove inhaler from mouth; breathe through nose while keeping lips closed
Repeating dose
Wait at least 30 seconds prior preceding second puff
Shake well prior to use; repeat steps (see under Oral Inhalation Administration)
Replace the cap after use
When finished administering 2 puffs, rinse mouth out with water (do not swallow water)
Cleaning
Wash and dry mouthpiece at least weekly
When mouthpiece becomes blocked, wash mouthpiece thoroughly
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.