Generic
Indacaterol + Glycopyrronium + Mometasone Furoate
3 brands available in the market
At a glance
Indacaterol + Glycopyrronium + Mometasone Furoate is used as a maintenance treatment of asthma and to reduce asthma exacerbations in adults not adequately controlled with a maintenance combination of LABA and ICS.
Description
Indacaterol + Glycopyrronium + Mometasone Furoate is an inhalation powder drug product for delivery of a combination of Indacaterol Acetate (an ultra-LABA), Glycopyrronium Bromide (an ultra-LAMA), and Mometasone Furoate (an ICS). Indacaterol acts locally in the lung as a bronchodilator, Glycopyrronium blocks the bronchoconstrictor action of acetylcholine on airway smooth muscle, and Mometasone Furoate is a synthetic corticosteroid with local anti-inflammatory properties.
Indications
- Maintenance treatment of asthma in adults (not adequately controlled on LABA + ICS)
- Reduction of asthma exacerbations
Pharmacological class
ultra-LABA + ultra-LAMA + ICS
Pharmacology
Indacaterol is an ultra-LABA that stimulates intracellular adenyl cyclase to relax bronchial smooth muscle. Glycopyrronium is an ultra-LAMA that blocks acetylcholine action on airway smooth muscle to dilate airways. Mometasone Furoate is a synthetic corticosteroid with high affinity for glucocorticoid receptors and local anti-inflammatory properties; it inhibits release of leukotrienes and pro-inflammatory cytokines (IL-1, IL-5, IL-6, TNF-alpha).
Mechanism of action
Indacaterol stimulates beta2-adrenergic receptors to relax bronchial smooth muscle; Glycopyrronium blocks muscarinic receptors to cause bronchodilation; Mometasone Furoate reduces inflammation by inhibiting release of inflammatory mediators.
Dosage
Adult Dose (Inhalation):
- One inhalation capsule once daily
- To be used with inhalation device only
- Do not take more than one capsule in a day
Administration
For oral inhalation only; use with inhalation device; do not swallow capsules; remove capsule from blister pack immediately before use; rinse mouth or brush teeth after use.
Missed dose
If you miss a dose, take it as soon as remembered; do not use more than once in 24 hours.
Drug interactions
Drug Interactions:
- Caution with MAO inhibitors, tricyclic antidepressants or drugs that prolong QT interval
- Methylxanthine derivatives, steroids or non-potassium-sparing diuretics may potentiate hypokalemic effect
- Should not be given with β2-adrenergic blockers
Food interactions
No food interaction found/established.
Contraindications
Contraindications:
- Hypersensitivity to any active substances or excipients
Side effects
Most Common (over 52 weeks):
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
Use in pregnancy
Use in Pregnancy: Insufficient data on use in pregnant women; animal studies show mometasone furoate caused fetal malformations and decreased fetal survival; use only if expected benefit justifies potential risk to fetus.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: No information on presence of indacaterol, glycopyrronium or mometasone in human milk; detected in milk of lactating rats.
Precautions & warnings
Precautions:
- Do not use to treat acute asthma symptoms or bronchospasm
- If allergic reactions (angioedema, urticaria) occur, discontinue immediately
- If pulse rate, blood pressure increase or symptoms occur, treatment may need to be discontinued
- Monitor plasma glucose in diabetic patients
- Rinse mouth or brush teeth after use to reduce risk of oropharyngeal candida infection
Pediatric use
Safety and efficacy in pediatric patients have not been established.
Geriatric use
No specific data for elderly.
Renal / hepatic impairment
No specific data for renal or hepatic impairment.
Overdose effects
No information on overdose.
Therapeutic class
Long-acting selective β-adrenoceptor stimulants
Storage conditions
Keep below 30°C temperature, away from light & moisture; keep out of reach of children.
Chemical structure
Indacaterol + Glycopyrronium + Mometasone Furoate