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
Therapeutic class
Long-acting selective β-adrenoceptor stimulants
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.
Side effects
Most Common (over 52 weeks):
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
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
Contraindications
Contraindications:
- Hypersensitivity to any active substances or excipients
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.
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.
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.
Storage conditions
Keep below 30°C temperature, away from light & moisture; keep out of reach of children.
Chemical structure
Indacaterol + Glycopyrronium + Mometasone Furoate