“May all be happy, may all be healed, may all be at peace and may no one ever suffer."
This cozycap is an inhalation powder drug product for delivery of a combination of futicasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. The pharmacologic efects of beta 2-adrenoceptor agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3, 5 -adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
The precise mechanism through which futicasone furoate afects COPD and asthma symptoms is not known. Infammation is an important component in the pathogenesis of COPD and asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in infammation.
Umeclidinium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar afnity to the subtypes of muscarinic receptors M1 to M5 . In the airways, it exhibits pharmacological efects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.
This is indicated in-
Adults: 18 years or older: For oral inhalation only. Should be taken by revolizer. Should be used at the same time every day, not more than 1 time every 24 hours. If shortness of breath or other asthma symptoms arise in the period between doses, an inhaled SABA should be taken for immediate relief.
COPD: Most common adverse reactions (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, infuenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.
Asthma: Most common adverse reactions (incidence ≥2%) are pharyngitis/nasopharyngitis, upper respiratory tract infection/viral upper respiratory tract infection, bronchitis, respiratory tract infection/viral respiratory tract infection, sinusitis/acute sinusitis, urinary tract infection, rhinitis, infuenza, headache, and back pain
Use in Special Populations
Elderly population: Based on available data, no adjustment of the dosage in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out.
Renal impairment: It has not been studied in subjects with renal impairment.
Hepatic impairment: It has not been studied in subjects with hepatic impairment.
Pediatric population: It is not indicated for use in children and adolescents. The safety and efficacy in pediatric patients (aged 17 years and younger) have not been established.
Pregnancy & Lactation
Insufficient data on the use of this preparation in pregnant women and lactating mothers.