Generic
Vilanterol Trifenatate + Fluticasone Furoate + Umeclidinium Bromide
12 brands available in the market
At a glance
Vilanterol Trifenatate + Fluticasone Furoate + Umeclidinium Bromide is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and the maintenance treatment of asthma in patients aged 18 years and older.
Description
This capsule is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation.
Indications
- Chronic obstructive pulmonary disease (COPD)
- Asthma (18 years and older)
Therapeutic class
Combined bronchodilators
Pharmacological class
ICS + LABA + LAMA Combination
Pharmacology
This capsule is an inhalation powder drug product. Vilanterol is a LABA that stimulates intracellular adenyl cyclase, increasing cyclic AMP, which relaxes bronchial smooth muscle. Fluticasone furoate is an ICS with a wide range of actions on multiple cell types and mediators involved in inflammation. Umeclidinium is a LAMA that inhibits M3 receptor, leading to bronchodilation.
Mechanism of action
Vilanterol acts as a β2-agonist causing bronchodilation; fluticasone furoate reduces inflammation; umeclidinium inhibits M3 receptor causing bronchodilation.
Dosage
Adult Dose (Inhalation):
- COPD maintenance: 1 inhalation capsule once daily
- Asthma maintenance: 1 inhalation capsule once daily
- Use at the same time every day, not more than once every 24 hours
Administration
- Do not swallow the inhalation capsule
- Only to be used with the device
- Remove capsule from blister pack only immediately before use
- Rinse mouth with water without swallowing after inhalation to reduce risk of oropharyngeal candidiasis
Missed dose
If you miss a dose, take it as soon as you remember; if almost time for next dose, skip it; do not double the dose.
Side effects
Common Side Effects:
- Upper respiratory tract infection
- Pneumonia
- Bronchitis
- Oral candidiasis
- Headache
- Back pain
- Arthralgia
- Influenza
- Sinusitis
- Pharyngitis
- Rhinitis
- Dysgeusia
- Constipation
- Urinary tract infection
- Diarrhea
- Gastroenteritis
- Oropharyngeal pain
- Cough
- Dysphonia
Precautions & warnings
- LABA monotherapy increases risk of serious asthma-related events
- Do not initiate in acutely deteriorating COPD or asthma
- Do not use to treat acute symptoms
- Do not use in combination with additional LABA-containing therapy
- Candida albicans infection of mouth and pharynx may occur; monitor periodically
- Increased risk of pneumonia in patients with COPD; monitor for signs and symptoms
- If paradoxical bronchospasm occurs, discontinue and institute alternative therapy
- Use with caution in patients with cardiovascular disorders
- Worsening of urinary retention may occur; caution in prostatic hyperplasia or bladder-neck obstruction
- Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis
Contraindications
- Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures
- Severe hypersensitivity to milk proteins or any ingredients
Drug interactions
- Strong CYP3A4 inhibitors (ketoconazole): use with caution; may cause systemic corticosteroid and cardiovascular effects
- MAOIs and tricyclic antidepressants: use with extreme caution; may potentiate the effect of vilanterol on the vascular system
- Beta-blockers: use with caution; may block bronchodilatory effects of beta-agonists and produce severe bronchospasm
- Diuretics: use with caution; ECG changes and/or hypokalemia may worsen
- Anticholinergics: may interact additively; avoid administration with other anticholinergic-containing drugs
Food interactions
Food interactions are not significant.
Use in pregnancy
Use in Pregnancy: Insufficient data on use in pregnant women.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Insufficient data on use in lactating mothers.
Pediatric use
Safety and efficacy not established in pediatric patients (aged 17 years and younger)
Geriatric use
No dosage adjustment necessary in geriatric patients, but greater sensitivity in some older individuals cannot be ruled out
Renal / hepatic impairment
Renal Impairment: Not studied
Hepatic Impairment: Not studied
Overdose effects
Symptoms: No data available from clinical trials on overdose.
Treatment: Supportive care.
Storage conditions
Avoid storage in direct sunlight or heat. Store in a cool & dry place. Keep away from eyes. Keep out of reach of children.