Do not use to treat acute asthma symptoms or an acute exacerbation in COPD. Discontinue immediately if paradoxical bronchospasm occurs. Cardiac arrhythmias (eg, supraventricular tachycardia & extrasystoles). Systemic effects may occur w/ inhaled corticosteroids particularly at high doses prescribed for long periods.
Patient w/ pulmonary TB or in patients w/ chronic or untreated infections. Visual disturbances may occur. History of or w/ risk factors for DM. Pneumonia in patients w/ COPD & asthma. Immunosuppression. Concomitant use of long-acting ?2-adrenergic agonists. Hepatic impairment. Pregnancy & lactation. Childn <12 yr.
Hypersensitivity to drug, any components/excipients, or milk proteins
Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required
Pregnancy
Disease-associated maternal and/or embryofetal risk; in women with poorly or moderately controlled asthma, there is increased risk of several perinatal outcomes such as pre-eclampsia in mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma
Labor and Delivery: There are no human studies evaluating effects during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use during labor should be restricted to those patients in whom benefits clearly outweigh risks
Lactation
There is no information available on presence of fluticasone furoate or vilanterol in human milk; effects on breastfed child, or effects on milk production; low concentrations of other inhaled corticosteroids have been detected in human milk; developmental and health benefits of breastfeeding should be considered along with mother?s clinical need for therapy and any potential adverse effects on breastfed child from fluticasone furoate or vilanterol or from underlying maternal condition
Adult Dose
Chronic Obstructive Pulmonary Disease
Indicated for long-term, once-daily, maintenance treatment of airflow obstruction with COPD, including chronic bronchitis and/or emphysema; also approved to reduce COPD exacerbations
25 mcg/100 mcg (1 actuation) inhaled PO once daily
Asthma
Indicated for once-daily treatment of asthma for patients not adequately controlled on a long-term asthma control medication (eg, inhaled corticosteroid), or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting beta agonist (LABA)
Prescribe strength (25 mcg/100 mcg or 25 mcg/200 mcg per actuation) once daily via oral inhalation
Hepatic impairment: No dosage adjustment required
Child Dose
N/A
Renal Dose
Renal impairment: No dosage adjustment required
Administration
After inhalation, rinse mouth with water and expectorate to help reduce risk of oropharyngeal candidiasis
Take at same time each day
Do not exceed 1 administration/24 hr
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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.