Vilaro Dry Powder Inhalation Capsule
Vilanterol + Umeclidinium
25 mcg+62.5 mcg
Beximco Pharmaceuticals Ltd.
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| Retail Price | 70.00 AED |
Indications
Vilaro Dry Powder Inhalation Capsule is used for:
Chronic Obstructive Pulmonary Disease
Adult Dose
Chronic Obstructive Pulmonary Disease
Inhalation/Respiratory
Maintenance therapy in chronic obstructive pulmonary disease
Adult: 62.5 mcg/25 mcg 1 inhalation once daily.
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Hepatic impairment:
Moderate hepatic impairment (Child-Pugh 7-9): No dosage adjustment is required
Severe hepatic impairment: Unknown, not evaluated
Child Dose
Renal Dose
Renal impairment (including severe [CrCl <30 mL/min]): No dosage adjustment is required
Administration
Contra Indications
Severe hypersensitivity to milk proteins.
Use without an inhaled corticosteroid in the treatment of asthma.
Acute episodes of bronchospasm or acutely deteriorating COPD. Concomitant use with other long-acting β2-agonists.
Precautions
Not indicated for relief of acute bronchospasm or for the treatment of asthma; data from a large placebo-controlled trial in subjects with asthma showed that LABAs may increase the risk of asthma-related death.
Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.
Do not exceed recommended dose (ie, 1 actuation once daily) or coadminister with other medicines containing a LABA; may result in overdose.
Patient with CV disease (e.g. cardiac insufficiency, arrhythmias, hypertension), diabetes mellitus, narrow-angle glaucoma, hypokalaemia, prostatic hyperplasia/bladder neck obstruction, seizure disorders, thyrotoxicosis. Concomitant use with other long-acting muscarinic antagonists.
Concomitant use w/ drugs potentially causing hypokalaemia.
Pregnancy-Lactation
Pregnancy
Use during pregnancy only if potential benefit justifies potential risk to fetus; women should be advised to contact their healthcare providers if they become pregnant while receiving therapy; use during late gestation and labor only if the potential benefit justifies potential risks related to beta-agonists interfering with uterine contractility
Umeclidinium: No evidence of teratogenic effects shown in rats and rabbits at approximately 50 and 200 times, respectively, the maximum recommended human daily inhaled dose (MRHDID) in adults
Vilanterol: No teratogenic effects in rats and rabbits shown at approximately 13,000 and 70 times, respectively, the MRHDID in adults; however, fetal skeletal variations observed, including decreased or absent ossification in cervical vertebral centrum and metacarpal in rabbits at approximately 450 times the MRHDID in adults
Labor and delivery
Not studied; because beta-agonists may potentially interfere with uterine contractility, therapy should be administered during labor only if potential benefit justifies potential risk
Lactation
There is no information available on presence of umeclidinium or vilanterol in human milk, effects on breastfed child, or on milk production; umeclidinium was detected in plasma of offspring of lactating rats treated with umeclidinium suggesting its presence in maternal 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 umeclidinium or vilanterol or from the underlying maternal condition
Interactions
Umeclidinium: Additive effect with other anticholinergic drugs.
Vilanterol: Increased exposure with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin). Increased risk of hypokalaemia with methylxanthine derivative, steroids or non-K-sparing diuretics. Diminished bronchodilatory effect with β-adrenergic blockers. Increased risk of CV adverse effects with MAOIs, and TCAs.
Potentially Fatal: Enhanced adverse effect with other long-acting β2-adrenergic agonists (e.g. formoterol, salmeterol).
Adverse Effects
Side effects of Vilanterol + Umeclidinium :
1-10%
Pharyngitis (2%)
Diarrhea (2%)
Pain in extremity (2%)
Muscle spasms (1%)
Neck pain (1%)
Chest pain (1%)
Sinusitis (1%)
Lower respiratory tract infection (1%)
Constipation (1%)
<1%
Productive cough
Dry mouth
Dyspepsia
Abdominal pain
GERD
Vomiting
Musculoskeletal chest pain
Chest discomfort
Asthenia
Atrial fibrillation
Ventricular extrasystoles
Supraventricular extrasystoles
Myocardial infarction
Pruritus
Rash
Conjunctivitis
Mechanism of Action
Umeclidinium bromide: Long-acting muscarinic antagonist (LAMA), often referred to as an anticholinergic; blocks action of acetylcholine at muscarinic receptors (M1 to M5) in the bronchial airways (M3) by preventing increase in intracellular calcium concentration, leading to relaxation of airway smooth muscle, improved lung function, and decreased mucous secretion; dissociates slowly from M3 muscarinic receptors extending its duration of action
Vilanterol: Long-acting selective beta2-adrenergic agonist (LABA); stimulates intracellular adenyl cyclase resulting in increased cAMP levels causing bronchial smooth muscle relaxation; also inhibits release of mediators of immediate hypersensitivity from cells, especially from mast cells
Note
Vilaro 25 mcg+62.5 mcg Dry Powder Inhalation Capsule manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Vilanterol + Umeclidinium. Vilaro is availble in Bangladesh.
Farmaco BD drug index information on Vilaro Dry Powder Inhalation Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.