Drug information of umeclidinium bromide/vilanterol inhaled


umeclidinium bromide/vilanterol inhaled


Brand drugs:Anoro Ellipta

Umeclidinium and vilanterol is a combination medicine used to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Drug forms
  • umeclidinium bromide/vilanterol inhaled

Mechanism of effect

Umeclidinium: A long-acting anticholinergic, competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation.

Vilanterol: A long-acting beta2-agonist, relaxes bronchial smooth muscle by selective action on beta2-receptors with little effect on heart rate.

Pharmacokinetics

Absorption:Umeclidinium and vilanterol: Systemic, primarily via lungs

Peak plasma time: 5-15 minutes (umeclidinium/vilanterol)

Distribution:IV: Umeclidinium: 86 L; Vilanterol: 165 L

Metabolism:Hepatic via CYP2D6 (umeclidinium) and CYP3A4 (vilanterol)

Excretion:Urine (<1% umeclidinium; 70% vilanterol); feces (92% umeclidinium; 30% vilanterol)

Half-Life Elimination:11 hours

Protein Binding:Umeclidinium: 89%; Vilanterol: 94%

Drug indications

chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease

Dosage

62.5 mcg/25 mcg (1 actuation) inhaled PO qDay

Drug contraindications

Hypersensitivity to this drug

Severe hypersensitivity to milk proteins

Demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients

Side effects

Sinusitis , Anxiety , Diarrhea , chest pain , dry mouth , Blurred vision , Angioedema , palpitations , dyspepsia , Cough , Pain , Tremor , itching , atrial fibrillation , increased ocular tension , glaucoma , Abdominal pain , Rash , Hypersensitivity to this drug , Myocardial Infarction

Pharyngitis

Diarrhea

Pain in extremity

Muscle spasms

Neck pain

Chest pain

Sinusitis

Lower respiratory tract infection

Constipation

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

Palpitations

Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria

Dysgeusia, tremor

Anxiety

Blurred vision, glaucoma, increased intraocular pressure

Dysuria, urinary retention

Dysphonia, paradoxical bronchospasm

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Alerts

-Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol, increase the risk for asthma-related death

-Safety and efficacy not established in patients with asthma; NOT approved for treatment of asthma

-Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of COPD

-Beta2-agonists can produce clinically significant cardiovascular effects including increased pulse rate or increased systolic or diastolic blood pressure

-Fatalities reported in association with excessive use of inhaled sympathomimetic drugs

-Paradoxical bronchospasm reported

-Beta2-agonists should be used with caution with convulsive disorders, thyrotoxicosis, narrow-angle glaucoma, conditions causing urinary retention, and in individuals who are unusually responsive to sympathomimetic amines

-Potential for beta2-agonists to produce significant hypokalemia and transient hyperglycemia

-Caution with coadministration with strong CYP3A4 inhibitors because increased cardiovascular adverse effects may occur

-Use beta2-agonists with extreme caution in patients being treated with MAOIs, TCAs, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents

 

Points of recommendation

-Do not exceed recommended dose (ie, 1 actuation once daily) or coadminister with other medicines containing a LABA; may result in overdose

-Store in a dry place away from direct heat or sunlight

-Throw the inhaler away 6 weeks after opening, or when the dose indicator shows a zero

-Before the inhaler is used for the 1st time, the counter should show the number 30.this is the number of doses in the inhaler

-Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

-Umeclidinium and vilanterol is not a rescue medicine. It will not work fast enough to treat an bronchospasm attack.

 

Pregnancy level

C

C

Use during pregnancy only if potential benefit justifies potential risk to fetus;

Breast feeding warning

There is no information available on presence of umeclidinium or vilanterol in human milk, effects on breastfed child, or on milk production

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

 

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Aclidinium


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