Trio Acucap^®

Trio^® Acucap is the preparation of Vilanterol, Umeclidinium and Fluticasone Furoate. Vilanterol is a LABA. The pharmacologic effects of beta₂-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. Umeclidinium is a long acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. Fluticasone Furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Corticosteroids have been shown to have a wide range of actions on multiple cell types and mediators involved in inflammation. Specific effects of Fluticasone Furoate demonstrated in in vitro and in vivo models included activation of the glucocorticoid response element, inhibition of pro-inflammatory transcription factors such as NFkB. These anti-inflammatory actions of corticosteroids may contribute to their efficacy

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Trio^® Acucap is indicated for-

• Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
• Maintenance treatment of asthma in patients aged 18 years and older

Trio^® Acucap is not indicated for the relief of acute bronchospasm.

Route of administration: Trio^® Acucap should be administered by oral inhalation route only.

Special Instructions: Trio^® Acucap should be administered as 1 inhalation once daily by oral inhalation. After inhalation, the mouth should be rinsed with water without swallowing to help reduce the risk of oropharyngeal candidiasis. Trio^® Acucap should be used at the same time every day.

Trio^® Acucap should not be used more than 1 time every 24 hours. Acucap must not be swallowed. Only to be used with aculizer.

Maintenance treatment of chronic obstructive pulmonary disease (COPD) The recommended dose of

Trio^® Acucap for maintenance treatment of COPD is 1 inhalation once daily by oral inhalation. If shortness of breath occurs in the period between doses, an inhaled, short-acting beta₂-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

Maintenance treatment of asthma

The recommended dose of

Trio® Acucap or Trio^® 200 Acucap for maintenance treatment of asthma is 1 inhalation once daily by oral inhalation according to patient’s response. The maximun recommended dose is 1 inhalation of Trio^® 200 Acucap once daily. If asthma symptoms arise in the period between doses, an inhaled, short-acting beta^agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

Pregnancy: There are insufficient data on the use of this combination or its individual components, fluticasone furoate, umeclidinium and vilanterol, in pregnant women to inform a drug associated risk. This combination should be used during late gestation and labor only if the potential benefit justifies the potential for risks related to beta-agonists interfering with uterine contractility.

Lactation: There is no information available on the presence of fluticasone furoate, umeclidinium or vilanterol in human milk; the effects on the breastfed child; or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this combination and any potential adverse effects on the breastfed child from fluticasone furoate, umeclidinium or vilanterol or from the underlying maternal condition.

Use in children and adolescents

This combination 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

LABA monotherapy increases the 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 therapy containing a LABA because of risk of overdose. Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. There is increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia. Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral or parasitic infections; ocular herpes simplex) may occur. Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. There is risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to this combination. Hypercorticism and adrenal suppression may occur with very high doses or at the regular dose In susceptible individuals. If such changes occur, discontinue this combination slowly. If paradoxical bronchospasm occurs, discontinue this combination and institute alternative therapy. Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation. Assess for decrease in bone mineral density initially and periodically thereafter. Glaucoma and cataracts may occur with long term use of ICS. Worsening of narrow angle glaucoma may occur. Use with caution in patients with narrow angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use this combination long term. Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus and ketoacidosis. Be alert to hypokalemia and hyperglycemia

COPD: Most common side effects are 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 and dysphonia.

Asthma: Most common side effects 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, influenza, headache and back pain

This combination is contraindicated in patients with known hypersensitivity to vilanterol, umeclidinium, fluticasone furoate or any other components of this combination. It is also contraindicated in primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required.

Drug Interaction with medication: Concomitant use of this combination with strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole) may cause systemic corticosteroid and cardiovascular effects. When monoamine oxidase inhibitors and tricyclic antidepressants are used concomitantly with this combination, effect of vilanterol on vascular system may be potentiated. Beta-blockers may block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Electrocardiographic changes and/or hypokalemia associated with non-potassium-sparing diuretics may worsen with concomitant beta-agonists. This combination may interact additively with concomitantly used anticholinergic medications.

Drug interaction with food and others: Not applicable.

No human overdose data has been reported for this combination. Treatment of overdose consists of discontinuation of this combination together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdose.

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No Data

Trio^® Acucap Inhaler Each Acucap capsule contains Vilanterol 25 mcg as Vilanterol Trifenatate INN, Umeclidinium 62.5 mcg as Umeclidinium Bromide INN and Fluticasone Furoate BP 100 mcg. Trio^® 200 Acucap Inhaler: Each Acucap capsule contains Vilanterol 25 mcg as Vilanterol Trifenatate INN, Umeclidinium 62.5 mcg as Umeclidinium Bromide INN and Fluticasone Furoate BP 200 mcg.

Storage

Store below 25°C in a dry place, protected from light. Keep away from the reach of children.

Packing

Trio®Acucap Inhaler: Carton of 20 Acucap capsules in blister pack.

Trio® 200 Acucap Inhaler: Carton of 10 Acucap capsules in blister pack.