Ultivent™ Cozycap Capsule

It is indicated as a maintenance treatment of asthma, and to reduce asthma exacerbations, in adults not adequately controlled with a maintenance combination of a long-acting ß2-agonist and an inhaled corticosteroid.

Description

This is an inhalation powder drug product for delivery of a combination of Indacaterol Acetate (an ultra-LABA), Glycopyrronium Bromide (an ultra-LAMA), and Mometasone Furoate (an ICS) to patients by oral inhalation.

Indacaterol: It is an ultra-LABA. When inhaled, Indacaterol acts locally in the lung as a bronchodilator. Indacaterol is a partial agonist at the human ß2-adrenergic receptor. In isolated human bronchus, Indacaterol has a rapid onset of action and a long duration of action.

Glycopyrronium: It is an ultra-LAMA, which works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.

Mometasone Furoate: Mometasone Furoate is a synthetic corticosteroid with high afnity for glucocorticoid receptors and local anti-infammatory properties. In vitro, Mometasone Furoate inhibits the release of leukotrienes from leukocytes of allergic patients.

Dosage & Administration

• For oral inhalation only, to be used with inhalation device
• One inhalation capsule to be inhaled once daily
• Do not take more than one inhalation capsule in a day

Interaction

• Ultivent-M, like other medicinal products containing LABA, should be administered with caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants or medicinal products known to prolong the QT interval.
• Concomitant treatment with methylxanthine derivatives, steroids or non-potassium-sparing diuretics may potentiate the possible hypokalemic effect of LABA.
• Ultivent-M should not be given together with ß2-adrenergic blockers.

Contraindications

It is contraindicated in patients with hypersensitivity to any of the active substances or excipients.

Side Effects

The most common adverse reactions over 52 weeks are nasopharyngitis, upper respiratory tract infection and headache.

Precautions & Warnings

• This should not be used to treat acute asthma symptoms including acute episodes of bronchospasm.
• If any allergic reactions occur, like angioedema, urticaria, Ultivent-M should be discontinued immediately, and alternative therapy is instructed.
• Ultivent-M may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, or symptoms. If such effects occur, treatment may need to be discontinued.
• Inhalation of high doses of ß2-adrenergic agonists and corticosteroids may increase in plasma glucose. Upon initiation of treatment with Ultivent-M, plasma glucose should be monitored more closely in diabetic patients.
• In order to reduce the risk of oropharyngeal candida infection, patients should be advised to rinse their mouth or gargle with water without swallowing it or brush their teeth after inhaling the prescribed dose.
• This must not be swallowed. Only to be used with inhalation device. Removecapsule from the blister pack only immediately before use it in the inhalation device.

Therapeutic Class

Long-acting selective β-adrenoceptor stimulants

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.