Ultivent M Cozycap

✔️ Indacaterol

• Class: Long-acting beta2-adrenergic agonist (LABA).
• Mechanism of Action:
  Indacaterol activates beta2-adrenergic receptors in the bronchial smooth muscle, increasing intracellular cyclic adenosine monophosphate (cAMP) levels via stimulation of adenyl cyclase. Elevated cAMP levels result in smooth muscle relaxation, causing bronchodilation.
• Receptor Selectivity:
  • Strong beta2 selectivity, with 24-fold higher potency for beta2 over beta1 receptors and 20-fold higher potency for beta2 over beta3 receptors.
  • Acts as a near full agonist at beta2 receptors, with nanomolar potency.
  • Displays a rapid onset of action with sustained efficacy due to its long duration of action.
• Cardiac Considerations:
  While predominantly targeting beta2 receptors, its partial interaction with beta1 and beta2 adrenergic receptors in the heart may cause minor cardiac effects.
• Clinical Effects: Rapid and prolonged bronchodilation with once-daily dosing.

✔️ Glycopyrronium

• Class: Long-acting muscarinic antagonist (LAMA).
• Mechanism of Action:
  Glycopyrronium inhibits the action of acetylcholine at muscarinic receptors on airway smooth muscle, preventing bronchoconstriction and promoting airway dilation.
• Receptor Specificity:
  • High affinity for M1, M2, and M3 receptors, with a 4- to 5-fold selectivity for M3 and M1 over M2.
  • This selectivity minimizes interference with M2 receptor-mediated negative feedback, reducing potential adverse effects.
• Onset and Duration:
  • Rapid onset due to favorable receptor-binding kinetics.
  • Sustained action is attributed to prolonged drug retention in lung tissues and a longer elimination half-life post-inhalation compared to intravenous administration.
• Clinical Effects: Enhances bronchodilation, improving airflow over 24 hours.

✔️ Mometasone Furoate

• Class: Inhaled corticosteroid (ICS).
• Mechanism of Action:
  Mometasone exerts anti-inflammatory effects by binding to glucocorticoid receptors with high affinity. It inhibits the release of inflammatory mediators and cytokines such as:
  • Leukotrienes (LTs).
  • Interleukins (IL-1, IL-5, IL-6).
  • Tumor Necrosis Factor-alpha (TNF-α).
  • Th2 cytokines (IL-4, IL-5).
• Local Pulmonary Activity:
  Studies show a favorable pulmonary-to-systemic activity ratio, minimizing systemic side effects.
• Clinical Effects:
  • Reduces airway inflammation and hyper-responsiveness.
  • Improves asthma control and prevents exacerbations.

✔️ Synergistic Benefits of the Indacaterol + Glycopyrronium + Mometasone Furoate

1. Indacaterol (Ultra-LABA): Provides long-lasting bronchodilation by relaxing bronchial muscles.
2. Glycopyrronium (Ultra-LAMA): Sustains airway patency by preventing bronchoconstriction.
3. Mometasone Furoate (ICS): Suppresses airway inflammation, improving long-term control and reducing exacerbation risk.

Indacaterol + Glycopyrronium + Mometasone Furoate combination ensures comprehensive management of asthma by addressing airflow limitation, inflammation, and symptom control with minimal dosing frequency.

✔️ Dosage & Administration

• Inhale 1 capsule daily using the provided inhalation device.
• Do not exceed one inhalation capsule per day.
  • Please follow the instructions carefully. the instructions of a registered physician when using this medication.

✔️ Drug Interactions

• Caution is advised when co-administered with:
  1. Monoamine oxidase inhibitors (MAOIs): Increased risk of cardiovascular side effects.
  2. Tricyclic antidepressants: Potential for enhanced cardiovascular effects.
  3. Medications prolonging the QT interval: May elevate the risk of arrhythmias.

• Potentiated by co-administration with methylxanthine derivatives, systemic corticosteroids, or non-potassium-sparing diuretics.
• Avoid concomitant use of beta2-adrenergic blockers, as they may counteract the bronchodilatory effects.

✔️ Contraindications

Contraindicated in patients with known allergies to any of the active ingredients (Indacaterol, Glycopyrronium, Mometasone Furoate) or excipients in the formulation.

✔️ Side Effects

• Nasopharyngitis (inflammation of the nasal passages and throat)
• Upper respiratory tract infection
• Headache

✔️ Use in Pregnancy & Lactation

Pregnant Women:

• There is limited information regarding the use of indacaterol, glycopyrronium, and mometasone furoate in pregnant women.
• Animal Studies:
  • Indacaterol and glycopyrronium were not teratogenic in animal studies.
  • Mometasone furoate caused increased fetal malformations and reduced fetal survival and growth in studies with pregnant mice, rats, and rabbits.
• Use during pregnancy only if the potential benefits outweigh the risks to the fetus.

Breastfeeding:

• No specific data on the presence of the drugs in human milk, their effects on breastfed infants, or milk production.
• Animal Studies:
  • Indacaterol, glycopyrronium, and mometasone furoate were detected in the milk of lactating rats, with glycopyrronium reaching concentrations up to 10 times higher than in the mother’s blood.
  • Similar corticosteroids may transfer into human milk.
• Use with caution in breastfeeding mothers.

✔️ Precautions & Warnings

• Not suitable for treating acute asthma attacks or bronchospasm episodes.
• Discontinue immediately if allergic symptoms, such as angioedema or urticaria, occur.
• May cause increased pulse rate, blood pressure, or other cardiovascular symptoms. Monitor patients for such effects, and discontinue treatment if necessary.
• High doses of ß2-agonists and corticosteroids may increase plasma glucose levels. Diabetic patients should have glucose levels monitored closely at the start of treatment.
• Patients should rinse their mouths or gargle with water (without swallowing) or brush their teeth after each dose to reduce the risk of fungal infections.
• Capsules must not be swallowed. Use only with the inhalation device provided.
• Capsules should be removed from the blister pack immediately before use.

✔️ Storage:

• Store below 30°C. Keep away from light and moisture. Keep out of the reach of children.