Catium ES

Indications

This medication is intended for daily, long-term maintenance therapy to improve airflow in patients with chronic obstructive pulmonary disease (COPD), including conditions such as chronic bronchitis and emphysema. It is not designed for use during sudden episodes of bronchospasm and is not indicated for asthma treatment.

Usage Note: Always use under the guidance of a licensed healthcare professional.

Composition

Each capsule for dry powder inhalation contains:

• Indacaterol 110 mcg (as Indacaterol Maleate INN, micronized)
• Glycopyrronium 50 mcg (as Glycopyrronium Bromide BP, micronized)

Pharmacology

This inhalation powder delivers a dual-acting formula of Glycopyrronium (an anticholinergic) and Indacaterol (a long-acting beta2-adrenergic agonist or LABA) via oral inhalation. Indacaterol’s effects stem from its action on intracellular adenyl cyclase, catalyzing ATP to cyclic AMP, which relaxes bronchial smooth muscles and prevents the release of hypersensitivity mediators. Glycopyrronium acts as a long-lasting muscarinic antagonist, blocking the M3 receptor in the smooth muscle of the airways to facilitate bronchodilation.

Dosage & Administration

• Adults (18 years and older): For oral inhalation only; administer once daily at the same time each day.
• COPD Maintenance: One inhalation per day.
• Use Limitations: Not intended for acute bronchospasm relief or asthma treatment.

Special Considerations:

• Elderly (65+ years): Recommended dosage is safe for elderly patients.
• Children & Adolescents: Not indicated for individuals under 18, as safety and efficacy have not been established.
• Renal Impairment: Safe for mild to moderate impairment; for severe impairment or dialysis patients, use only if benefits outweigh risks.
• Hepatic Impairment: Safe for mild to moderate impairment; caution advised for severe impairment due to limited data.

Interactions

No specific studies were conducted on the combined use of Glycopyrronium and Indacaterol. However, simultaneous use with β-adrenergic blockers, anticholinergics, or sympathomimetic agents is discouraged. Sympathomimetic agents may amplify the side effects of Indacaterol, and caution is needed when used alongside treatments that lower potassium levels.

Contraindications

• Not to be used in patients allergic to Glycopyrronium, Indacaterol, or any component of this medication.
• Contraindicated for those with severe milk protein allergies.
• Not for asthma patients unless combined with a long-term asthma control medication.

Side Effects

• Muscarinic Antagonists: May cause cardiovascular effects (such as arrhythmias), vision issues, urinary retention, gastrointestinal discomfort, dry mouth, and cough.
• Beta2-Agonists: Possible reactions include hypersensitivity (such as rash or bronchospasm), cardiovascular effects (like tachycardia), electrolyte imbalances, hyperglycemia, headache, nervousness, insomnia, muscle cramps, fatigue, and tremors.
• Most Common: Cough and sore throat (3% occurrence, more than placebo).

Pregnancy & Lactation

• Pregnancy: Category C – limited data on use during pregnancy. Administer only if the potential benefit justifies the risk to the fetus.
• Lactation: Unknown if ingredients are present in breast milk; use cautiously, weighing benefits for the mother against possible risks to the infant.

Precautions & Warnings

• LABA use increases the risk of serious asthma-related events.
• Not suitable for acute worsening of COPD or asthma or for immediate symptom relief.
• Avoid combining with additional LABA therapy to prevent overdose.
• Discontinue if paradoxical bronchospasm occurs, and consider alternative treatment.
• Use cautiously in patients with heart conditions, convulsive disorders, thyroid issues, diabetes, or ketoacidosis.
• Can exacerbate narrow-angle glaucoma and urinary retention; patients with related conditions should seek medical attention if symptoms worsen.
• Monitor for potassium and glucose imbalances.

Overdose Effects

In cases of overdose, effects of excessive beta2-agonist activity may occur, such as tachycardia, tremors, palpitations, nausea, and metabolic imbalances. Anticholinergic symptoms, such as increased eye pressure, constipation, or urinary retention, may also present. Symptomatic and supportive care is recommended, and hospitalization may be required in severe cases.

Therapeutic Class

Classified as a combination bronchodilator.

Storage Conditions

Store in a cool, dry place away from direct sunlight and heat. Keep all medications out of children’s reach and avoid contact with the eyes.