Catium 27.5 mcg+15.6 mcg (Inhalation Capsule)

Indications

• Long-term once-daily maintenance bronchodilator treatment
• Airflow obstruction in COPD patients
• Chronic bronchitis treatment
• Emphysema treatment
• Not for acute episodes of bronchospasm
• Not indicated for asthma

Composition

• Each dry powder inhaler capsule contains Indacaterol 110 mcg
• Indacaterol Maleate INN (Micronized)
• Glycopyrronium 50 mcg
• Glycopyrronium Bromide BP (Micronized)

Pharmacology

• Combination of Glycopyrronium (an anticholinergic) and Indacaterol (a LABA)
• Stimulation of intracellular adenyl cyclase
• Relaxation of bronchial smooth muscle
• Inhibition of release of mediators of immediate hypersensitivity from cells

Dosage & Administration

• For oral inhalation only
• Use at the same time every day
• Limitation for relief of acute bronchospasm or asthma treatment
• Recommended dose for elderly patients (65 years of age and older)
• Not indicated for use in children and adolescents
• Use in patients with mild to moderate renal impairment
• Caution in patients with severe renal impairment or end-stage renal disease
• Use in patients with mild and moderate hepatic impairment
• Caution in patients with severe hepatic impairment

Interaction

• No specific interaction studies conducted for the combination
• Concomitant use with β-adrenergic blockers not recommended
• Caution required with concomitant use of hypokalemic treatment

Contraindications

• Hypersensitivity to Glycopyrronium or Indacaterol
• Severe hypersensitivity to milk proteins
• LABA use in asthma patients without long-term asthma control medication

Side Effects

• Cardiovascular effects
• Ocular disorders
• Urinary retention
• Gastrointestinal disorders
• Dry mouth
• Cough
• Immediate hypersensitivity reactions
• Hypokalemia
• Hyperglycemia
• Headache
• Nervousness
• Insomnia
• Muscle spasms
• Fatigue
• Malaise
• Tremor

Pregnancy & Lactation

• Pregnancy category C
• Use during pregnancy should justify potential risk to the foetus
• Consideration for breast-feeding women should justify expected benefit to the woman

Precautions & Warnings

• LABA monotherapy risk in serious asthma-related events
• Do not initiate in acutely deteriorating COPD or asthma
• Caution in combination with additional therapy containing LABA
• Discontinue if paradoxical bronchospasm occurs
• Use with caution in patients with cardiovascular disorders
• Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis
• Caution in patients with narrow-angle glaucoma
• Caution in patients with prostatic hyperplasia or bladder-neck obstruction
• Alert to hypokalemia and hyperglycemia

Overdose Effects

• No information on clinically relevant overdosing with the product
• Supportive and symptomatic treatment indicated
• Hospitalization in serious cases

Therapeutic Class

• Combined bronchodilators

Storage Conditions

• Avoid storage in direct sunlight or heat
• Store in a cool & dry place
• Keep away from eyes
• Keep all medicines out of reach of children

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