Indica-G 110 mcg+50 mcg (Inhalation Capsule)

Indications

• Long-term maintenance bronchodilator treatment
• Chronic obstructive pulmonary disease (COPD)
• Chronic bronchitis
• Emphysema
• Once-daily usage
• Not for acute episodes of bronchospasm
• Not for asthma

Composition

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

Pharmacology

• Delivery through oral inhalation
• Combined action of Glycopyrronium and Indacaterol
• Stimulation of intracellular adenyl cyclase
• Relaxation of bronchial smooth muscle
• Inhibition of release of mediators of immediate hypersensitivity
• Long-acting muscarinic antagonist
• Inhibition of M3 receptor at the smooth muscle
• Bronchodilation

Dosage & Administration

• For adults (18 years or older)
• Maintenance treatment of COPD: 1 inhalation once daily
• Not for relief of acute bronchospasm
• Not for children and adolescents
• Use in patients with renal impairment
• Use in patients with hepatic impairment

Interaction

• No specific interaction studies
• Caution with concomitant use of hypokalemic treatment
• Not recommended with β-adrenergic blockers, anticholinergics, or sympathomimetic agents

Contraindications

• Hypersensitivity to Glycopyrronium or Indacaterol
• Severe hypersensitivity to milk proteins
• LABA use in patients with asthma 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 if expected benefit justifies potential risk to the foetus
• Consideration for breast-feeding women if expected benefit to the woman is greater than any possible risk to the infant

Precautions & Warnings

• Increased risk of serious asthma-related events with LABA monotherapy
• Avoid initiation in acutely deteriorating COPD or asthma
• Caution with cardiovascular disorders
• Caution with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis
• Potential worsening of narrow-angle glaucoma
• Potential worsening of urinary retention
• Alert for hypokalemia and hyperglycemia

Overdose Effects

• Exaggerated effects typical of β2-adrenergic stimulants
• Tachycardia
• Tremor
• Palpitations
• Headache
• Nausea
• Vomiting
• Drowsiness
• Ventricular arrhythmias
• Metabolic acidosis
• Hypokalemia
• Hyperglycaemia
• Anticholinergic effects
• Increased intraocular pressure
• Obstipation
• Difficulties in voiding
• Supportive and symptomatic treatment

Therapeutic Class

• Combined bronchodilators

Storage Conditions

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

Related Brands

• Ultibro 110 mcg+50 mcg (Inhalation Capsule) - novartis-bangladesh-ltd