Indarol Plus 110 mcg+50 mcg (Inhalation Capsule)

Indications

• Long-term once-daily maintenance bronchodilator treatment
• Airflow obstruction
• COPD (Chronic Obstructive Pulmonary Disease)
• Chronic bronchitis
• Emphysema

Composition

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

Pharmacology

• Delivery of a combination of Glycopyrronium and Indacaterol by oral inhalation
• 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
• Maintenance treatment of COPD: 1 inhalation once daily
• Limitations of use: Not indicated for relief of acute bronchospasm or for the treatment of asthma
• Geriatric use
• Use in Children & Adolescents: Not indicated
• Renal impairment use
• Hepatic impairment use

Interaction

• No specific interaction studies conducted for Glycopyrronium and Indacaterol combination
• Concomitant use with β-adrenergic blockers, anticholinergics or sympathomimetic agents not recommended
• Caution required with concomitant use of hypokalemic treatment

Contraindications

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

Side Effects

• Cardiovascular effects
• Ocular disorders
• Urinary retention
• Gastrointestinal disorders
• Dry mouth
• Cough
• β2-agonist immediate hypersensitivity reactions
• Hypokalemia
• Hyperglycemia
• Headache
• Nervousness
• Insomnia
• Muscle spasms
• Fatigue
• Malaise
• Tremor
• Oropharyngeal pain

Pregnancy & Lactation

• Pregnancy category C
• Use during pregnancy should justify potential risk to the fetus
• Consideration of use during breastfeeding 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
• Not to be initiated in acutely deteriorating COPD or asthma
• Caution in patients with cardiovascular disorders
• Caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis
• Risk of paradoxical bronchospasm
• Worsening of narrow-angle glaucoma
• Worsening of urinary retention
• Alert to hypokalemia and hyperglycemia

Overdose Effects

• Clinically relevant overdosing effects
• Exaggerated effects typical of β2-adrenergic stimulants
• Anticholinergic effects
• Hospitalization in serious cases

Therapeutic Class

• Combined bronchodilators

Storage Conditions

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

Related Brands

• Indarol Plus 27.5 mcg+15.6 mcg (Inhalation Capsule) - healthcare-pharmaceuticals-ltd