Indigo Dry Powder Inhalation Capsule (DPI)

Indigo dry power inhaler is indicated for the treatment of:

• Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
• Maintenance bronchodilator treatment to reduce exacerbations in adult patients with chronic obstructive pulmonary disease (COPD).

This dry powder inhaler consists of indacaterol 110 meg and glycopyrronium 50 meg. One active component of this dry powder inhaler is indacaterol maleate, a selective beta2-adrenergic agonist. The pharmacological effects of beta2-adrenoceptor agonists attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle. The other active component of this dry powder inhaler is Glycopyrronium Bromide, acts as a competitive antagonist. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. When indacaterol and glycopyrronium are administered together, they provide additive efficacy due to their different mode of action targeting different receptors and pathways to achieve smooth muscle relaxation. Due to the differential density of beta2-adrenoceptors and M3-receptors in central versus peripheral airways, beta2-agonists should be more effective in relaxing peripheral airways, whilst an anticholinergic compound may be more effective in central airways. Thus, for bronchodilation in both peripheral and central airways of the human lung a combination of a beta2-adrenergic agonist and a muscarinic antagonist may be beneficial.

Recommended Dosage: Once daily inhalation of 110 mcg/ 50 mcg at the same time of the day each day using this dry powder inhaler.

Maximum Total Daily Dosage: should not exceed more than one dose each day. If a dose is missed, it should be taken as soon as possible on the same day.

Pediatric use: This inhaler should not be used in patients under 18 years of age.

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

• Take off the cap.
• Shake the inhaler (at least six times) vigorously before each use.
• If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
• Breathe out as full as comfortably possible & hold the inhaler upright.
• Place the actuator into mouth between the teeth and close lips around the mouthpiece.
• While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
• Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
• If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
• After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
• Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Concomitant use not recommended with beta-adrenergic blockers (including eye drops), Anticholinergics, sympathomimetics. Caution required in Concomitant hypokaiaemic treatment with methylxanthine derivatives, steroids, or non-potassium sparing diuretics.

This is contraindicated in patients with hypersensitivity to any of its ingredients.

Very common (>1/10): Upper respiratory tract infection.

Common (>1/100 to <1/10): Nasopharyngitis, urinary tract infection, sinusitis, rhinitis, hypersensitivity, hyperglycaemiaand diabetes mellitus, dizziness, headache, cough, oropharyngeal pain including throat irritation, dyspepsia, dental caries, bladder obstruction and urinary retention, pyrexia and chest pain.

Uncommon (>1/1,000 to <1/100): Angioedema, insomnia, glaucoma, ischaemic heart disease, atrial fibrillation, tachycardia, palpitations, paradoxical bronchospasm, dysphonia, epistaxis, gastroenteritis, dry mouth, pruritus/rash, musculoskeletal pain, muscle spasm, myalgia, pain in extremity, peripheral edema and fatigue.

Rare (>1/10,000, <1/1,000): Paraesthesia.

There is insufficient data of this dry powder inhaler in pregnant women. Indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. Therefore, this inhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus. It is not known whether this inhaler and their metabolites are excreted in human milk. The use of this dry powder inhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant. Reproduction studies are not known to indicate a concern regarding fertility in either males or females.

Avoid use in patients with Asthma because Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths.

This medicine is not indicated for the treatment of acute episodes of bronchospasm.

Hypersensitivity reactions e.g., angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face) urticaria or skin rash, treatment should be discontinued immediately.

Administration of this dry powder inhaler may result in paradoxical bronchospasm which can be life-threatening.

Should be used with caution in patients with Narrow-angle glaucoma & Urinary retention.

This dry powder inhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).

Patients with severe renal impairment should be monitored closely for potential adverse reactions.

Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose. Upon initiation of treatment with this dry powder inhaler, plasma glucose should be monitored more closely in diabetic patients.

In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment, which may increase the susceptibility to cardiac arrhythmias.

This dry powder inhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis,

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take This.

There is no information on clinically relevant overdosing with this dry powder inhaler. An overdose could lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia or could induce anticholinergic effects such as increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding.

Store below 25°C temperature. Keep away from light & wet place. Keep out of reach of children.