Dilgly UniCap Dry Powder Inhalation Capsule (DPI)

Dilgly UniCap inhalation capsule is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).

Glycopyrronium is a long-acting, specific antimuscarinic agent, in clinical medicine often called an anticholinergic. It has a similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, inhibition of M3-receptors at the smooth muscle results in relaxation. The high potency and slow receptor dissociation found its clinical correlate in significant and long-acting bronchodilation in patients with COPD.

The recommended dose of one inhalation capsule once daily of the content of one 50 microgram capsule using the inhalation device. This should be administered once daily every day at the same time of the day by orally inhaled route. For a missed dose, the next dose should be taken, as soon as it is remembered. This inhalation capsule should not be taken more than one time every 24 hours.

No specific interaction studies were conducted for the co-administration of this inhalation capsule with inhaled anti-cholinergic drugs and is therefore, like for other anticholinergics, not recommended. Although no formal drug interaction studies have been performed, this inhalation capsule has been used concomitantly with other drugs commonly used in the treatment of COPD without clinical evidence of drug interactions. These include sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids. Concomitant administration of this inhalation capsule and orally inhaled indacaterol, a (32 adrenergic agonist, under steady-state conditions of both drugs does not affect the pharmacokinetics of either drug.

This is contraindicated in patients with hypersensitivity to glycopyrronium or to any of the excipients of the preparation.

The common side effects experienced are dry mouth, cough, nasopharyngitis, vomiting, musculoskeletal pain, neck pain, diabetes mellitus, gastroenteritis, insomnia. Some side effects may result in fewer instances such as paradoxical bronchospasm, dysphonia, angioedema, hypersensitivity, pruritus, sinus congestion, throat irritation. In elderly patients above 75 years of age, the frequencies of urinary tract infection and headache is common.

Pregnancy: There is no adequate or well-controlled studies of the use of inhalation capsule in pregnant women with COPD available. Therefore, inhalation capsule should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.

Lactation: It is not known whether Glycopyrronium Bromide and their metabolites are excreted in human milk. Therefore, the use of inhalation capsule by breast-feeding women should be done with caution, and only be considered if the expected benefit to the woman is greater than any possible risk to the infant.

Fertility: Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females.

This inhalation capsule is a once daily long term maintenance treatment and it is not indicated for the treatment of acute cases of bronchospasm i.e. as a rescue therapy.

This inhalation capsule should not be used in patients under 18 years of age.

Like other anticholinergic drugs, this inhalation capsule should be used with caution in patients with narrow-angle glaucoma or urinary retention. If signs suggesting any allergic reaction occur, in particular, angioedema (including difficulties in breathing and swallowing, swelling of the tongue, lips and face), urticaria or skin rash, this inhalation capsule should be discontinued immediately and alternative therapy instituted. As with other inhalation therapy, administration of this inhalation capsule may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, this inhalation capsule should be discontinued immediately and alternative therapy instituted.

For patients with severe renal impairment (estimated glomerular filtration rate below 30 mL/min/1.73 m2) including those with end stage renal disease requiring dialysis, this inhalation capsule should only be used if only the expected benefit outweighs the potential risk.

High doses of Dilgly UniCap may lead to anticholinergic signs and symptoms for which, symptomatic treatment may be indicated. In COPD patients, repeated orally inhaled administration of Dilgly UniCap at total doses of 100 and 200 microgram once daily for 28 days is well tolerated. Acute intoxication by inadvertent oral ingestion of glycopyrronium capsules is unlikely.

Bronchodilator

This capsule must not be swallowed. Only to be used with an inhalation device. Insert the Easycap in the Easyhaler for best performance. Remove this capsule from the blister pack immediately before using, as this capsule exposed to moisture may not tear easily. Store at a temperature not exceeding 30°C in a dry place. Protect from light & moisture.