Seebri Breezhaler50 mcg

Glycopyrronium bromide is indicated as a long-term once daily maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.Geriatrics (>65 years of age): This can be used at the recommended dose in elderly patients 65 years of age and older.Pediatrics (<18 years of age): This should not be used in patients under 18 years of age.

Bronchodilator

Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anti-cholinergic) for once-daily maintenance bronchodilator treatment of COPD. Parasympathetic nerves are the major bronchoconstrictive neural pathway in airways, and cholinergic tone is the key reversible component of airflow obstruction in COPD. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells thereby dilating the airways. Of the five known muscarinic receptor subtypes (M1-5), only subtypes M1-3 have a defined physiological function in the human lung. Glycopyrronium is a high affinity muscarinic receptor antagonist of these three receptor subtypes. It demonstrated 4- to 5-fold selectivity for the human M3 and M1 receptors over the human M2 receptor in competition binding studies. It has a rapid onset of action as evidenced by observed receptor association/dissociation kinetic parameters and the onset of action after inhalation in clinical studies.The long duration of action can be partly attributed to sustained drug concentrations in the lungs as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Glycopyrronium inhaler in contrast to the half-life after i.v. administration. Lung pharmacokinetic data in rats following inhalation of Seebri Breezhaler 50 mcg provides further evidence for this.

The recommended dosage of Glycopyrronium is the once-daily oral inhalation of the content of one 50 mcg capsule using the Glycopyrronium inhaler. The clinical trials were conducted based on dosing in the morning. The capsule must not be swallowed.Glycopyrronium is recommended for once-daily administration at the same time each day. This capsules must be administered only by the oral inhalation route and only using the inhaler.

Although no formal drug interaction studies have been performed, in clinical studies Glycopyrronium has been used concomitantly with other drugs commonly used to treat COPD including sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids. No safety findings were observed to contraindicate administration of these agents with Glycopyrronium

Glycopyrronium bromide is contraindicated in: Patients with hypersensitivity to Seebri Breezhaler 50 mcg or to any other component of this molecule. Patients with severe hypersensitivity to milk proteins. The relief of an acute deterioration of COPD.

Pregnant Women: There are no data available on the use of Glycopyrronium in pregnant women. Therefore, Glycopyrronium should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.Nursing Women: It is not known whether glycopyrronium passes into human breast milk. However, glycopyrronium (including its metabolites) was excreted into the milk of lactating rats. The use of Glycopyrronium by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.Women of child-bearing potential: There are no special recommendations for women of child-bearing potential.

Glycopyrronium is a once-daily long-term maintenance treatment and is not indicated for the treatment of acute episodes of bronchospasm, i.e. as a rescue therapy. When beginning treatment with Glycopyrronium, patients who have been taking inhaled, short-acting bronchodilators on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. When prescribing Glycopyrronium, the healthcare professional should also provide the patient with an inhaled, short-acting bronchodilator (i.e. short-acting beta-agonist) for treatment of COPD symptoms that occur acutely, despite regular once-daily use of Glycopyrronium

High doses of glycopyrronium may lead to signs and symptoms of exaggerated anticholinergic effects for which symptomatic treatment may be indicated. Such effects may include increased intraocular pressure causing pain, vision disturbances or reddening of the eye, obstipation or voiding difficulties.In COPD patients, repeated orally inhaled administration of Glycopyrronium at total doses of 100 and 200 mcg once-daily for 28 days were well tolerated. Acute intoxication by inadvertent oral ingestion of Glycopyrronium capsules is unlikely due to the low oral bioavailability (about 5%).

Store at room temperature between 15-25°C. Do not store above 25°C and protect from moisture. Keep out of the reach of children.

Pediatrics (< 18 years of age): Glycopyrronium should not be used in patients under 18 years of age.Geriatric patients: Glycopyrronium can be used at the recommended dose in elderly patients 65 years of age and older.Renal impairment: Glycopyrronium can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis Glycopyrronium should be used only if the expected benefit outweighs the potential riskHepatic impairment: No specific studies have been conducted in patients with hepatic impairment. Glycopyrronium is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment. No dose adjustment is required in patients with hepatic impairment.