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Brand of Glycopyrronium
GLYCOPYRRONIUM / FORMOTEROL FUMARATE DIHYDRATE PRESSURIZED INHALATION is a brand name for Glycopyrronium, supplied as a aerosol, metered dose. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA), indicated for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary…
Verbatim from this product's HC label. Tap a section to expand.
, chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. As with other inhaled drugs containing beta2-adrenergic agents, glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing a long-acting beta-adrenergic agonist or a long-acting muscarinic antagonist, as an overdose may result.
, 4 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. Patients should be made aware that for optimum benefit, glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension must be used regularly, even when asymptomatic.
2 Recommended Dose and Dosage Adjustment The recommended dose of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension is twice daily, administered as 2 inhalations in the morning and 2 inhalations in the evening via oral inhalation.
Patients should be advised not to take more than two inhalations twice daily. COPYRIGHT 2018 – 2022 ASTRAZENECA CANADA INC. Page 6 of 46 Pediatrics (< 18 years of age): glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension should not be used in patients under 18 years of age.
Geriatrics (≥ 65 years of age): no dose adjustments are required for elderly patients but greater sensitivity in some older individuals cannot be ruled out. Hepatic impairment: no dose adjustments are required for patients with hepatic impairment.
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However, because formoterol fumarate is primarily eliminated via hepatic metabolism, patients with hepatic disease should be closely monitored. Renal impairment: no dose adjustments are required for patients with renal impairment. 73 m2) or end-stage renal disease requiring dialysis, should be treated with glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension only if the expected benefits outweigh the potential risks and should be closely monitored.
4 Administration Glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension should be administered as 2 inhalations twice daily, in the morning and in the evening via oral inhalation. To ensure proper administration of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension, the doctor or other qualified health professional should teach the patient how to operate the inhalation device (see PATIENT MEDICATION INFORMATION,Instructions for Use).
5 Missed Dose If a dose is missed, the next dose should be taken as soon as possible. However, if it is nearly time for the next dose, the patient should not take the missed dose and just go back to the regular dosing schedule. The patient should not take a double dose.
1 Adverse Reaction Overview Long-acting beta2-adrenergic agonists such as formoterol fumarate, one of the active ingredients of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension, increase the risk of asthma-related death.
Glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension is not indicated for the treatment of asthma (see 1 INDICATIONS, 2 CONTRAINDICATIONS and Not for use in asthma). Glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension is a combination of a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA).
Adverse reactions to glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension are expected to be similar in nature to other beta2-agonists and muscarinic antagonists. , blurred vision), urinary retention, gastrointestinal disorders and dry mouth.
, tachycardia, arrhythmia, palpitations, myocardial ischemia, hypertension or hypotension), hypokalemia, hyperglycemia, headache, nervousness, insomnia, dizziness, metabolic acidosis, muscle spasms, fatigue, malaise and tremor. Other adverse drug reactions that have been associated with glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension include nausea and anxiety.
COPYRIGHT 2018 – 2022 ASTRAZENECA CANADA INC. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. A total of 1491 COPD patients have received at least 1 dose of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension in the clinical program.
The safety data described below are based on two 24-week Phase III clinical studies and a 28-week long-term safety extension study. Adverse reactions observed in other studies were similar to those observed in these pivotal studies.
24-week studies A total of 1036 subjects with COPD were treated with glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension twice daily at the recommended therapeutic dose. Other treatments included individual components (glycopyrronium or formoterol fumarate) or placebo.
Table 2 shows all adverse events, irrespective of causality towards the drug, that occurred with a rate of 1% or greater in patients receiving glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension in the two 24-week placebo-controlled studies, where the rates in patients receiving glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension exceeded placebo.
1) COPYRIGHT 2018 – 2022 ASTRAZENECA CANADA INC. 1) Long-term safety extension study Glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension was studied in a 28-week long-term safety extension study to the 24-week placebo-controlled studies.
8 mcg (n=213) administered twice daily or active control. The adverse events reported on the long term safety study were similar to those occurring in the 24-week placebo-controlled studies. 0% in patients COPYRIGHT 2018 – 2022 ASTRAZENECA CANADA INC.
Page 15 of 46 receiving glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension and […]
). 1 Pediatrics Pediatrics (<18 years of age): Glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension should not be used in patients under 18 years of age. The safety and effectiveness of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension in patients less than 18 years of age have not been established.
2 Geriatrics Geriatrics (≥65 years of age): No dosage adjustment is required in patients 65 years of age and older. 2 CONTRAINDICATIONS Patients who are hypersensitive to glycopyrronium, formoterol fumarate dihydrate (formoterol fumarate) or to any ingredient in the formulation or component of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication (see 7 WARNINGS AND PRECAUTIONS). COPYRIGHT 2018 – 2022 ASTRAZENECA CANADA INC.
Page 5 of 46 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions ASTHMA-RELATED DEATH Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT® Inhalation Aerosol) or placebo added to patients’ usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol.
This finding with salmeterol is considered a class effect of LABAs, including formoterol fumarate, one of the active ingredients in glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension. Glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension is only indicated for COPD.
The safety and efficacy of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension in patients with asthma have not been established. Glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension is therefore not indicated for the treatment of asthma.
, chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. As with other inhaled drugs containing beta2-adrenergic agents, glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing a long-acting beta-adrenergic agonist or a long-acting muscarinic antagonist, as an overdose may result.
, 4 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. Patients should be made aware that for optimum benefit, glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension must be used regularly, even when asymptomatic.
2 Recommended Dose and Dosage Adjustment The recommended dose of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension is twice daily, administered as 2 inhalations in the morning and 2 inhalations in the evening via oral inhalation.
Patients should be advised not to take more than two inhalations twice daily. COPYRIGHT 2018 – 2022 ASTRAZENECA CANADA INC. Page 6 of 46 Pediatrics (< 18 years of age): glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension should not be used in patients under 18 years of age.
Geriatrics (≥ 65 years of age): no dose adjustments are required for elderly patients but greater sensitivity in some older individuals cannot be ruled out. Hepatic impairment: no dose adjustments are required for patients with hepatic impairment.
However, because formoterol fumarate is primarily eliminated via hepatic metabolism, patients with hepatic disease should be closely monitored. Renal impairment: no dose adjustments are required for patients with renal impairment. 73 m2) or end-stage renal disease requiring dialysis, should be treated with glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension only if the expected benefits outweigh the potential risks and should be closely monitored.
4 Administration Glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension should be administered as 2 inhalations twice daily, in the morning and in the evening via oral inhalation. To ensure proper administration of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension, the doctor or other qualified health professional should teach the patient how to operate the inhalation device (see PATIENT MEDICATION INFORMATION,Instructions for Use).
5 Missed Dose If a dose is missed, the next dose should be taken as soon as possible. However, if it is nearly time for the next dose, the patient should not take the missed dose and just go back to the regular dosing schedule. The patient should not take a double dose.
5 OVERDOSAGE No data from clinical studies are available regarding overdose with glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension. An overdose of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension may lead to signs and symptoms due to the individual components’ actions, consistent with known inhaled muscarinic antagonist adverse effects […]
Patients who are hypersensitive to glycopyrronium, formoterol fumarate dihydrate (formoterol fumarate) or to any ingredient in the formulation or component of glycopyrronium/formoterol fumarate dihydrate pressurized inhalation suspension.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication (see 7 WARNINGS AND PRECAUTIONS). COPYRIGHT 2018 – 2022 ASTRAZENECA CANADA INC.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.