Glycopyrrolate (Oral Inhalation)
(glye koe PYE roe late)
- Glycopyrronium Bromide
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Seebri Neohaler: 15.6 mcg [contains milk protein]
Brand Names: U.S.
- Seebri Neohaler
- Anticholinergic Agent
- Anticholinergic Agent, Long-Acting
Competitively and reversibly inhibits the action of acetylcholine at muscarinic receptor subtypes 1 to 3 (greater affinity for subtypes 1 and 3) in bronchial smooth muscle thereby causing bronchodilation
Vd: Steady state: 83 L; Terminal phase: 376 L
Clearance: Children (1 to 14 years): Mean range: 1 to 1.4 L/kg/hour; Adults: Mean range: 0.4 to 0.68 L/kg/hour
Time to Peak
Plasma: 5 minutes
33 to 53 hours
38% to 41%
Special Populations: Renal Function Impairment
A moderate mean increase in total systemic exposure (AUClast) of up to 1.4-fold was seen in mild and moderate impairment estimated glomerular filtration rate (eGFR) ≥30 mL/minute/1.73m2) and up to 2.2-fold in subjects with severe impairment and ESRD (eGFR <30 mL/minute/1.73m2).
Use: Labeled Indications
Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Limitations of use: Not indicated for the relief of an acute deterioration of COPD.
Hypersensitivity to glycopyrrolate or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): Severe hypersensitivity to milk proteins.
Chronic obstructive pulmonary disease (COPD): Oral inhalation:
US labeling: One capsule (15.6 mcg) inhaled twice daily. If a dose is missed, administer the next capsule at the usual time; do not use 2 capsules at one time and do not use >2 capsules/day (maximum: 31.2 mcg/day).
Canadian labeling: One capsule (50 mcg) inhaled once daily. If a dose is missed, administer as soon as possible on that day; do not take 2 doses on the same day.
Refer to adult dosing.
Dosing: Renal Impairment
Glomerular filtration rate (estimated) ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
Glomerular filtration rate (estimated) <30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; systemic exposure may be increased.
End-stage renal disease (ESRD) requiring dialysis: There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; systemic exposure may be increased.
Dosing: Hepatic Impairment
No dosage adjustment necessary.
Oral inhalation: For oral inhalation only. Do not swallow capsules. Administer at the same time each day. Do not remove capsules from blister until immediately before use. Use the new inhaler included with each prescription. Discard any capsules that are exposed to air and not used immediately. Refer to manufacturer’s product labeling for additional administration instructions.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture. Remove capsule from blister pack immediately before use; discard capsule if not used immediately.
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Anticholinergic Agents: May enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
1% to 10%:
Central nervous system: Fatigue (≥2%)
Gastrointestinal: Diarrhea (≥2%), nausea (≥2%), upper abdominal pain (≥2%)
Neuromuscular & skeletal: Arthralgia (≥2%), back pain (≥2%)
Respiratory: Upper respiratory tract infection (2% to 3%), bronchitis (≥2%), dyspnea (≥2%), nasopharyngitis (≥2%), pneumonia (≥2%), rhinitis (≥2%), wheezing (≥2%), oropharyngeal pain (2%), sinusitis (1%)
<1% (Limited to important or life-threatening): Angioedema, atrial fibrillation, diabetes mellitus, dysuria, gastroenteritis, hypersensitivity reaction, insomnia, paradoxical bronchospasm, peripheral pain, productive cough, pruritus, vomiting
Concerns related to adverse effects:
• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; discontinue use and consider other therapy if bronchospasm occurs.
• CNS effects: May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Hypersensitivity: Immediate hypersensitivity reactions have been reported; if signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips, and face), urticaria, or skin rash, discontinue therapy immediately. Use with caution in patients with severe hypersensitivity to milk proteins (contraindicated in the Canadian labeling).
• Cardiovascular disease: Cardiovascular effects (eg, atrial fibrillation, tachycardia) may occur after administration. Use with caution in patients with unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc was prolonged at screening. In some cases, treatment may need to be discontinued.
• Glaucoma: Use with caution in patients with narrow-angle glaucoma. Monitor for signs/symptoms of glaucoma.
• Renal impairment: Use with caution in patients with severe renal impairment, including end stage renal disease (ESRD) requiring dialysis; systemic exposure to glycopyrrolate may be increased.
• Urinary retention: Use with caution in patients with urinary retention. Monitor for signs and symptoms of urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Dosage form specific issues:
• Appropriate use: Not indicated for the initial (rescue) treatment of acute episodes of bronchospasm or with acutely deteriorating or potentially life-threatening COPD; after initiation of therapy, patients should use short-acting bronchodilators only on an as needed basis for acute symptoms.
• Lactose: May contain lactose; Canadian labeling contraindicates use in patients with severe hypersensitivity to milk proteins.
FEV1, peak flow (or other pulmonary function studies)
Adverse events have been observed in some animal reproduction studies. Small amounts of glycopyrrolate cross the human placenta following IM injection.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nasal irritation, rhinorrhea, or pharyngitis. Have patient report immediately to prescriber difficulty swallowing, severe nausea, severe vomiting, vision changes, eye pain, severe eye irritation, visual halos or bright colors around lights, eye redness, painful urination, difficult urination, polyuria, difficulty breathing, wheezing, or cough (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.