Version November 2024
Chronic obstructive pulmonary disease, maintenance: Note: Depending on symptoms and exacerbation risk, may use monotherapy long-acting bronchodilator (long-acting beta agonist or long-acting muscarinic antagonist). In patients with more symptoms (eg, Group B), use in combination with long-acting beta agonist. In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Seebri Neohaler: Dry powder inhaler (15.6 mcg/capsule): Oral inhalation: Contents of 1 capsule inhaled twice daily using Neohaler device.
Seebri Breezhaler [Canadian product]: Dry powder inhaler (50 mcg/capsule): Oral inhalation: Contents of 1 capsule inhaled once daily using Breezhaler device.
Lonhala Magnair: Nebulization solution (25 mcg/1 mL vial): Oral inhalation: 1 vial inhaled twice daily using Magnair device.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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.
No dosage adjustment necessary.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Cardiovascular: Hypertension (≥2%), peripheral edema (1% to 2%)
Gastrointestinal: Diarrhea (≥2%), nausea (≥2%), upper abdominal pain (≥2%)
Genitourinary: Urinary tract infection (2%)
Nervous system: Fatigue (1% to 2%), headache (≥2%)
Neuromuscular & skeletal: Arthralgia (≥2%), back pain (≥2%)
Respiratory: Dyspnea (5%), nasopharyngitis (1% to 2%), oropharyngeal pain (2%), pneumonia (≥2%), rhinitis (≥2%), sinusitis (1%), upper respiratory tract infection (1% to 3%), wheezing (1% to 2%)
<1%:
Cardiovascular: Atrial fibrillation
Dermatologic: Pruritus, skin rash
Endocrine & metabolic: Diabetes mellitus, hyperglycemia
Gastrointestinal: Gastroenteritis, vomiting
Genitourinary: Dysuria
Hypersensitivity: Hypersensitivity reaction
Nervous system: Insomnia
Neuromuscular & skeletal: Limb pain
Respiratory: Productive cough
Postmarketing:
Cardiovascular: Prolonged QT interval on ECG (Chiu 2016)
Hypersensitivity: Angioedema, type 1 hypersensitivity reaction
Nervous system: Voice disorder
Respiratory: Paradoxical bronchospasm
Hypersensitivity to glycopyrrolate or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): Severe hypersensitivity to milk proteins.
Concerns related to adverse effects:
• Bronchospasm: Paradoxical bronchospasm may occur with the use of inhaled agents which may be life-threatening; discontinue use immediately 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 and initiate alternative therapy. Use with caution in patients with severe hypersensitivity to milk proteins.
Disease-related concerns:
• 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 and/or end-stage renal disease; 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.
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: The dry powder inhaler formulation may contain lactose.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Inhalation:
Lonhala Magnair Refill Kit: 25 mcg/mL (1 mL [DSC])
Lonhala Magnair Starter Kit: 25 mcg/mL (1 mL [DSC])
No
Solution (Lonhala Magnair Refill Kit Inhalation)
25 mcg/mL (per mL): $25.20
Solution (Lonhala Magnair Starter Kit Inhalation)
25 mcg/mL (per mL): $25.20
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Inhalation:
Seebri Breezhaler: 50 mcg [contains fd&c yellow #6 (sunset yellow), lactose monohydrate]
Inhalation: For oral inhalation only.
Dry powder inhaler (capsule): Do not swallow capsules. Administer at the same time each day; use only with the Neohaler device. 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.
Nebulization solution: Do not inject or swallow solution; use only with Magnair device. Remove vials from foil pouch immediately before use. Administer once in morning and once in evening at the same time each day. Refer to manufacturer's product labeling for additional administration instructions.
Chronic obstructive pulmonary disease, maintenance: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Clinically Relevant Anticholinergic Effects: May enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination
Inhaled Anticholinergic Agents: May enhance the anticholinergic effect of other Inhaled Anticholinergic Agents. Risk C: Monitor therapy
Methacholine: Long-acting muscarinic antagonists (LAMAs) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting muscarinic antagonists (LAMAs) for at least 7 days before methacholine use. Risk D: Consider therapy modification
Teratogenic events were not observed in animal reproduction studies conducted with inhaled glycopyrrolate.
When given as a single maternal injection prior to delivery, glycopyrrolate was not found to cross the placenta in significant amounts (Abboud 1981). Refer to the Glycopyrrolate (Systemic) monograph for additional information.
It is not known if glycopyrrolate is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
FEV1 or other pulmonary function tests; signs/symptoms of glaucoma (blurred vision, worsening eye pain, or discomfort); hypersensitivity reactions; urinary retention.
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
Absorption: Rapid
Distribution: Vd: Steady state: 83 L; Terminal phase: 376 L
Protein binding: 38% to 41%
Metabolism: Hepatic (minimal)
Bioavailability: ~40%
Half-life elimination: 33 to 53 hours
Time to peak, plasma: Dry powder inhaler (capsule): 5 minutes; Nebulization solution: <20 minutes
Excretion: Urine; bile
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