Dosing and uses of Seebri Neohaler (glycopyrrolate inhaled)
Adult dosage forms and strengths
inhalant powder
- 15.6mcg/capsule
Chronic Obstructive Pulmonary Disease (COPD)
Long-acting muscarinic antagonist inhalant indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema
Orally inhale contents of 1 capsule q12hr using the Neohaler device
Dosage modifications
No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or patients with mild-to-moderate renal impairment
Severe renal or hepatic impairment: Not studied
Dosing Considerations
Limitations of use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma
Pediatric dosage forms and strengths
Safety and efficacy not established
Seebri Neohaler (glycopyrrolate inhaled) adverse (side) effects
1-10%
Upper respiratory tract infection (3.4%)
Nasopharyngitis (2.1%)
Oropharyngeal pain (1.8%)
Urinary tract infection (1.4%)
Sinusitis (1.4%)
Warnings
Contraindications
Hypersensitivity
Cautions
Should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD; also do not use for the relief of acute symptoms (ie, as rescue therapy) for treating acute episodes of bronchospasm
Can produce paradoxical bronchospasm that may be life-threatening
Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrrolate
Worsening of narrow-angle glaucoma or urinary retention may occur; use with caution in patients with prostatic hyperplasia, or bladder-neck obstruction and instruct patients to contact a physician immediately if symptoms occur
Pregnancy
Pregnancy
There are no adequate and well-controlled studies in humans
Animal studies have not shown teratogenicity
Lactation
Unknown if distributed in human breast milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Seebri Neohaler (glycopyrrolate inhaled)
Mechanism of action
Long-acting muscarinic antagonist (LAMA); often referred to as an anticholinergic; produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle
Absorption
Absolute bioavailability: 40%
Peak plasma time: 5 minutes
Distribution
Protein bound: 38-41%
Vd: 83-376 L
Metabolism
Hydroxylated to a variety of mono-and bishydroxylated metabolites and direct hydrolysis results in the formation of a carboxylic acid derivative (M9)
M9 is hydrolyzed by multiple CYP isoenzymes
Elimination
Half-life: 33-53 hr (glycopyrrolate inhaled)
Excretion: 60-70% urine; 30-40% nonrenal (mostly by metabolism; also biliary)
Administration
Instructions
For oral inhalation only
Do not swallow the capsules, as the intended effects on the lungs will not be obtained
Capsules should only be used with the Neohaler device
Should be administered at the same time of the day, (1 capsule in the morning and 1 capsule in the evening), every day
More frequent administration or a greater number of inhalations (>1 capsule BID) is not recommended
Storage
Store in a dry place at controlled room temperature (77°F [25°C]); excursions permitted to 59-86°F (15-30°C)
Store capsules in the blister package that they are packaged in, and only remove immediately before use with the Neohaler device
