glycopyrrolate inhaled (Rx)

Brand and Other Names:Seebri Neohaler, Lonhala Magnair
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

encapsulated powder for oral inhalation

  • 15.6mcg/capsule (Seebri Neohaler)

solution for oral inhalation via nebulizer

  • 25mcg/mL vial (Lonhala Magnair)

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

Seebri Neohaler: Orally inhale contents of 1 capsule q12hr using the Neohaler device

Lonhala Magnair: Orally inhale contents of 1 vial (25mcg/mL) q12hr using the Magnair 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

Safety and efficacy not established

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Interactions

Interaction Checker

and glycopyrrolate inhaled

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            Adverse Effects

            1-10%

            Upper respiratory tract infection (3.4%)

            Nasopharyngitis (2.1%)

            Oropharyngeal pain (1.8%)

            Urinary tract infection (1.4%)

            Sinusitis (1.4%)

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            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

            Drug interaction overview

            • Concomitant use with anticholinergic medications may cause additive anticholinergic effects; if possible, avoid coadministration
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            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.

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            Pharmacology

            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)

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            Administration

            Oral Inhalation

            Encapsulated powder for inhalation

            • Do not swallow the capsules, as the intended effects on the lungs will not be obtained
            • Seebri 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

            Solution for inhalation

            • Lonhala vials should be used with Magnair device for nebulization only; do not use Magnair with any other vials
            • Should be administered at the same time of the day, (1 vial in the morning and 1 vial in the evening), every day

            Storage

            Encapsulated powder for inhalation

            • Store in a dry place at controlled room temperature (25°C [77°F]); excursions permitted to 15-30°C (59-86°F)
            • Store capsules in the blister package that they are packaged in, and only remove immediately before use with the Neohaler device

            Solution for inhalation

            • Store vials in the protective foil pouch at 20-25°C (68-77°F)
            • After opening the foil pouch, unused unit-dose vials should be returned to, and stored in, the foil pouch
            • Once a foil pouch is opened, discard the vials if not used within 7 days
            • An opened unit-dose vial should be used right away
            • Discard any unit-dose vial if the solution is not colorless
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.