TM Owner Sunovion / Novartis
Seebri Neohaler 15.6mcg Inhalation Powder
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Indications & Clinical Uses
- Seebri Neohaler 15.6 mcg is an inhalation powder capsule containing glycopyrrolate (called glycopyrronium bromide in Europe), a long-acting muscarinic antagonist (LAMA) bronchodilator used with its dedicated Neohaler device.
- It is approved by the FDA for the long-term, maintenance treatment of airflow obstruction in adults with chronic obstructive pulmonary disease (COPD); it is not approved for asthma and is not a rescue treatment for sudden breathlessness.
- It is marketed in the United States by Sunovion Pharmaceuticals Inc. under licence from Novartis, which originated the molecule.
- One capsule is inhaled twice daily, morning and evening, using the Neohaler device provided; capsules are never swallowed.
- Seebri Neohaler is the US regional counterpart of Seebri Breezhaler, the once-daily 44 mcg EU/UK capsule for the same molecule used with a different device - the two are not interchangeable and use different strengths and dosing frequencies.
Side Effects
- The most common effects with Seebri Neohaler include upper respiratory tract infection (3.4% versus 2.3% with placebo), nasopharyngitis, oropharyngeal pain, and sinusitis or urinary tract infection (each about 1.4%).
- There is no boxed warning on the current Seebri Neohaler prescribing information.
- As with other anticholinergic bronchodilators, immediate paradoxical bronchospasm can occur after inhaling; if this happens, treat with a fast-acting reliever and discontinue Seebri Neohaler, seeking medical advice before using it again.
- Because glycopyrrolate is an anticholinergic, it can worsen narrow-angle glaucoma or urinary retention linked to prostate enlargement, so report eye pain, blurred vision, or difficulty passing urine promptly.
- Seek urgent care for sudden worsening of breathlessness, wheeze, chest tightness, or swelling of the face, lips or throat, which could indicate a serious hypersensitivity reaction.
Precautions & Warnings
- Seebri Neohaler is for maintenance treatment only and is not for use to relieve a sudden attack of breathlessness; keep a fast-acting reliever inhaler available for that purpose.
- Use with caution in narrow-angle glaucoma or urinary retention associated with prostatic hyperplasia or bladder-neck obstruction, since anticholinergic effects can worsen these conditions.
- No dose adjustment is needed for mild-to-moderate kidney or any liver impairment, or in patients 75 and older, but in severe kidney impairment (eGFR under 30) it is used only if the expected benefit outweighs the risk, since glycopyrrolate exposure may be increased.
- Safety in pregnancy has not been established in humans - it is FDA pregnancy category C and should be used only if the potential benefit justifies the potential risk to the fetus.
- Always check inhaler technique with a healthcare provider and keep capsules in the blister, never in the device, until immediately before use.
Avoid Interactions
- Tell your healthcare provider about every other medicine you use, particularly other inhaled anticholinergic (antimuscarinic) medicines such as tiotropium or ipratropium, because combining anticholinergics increases the risk of dry mouth, constipation and urinary retention and is generally avoided.
- Seebri Neohaler can be used alongside beta-agonist bronchodilators, methylxanthines such as theophylline, and inhaled corticosteroids, since no clinically significant interaction with these classes has been identified.
- Glycopyrrolate is partly cleared through the kidney's organic cation transport system, so caution applies with other drugs handled the same way, though no specific dose adjustment is recommended.
- There is no known food interaction, but capsules should be taken at consistent times, morning and evening, for steady symptom control.
References
Frequently Asked Questions
Seebri Neohaler (glycopyrrolate) 15.6 mcg is a twice-daily inhaled capsule approved in the US for long-term maintenance treatment of airflow obstruction in adults with chronic obstructive pulmonary disease (COPD). It is not a rescue inhaler and is not approved for asthma. It is marketed by Sunovion under licence from Novartis.
Inhale the contents of one capsule twice daily, morning and evening, using the Neohaler device provided; never swallow the capsule. Load a new capsule from the blister immediately before each use, since moisture reduces its effectiveness. Keep a fast-acting reliever inhaler available separately for sudden shortness of breath.
The most common effects include upper respiratory tract infection, nasopharyngitis, sore throat, and sinusitis or urinary tract infection. Anticholinergic effects like dry mouth or urinary difficulty can occur, especially with prostate enlargement or glaucoma. Seek urgent help if breathing suddenly worsens right after inhaling, which can signal paradoxical bronchospasm.
Avoid using Seebri Neohaler with other inhaled anticholinergic medicines, such as tiotropium or ipratropium, since combining them increases dry mouth, constipation and urinary retention. Tell your healthcare provider about all your medicines, especially if you have narrow-angle glaucoma, urinary retention or severe kidney disease, which need extra caution.
Store Seebri Neohaler capsules at 25 degrees C (77 degrees F), with excursions allowed between 15 and 30 degrees C, in a dry place away from moisture. Keep each capsule in its blister until you are ready to use it, and never store a loose capsule inside the Neohaler device between doses.
No dose change is needed for mild-to-moderate kidney or any liver impairment. In severe kidney impairment (eGFR under 30), Seebri Neohaler is used only if the benefit outweighs the risk, since glycopyrrolate levels can rise. Tell your healthcare provider about your kidney function before starting treatment.
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