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Seebri Breezhaler

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Seebri Breezhaler

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Seebri Breezhaler

Quick Facts

Property Description
Active ingredient Glycopyrronium
Form Inhalation powder (in capsule)
Pharmacological class Long-acting muscarinic antagonist (LAMA)
Route of administration Oral inhalation
Origin Synthetic quaternary ammonium compound
General purpose Sustained airway dilation

What is Glycopyrronium and its Pharmacological Class?

Glycopyrronium for inhalation is a synthetic prescription-only medicine that belongs to the pharmacological class of long-acting muscarinic antagonists (LAMAs). This compound is specifically designated as a single active ingredient product, meaning its therapeutic effect relies solely on Glycopyrronium (INN). The substance is chemically classified as a quaternary ammonium compound, a synthetic type of molecule. It functions as an anticholinergic agent used to promote bronchodilation. This long-acting classification is clinically recognized for supporting sustained therapeutic coverage over a twenty-four-hour period, which is a key feature of its use in maintenance therapy.


How is Seebri Breezhaler Delivered and Composed?

Seebri Breezhaler is provided as a fine inhalation powder sealed within capsules, which are administered to the lungs via oral inhalation using a dedicated Breezhaler device. This dosage form is specifically tailored for direct delivery to the airways. The core composition consists of the active ingredient, Glycopyrronium (often as the bromide salt), combined with a pharmaceutical-grade carrier substance, which is typically lactose. This method of delivery minimizes the amount of medicine absorbed into the bloodstream, focusing its action directly on the lungs. The specialized delivery system is designed for simplified, once-daily administration.


What is the General Therapeutic Purpose of this Medicine?

The primary general purpose of this medicine is to act as a bronchodilator for use in long-term maintenance treatment. The function of the drug is to achieve sustained airway dilation by preventing the muscles around the breathing tubes from tightening. Medicines of this class help relax the muscles around the air passages, allowing them to remain open. This mechanism results in a consistent, long-acting effect that fundamentally improves air flow and addresses the general difficulty of restricted breathing over time.

Regulatory References

  1. MedlinePlus Drug Information on Glycopyrrolate Oral Inhalation
  2. EMA medicine overview for Seebri Breezhaler (Glycopyrronium)
  3. EMA EPAR for Seebri Breezhaler (Glycopyrronium)
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What side effects are possible with Seebri Breezhaler?

Seebri Breezhaler (glycopyrronium bromide) is a maintenance treatment for Chronic Obstructive Pulmonary Disease (COPD) and is not intended for use as a rescue medication for acute bronchospasm. As with all medications, it can cause side effects, though not everyone experiences them.

Common and Uncommon Side Effects

Common (may affect up to 1 in 10 people) side effects include dry mouth (the most frequently reported anticholinergic effect), headache, nasopharyngitis (cold-like symptoms), insomnia (difficulty sleeping), and gastroenteritis (diarrhea or vomiting).

Uncommon (may affect up to 1 in 100 people) side effects include difficulty or pain when passing urine (dysuria), urinary retention, rhinitis (runny nose), sinusitis, throat irritation, palpitations, rash, and signs of high blood sugar (hyperglycemia) such as excessive thirst or frequent urination.


Important Safety Information

Paradoxical Bronchospasm: Inhalation therapy can, in rare cases, lead to an immediate and life-threatening worsening of breathing or wheezing. If this occurs, stop treatment immediately and seek urgent medical attention.

Allergic Reactions: Stop using Seebri Breezhaler and contact a healthcare professional right away if you experience signs of a severe allergic reaction, such as swelling of the tongue, lips, or face (angioedema), difficulty breathing or swallowing, hives, or skin rash.

Pre-existing Conditions: Due to its anticholinergic properties, use this medicine with caution and inform your doctor if you have:

  • Narrow-angle glaucoma (can worsen the condition).
  • Urinary retention or other prostate/bladder issues.
  • Severe kidney impairment (monitoring may be needed).
  • Heart problems (especially irregular or fast heartbeats).

Seebri Breezhaler is not recommended for use in children under 18 years of age.

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Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Glycopyrronium is defined by the potential for exaggerated anticholinergic effects resulting from exposure to doses substantially higher than the recommended therapeutic level. Documented manifestations of an overdose include signs affecting various physiological systems.

Documented Overdose Manifestations and Emergency Action

Domain Official Regulatory Statement
Overdose Presentations Signs and symptoms of exaggerated anticholinergic effects are expected following high doses of glycopyrronium.
Physiological Signs Manifestations include increased intraocular pressure (leading to ocular pain or visual disturbances), obstipation (severe constipation), and voiding difficulties (urinary retention).
Urgent Care Triggers Patients must consult a physician immediately if symptoms of acute narrow-angle glaucoma or worsening urinary retention occur.
Immediate Action In case of a suspected overdose, it is mandated to contact a regional poison control centre for advice.
Management No specific antidote is documented in the regulatory labeling; treatment is symptomatic and supportive.

Acute intoxication resulting from inadvertent oral ingestion of the inhalation capsule contents is considered unlikely due to the low bioavailability of the active ingredient. While systemic exposure is generally low, caution is advised for patients with severe renal impairment due to the drug’s primary elimination pathway. The overall profile focuses on managing anticholinergic over-effects and immediately addressing any life-threatening complications.

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Therapeutic Uses of Seebri Breezhaler

What Seebri Breezhaler Treats: Main Uses and Benefits

This medication is commonly applied for long-term maintenance treatment for adult patients generally diagnosed with Chronic Obstructive Pulmonary Disease (COPD). The treatment is used for conditions where functional stability becomes affected, which is characterized by chronic airflow limitation. Its purpose is to support the ongoing management of this condition.


The primary focus of therapeutic support is relevant for easing ongoing, distressing respiratory manifestations. This helps address symptom clusters that create noticeable physiological strain, including persistent shortness of breath (dyspnea), frequent wheezing, and the sensation of chest tightness that results from restricted airways. By providing continuous support for air passage, the medicine contributes to easing the overall symptom load throughout the day.

“The treatment is commonly used in clinical settings where chronic airflow support is needed to manage persistent daily symptoms.”

Regular use may assist with supporting better overall lung function and is commonly used across conditions presenting with chronic manifestations. This long-acting support is considered relevant when symptomatic management is appropriate, and the continuous therapeutic effect may play a role in managing the risk of symptom flare-ups (exacerbations), which helps improve day-to-day comfort during symptomatic periods.

Quick Fact: Relief for Chronic Respiratory Symptoms
Primary Indication: Maintenance treatment of COPD
Symptom Focus: Easing persistent dyspnea, wheezing, and chest tightness
Benefit Context: Continuous support for air passage for stability

Regulatory References

  1. European Medicines Agency overview
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Eligibility and Restrictions for Use

Seebri Breezhaler is approved as a once-daily maintenance bronchodilator treatment for adult patients with Chronic Obstructive Pulmonary Disease (COPD) to relieve symptoms and improve lung function. It is important to note that this medication is not indicated for the relief of sudden, acute episodes of bronchospasm (as a rescue therapy).


Who Should NOT Use Seebri Breezhaler (Contraindications)

Condition Reason for Restriction
Allergy/Hypersensitivity To the active ingredient glycopyrronium bromide or any excipients, including a severe milk protein allergy (due to the lactose content).
Age It is not for use in patients under 18 years of age, as the indication (COPD) is an adult disease.
Acute Symptoms Not for use in treating acute flare-ups or rapidly worsening COPD (rescue use).

Use with Caution (Warnings and Precautions)

Caution is advised, and close monitoring by a doctor is required, for patients with the following pre-existing conditions:

  • Narrow-angle glaucoma
  • Urinary retention (difficulty passing urine), often associated with prostate issues or bladder-neck obstruction.
  • Severe renal (kidney) impairment or end-stage renal disease (use only if benefits outweigh risks).
  • Certain cardiovascular diseases, such as unstable heart disease, recent myocardial infarction, or severe arrhythmias.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines interactions with other drugs and substances as documented in official regulatory information for Seebri Breezhaler (glycopyrronium).

Pharmacodynamic Interactions and Restrictions

Interacting Substance/Class Official Constraint Primary Effect
Other Inhaled Anticholinergic-Containing Drugs Co-administration is not recommended. Potential for additive effects, increasing the risk of anticholinergic side effects.

Pharmacokinetic Interactions

Regulatory studies have examined the potential for Seebri Breezhaler to interact with other drugs via metabolic or transport pathways.

  • Cimetidine: When co-administered, this inhibitor of organic cation transport was observed to slightly increase the total systemic exposure (AUC) to glycopyrronium and decrease its renal clearance. However, based on the magnitude of this change, no clinically relevant drug interaction is expected.
  • Indacaterol: Co-administration with the LABA indacaterol did not affect the pharmacokinetics of either drug.
  • Enzyme Metabolism: In vitro data suggest that glycopyrronium is unlikely to inhibit or induce the metabolism of other medicines, indicating a low risk of CYP-mediated interactions.

Population-Specific Interaction Notes

Patients with severe renal impairment or end-stage renal disease (eGFR <30 mL/min/1.73 m^2) may experience increased systemic exposure to glycopyrronium. Use in this population is only advised if the expected benefit outweighs the potential risk.

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Mechanism of Action

How Seebri Breezhaler Works: Mechanism of Action

Glycopyrronium's function is to interrupt the cholinergic signal that causes airway muscles to constrict, resulting in sustained relaxation of airway smooth muscle. This mechanism involves the competitive antagonism of the muscarinic acetylcholine receptors (primarily the M3 subtype) found on the smooth muscle of the airways.

By binding to these receptors, Glycopyrronium blocks the action of the neurotransmitter acetylcholine, which is the body's natural signal for bronchoconstriction transmitted via the parasympathetic nervous system. This blockade suppresses the intracellular signaling sequence that requires the release of calcium ions ( Ca^2+) for muscle contraction to occur. This interruption leads directly to prolonged relaxation of the airway smooth muscle, which physiologically results in an increase in the airway lumen and a consequential decrease in resistance to airflow.

The mechanism is targeted against constriction driven by cholinergic over-activity but does not directly influence airway changes mediated by other factors, such as inflammatory mediators or structural remodeling of the lung tissue.

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Dosage and Administration Information

How to Use Seebri Breezhaler: Administration Guidelines

Seebri Breezhaler (glycopyrronium) is administered strictly as an oral inhalation using the specific Breezhaler device provided with the medicine. The medication is contained within capsules, which must never be swallowed.


Dosing and Timing

Administration Scope Instruction Details
Route of Administration Oral inhalation (capsule contents must not be swallowed)
Dosing Schedule Inhalation of the content of one capsule (50 mcg) once daily
Frequency Once daily, preferably at the same time each day
Missed Dose Rule Take the missed dose as soon as possible, but do not take more than one dose in a day

Procedural Steps

The capsules should be removed from the blister pack immediately before use and placed into the chamber of the Breezhaler inhaler. Once the capsule is correctly positioned, the user must press the side buttons to pierce it. Prior to inhalation, the user should breathe out fully, away from the inhaler. The inhalation must then be quick and deep through the mouthpiece to ensure the capsule contents are released. After inhalation, the breath must be held for five to ten seconds. The capsule should be checked to ensure it is empty; if powder remains, the inhalation step must be repeated. The inhaler should be disposed of after all capsules in the pack have been used, or after a maximum of 30 days of use.

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Recent Clinical Evidence

Seebri Breezhaler contains the active ingredient glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA) studied as a maintenance treatment for the symptoms of Chronic Obstructive Pulmonary Disease (COPD).

Lung Function and Symptom Improvement

Clinical trials, including the GLOW 1 (26 weeks) and GLOW 2 (52 weeks) studies, have provided key evidence for the efficacy of glycopyrronium in patients with moderate to severe COPD. The primary measure of effectiveness in these trials was Forced Expiratory Volume in one second ( FEV1), a metric of lung function. The results indicated that the drug led to a statistically significant improvement in FEV1 compared to placebo.

Improvements in patient-reported outcomes were also observed. This included a reduction in the need for rescue medication (such as short-acting bronchodilators) and a clinically meaningful improvement in Transition Dyspnea Index (TDI) scores, which measure breathlessness. Patients also reported improvements in health status, assessed by the St. George’s Respiratory Questionnaire (SGRQ) total score, compared to placebo.

Exacerbations and Tolerability

Research has explored the effect of glycopyrronium on COPD exacerbations. A pooled analysis of the GLOW 1 and GLOW 2 studies suggested that treatment with glycopyrronium was associated with a reduced annual rate of moderate to severe COPD exacerbations when compared to placebo. Additionally, the incidence of hospitalizations due to COPD exacerbations was reported as significantly lower with glycopyrronium than with placebo in this analysis.

The overall safety profile observed in clinical trials, involving patients treated for up to 52 weeks, was consistent with that of other long-acting muscarinic antagonists. The most commonly reported adverse event associated with the use of glycopyrronium was dry mouth.

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Frequently Asked Questions (FAQ)

Common questions about Seebri Breezhaler (FAQ)


Q: How quickly does Seebri Breezhaler start to work after the first dose?

A: Clinical trial data indicates that an improvement in lung function is generally seen rapidly after the first dose. According to the official product information, some studies noted the onset of effect within five to twenty minutes following initial use.


Q: What evidence is there that Seebri Breezhaler improves quality of life or exercise tolerance?

A: Studies and official information indicate that patients experienced improvements in measures of breathlessness (Transition Dyspnea Index) and overall health status. Clinical trial results indicated that patients experienced improved exercise endurance when compared to placebo groups.


Q: What happens if I accidentally inhale the capsule powder without hearing the 'click'?

A: The piercing sound, or 'click', is a feedback mechanism that confirms the capsule has been successfully opened. If the sound is not heard, the user should check the capsule after inhalation. If powder remains inside, official instructions advise repeating the inhalation process.


Q: Can patients with liver problems (hepatic impairment) use Seebri Breezhaler?

A: Official information states that no specific studies have been conducted in patients with hepatic (liver) impairment. However, because the medicine is primarily cleared by the kidneys, a major increase in the drug’s exposure in the body is not expected. Based on this information, dose adjustment is not expected to be required.


Q: Does Seebri Breezhaler provide 24-hour symptom relief?

A: Official documents describe this medicine as a long-acting bronchodilator. Clinical data from trials indicated that the bronchodilation benefit was sustained for 24 hours over the maintenance treatment period.


Q: Can Seebri Breezhaler be used for conditions other than COPD, like asthma?

A: Seebri Breezhaler is approved for the long-term maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults to relieve symptoms. The medicine is not indicated or approved for the treatment of asthma or other respiratory conditions.


Q: Is it common to feel a mild cough or throat irritation after using the Breezhaler device?

A: Throat irritation is listed as an uncommon adverse drug reaction in official documents. Patient instructions indicate that a cough after inhalation may occur, but it does not affect the dose received if the capsule is empty afterward.


Q: What is the 'whirring sound' I'm supposed to hear when I use the inhaler?

A: The whirring sound is a feedback mechanism specific to the Breezhaler device. It confirms that the patient has inhaled quickly and deeply enough to properly release the medicine powder from the capsule for delivery to the lungs.


Q: What should I do if the capsule is stuck in the Breezhaler device?

A: If the capsule becomes stuck, official device instructions advise carefully loosening the capsule by gently tapping the base of the inhaler. The patient instructions then advise repeating the inhalation process to ensure the dose is delivered.


Q: Are there any common long-term side effects associated with Seebri Breezhaler use?

A: Clinical trials tracked the safety profile of the medicine for up to 52 weeks (one year). The most frequently reported adverse event observed during this long-term period was dry mouth, which is consistent with other medicines in the same class.


Q: Is dry mouth a common side effect, and does it go away over time?

A: Dry mouth is the most frequently reported anticholinergic adverse reaction in clinical trials (a common side effect). It was generally reported to be of mild degree, but official documents do not include specific information on whether dry mouth diminishes over time.


Q: Is Seebri Breezhaler safe for use during pregnancy or while breastfeeding?

A: The use of Seebri Breezhaler is generally not recommended during pregnancy or while breastfeeding, as it is unknown whether the active ingredient passes into breast milk. This aligns with official product information.


Q: Does Seebri Breezhaler have any potential effect on heart rhythm or heart rate?

A: At the recommended dosage, the medicine is described in official documents as being devoid of effects on blood pressure or heart rate. However, regulatory warnings indicate that caution is advised for use in patients with pre-existing heart conditions, particularly certain types of arrhythmia (irregular heartbeats).


Q: Do I need to rinse my mouth after using the Seebri Breezhaler?

A: Official patient instructions advise rinsing the mouth with water and spitting the water out after using the inhaler.


Q: Does Seebri Breezhaler cause increased urination or difficulty passing urine?

A: Difficulty passing urine (such as urinary retention or painful urination) is listed as an uncommon side effect. Increased or frequent urination is also reported as a possible sign of a different, uncommon side effect (high blood sugar).


Q: Is the Breezhaler device complicated to use compared to other inhalers?

A: The Breezhaler device is designed with low airflow resistance. This feature may help patients with varying degrees of COPD severity more easily achieve the required quick, deep inhalation flow rate for effective delivery of the medicine to the lungs.


Q: Can the powder residue be seen in the capsule after a successful inhalation?

A: After inhalation, patients are advised to check the capsule to ensure it is empty or near-empty. If powder remains, patient instructions advise repeating the inhalation steps.


Q: Are there any known interactions with over-the-counter cold or flu medications?

A: While specific over-the-counter medicines are not individually listed, the co-administration of Seebri Breezhaler with other inhaled anticholinergic-containing drugs is not recommended. This is due to the potential for an increase in anticholinergic-related side effects.


Q: What is the shelf life of the Seebri capsules?

A: The capsules have a manufacturer-stated shelf life (e.g., up to two years) before their expiry date. The inhaler device itself should be disposed of after all capsules in the pack have been used, or after a maximum of 30 days of use, whichever comes first, according to official disposal protocols.


Q: Why are the capsules stored inside a foil blister pack instead of a bottle?

A: Official storage instructions require that the capsules must always be stored in the original blister packaging to protect them from moisture and light. This protection is necessary to ensure the quality of the inhalation powder for proper delivery.


Q: Can Seebri Breezhaler affect blood pressure?

A: At the recommended dosage, official documents describe the medicine as being devoid of effects on blood pressure or heart rate. This information is based on the results from clinical trials.


Q: Is it normal to feel a change in taste after using the inhaler?

A: A change in taste (dysgeusia) has been reported in post-marketing experience with the active ingredient (glycopyrronium), though it was not listed as a common or uncommon side effect in the main clinical trials.


Q: Is there a risk of developing a cough or lung infection while on Seebri Breezhaler?

A: Infections of the upper airways, such as nasopharyngitis (cold-like symptoms), sinusitis, and rhinitis, have been reported as common or uncommon side effects in clinical trials.


Q: Can Seebri Breezhaler make my vision blurry?

A: As an anticholinergic medicine, there is a possibility of experiencing effects like transient blurred vision. Regulatory warnings advise consulting a healthcare provider immediately if any visual changes occur.


Q: Do I need to clean the Breezhaler device, and if so, how?

A: The Breezhaler device must not be washed with water. If cleaning is needed, the mouthpiece can be gently wiped with a dry cloth or tissue only, as specified in patient instructions.


Q: Is it required to keep using my other COPD medications when starting Seebri Breezhaler?

A: The co-administration of Seebri Breezhaler with other inhaled anticholinergic-containing drugs is not recommended. The continued use of other classes of maintenance COPD medicines should be determined by a healthcare provider based on the individual treatment plan.


Q: Are headaches a common side effect when starting Seebri Breezhaler?

A: Yes, headache is listed as a common side effect in official documents, meaning it may affect up to 1 in 10 people reported during clinical trials.


Q: Can the use of this drug lead to a worsening of my COPD symptoms over time?

A: Clinical trial data indicated that treatment was associated with a reduced annual rate of moderate to severe COPD exacerbations compared to placebo. However, the medicine may rarely cause an immediate, acute worsening of breathing called paradoxical bronchospasm upon inhalation, which requires immediate medical attention.

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How should Seebri Breezhaler be stored and disposed of?

How to Store and Dispose of Seebri Breezhaler

Storage Requirements

Seebri Breezhaler capsules must be stored in the original blister packaging to protect them from moisture and light. The required storage temperature is generally not above 25°C or below 30°C, depending on the regulatory region. The medicine must be kept away from heat and direct sunlight.

Condition Requirement
Temperature Not above 25 °C or below 30 °C
Container Must be kept in original blister pack
Safety Keep out of the sight and reach of children

Disposal Protocol

The capsule should be removed from the blister only immediately prior to use. After inhalation, the empty capsule may be placed in household waste. Any unused, unwanted, or expired medicine and the used inhaler device should be returned to a pharmacy or a designated collection point for safe disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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