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SEEBRI BREEZHALER is a brand name for Glycopyrronium, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SEEBRI® BREEZHALER® (glycopyrronium bromide) is indicated as a long-term once-daily maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SEEBRI BREEZHALER is not indicated for the relief of an acute deterioration of COPD. 1.1…
Verbatim from this product's HC label. Tap a section to expand.
e. chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. Elderly patients, hepatically impaired patients, and renally impaired patients can use SEEBRI BREEZHALER at the recommended dose.
However, as with all renally excreted drugs, SEEBRI BREEZHALER use should be monitored closely in patients with renal impairment or end stage renal disease. There is no experience with SEEBRI BREEZHALER in infants and children and therefore it should not be used in this age group.
2 Recommended Dose and Dosage Adjustment The recommended dosage of SEEBRI BREEZHALER is the once-daily oral inhalation of the content of one 50 mcg capsule using the SEEBRI BREEZHALER inhaler. The clinical trials were conducted based on dosing in the morning.
PrSEEBRI® BREEZHALER® (glycopyrronium bromide) Page 5 of 35 The capsule must not be swallowed. Dosing in special populations Renal impairment SEEBRI BREEZHALER can be used at the recommended dose in patients with mild to moderate renal impairment.
In patients with severe renal impairment or end-stage renal disease requiring dialysis SEEBRI BREEZHALER should be used only if the expected benefit outweighs the potential risk (See also 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
Hepatic impairment No specific studies have been conducted in patients with hepatic impairment. SEEBRI BREEZHALER is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment.
No dose adjustment is required in patients with hepatic impairment. Geriatric patients SEEBRI BREEZHALER can be used at the recommended dose in elderly patients 65 years of age and older. Pediatric patients SEEBRI BREEZHALER should not be used in patients under 18 years of age.
4 Administration SEEBRI BREEZHALER is recommended for once-daily administration at the same time each day. SEEBRI BREEZHALER capsules must be administered only by the oral inhalation route and only using the SEEBRI BREEZHALER inhaler.
SEEBRI BREEZHALER capsules must not be swallowed (see also
1 Adverse Reaction Overview The safety and tolerability of SEEBRI BREEZHALER was evaluated at the recommended dose of 50 mcg once-daily in 1353 COPD patients. Of these, 842 patients have been treated for at least 26 weeks (6 months), and 351 patients for at least 52 weeks (12 months).
Patients with unstable cardiac disease, long QT syndrome or QT prolongation, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction were excluded from the studies. g. blurred vision), urinary retention, gastrointestinal disorders, dry mouth, cough a nd immediate hypersensitivity reactions.
Adverse drug reactions to SEEBRI BREEZHALER related to local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Adverse drug reactions with SEEBRI BREEZHALER reported during the first 6 months of two pooled pivotal Phase III trials of 6- and 12-months duration are listed by MedDRA system organ class (Table 2). Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
7) 1 n= number of patients analysed 2 N= number of patients with an adverse reaction The most common anticholinergic adverse drug reaction was dry mouth. The majority of the reports of dry mouth were suspected to be drug related and of mild degree, none was severe.
Rash was uncommon and generally mild. 3 versus 0%, respectively. 5 Post-Market Adverse Reactions The following adverse drug reactions have been reported with SEEBRI BREEZHALER in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
and 10 CLINICAL PHARMACOLOGY). Hepatic impairment No specific studies have been conducted in patients with hepatic impairment. SEEBRI BREEZHALER is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment.
No dose adjustment is required in patients with hepatic impairment. Geriatric patients SEEBRI BREEZHALER can be used at the recommended dose in elderly patients 65 years of age and older. Pediatric patients SEEBRI BREEZHALER should not be used in patients under 18 years of age.
4 Administration SEEBRI BREEZHALER is recommended for once-daily administration at the same time each day. SEEBRI BREEZHALER capsules must be administered only by the oral inhalation route and only using the SEEBRI BREEZHALER inhaler.
SEEBRI BREEZHALER capsules must not be swallowed (see also 5 OVERDOSAGE). SEEBRI BREEZHALER capsules must always be stored in the blister to protect from moisture, and only removed IMMEDIATELY BEFORE USE. When prescribing SEEBRI BREEZHALER, patients should be instructed on the correct use of the inhaler.
Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it. 5 Missed Dose If a dose is missed, the next dose should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day.
5 OVERDOSAGE High doses of glycopyrronium may lead to signs and symptoms of exaggerated anticholinergic effects for which symptomatic treatment may be indicated. Such effects may include increased intraocular pressure causing pain, vision disturbances or reddening of the eye, obstipation or voiding difficulties.
In COPD patients, repeated orally inhaled administration of SEEBRI BREEZHALER at total doses of 100 and 200 mcg once-daily for 28 days were well tolerated. PrSEEBRI® BREEZHALER® (glycopyrronium bromide) Page 6 of 35 Acute intoxication by inadvertent oral ingestion of SEEBRI BREEZHALER capsules is unlikely due to the low oral bioavailability (about 5%).
SEEBRI BREEZHALER (glycopyrronium bromide) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients with severe hypersensitivity to milk proteins.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Immune system disorders: hypersensitivity, angioedema. Respiratory, thoracic and mediastinal disorders: paradoxical bronchospasm, dysphonia Skin and subcutaneous tissue disorders: pruritus
v. administration of 120 mcg glycopyrronium in healthy volunteers were about 50-fold and 6-fold higher, respectively, than the peak and total systemic exposure at steady-state achieved with the recommended dose (50 mcg inhaled once-daily) of SEEBRI BREEZHALER in COPD patients and were well tolerated.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging 50 mcg SEEBRI BREEZHALER contains: Aluminium blister-packaged glycopyrronium as (glycopyrronium bromide) transparent orange capsules with the product code GPL50 printed in black above a black bar and the Novartis company logo printed under a black bar.
Each capsule contains 63 mcg glycopyrronium bromide equivalent to 50 mcg glycopyrronium. The delivered dose (the dose that leaves the mouthpiece of the SEEBRI BREEZHALER inhaler) is equivalent to 44 mcg glycopyrronium. Each capsule also contains lactose monohydrate and magnesium stearate.
The capsule shell components are carrageenan, FDC Yellow 6 (110 Sunset Yellow FCF), hypromellose, potassium chloride and purified water. The following pack types are available: Carton of 30 SEEBRI BREEZHALER capsules (3 blister cards) and one SEEBRI BREEZHALER device.
Carton of 10 SEEBRI BREEZHALER capsules (1 blister card) and 5 SEEBRI BREEZHALER devices. e. as a rescue therapy. , four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral inhalation Inhalation powder hard capsules/ contain 50 mcg glycopyrronium as glycopyrronium bromide Carrageenan, FDC Yellow 6 (110 Sunset Yellow FCF), hypromellose, lactose monohydrate, magnesium stearate, potassium chloride, and purified water.
e. short-acting beta-agonist) for treatment of COPD symptoms that occur acutely, despite regular once-daily use of SEEBRI BREEZHALER. COPD Deterioration SEEBRI BREEZHALER should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.
The use of SEEBRI BREEZHALER in this setting is inappropriate. COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If SEEBRI BREEZHALER no longer controls the symptoms of bronchoconstriction, or the patient’s inhaled, short - acting beta2-agonist becomes less effective or the patient needs more inhalation of short-acting beta2- agonist than usual, these may be markers of deterioration of disease.
In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dosage of SEEBRI BREEZHALER beyond the recommended dose is not appropriate in this situation. Excessive Use SEEBRI BREEZHALER should not be used more frequently than once daily or at higher doses than recommended.
SEEBRI BREEZHALER should not be administered concomitantly with other medicines containing a long-acting muscarinic antagonist, as this has not been studied, and an overdose may result. Anticholinergic Effects Like other anticholinergic drugs, SEEBRI BREEZHALER should be used with caution in patients with narrow-angle […]