Medication info

Breztri Aerosphere

Prescription medicationSolution
Ingredient · strength
Tiotropium Bromide Hydrate›28.27mg / 100mLOlodaterol Hydrochloride›24.76mg / 100mL
Manufacturer / importer
Boehringer Ingelheim Korea
Appearance
A colorless, transparent solution contained in an aluminum cylinder with a 4.5 mL cartridge (may come with a Breezhaler inhaler with a light green cap)
Packaging
60 doses/cartridge (multi-dose) 1 unit + Breezhaler inhaler (multi-dose) 1 unit 60 doses/cartridge (multi-dose) (refill) 1 unit
Approval status
Active

MFDS item code 201506154 · Approved 2015.08.31 · Insurance code 653501492,653501493

Summary

Main use
Relief of symptoms of chronic obstructive pulmonary disease in adults
Who uses it
Adults · Children
Adult dosage
Recommended dose: 5ug of tiotropium and 5ug of olodaterol. Inhale 2 sprays using the Respimat inhaler once daily at the same time each day. Do not exceed the recommended dose. This medicine is for inhalation only. The recommended dose may also be given to elderly patients. The recommended dose may be used in patients with mild or moderate hepatic impairment. There are no data on the use of olodaterol in patients with severe hepatic impairment. The recommended dose may also be used in patients with renal impairment. As this medicine contains tiotropium, which is primarily excreted by the kidneys, it should be used under close monitoring in patients with moderate to severe renal impairment (creatinine clearance 50 ml/min or less).
Children's dosage
Do not use in children under 18 years of age.

Ingredients

Importer
Boehringer Ingelheim Korea

Efficacy & effects

Relief of symptoms of chronic obstructive pulmonary disease in adults

  • Symptoms of chronic obstructive pulmonary disease
View approved original text

This medication is used as a bronchodilator to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. It works by relaxing the bronchial muscles to ease breathing and reduce airway obstruction. With regular maintenance therapy, it helps improve the patient's lung function and alleviate discomfort in daily activities. It effectively controls the symptoms of chronic obstructive pulmonary disease and helps enhance the quality of life. For these reasons, this medication is used for the relief of symptoms of chronic obstructive pulmonary disease.

Dosage and Administration

Adult dosage

Recommended dose: 5ug of tiotropium and 5ug of olodaterol. Inhale 2 sprays using the Respimat inhaler once daily at the same time each day. Do not exceed the recommended dose. This medicine is for inhalation only. The recommended dose may also be given to elderly patients. The recommended dose may be used in patients with mild or moderate hepatic impairment. There are no data on the use of olodaterol in patients with severe hepatic impairment. The recommended dose may also be used in patients with renal impairment. As this medicine contains tiotropium, which is primarily excreted by the kidneys, it should be used under close monitoring in patients with moderate to severe renal impairment (creatinine clearance 50 ml/min or less).

Children's dosage

Do not use in children under 18 years of age.

Precautions

This medication is a bronchodilator that should be used only once a day. In the event of an acute bronchospasm, this medication should not be used; instead, a fast-acting medication should be utilized. Rarely, bronchospasm may occur after using this medication, leading to difficulty in breathing; if such symptoms occur, the use should be stopped immediately and a doctor should be consulted. This medication should not be used in patients with asthma, as safety and efficacy in asthma have not been established. It contains an anticholinergic component, so caution should be taken in patients with narrow-angle glaucoma or difficulty in urination to avoid contact with the eyes. Allergic reactions may occur immediately after use, so if symptoms such as difficulty breathing, rash, or itching arise, medical personnel should be informed at once. Due to the anticholinergic effects, dryness of the mouth may occur, and prolonged dry mouth may increase the risk of dental caries. Do not use more than once a day and strictly adhere to the prescribed dosage. The benzalkonium chloride contained in this medication may provoke wheezing or difficulty in breathing in patients with asthma, so caution is advised. Patients with known allergies to the active ingredients or excipients in this medication, or who have previously experienced allergic reactions to similar medications, should not use this drug. Patients with heart disease, glaucoma, prostatic hyperplasia, seizure disorders, hyperthyroidism, hypokalemia, diabetes, pheochromocytoma, or seriously impaired renal or liver function should use this medication with caution. Common side effects while using this drug include dry mouth, palpitations, dizziness, cough, insomnia, constipation, etc.; severe cases may present with cardiac arrhythmias, glaucoma, or urinary retention. This medication can affect the cardiovascular system, so patients with heart disease should closely monitor symptoms and consult healthcare providers immediately if abnormalities arise. This medication should not be used with other beta-2 adrenergic agonists, and caution is necessary when used concurrently with certain medications as side effects may increase; consultation with a physician is required. If pregnant or breastfeeding, the safety of this medication has not been fully established; it should be avoided during pregnancy, and consultation with a physician is needed while breastfeeding. In case of overdose, symptoms such as abnormal heart rhythm, blood pressure changes, dizziness, anxiety, tremors, and increased blood sugar may occur; in such cases, the medication should be stopped immediately, and appropriate medical treatment should be sought. This medication is used by inhaling it once or twice daily, and it is important to understand the management and how to use the inhaler correctly to ensure it is effective and safe. Store out of reach of children, keep in designated inhaler containers, and store at room temperature without freezing.

Side effects

  • Paradoxical bronchoconstriction
  • acute angle-closure glaucoma
  • anaphylactic reaction
  • dry mouth
  • wheezing
  • difficulty breathing
  • nasopharyngitis
  • dehydration
  • dizziness
  • insomnia
Show 80 more
  • headache
  • blurred vision
  • glaucoma
  • increased intraocular pressure
  • atrial fibrillation
  • palpitations
  • tachycardia
  • ventricular tachycardia
  • hypertension
  • cough
  • dysphonia
  • epistaxis
  • laryngitis
  • pharyngitis
  • bronchospasm
  • sinusitis
  • constipation
  • gingivitis
  • nausea
  • oral candidiasis
  • paralytic ileus
  • dental caries
  • dysphagia
  • gastroesophageal reflux disease
  • glossitis
  • stomatitis
  • angioedema
  • urticaria
  • hypersensitivity
  • pruritus
  • anaphylaxis
  • rash
  • dry skin
  • skin infection
  • skin ulcer
  • back pain
  • joint pain
  • joint swelling
  • urinary retention
  • dysuria
  • urinary tract infection
  • difficulty breathing
  • productive cough
  • hemoptysis
  • sputum discoloration
  • chronic respiratory distress
  • oropharyngeal pain
  • idiopathic pulmonary fibrosis
  • oropharyngeal discomfort
  • upper respiratory infection
  • dyspepsia
  • aphthous ulcer
  • gastrointestinal disturbance
  • hyperkalemia
  • hypoalbuminemia
  • flank pain
  • chest pain
  • facial swelling
  • thirst
  • progression of malignant tumors
  • hematuria
  • kidney damage
  • limb fracture
  • contact dermatitis
  • skin disorder
  • benign prostatic hyperplasia
  • cervical polyp
  • bleeding
  • retinal vein occlusion
  • myocardial ischemia
  • hypotension
  • arrhythmia
  • tremor
  • nervousness
  • muscle spasm
  • fatigue
  • lethargy
  • hypokalemia
  • hyperglycemia
  • metabolic acidosis

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, the storage temperature should be maintained between 1 to 30 degrees Celsius, and precautions should be taken to avoid freezing.

Appearance and packaging

Appearance

A colorless, transparent solution contained in an aluminum cylinder with a 4.5 mL cartridge (may come with a Breezhaler inhaler with a light green cap)

Package unit

60 doses/cartridge (multi-dose) 1 unit + Breezhaler inhaler (multi-dose) 1 unit 60 doses/cartridge (multi-dose) (refill) 1 unit

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.