Medication info
Onbrez Inhalation Capsule 150 Micrograms (Indacaterol Maleate)

Onbrez Inhalation Capsule 150 Micrograms (Indacaterol Maleate)

Prescription medication외용
Ingredient · strength
Indacaterol Maleate›0.194mg / 1 capsule
Manufacturer / importer
한국노바티스(주)
Appearance
A transparent inhalation capsule with yellow coloring containing a white powder (attached to the inhaler called Breezhaler)
Packaging
30 capsules (10 capsules/PTP packaging x 3)
Approval status
Active

MFDS item code 201005169 · Approved 2010.08.26 · Insurance code 653602121

Summary

Main use
Maintenance therapy effect for chronic obstructive pulmonary disease (bronchodilation)
Who uses it
Adults
Adult use
Recommended dosage for adults (18 years and older): 1 capsule of 150 micrograms inhaled once a day using the Breezhaler inhaler. Inhalation of 300 micrograms (1 capsule) once a day has shown additional clinical benefit for patients with severe chronic obstructive pulmonary disease experiencing dyspnea. The maximum dose is 300 micrograms once daily. It must be inhaled at the same time every day.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

Maintenance therapy effect for chronic obstructive pulmonary disease (bronchodilation)

  • Chronic obstructive pulmonary disease
View approved original text

This drug helps to open the airways, making it easier to breathe, and is used to relieve the symptoms of chronic obstructive pulmonary disease and prevent exacerbations. As a bronchodilator, it is effective as a maintenance therapy for chronic obstructive pulmonary disease.

How to use

Adult use

Recommended dosage for adults (18 years and older): 1 capsule of 150 micrograms inhaled once a day using the Breezhaler inhaler. Inhalation of 300 micrograms (1 capsule) once a day has shown additional clinical benefit for patients with severe chronic obstructive pulmonary disease experiencing dyspnea. The maximum dose is 300 micrograms once daily. It must be inhaled at the same time every day.

Precautions

This medication is a maintenance treatment for bronchodilation to be used only once daily and should not be used as an emergency treatment for sudden bronchospasm. Serious bronchoconstriction can occur when used with other inhalers; if such symptoms occur, stop use immediately and seek alternative treatment. This medication should not be used in patients with asthma, as the risk of serious side effects associated with asthma may increase. Individuals with allergies to this drug or its components, or with specific genetic issues such as lactose intolerance, should avoid using it. Patients with heart disease, seizures, thyroid problems, hypokalemia, or diabetes should take special caution while using this drug. Common symptoms such as rhinitis, cold, cough, headache, and muscle cramps may occur, most of which are mild and diminish over time. This drug can have cardiovascular effects such as increased heart rate or blood pressure; if such symptoms occur, see a doctor. Women who are pregnant or breastfeeding should carefully consider the risks and benefits of using this drug, especially as it may delay labor. Children under 18 years old should not use this drug as its safety and efficacy have not been established. In case of overdose, symptoms may include increased heart rate, trembling, nausea, vomiting, and in severe cases, hospitalization may be required. This drug must be used strictly according to the prescribed dosage and administration, and users must follow inhaler instructions closely for effective treatment. There may be interactions with other medications, so inform your doctor or pharmacist about any medications you are currently taking. This drug should be stored in a dry place below 30 degrees Celsius and kept out of reach of children. Users should be attentive to any adverse reactions or changes in symptoms while using this drug and consult medical personnel immediately if problems arise.

Side effects and when to seek care immediately

Serious side effects

Urticaria, paradoxical bronchospasm, severe allergic reactions. Acute respiratory failure, dyspnea, worsening dyspnea, asthma attack, hemoptysis, pulmonary embolism, hemothorax, acute renal failure, renal impairment. Severe headache, seizures, cerebral infarction, cerebrovascular accidents, facial paralysis, hemiparesis, hepatic encephalopathy, hypoxic cerebral infarction, syncope. While adverse reactions related to jaundice (yellowing of the skin and eyes) are not specified, worsening liver disease, cirrhosis, acute may occur.

Mild side effects

  • Rhinitis
  • upper respiratory tract infections
  • cough
  • headache
  • muscle cramps
  • dizziness
  • paresthesia
  • palpitations
  • atrial fibrillation
  • tachycardia
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  • sore throat
  • runny nose
  • musculoskeletal pain
  • myalgia
  • chest pain
  • peripheral edema
  • trembling
  • sputum
  • increased sputum
  • pleural effusion
  • bronchiectasis
  • hemothorax
  • interstitial lung disease
  • worsening of interstitial pneumonia
  • spontaneous pneumothorax
  • pulmonary embolism
  • vocal cord cyst
  • asthenia
  • chest discomfort
  • fever
  • diarrhea
  • dyspepsia
  • abdominal distension
  • epigastric discomfort
  • blood in stool

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

Storage

This drug must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the effectiveness of the drug for a longer period.

Appearance and packaging

Appearance

A transparent inhalation capsule with yellow coloring containing a white powder (attached to the inhaler called Breezhaler)

Package unit

30 capsules (10 capsules/PTP packaging x 3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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.