Medication info
Onbrez Inhalation Capsule 300 Micrograms (Indacaterol Maleate)

Onbrez Inhalation Capsule 300 Micrograms (Indacaterol Maleate)

Prescription medication외용
Ingredient · strength
Indacaterol Maleate›0.389mg / 1 capsule
Manufacturer / importer
한국노바티스(주)
Appearance
A transparent inhalation capsule with a yellow color containing a white powder (attached to the inhaler Breezhaler)
Packaging
30 capsules (10 capsules/PTP packaging x 3)
Approval status
Active

MFDS item code 201005170 · Approved 2010.08.26 · Insurance code 653602131

Summary

Main use
Effective for maintenance therapy of chronic obstructive pulmonary disease (bronchodilation)
Who uses it
Adults
Adult use
Recommended dose for adults (18 years and older): once daily, inhale one capsule of 150 micrograms of this medication using the Breezhaler (inhaler). The once daily inhalation dose of 300 micrograms of this medication showed additional clinical benefits in patients with moderate to severe chronic obstructive pulmonary disease and shortness of breath. The maximum dose is 300 micrograms once daily. This medication should be inhaled at the same time every day.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

Effective for maintenance therapy of chronic obstructive pulmonary disease (bronchodilation)

  • Chronic obstructive pulmonary disease
View approved original text

This medication helps to dilate the airways, facilitating airflow in the respiratory tract. It is primarily used as a maintenance therapy to alleviate the symptoms of chronic obstructive pulmonary disease and prevent exacerbations. It effectively assists patients when experiencing shortness of breath and contributes to improving lung function and quality of life. Regular use makes this medication very useful for managing chronic obstructive pulmonary disease.

How to use

Adult use

Recommended dose for adults (18 years and older): once daily, inhale one capsule of 150 micrograms of this medication using the Breezhaler (inhaler). The once daily inhalation dose of 300 micrograms of this medication showed additional clinical benefits in patients with moderate to severe chronic obstructive pulmonary disease and shortness of breath. The maximum dose is 300 micrograms once daily. This medication should be inhaled at the same time every day.

Precautions

This drug is a bronchodilator and should only be used once a day. It should not be used as an emergency treatment during acute bronchospasm. Using it together with other inhalers can lead to dangerous sudden contractions of the airways, so caution is required, and if such symptoms appear, use should be discontinued immediately and alternative treatment sought. It is advisable not to use this medication in patients with asthma, as there may be an increased risk of serious side effects in asthma patients. Individuals allergic to this drug or its components, those with lactose intolerance or specific genetic metabolic disorders, should not use it. Patients with heart disease, seizure disorders, hyperthyroidism, hypokalemia, and diabetes should use this medication with caution and consult a doctor immediately if any adverse reactions occur. The most common side effects include cold symptoms, cough, headache, muscle cramps, etc., and most are mild and decrease over time. This drug may cause cardiovascular side effects such as increased heart rate or elevated blood pressure; if these symptoms occur, use should be stopped. If pregnant or breastfeeding, careful use is advised after consulting a doctor, with particular caution needed in early pregnancy. Use in children is not recommended as safety and efficacy have not been established. In case of overdose, symptoms such as increased heart rate, tremors, headache, nausea, and drowsiness may occur; medical attention should be sought immediately in such cases. This medication must only be administered through the dedicated inhaler, and capsules should not be swallowed. Store in a tightly sealed container away from air and moisture, and keep at room temperature between 1 to 30 degrees Celsius to maintain the medication's effectiveness and prevent deterioration.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • paradoxical bronchospasm
  • acute respiratory failure
  • seizures
  • confusion
  • visual disturbances
  • paralysis
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  • sudden and very severe headaches
  • jaundice (yellowing of skin or eyes)
  • profound lethargy
  • a significant decrease in urine output
  • generalized severe edema
  • elevated blood pressure
  • cardiac arrest
  • congestive heart failure
  • worsening angina
  • worsening atrial fibrillation
  • heart failure
  • exacerbation of coronary artery disease.

Mild side effects

  • Nasopharyngitis
  • upper respiratory tract infection
  • cough
  • headache
  • muscle spasms
  • sinusitis
  • dizziness
  • paresthesia
  • palpitations
  • tachycardia
Show 28 more
  • sore throat
  • runny nose
  • musculoskeletal pain
  • myalgia
  • chest pain
  • peripheral edema
  • tremor
  • sputum
  • increased sputum
  • abdominal discomfort
  • dyspepsia
  • nausea
  • drowsiness
  • insomnia
  • anxiety
  • dry eyes
  • vomiting
  • diarrhea
  • constipation
  • rash
  • itching
  • dizziness
  • increased blood sugar
  • elevated serum creatinine
  • decreased hemoglobin
  • anemia
  • neuralgia
  • ankle syndrome

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

Storage

This drug must be stored in a tightly sealed container to prevent exposure to air and moisture, ideally at room temperature between 1 and 30 degrees Celsius. This storage method preserves the medication's potency and prevents degradation.

Appearance and packaging

Appearance

A transparent inhalation capsule with a yellow color containing a white powder (attached to the inhaler 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.