Medication info

Budesonide Suspension for Inhalation (Microcrystalline Budesonide)

Prescription medicationSuspension
Ingredient · strength
Budesonide Micronized›0.5mg
Manufacturer / importer
Penmix Co., Ltd.
Appearance
A uniform white to off-white suspension for mucosal spray filled in a single-use plastic bottle
Packaging
2 milliliters/bottle [(2mL x 5 bottles) x 6/case]
Approval status
Active

MFDS item code 202600118 · Approved 2026.01.13

Summary

Main use
Treatment of bronchial asthma and acute laryngotracheobronchitis (croup) in infants and young children
Who uses it
Adults · Children
Adult dosage
This medication should be administered using a suitable nebulizer. The dose delivered to the patient is approximately 40~60% of the labeled dose, depending on the nebulizer used. Nebulization time and dose vary according to the flow rate, nebulizer chamber, and fill volume. A fill volume of 2~4 milliliters is suitable for most nebulizers. Bronchial asthma, when starting inhalation therapy, during treatment of severe asthma, or when reducing or discontinuing oral corticosteroids: Adults; administer 1~2 milligrams (2~4 vials) twice daily Bronchial asthma, maintenance dose: Adults; administer 0.5~1 milligrams (1~2 vials) twice daily
Children's dosage
Bronchial asthma, when starting inhalation therapy, during treatment of severe asthma, or when reducing or discontinuing oral corticosteroids: Children; administer 0.5~1 milligrams (1~2 vials) twice daily Bronchial asthma, maintenance dose: Children; administer 0.25~0.5 milligrams (½ vial~1 vial) twice daily Acute laryngotracheobronchitis: Administer 2mg once daily to infants and young children.

Ingredients

Manufacturer
Penmix Co., Ltd.

Efficacy & effects

Treatment of bronchial asthma and acute laryngotracheobronchitis (croup) in infants and young children

  • Bronchial asthma
  • acute laryngotracheobronchitis
View approved original text

This medication is used for bronchial asthma, especially when steroid treatment alone is not adequate or appropriate. It is also effective for the treatment of acute laryngotracheobronchitis, i.e., croup symptoms in infants and children. It helps alleviate inflammation in the bronchial tubes and assist breathing. It can help improve the patient's symptoms, so you can take it with confidence.

Dosage and Administration

Adult dosage

This medication should be administered using a suitable nebulizer. The dose delivered to the patient is approximately 40~60% of the labeled dose, depending on the nebulizer used. Nebulization time and dose vary according to the flow rate, nebulizer chamber, and fill volume. A fill volume of 2~4 milliliters is suitable for most nebulizers. Bronchial asthma, when starting inhalation therapy, during treatment of severe asthma, or when reducing or discontinuing oral corticosteroids: Adults; administer 1~2 milligrams (2~4 vials) twice daily Bronchial asthma, maintenance dose: Adults; administer 0.5~1 milligrams (1~2 vials) twice daily

Children's dosage

Bronchial asthma, when starting inhalation therapy, during treatment of severe asthma, or when reducing or discontinuing oral corticosteroids: Children; administer 0.5~1 milligrams (1~2 vials) twice daily Bronchial asthma, maintenance dose: Children; administer 0.25~0.5 milligrams (½ vial~1 vial) twice daily Acute laryngotracheobronchitis: Administer 2mg once daily to infants and young children.

Precautions

This medication is an inhaled steroid containing budesonide, primarily used for the treatment of asthma or chronic pulmonary diseases. It should not be used in patients with hypersensitivity to this drug. Patients with pulmonary tuberculosis or airway infections should use this medication with special caution, as infection symptoms may worsen. When switching a patient from oral steroids to this medication, careful dose adjustment is needed as recovery of adrenal function may take time. Using this medication can cause inflammation or fungal infections like candidiasis in the mouth and throat, so it is important to rinse the mouth thoroughly after inhalation. Rarely, side effects such as headaches, skin rashes, bronchospasm, or blurred vision may occur, so consult a physician immediately if any adverse symptoms appear. Using a bronchodilator 5-10 minutes before inhalation can help prevent bronchospasm. This medication is not for rapid relief of acute asthma attacks, so other treatments should be combined when symptoms are severe. Long-term high-dose use may increase the risk of adrenal function suppression or infection, thus regular check-ups are necessary. Do not abruptly discontinue this medication; consult a physician to gradually reduce the dose. During pregnancy, controlling asthma is important, so this medication should be used when its benefits outweigh the risks. It can also be used relatively safely during breastfeeding. When used in children, it may affect growth, so the minimum effective dose should be used and growth status should be regularly checked. Taking doses that exceed the recommended amount may result in adrenal suppression and other issues, so prescribed dosages must be adhered to. This medication is for inhalation only and should not be swallowed or injected. After use, wash the mouth and face thoroughly to reduce the risk of infection, and discard if sediment forms during storage that does not re-suspend upon shaking. It should be used within 3 months after opening, as efficacy may decrease afterward.

Side effects

  • sore throat
  • oral and glossitis
  • dry mouth
  • cough
  • oral candidiasis
  • hoarseness
  • laryngitis
  • headache
  • cervical discomfort
  • taste disturbance
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  • thirst
  • diarrhea
  • nausea
  • weight gain
  • fatigue
  • urticaria
  • rash
  • dermatitis
  • angioedema
  • bronchospasm
  • anxiety
  • restlessness
  • depression
  • bronchial constriction
  • skin abrasion
  • facial skin irritation
  • blurred vision

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

Storage

This medication may be sensitive to light, so it should be stored in a sealed container within the included aluminum foil pouch. Additionally, it is best to store the medication at room temperature between 1 and 30 degrees Celsius. This way of storage helps maintain the medication's efficacy and ensures safe use.

Appearance and packaging

Appearance

A uniform white to off-white suspension for mucosal spray filled in a single-use plastic bottle

Package unit

2 milliliters/bottle [(2mL x 5 bottles) x 6/case]

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.

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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.