Medication info

Pulmicool Suspension for Inhalation (Budesonide, Unmodified)

Prescription medicationSuspension
Ingredient · strength
Budesonide Micronized›0.5mg / 1 bottle
Manufacturer / importer
Youngjin Pharmaceutical Co., Ltd.
Appearance
A uniform white to grayish-white suspension for mucosal spray, filled in a single-use plastic bottle.
Packaging
2 milliliters per bottle[((2mL x 5 bottles) x 6/case)]
Approval status
Active

MFDS item code 202600153 · Approved 2026.01.16

Summary

Main use
Treatment of bronchial asthma and acute laryngotracheobronchitis (croup) in infants and 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: The maintenance dose varies by individual and should be the lowest dose possible. Recommended maintenance dose: Adults; administer 0.5~1 milligrams (1~2 vials) twice daily For patients in whom enhanced therapeutic effect is desired, increasing the dose of this medication is generally preferable to concomitant use with oral corticosteroids, because it carries a lower risk of systemic adverse effects. In particular, it is preferable to administer this medication before oral corticosteroids when there is no mucus secretion in the airways.
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: Recommended 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
Youngjin Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Bronchial asthma
  • acute laryngotracheobronchitis
View approved original text

This medicine is used primarily for patients with bronchial asthma for whom steroid treatment alone is insufficient or inappropriate. It is also effective in treating acute laryngotracheobronchitis (croup) that occurs in infants and children. It helps alleviate respiratory symptoms and improve the patient's respiratory condition.

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: The maintenance dose varies by individual and should be the lowest dose possible. Recommended maintenance dose: Adults; administer 0.5~1 milligrams (1~2 vials) twice daily For patients in whom enhanced therapeutic effect is desired, increasing the dose of this medication is generally preferable to concomitant use with oral corticosteroids, because it carries a lower risk of systemic adverse effects. In particular, it is preferable to administer this medication before oral corticosteroids when there is no mucus secretion in the airways.

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: Recommended 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 contains Budesonide, an inhaled steroid used primarily for the treatment of respiratory diseases such as asthma. First, patients who are allergic to Budesonide or any excipients contained in this medication should not use it. Patients with pulmonary tuberculosis or fungal or viral infections should exercise caution when using this medication, as symptoms of infection may worsen. Moreover, when switching from oral steroids to this medication, it is important to gradually reduce the oral steroid while taking it initially due to the slow recovery of adrenal function. Using this medication may cause inflammation in the mouth and throat or candidiasis (fungal infection), so it is essential to rinse the mouth and throat thoroughly after inhalation to minimize these side effects. Rarely, side effects such as laryngitis, headache, distortion of taste, skin rash, and bronchospasm may occur, and mental symptoms such as anxiety or depression may also arise. To prevent bronchospasm, it is helpful to use a bronchodilator 5 to 10 minutes before using this medication. Since skin irritation may occur on the facial skin, it is recommended to wash the face thoroughly after use. Symptoms of blurred vision may rarely occur, so if there are changes in vision, consult a specialist. This medication is not suitable for rapidly alleviating asthma symptoms, and in cases of severe symptoms, it should not be used alone but in combination with other treatments. When switching from oral steroids to this medication, cautious management is required due to the time taken for adrenal function to recover. In cases where infection is suspected or worsening, appropriate antibiotic treatment and dosage adjustment of this medication may be necessary. Do not suddenly discontinue this medication; always consult a doctor or pharmacist before adjusting the dose. In particular, patients at risk of exposure to infections such as chickenpox or measles should check their medical history and vaccination status before using this medication, and seek immediate medical attention if infected. Using this medication during pregnancy does not pose great risk to the fetus and can help control asthma, so it can be used when necessary. While breastfeeding, if the amount of the drug's components transmitted in breast milk is small and the benefits of treatment outweigh the risks, it can be used. When children use this medication, it may affect their growth, so the minimum effective dose should be used, and growth status should be monitored regularly. In cases of overdose, serious problems are rare, but prolonged excessive use may lead to side effects such as adrenal function impairment, requiring caution. Finally, this medication is for inhalation use only and should never be swallowed or injected. When storing the medication, if precipitation occurs and it does not remix even after shaking, it should be discarded, and it is safe to use within three months after opening.

Side effects

  • sore throat
  • oral and glossitis
  • dry mouth
  • cough
  • oral candidiasis
  • hoarseness
  • laryngitis
  • headache
  • cervical discomfort
  • taste disturbance
Show 17 more
  • thirst
  • diarrhea
  • nausea
  • weight gain
  • fatigue
  • urticaria
  • rash
  • dermatitis
  • angioedema
  • bronchospasm
  • anxiety
  • restlessness
  • depression
  • bronchial stricture
  • skin abrasion
  • facial skin irritation
  • blurred vision

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

Storage

This medication is sensitive to light, so it should be stored in a sealed container inside the provided aluminum foil pouch. It is best to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

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

Package unit

2 milliliters per 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.