Medication info

Budenotide Inhalation Solution (Unrefined Budesonide)

Prescription medicationApproval withdrawn
Ingredient · strength
Budesonide Micronized›Strength being verified
Manufacturer / importer
Daehan Pharmaceutical Co., Ltd.
Appearance
A uniform white to grayish-white suspension for inhalation filled in a single-use plastic bottle.
Packaging
2 milliliters/bottle
Approval status
Approval withdrawn

MFDS item code 200300250 · Notified 2003.05.21

This product's status changed to Approval withdrawn on 2023.09.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 an appropriate 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 2~4ml is suitable for most nebulizers. Bronchial asthma — At the start of inhalation therapy, during treatment of severe asthma, or when reducing or discontinuing oral corticosteroids: Adults: Administer 1~2mg (2 bottles~4 bottles) twice daily Bronchial asthma — Maintenance dose: Adults: Administer 0.5~1mg (1 bottle~2 bottles) twice daily
Children's dosage
Bronchial asthma — At the start of inhalation therapy, during treatment of severe asthma, or when reducing or discontinuing oral corticosteroids: Children: Administer 0.5~1mg (1 bottle~2 bottles) twice daily Bronchial asthma — Maintenance dose: Children: Administer 0.25~0.5mg (1/2 bottle~1 bottle) twice daily Acute laryngotracheobronchitis — Infants and young children: Administer 2mg once daily.

Ingredients

Manufacturer
Daehan Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Bronchial asthma
  • acute laryngeal bronchitis
View approved original text

This medication is used for bronchial asthma, particularly when steroid treatment alone is insufficient. It also helps alleviate the symptoms of acute laryngeal bronchitis (croup) occurring in infants and children. Therefore, it is effectively used to treat bronchial-related respiratory diseases.

Dosage and Administration

Adult dosage

This medication should be administered using an appropriate 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 2~4ml is suitable for most nebulizers. Bronchial asthma — At the start of inhalation therapy, during treatment of severe asthma, or when reducing or discontinuing oral corticosteroids: Adults: Administer 1~2mg (2 bottles~4 bottles) twice daily Bronchial asthma — Maintenance dose: Adults: Administer 0.5~1mg (1 bottle~2 bottles) twice daily

Children's dosage

Bronchial asthma — At the start of inhalation therapy, during treatment of severe asthma, or when reducing or discontinuing oral corticosteroids: Children: Administer 0.5~1mg (1 bottle~2 bottles) twice daily Bronchial asthma — Maintenance dose: Children: Administer 0.25~0.5mg (1/2 bottle~1 bottle) twice daily Acute laryngotracheobronchitis — Infants and young children: Administer 2mg once daily.

Precautions

This drug is an inhaler containing budesonide, used for treating asthma and chronic pulmonary diseases. Firstly, those who are allergic to this medication or have experienced side effects should not use it. Patients with pulmonary tuberculosis or fungal, viral infections should exercise special caution when using this medication. Patients reliant on oral steroids need to switch to this drug cautiously, starting with concurrent oral steroids while gradually reducing the dosage. Using this medication may cause sore throat, inflammation in the mouth, dryness, cough, hoarseness, etc. It is particularly important to rinse the mouth thoroughly with water after inhalation to prevent oral candidiasis (fungal infection). Rarely, side effects such as headaches, taste abnormalities, skin rashes, bronchospasms, anxiety, and depression may occur. To prevent bronchospasms, it is advisable to use a bronchodilator 5-10 minutes before inhaling this medication. Since this drug may cause facial irritation, it is recommended to wash the face after use. This medication is not intended for rapid relief of acute asthma attacks, so it should not be used alone during severe symptoms. When switching from oral steroids to this drug, recovery of adrenal function takes time, so it should be done under the guidance of a physician. In cases of asthma exacerbation due to bacterial infections, antibiotic therapy and dosage adjustments may be necessary. When discontinuing this medication, consulting a doctor or pharmacist is essential, and it is necessary to check for the history of varicella or measles and vaccination status to reduce infection risks. During pregnancy, this drug can be used for asthma management and is reported to pose no significant risk to the fetus. While breastfeeding, the inhalation amount of this drug is low, and it is expected to have minimal effects on the infant through breast milk. When used by children, it should be administered in minimal amounts to avoid impacting growth, with regular checks on their growth status. Overdosage may not commonly cause serious issues, but prolonged overdosage can lead to side effects such as adrenal suppression. After inhalation, the mouth and face should be thoroughly washed to reduce the occurrence of candidiasis; if sediment occurs during storage, it should be discarded if it does not mix well even after shaking. It should be used within 3 months after opening, and the aerosol solution is only for inhalation and should not be swallowed or injected.

Side effects

  • Sore throat
  • oral and glossitis
  • dry mouth
  • cough
  • oral candidiasis
  • hoarseness
  • laryngitis
  • headache
  • cranial discomfort
  • taste disturbances
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  • 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 drug should be stored in a tightly closed container to prevent moisture or air from entering, and it is safe to keep it at room temperature between 1°C and 30°C. Storing it this way will help maintain the drug's efficacy and prevent degradation.

Appearance and packaging

Appearance

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

Package unit

2 milliliters/bottle

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.