Medication info

Airfluzal Fospiron 500

Prescription medicationApproval withdrawn
Ingredient · strength
Salmeterol Xinafoate Micronized›Strength being verifiedFluticasone Propionate›Strength being verified
Manufacturer / importer
한국산도스(주)
Appearance
A metered-dose inhaler filled with a uniform white powder mounted in a plastic container.
Packaging
60 doses/1 container
Approval status
Approval withdrawn

MFDS item code 201400922 · Approved 2014.02.28

This product's status changed to Approval withdrawn on 2023.07.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms of asthma (bronchodilation, inflammation)
Who uses it
Adults · Children
Adult dosage
Adults and children aged 12 and older: Inhalation doses should be administered according to the severity of the disease: Inhale 50 μg of salmeterol + 100 μg of fluticasone propionate twice daily or Inhale 50 μg of salmeterol + 250 μg of fluticasone propionate twice daily or Inhale 50 μg of salmeterol + 500 μg of fluticasone propionate twice daily.
Children's dosage
Children aged 4 to 11 years: Inhale 50 μg of salmeterol + 100 μg of fluticasone propionate twice daily.

Ingredients

Importer
한국산도스(주)

Efficacy & effects

Improvement of symptoms of asthma (bronchodilation, inflammation)

  • Asthma
View approved original text

This medication is highly effective for asthma patients when used in combination with a bronchodilator and an inhaled corticosteroid. These two drugs respectively relax the muscles of the airways and reduce inflammation, making it easier to breathe. The combination treatment helps alleviate symptoms and prevent asthma attacks. It assists in improving respiratory health and reducing difficulties in daily life. Therefore, the combination therapy of this medication is recommended for asthma treatment.

Dosage and Administration

Adult dosage

Adults and children aged 12 and older: Inhalation doses should be administered according to the severity of the disease: Inhale 50 μg of salmeterol + 100 μg of fluticasone propionate twice daily or Inhale 50 μg of salmeterol + 250 μg of fluticasone propionate twice daily or Inhale 50 μg of salmeterol + 500 μg of fluticasone propionate twice daily.

Children's dosage

Children aged 4 to 11 years: Inhale 50 μg of salmeterol + 100 μg of fluticasone propionate twice daily.

Precautions

This medication takes about 10–20 minutes to display bronchodilation effects; thus, it should not be used for acute asthma attacks or severe asthma exacerbations. This drug is not for acute asthma treatment, and quick-relief inhalers should be used for acute symptoms, and patients should always be advised to carry a quick-relief inhaler. It should not be used if there is an allergy to any ingredient in this medication or in patients with cardiac arrhythmia, untreated respiratory infections, or severe bronchiectasis. Caution should be exercised in patients with cardiovascular diseases, diabetes, hyperthyroidism, convulsive disorders, or pulmonary tuberculosis, and the potassium levels in the blood should be monitored carefully. Rarely, various side effects like bronchospasm, palpitations, headache, nausea, muscle pain, skin rash, etc., may occur. If unusual symptoms arise, consult a physician immediately. After inhalation, it is advisable to rinse the mouth and throat with water to prevent side effects like oral candidiasis. If asthma symptoms worsen or if there is an increase in the use of quick-relief inhalers, an evaluation by a physician should be received immediately, and do not suddenly discontinue this medication; taper off according to medical advice. This medication should only be used during pregnancy when the benefits outweigh the risks to the fetus, and if breastfeeding, consultation regarding stopping breastfeeding or discontinuing the medication is needed. Special caution is required for children and elderly patients, especially as safety and efficacy in children under 4 years of age have not been established. When taken with other medications, there may be potential interactions, so caution is advised, especially when taken with cardiac drugs, antibiotics, or antifungals. In the case of overdose, serious symptoms such as cardiac arrhythmia, blood pressure changes, muscle spasms may occur, and immediate medical attention should be sought. This medication is for inhalation only and should not be taken orally. Always adhere to the appropriate dosage and usage as directed by a physician, and regularly monitor the condition during treatment. Additionally, care should be taken for increased infection risks, and attention to preventing chickenpox or measles is essential; seek medical care immediately if any symptoms of infection occur.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • angioedema
  • difficulty breathing
  • wheezing
  • paradoxical bronchospasm
  • very rare anaphylactoid reactions
  • hyperglycemia
  • palpitations
  • pneumonia
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  • sudden and severe headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • severe edema
  • hypertension
  • hypokalemia
  • severe allergic reactions
  • severe skin reactions
  • respiratory problems
  • liver issues (jaundice)
  • severe neurological symptoms
  • severe edema.

Mild side effects

  • Viral gastroenteritis
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • perceived palpitations
  • headache
  • tremor
  • palpitations
  • tachycardia
Show 25 more
  • atrial fibrillation
  • arterial spasm
  • ventricular tachycardia
  • extrasystole
  • bronchitis
  • rhinitis
  • laryngitis
  • oral and throat irritation
  • abdominal pain
  • muscle cramps
  • myalgia/myositis
  • muscle soreness
  • arthralgia
  • muscle spasms
  • menstrual irregularities
  • flushing
  • rash
  • urticaria
  • edema
  • angioedema
  • irritation
  • dental pain
  • hyperglycemia
  • hoarseness/voice disturbances
  • oropharyngeal candidiasis.

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

Storage

This medication should be stored in specially designed containers to prevent exposure to light and air, and it is recommended to be kept in a cool place at or below 25 degrees Celsius. Proper storage helps maintain the effectiveness of the medication and prevents degradation.

Appearance and packaging

Appearance

A metered-dose inhaler filled with a uniform white powder mounted in a plastic container.

Package unit

60 doses/1 container

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.