Medication info
Fluteral Inhalation Capsule 250/50 (Fluticasone Propionate, Salmeterol)

Fluteral Inhalation Capsule 250/50 (Fluticasone Propionate, Salmeterol)

Prescription medication외용
Ingredient · strength
Salmeterol Xinafoate Micronized›72.5μg / 1 capsuleFluticasone Propionate Micronized›250μg / 1 capsule
Manufacturer / importer
한미약품(주)
Appearance
White powder-filled upper and lower colorless transparent inhalation capsule (may be accompanied by Hanmi Haler, an inhaler).
Packaging
30 capsules/box [10 capsules/PTP × 3], 60 capsules/box [10 capsules/PTP × 6]
Approval status
Active

MFDS item code 201400307 · Approved 2014.01.22 · Insurance code 643506791

Summary

Main use
Treatment of asthma (bronchodilation, inflammation) and alleviation of airway obstruction in chronic obstructive pulmonary disease
Who uses it
Adults · Children
Adult use
Attach one capsule of this medication to the inhaler provided and inhale through the mouth. For asthma, adults and children over 12 years of age should inhale Salmeterol 50 μg + Fluticasone Propionate 100 μg twice daily or Salmeterol 50 μg + Fluticasone Propionate 250 μg twice daily or Salmeterol 50 μg + Fluticasone Propionate 500 μg twice daily.
Child use
Children aged 4 to 11 years should inhale Salmeterol 50 μg + Fluticasone Propionate 100 μg twice a day. There is no useful data for children under 4 years old.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Treatment of asthma (bronchodilation, inflammation) and alleviation of airway obstruction in chronic obstructive pulmonary disease

  • Airway obstruction in asthma
  • chronic bronchitis
  • and chronic obstructive pulmonary disease patients
View approved original text

This medication helps to open airways in patients with asthma for easier breathing, and when used with inhaled corticosteroids, it aids in reducing inflammation. It is also used as maintenance therapy to improve airway obstruction symptoms in patients with chronic obstructive pulmonary disease associated with chronic bronchitis. This drug is effective in alleviating symptoms of respiratory diseases and improving lung function.

How to use

Adult use

Attach one capsule of this medication to the inhaler provided and inhale through the mouth. For asthma, adults and children over 12 years of age should inhale Salmeterol 50 μg + Fluticasone Propionate 100 μg twice daily or Salmeterol 50 μg + Fluticasone Propionate 250 μg twice daily or Salmeterol 50 μg + Fluticasone Propionate 500 μg twice daily.

Child use

Children aged 4 to 11 years should inhale Salmeterol 50 μg + Fluticasone Propionate 100 μg twice a day. There is no useful data for children under 4 years old.

Precautions

This drug has a bronchodilator effect that takes approximately 10 to 20 minutes to onset, so it should not be used in cases of severe acute asthma attacks or life-threatening conditions. Rapid-acting inhalers should be used for acute asthma treatment, and this drug is not suitable for acute symptom relief. It should not be administered to individuals with allergies to this medication or to patients with cardiac arrhythmias, untreated respiratory infections, or severe bronchiectasis. Caution is particularly advised for patients with cardiovascular disease, diabetes, hyperthyroidism, seizure disorders, or pulmonary tuberculosis, and blood tests may be necessary under a doctor's guidance. Counsel a physician immediately if unusual reactions like difficulty breathing, coughing, or hoarseness occur after inhalation. It is important to rinse the mouth well with water after inhalation to prevent oral candidiasis. Asthma or chronic obstructive pulmonary disease patients should seek immediate medical attention if their symptoms worsen or if they find themselves using a rapid-acting inhaler more frequently while using this medication. During pregnancy, it should be used cautiously and at the minimum effective dose if treatment is necessary; during breastfeeding, decisions should be made after consulting with a professional. In children, prolonged high-dose use may lead to systemic side effects such as growth retardation, requiring regular growth monitoring. Elderly patients should use this medication cautiously, paying attention to cardiovascular side effects and monitoring their condition. This medication is for inhalation use only and will not be effective if taken orally or for other purposes. There may be interactions when used with other medications, so inform the healthcare provider of any current medications, especially if using certain antifungals or HIV treatments. It is vital to learn the correct inhaler technique to ensure proper usage, and after use, the mouth should be rinsed to reduce the risk of oral infections. Store this medication in a cool place out of reach of children and maintain its original packaging until opened.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, choking, severe allergic reactions, paradoxical bronchospasm, anaphylactic reactions, cardiac arrhythmias, acute adrenal crisis, sudden and severe headaches, seizures, confusion, visual disturbances, paralysis, severe swelling accompanied by elevated blood pressure, arrhythmias due to hypokalemia, palpitations, tachycardia, atrial fibrillation, arterial spasm, ventricular tachycardia, extrasystole, jaundice, adrenal suppression, Cushing's syndrome

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • viral gastroenteritis
  • palpitations
  • headache
  • tremors
  • tachycardia
  • atrial fibrillation
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  • arterial spasm
  • ventricular tachycardia
  • extrasystole
  • bronchitis
  • rhinitis
  • laryngitis
  • oral-pharyngeal irritation
  • abdominal pain
  • muscle contraction
  • myalgia
  • myositis
  • muscle ache
  • arthralgia
  • muscle spasms
  • menstrual irregularities
  • flushing
  • rash
  • urticaria
  • edema
  • angioedema
  • irritability
  • dental pain
  • hyperglycemia
  • hoarseness
  • speech disorders

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 tightly sealed container that blocks light. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage helps to maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

White powder-filled upper and lower colorless transparent inhalation capsule (may be accompanied by Hanmi Haler, an inhaler).

Package unit

30 capsules/box [10 capsules/PTP × 3], 60 capsules/box [10 capsules/PTP × 6]

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.