Medication info

Serevent Diskus 100

Prescription medicationApproval withdrawn
Ingredient · strength
Salmeterol Xinafoate Micronized›72.5μgFluticasone Propionate Micronized›100μg
Manufacturer / importer
(주)글락소스미스클라인
Appearance
The inhaler is a purple circular plastic device filled with a white powder.
Packaging
60 doses / container
Approval status
Approval withdrawn

MFDS item code 199906870 · Approved 1999.07.24

This product's status changed to Approval withdrawn on 2024.10.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms related to asthma (bronchodilation, inflammation)
Who uses it
Adults · Children
Adult dosage
Adults and children aged 12 and above should inhale one of the following combinations based on the severity of the condition: 50 μg of salmeterol with 100 μg, 250 μg, or 500 μg of fluticasone propionate, twice a day.
Children's dosage
Children ages 4 to 11 should inhale 50 μg of salmeterol and 100 μg of fluticasone propionate twice a day.

Ingredients

Importer
(주)글락소스미스클라인

Efficacy & effects

Improvement of symptoms related to asthma (bronchodilation, inflammation)

  • Asthma
View approved original text

This medication is used to effectively treat the symptoms of asthma patients who require the combined use of a bronchodilator and inhaled corticosteroids.

Dosage and Administration

Adult dosage

Adults and children aged 12 and above should inhale one of the following combinations based on the severity of the condition: 50 μg of salmeterol with 100 μg, 250 μg, or 500 μg of fluticasone propionate, twice a day.

Children's dosage

Children ages 4 to 11 should inhale 50 μg of salmeterol and 100 μg of fluticasone propionate twice a day.

Precautions

This medication should not be used in cases of acute asthma attacks or in patients with severely exacerbated asthma. The bronchodilator effect of this medication appears approximately 10 to 20 minutes after administration; therefore, a rapid-acting inhaler should be used in acute symptoms. This medication should not be used for the acute treatment of asthma or chronic obstructive pulmonary disease. If asthma symptoms suddenly worsen or if there is an increase in the use of rapid-acting inhalers, immediate medical advice should be sought. This medication is contraindicated in patients with a history of allergies to the drug or its components as well as in patients with cardiac arrhythmias, untreated lung infections, or moderate to severe bronchiectasis. Caution is advised when administering this drug to patients with specific conditions such as cardiovascular disease, diabetes, hyperthyroidism, seizure disorders, and pulmonary tuberculosis. Rarely, after inhalation, this medication can cause symptoms such as wheezing or sudden tightening of the airways, so if these symptoms appear, use should be immediately stopped and consultation with a doctor should be sought. Common side effects may include palpitations, headache, muscle pain, oral candidiasis (thrush), and hoarseness; rinsing the mouth after inhalation can help. The risk of cardiac side effects may increase when used in combination with other beta-2 agonists or certain medications, so caution is necessary when combining treatments. During pregnancy, the benefits and risks to the fetus should be weighed under a doctor's guidance, and during breastfeeding, it should be used cautiously at dosages that have minimal impact on the newborn. Safety and effectiveness in children under 4 years of age has not been established, and there may be systemic side effects such as growth retardation, particularly with long-term high-dose therapies. Elderly patients may be at increased risk for cardiovascular adverse reactions and should be monitored closely during use. In cases of overdose, symptoms such as cardiac arrhythmias, headache, tremors, and hypokalemia may occur, requiring immediate medical evaluation, and dosages should be within approved ranges. This medication is intended for inhalation only, and the oral route will not be effective; thus, it must be used correctly with the inhaler, and after inhalation, the mouth should be rinsed or rinsed with water to prevent oral candidiasis. Patients should always carry a rapid-acting inhaler for emergencies during treatment and consult healthcare providers at the first sign of worsening symptoms. This medication should be stored away from light due to its sensitivity to light and kept in a container that does not allow light in. Additionally, it is better to store the medication at room temperature between 1 and 30 degrees Celsius to maintain its efficacy over time.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, pallor, severe allergic reactions, severe rashes with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, asthma attacks, breathing difficulties associated with cough and fever, shortness of breath or difficulty in breathing, bronchospasm, paradoxical bronchospasm, liver abnormalities (jaundice), sudden and severe headache, lightning headache, seizures,

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • headache
  • tremors
  • awareness of heart palpitations
  • tachycardia
  • atrial fibrillation
  • arterial spasm
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  • ventricular tachycardia
  • ectopic beats
  • bronchitis
  • rhinitis
  • laryngitis
  • wheezing
  • oral and throat irritation
  • muscle pain/myositis
  • ache in muscles
  • joint pain
  • muscle cramps
  • menstrual irregularities
  • redness
  • rash
  • angioedema
  • irritation
  • toothache
  • hoarseness/voice difficulties
  • throat irritation
  • bruising
  • arthralgia
  • muscle cramps
  • anxiety
  • sleep disturbances
  • dizziness
  • stomatitis

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 an opaque container. Additionally, it is recommended to keep the medication at room temperature between 1 degree and 30 degrees Celsius. This helps to maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

The inhaler is a purple circular plastic device filled with a white powder.

Package unit

60 doses / 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.