Fluticasone Propionate and Salmeterol Inhalation Capsule 100/50

Adult use

Adults and children aged 12 and older: The following doses should be inhaled depending on the severity of the condition: 50 μg of Salmeterol + 100 μg of Fluticasone Propionate twice daily or 50 μg of Salmeterol + 250 μg of Fluticasone Propionate twice daily or 50 μg of Salmeterol + 500 μg of Fluticasone Propionate twice daily.

Child use

Children aged 4 to 11 years: Inhale 50 μg of Salmeterol + 100 μg of Fluticasone Propionate twice daily.

This drug takes about 10 to 20 minutes to show its bronchodilatory effect, so it should not be used in patients with acute asthma or very severe asthma exacerbations. Fast-acting inhalers should be used for acute asthma attacks, and patients should always carry these rapid-acting inhalers. This drug is not intended for the acute treatment of asthma or chronic obstructive pulmonary disease and should be evaluated by a physician if symptoms worsen. It should not be administered to patients with a known allergy to this drug or its components, heart arrhythmias, untreated respiratory infections, severe bronchiectasis, urgent asthma status, or lactose intolerance. Caution should be exercised in patients with heart disease, diabetes, hyperthyroidism, seizures, pulmonary tuberculosis, or suspected infections in chronic obstructive pulmonary disease patients and liver impairment. There may be sudden bronchoconstriction after inhalation, so use should be discontinued immediately if symptoms occur and a doctor should be consulted. Oral candidiasis (thrush) or hoarseness may occur as side effects, so it is recommended to rinse the mouth after inhalation. Various side effects, such as palpitations, headache, muscle pain, rashes, and others may occur, and unusual symptoms should be reported to a physician. If asthma symptoms worsen or if the use of rapid-acting inhalers increases, immediate medical evaluation is required, and patients should not discontinue use without a doctor’s guidance and should gradually adjust the dosage as directed. Patients must be familiar with the correct usage before inhalation, use the specified inhaler, and prevent side effects by rinsing their mouths or brushing their teeth afterward. This drug can interact with other medications, so patients taking heart medications, antidepressants, antibiotics, or steroids should consult their doctor or pharmacist. When usage is necessary during pregnancy or breastfeeding, it should be administered at the minimum dosage under a doctor’s recommendation, and use during delivery should be limited. Safety and efficacy have not been established in children under 4 years of age, and caution is advised as high-dose long-term use may risk growth retardation. Elderly patients are at risk for cardiovascular side effects and should be administered with care while closely monitoring their condition. Overdose can lead to serious symptoms such as heart arrhythmias, blood pressure changes, muscle cramps, and seizures, necessitating immediate medical attention. This drug is intended for inhalation only and will not be effective if taken orally, so it must be administered with an inhaler. Upon storage, keep in a cool place out of reach of children, maintaining its original packaging.

Serious side effects

• Hives
• severe swelling
• difficulty breathing
• anaphylactic reactions
• bronchospasm
• angioedema
• wheezing
• choking
• severe allergic reactions
• severe skin abnormal reactions

Mild side effects

Nausea, vomiting, diarrhea, abdominal pain, viral gastroenteritis, self-perceived palpitations, headache, tremors, palpitations, tachycardia, atrial fibrillation, arterial spasms, ventricular tachycardia, ectopic beats, nonspecific chest pain, systolic and diastolic blood pressure changes, heart rate changes, bronchitis, rhinitis, laryngitis, oral and throat irritation, abdominal pain, muscle contraction, muscle pain/myositis, muscle soreness, joint pain, muscle cramps, menstrual irregularities, flushing, rash, angioedema, irritation,

This drug may be sensitive to light, so it should be stored in a container that protects it from light. Additionally, it is recommended to store the drug at room temperature between 1 and 30 degrees Celsius, which will help maintain its effectiveness for a longer period.

Appearance

A colorless, transparent inhalation capsule filled with white powder (a Hanmi inhaler may be included).

Package unit

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