DuoResp Spiromax 160/4.5 micrograms (Budesonide, Formoterol Fumarate Dihydrate)

Adult dosage

1. Anti-inflammatory symptom relief therapy (for mild asthma patients): For adolescents aged 12 years and older: Inhale as needed for symptom relief, may also be used to prevent bronchoconstriction triggered by allergens or exercise. Do not exceed 6 inhalations in one occasion, total daily inhalation dose should not exceed 8 times, and in exceptional cases, up to 12 times may be allowed. 2. Maintenance therapy including anti-inflammatory symptom relief therapy: For adolescents aged 12 years and older

Children's dosage

1. Anti-inflammatory symptom relief therapy (for mild asthma patients): Efficacy and safety for children aged 4-11 years have not been studied. 2. Maintenance therapy including anti-inflammatory symptom relief therapy: Not recommended for children under 12 years.

This medication is an inhalant containing two ingredients, Budesonide and Formoterol. This medication should not be used by individuals allergic to Budesonide, Formoterol, or inhalation lactose. Additionally, individuals with a genetic disorder that prevents the breakdown of lactose should not take this medication. This medication is not to be administered to children under the age of 6. Those who have previously received systemic steroid treatment and have impaired adrenal function should exercise caution while using this medication. During the use of this medication, symptoms such as tremors and palpitations may occur, which are common side effects of the drug and typically disappear within several days. Patients with chronic obstructive pulmonary disease may experience skin bruising or pneumonia, hence caution is required. This medication may have various side effects; thus, if symptoms such as headaches, dizziness, skin rash, oral candidiasis, hypokalemia, etc., occur, it is important to consult a physician. Dosage should not be suddenly stopped, but rather it should be gradually reduced under a doctor's instructions. If asthma or chronic obstructive pulmonary disease symptoms suddenly worsen, immediate evaluation by medical personnel is necessary, and additional treatment may be required. It is advisable to always carry a fast-acting bronchodilator to relieve symptoms during the use of this medication. Even if there are no symptoms, the medication should be inhaled consistently every day as prescribed by a doctor. It may also help prevent bronchoconstriction due to allergies or exercise. While using this medication, it is crucial to gradually reduce the dose if asthma symptoms are well controlled. During severe asthma exacerbations, this medication alone may not be sufficient, and alternative treatments may be necessary. If coughing or wheezing worsens after use, it is essential to stop using the medication immediately and reevaluate the treatment approach. Long-term use at high doses may lead to systemic side effects such as adrenal insufficiency, growth retardation, decreased bone density, cataracts, and glaucoma, therefore caution is necessary. This medication may affect blood sugar and potassium levels, so patients with diabetes or those at risk of hypokalemia should exercise caution. When using this medication, special attention is required if there are specific heart conditions, and it is crucial to inform the doctor about potential interactions with other medications. During pregnancy or breastfeeding, the benefits and risks of using this medication should be carefully considered. In children, growth status should be regularly monitored, and if growth retardation is suspected, treatment methods should be re-evaluated. In case of overdose, symptoms such as tremors, headaches, palpitations, hypokalemia, etc., may occur, and immediate medical assistance should be sought. When using the inhaler, do not shake before use, and rinse the mouth with water afterward to reduce the risk of oral candidiasis. Check the remaining dose of the inhaler and be careful not to unnecessarily open or close the inhaler cover.

Serious side effects

Hives, angioedema, anaphylaxis, severe swelling (edema), angina, systemic corticosteroid effects (including adrenal insufficiency), respiratory abnormalities accompanied by cough and fever, bronchospasm, paradoxical bronchospasm, atrial fibrillation, supraventricular tachycardia, ectopic beats, severe rash with high fever, blisters, skin shedding, oral/ocular mucosal pain, difficulty breathing, asthma attacks, chest tightness, skin or eye

Mild side effects

• Tremors
• palpitations
• tachycardia
• nausea
• oral pharyngeal candidiasis
• hypokalemia
• hyperglycemia
• muscle cramps
• headaches
• dizziness

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is best kept in a cool place below 25 degrees Celsius. Storing it this way helps maintain the medication's efficacy and safety for a long time.

Appearance

A white or off-white dry powdered inhaler contained in a metered-dose container

Package unit

120 doses per inhaler