DuoResp Spiromax 320/9 micrograms (Budesonide, Formoterol Fumarate Dihydrate)

Adult dosage

Asthma: Inhale 1 dose twice a day. Some patients may inhale a maximum of 2 doses twice a day. Chronic obstructive pulmonary disease: Inhale 1 dose twice a day.

Children's dosage

Adolescents aged 12 to 17 years: Inhale 1 dose twice a day. Children under 12 years: Not recommended for administration due to insufficient safety and efficacy.

This medication contains two active ingredients, Budesonide and Formoterol, and is used for the treatment of asthma or chronic obstructive pulmonary disease. This medication should not be used in patients with known allergies to Budesonide, Formoterol, or inhalation lactose, patients with lactose intolerance or specific genetic metabolic disorders, and children under 6 years of age. Caution is required when administering this medication to patients who are suspected to have adrenal function issues from past systemic steroid treatment. While using this medication, symptoms such as tremors and palpitations may commonly occur, but most are mild and disappear within a few days. Patients with chronic obstructive pulmonary disease may experience skin bruising or pneumonia, and if these symptoms occur, consultation with a physician is necessary. This medication may cause oral and throat candidiasis (fungal infections), so it is important to rinse the mouth thoroughly after inhalation. Various side effects such as arrhythmias, hypokalemia, increased blood sugar, headache, dizziness, anxiety, sleep disorders, etc., may occur rarely, so immediate consultation with healthcare personnel is necessary if unusual symptoms arise. When discontinuing treatment, do not stop abruptly but gradually reduce the dosage according to the physician's instructions. If asthma symptoms worsen or are not adequately controlled, immediate medical evaluation and treatment are necessary. During the use of this medication, always carry a rescue inhaler and consistently inhale the prescribed dosage even if no symptoms are present. As with other inhalers, the rare occurrence of paradoxical bronchospasm may happen after administration of this medication; if such symptoms arise, the administration should be stopped immediately and the physician consulted. Long-term high-dose use may lead to systemic side effects, such as adrenal insufficiency, growth delay, decreased bone mineral density, cataracts, and glaucoma, hence regular check-ups are needed. This medication may interact with specific drugs, thus it should not be used concurrently with beta-blockers or strong CYP3A4 inhibitors, and any other medications being taken must be reported to healthcare personnel. Pregnant or breastfeeding women should consult their physician before using this medication, considering potential effects on the fetus or infant. In the case of children, growth status should be regularly monitored, and if growth delay is suspected, treatment methods should be reevaluated. In case of overdose, symptoms such as tremors, headaches, heart palpitations, and hypokalemia may occur, so immediate medical attention is required. Do not shake the inhaler before use, and rinse the mouth with water after use to reduce the risk of oral infections. The inhaler mouthpiece cover should be opened and closed only when necessary, and it is advisable to clean it with a dry cloth to maintain hygiene. The number of inhalations can be checked via the display, and if the remaining doses are few, it should be replaced with a new product. For effective inhalation, exhale first, place the inhaler in the mouth, take a deep breath, and hold for more than 10 seconds. It is safe to follow the physician's directions when using this medication, and immediate consultation is encouraged if unusual symptoms arise.

Serious side effects

Urticaria, angioedema, anaphylaxis, angina, symptoms or signs caused by systemic corticosteroid effects (including adrenal insufficiency), paradoxical bronchospasm, adrenal suppression, adrenal insufficiency, severe edema, hypertension, blood pressure fluctuations, pneumonia, asthma exacerbation, serious asthma-related adverse reactions, ventricular arrhythmias, myocardial infarction, serious allergic reactions, severe skin adverse reactions, respiratory distress, difficulty breathing

Mild side effects

• Tremors
• palpitations
• tachycardia
• atrial fibrillation
• supraventricular tachycardia
• ectopic beats
• nausea
• rash
• itching
• dermatitis

This medication should be stored in a sealed container to prevent air or moisture ingress and it is advisable to store it at a cool temperature below 25 degrees Celsius. Storing it this way will help maintain the efficacy of the medication for a longer time.

Appearance

Dry powder inhaler contained in a metered-dose container, white or off-white

Package unit

60 doses per inhaler