Treatment of Asthma: This combination inhaler is indicated for the management of asthma in patients aged 12 years and older. It is not intended for the immediate relief of acute bronchospasm.

Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD): This inhalation capsule is used for the regular maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. It is approved as a maintenance therapy for COPD-related airflow limitation.

This product is a dry powder inhalation capsule designed for oral inhalation use only. It contains a combination of Formoterol Fumarate Dihydrate and Budesonide. Budesonide is an inhaled corticosteroid with dose-dependent anti-inflammatory effects in the airways, helping to reduce asthma symptoms and exacerbations, with fewer systemic side effects compared to oral corticosteroids. Formoterol is a selective beta-2 adrenergic agonist that provides rapid and long-lasting bronchodilation. Its bronchodilatory effect is dose-dependent, begins within 1–3 minutes, and lasts for at least 12 hours after a single dose.

Budesonide: Budesonide is a corticosteroid with strong anti-inflammatory properties and minimal mineralocorticoid activity. It inhibits multiple inflammatory cells (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (such as histamine, leukotrienes, eicosanoids, and cytokines), thereby reducing airway inflammation associated with asthma.

Formoterol Fumarate Dihydrate: Formoterol is a long-acting, selective beta-2 adrenergic receptor agonist with a rapid onset of action. It acts locally in the lungs as a bronchodilator. Its effects are mediated through activation of adenylate cyclase via beta-2 receptor stimulation, increasing cyclic AMP levels. This results in relaxation of bronchial smooth muscle and inhibition of mediator release from inflammatory cells, especially mast cells.

Inhaler (For Asthma)-

• Adults and adolescents (12 years and older): The recommended maintenance dose is 1 puff twice daily or 2 puffs once daily. For some patients a maintenance dose of 2 puffs twice daily may be appropriate (for 160/4.5 mcg/inhalation only). Patients should take 1 additional puff as needed in response to symptoms. If symptoms persist after a few minutes, the additional puff should be taken. Not more than 6 puffs should be taken on any single occasion.
• Children: The usual maintenance dose is 1-2 puffs once or twice daily. Patients should take 1 additional puff as needed in response to symptoms. If symptoms persist after a few minutes, the additional puff should be taken. Not more than 4 puffs should be taken on any single occasion.

Inhalation Capsule (For Asthma): There are two alternative dosage regimens for the treatment of asthma with Budesonide and Formoterol combination. Budesonide and Formoterol 100 & 200 Inhalation Capsule maintenance and reliever therapy.
Adults and adolescents (12 years and older):

• Maintenance dose: Budesonide and Formoterol 100 & 200 Inhalation Capsule twice daily
• Reliever dose: 1 additional Inhalation Capsule as needed in response to symptoms. If symptoms persist after a few minutes, an additional Inhalation Capsule should be taken. Not more than 6 Inhalation Capsule should be taken on any single occasion. A total daily dose of more than 8 Inhalation Capsule is not normally needed, however, a total daily dose of up to 12 Inhalation Capsule can be used temporarily.

Children (4 years and older):

• Maintenance dose: Budesonide and Formoterol 100 Inhalation Capsule once daily.
• Reliever dose: 1 additional Inhalation Capsule as needed in response to symptoms. If symptoms persist after a few minutes, an additional Inhalation Capsule should be taken. Not more than 4 Inhalation Capsule should be taken on any single occasion. A total daily dose of more than 4 Inhalation Capsule is not normally needed, however, a total daily dose of up to 8 Inhalation Capsule could be used temporarily.

Inhalation Capsule (For COPD): Adults (40 years and older)

• 200 Inhalation Capsule: 2 Inhalation Capsule twice daily. Maximum daily maintenance dose: 4 Inhalation Capsule.
• 400 Inhalation Capsule: 1 Inhalation Capsule twice daily. Maximum daily maintenance dose: 2 Inhalation Capsule.

Administration

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

• Take off the cap.
• Shake the inhaler (at least six times) vigorously before each use.
• If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
• Breathe out as full as comfortably possible & hold the inhaler upright.
• Place the actuator into mouth between the teeth and close lips around the mouthpiece.
• While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
• Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
• If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
• After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
• Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Co-administration of Budesonide + Formoterol Fumarate with strong CYP3A4 inhibitors (e.g., ritonavir) should be avoided as it may increase systemic corticosteroid effects. Use with monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants requires caution due to possible enhancement of cardiovascular effects of formoterol. Beta-blockers may reduce the bronchodilatory effect of beta-agonists and may provoke severe bronchospasm. Concurrent use with diuretics may increase the risk of hypokalemia and electrocardiographic changes.

This combination is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or severe acute episodes of asthma or COPD
• Known hypersensitivity to any component of the formulation

As this inhaler contains both budesonide and formoterol, adverse effects related to each component may occur. No additional adverse effects have been observed with combined use.

Formoterol Fumarate: Common side effects include tremor, palpitations, and headache. Less common effects include cardiac arrhythmias, muscle cramps, and hypersensitivity reactions such as rash, edema, and angioedema.

Budesonide: Hoarseness, oropharyngeal candidiasis, and throat irritation may occur.
Other effects include skin hypersensitivity, respiratory infections, immunosuppression, growth effects in children, glaucoma, and cataract.

There are limited clinical data regarding the use of this combination during pregnancy. Animal studies have not shown significant additional risks, but human data are insufficient. Budesonide is excreted into breast milk, while it is unknown whether formoterol passes into human milk. This medication should be used only if the expected benefit outweighs potential risks.

Use with caution in patients with diabetes, thyrotoxicosis, untreated hypokalemia, hypertension, or severe cardiovascular disorders. Paradoxical bronchospasm may occur; if it happens, treatment should be discontinued immediately.

In children receiving long-term therapy, growth should be regularly monitored. Dose adjustment may be required if growth suppression occurs.

Overdose of formoterol may cause tremor, headache, palpitations, tachycardia, hyperglycemia, hypokalemia, arrhythmia, nausea, and vomiting.
Chronic excessive use of budesonide may result in hypercorticism and adrenal suppression.

Inhalation capsules must not be swallowed and should only be used with an appropriate inhalation device. Store below 25°C, protected from light and moisture. Keep out of reach of children. Remove capsules from the blister pack immediately before use.