PRODUCT DETAILS

Composition

• Budesonide 160 mcg per dose (inhaled corticosteroid)
• Formoterol fumarate dihydrate 4.5 mcg per dose (long-acting beta₂-agonist bronchodilator)

Use / Indications

• Maintenance treatment of asthma in adults and children (as prescribed).
• Maintenance treatment of chronic obstructive pulmonary disease (COPD).
• Helps reduce airway inflammation and keep airways open for easier breathing.
• Not intended for the immediate relief of acute asthma attacks.

Directions for Use

• Usually inhaled as 1–2 inhalations twice daily, according to the prescribed regimen.
• Inhale deeply and forcefully through the mouthpiece.
• Rinse the mouth with water after each dose and spit out the water to reduce the risk of oral thrush.
• Continue using regularly even when symptoms are controlled, unless advised otherwise by a healthcare provider.

Side Effects

• Oral thrush (Candida infection)
• Hoarseness
• Throat irritation
• Cough
• Headache
• Tremor
• Palpitations
• Increased heart rate
• Dizziness
• Muscle cramps
• Nervousness
• Sleep disturbances
• Nausea

Warnings

• Not for treatment of sudden asthma attacks or acute bronchospasm.
• Do not exceed the prescribed dose.
• Do not use with another long-acting beta₂-agonist (LABA) unless specifically instructed.
• Seek medical attention if breathing worsens or the inhaler becomes less effective.

Interactions

• Beta-blockers (e.g., propranolol, atenolol) may reduce effectiveness.
• Diuretics may increase the risk of low potassium levels.
• Other sympathomimetic medicines may increase cardiovascular side effects.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase budesonide exposure.
• Caution with medicines that affect heart rhythm.

Cautions

• Use cautiously in patients with:
• Heart disease
• Hypertension
• Diabetes mellitus
• Hyperthyroidism
• Tuberculosis
• Respiratory fungal or viral infections
• Liver impairment
• Do not stop treatment abruptly without medical advice.
• Monitor for signs of oral thrush and rinse the mouth after use.
• Use during pregnancy and breastfeeding only under medical supervision.