Budison-FG

• Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)

This Inhaler is a pressurized metered-dose inhaler that delivers a combination of micronized Budesonide (an inhaled corticosteroid), micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate (an inhaled long-acting beta2-adrenergic agonist). Budesonide helps to decrease inflammation in the lungs. Glycopyrrolate and formoterol fumarate help the muscles around the airways in the lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.

Adult Dose (COPD):

• Two inhalations twice daily (morning and evening) by oral inhalation.
• Do not take more than two inhalations twice daily.
• After inhalation, rinse mouth with water without swallowing.

* Use as directed by the registered physician

Common Side Effects:

• Candida albicans infection (mouth and pharynx)
• Increased risk of pneumonia
• Paradoxical bronchospasm
• Hypercorticism and adrenal suppression
• Reduction in bone mineral density
• Worsening of narrow-angle glaucoma and cataracts
• Worsening of urinary retention
• Cardiovascular effects (increased heart rate, arrhythmias)

Use in Pregnancy: No adequate and well-controlled studies in pregnant women. Use only if the expected benefit to the mother is greater than any possible risk to the fetus.

Precautions:

• Safety and efficacy in patients with asthma have not been established - not indicated for the treatment of asthma.
• Should not be used as rescue therapy for acute symptoms.
• Physicians should remain vigilant for the possible development of pneumonia in COPD patients.
• Daily dosage should not be increased beyond the recommended dose.
• Should not be used with other LABA-containing medications.
• Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Overdose:

• Budesonide: Excessive doses for prolonged periods may cause hypercorticism.
• Glycopyrrolate: High doses may lead to anticholinergic signs (nausea, vomiting, dizziness, blurred vision, difficulties in voiding).
• Formoterol Fumarate: Seizures, angina, hypertension/hypotension, tachycardia, arrhythmias, hyperglycemia, hypokalemia.

Storage: Pressurized canister - do not puncture, break or incinerate. Avoid exposure to direct sunlight or heat. Do not store above 30°C. Keep in a dry place. Protect from light and keep out of reach of children. Discard within three months after removing from the foil pouch.