Budison F (160 mcg+4.5 mcg)/puff (Inhaler)

Title

• Dry Powder Inhaler
• Combination Inhalation Capsule
• Formoterol Fumarate Dihydrate BP and Budesonide BP

Category

• Asthma Treatment
• COPD Maintenance Treatment
• Inhalation Therapy

Dosage

• 1 puff twice daily for adults and adolescents (12 years and older)
• 2 puffs once daily for adults and adolescents (12 years and older)
• 2 puffs twice daily for some patients (160/4.5 mcg/inhalation only)
• Maintenance dose of Budesonide and Formoterol 100 & 200 Inhalation Capsule twice daily for adults and adolescents (12 years and older)
• Reliever dose of 1 additional Inhalation Capsule as needed in response to symptoms for adults and adolescents (12 years and older)
• Usual maintenance dose of 1 - 2 puffs once or twice daily for children
• Maintenance dose of Budesonide and Formoterol 100 Inhalation Capsule once daily for children (4 years and older)
• Reliever dose of 1 additional Inhalation Capsule as needed in response to symptoms for children (4 years and older)
• 2 Inhalation Capsule twice daily for adults (40 years and older)
• 1 Inhalation Capsule twice daily for adults (40 years and older)

Description

• Combination of Formoterol Fumarate Dihydrate BP and Budesonide BP
• Intended for oral inhalation only
• Formoterol is a selective β2 adrenoceptor agonist
• Formoterol results in rapid and long-acting relaxation of bronchial smooth muscle
• Budesonide is a glucocorticosteroid with anti-inflammatory action in the airways

Storage Conditions

• Inhalation capsules must not be swallowed
• Keep away from light and wet place
• Store at or below 25°C temperature
• Keep out of reach of children
• Remove Inhalation capsule from the blister pack only immediately before use

Indications

• Treatment of Asthma in patients 12 years of age and older
• Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)
• Twice-daily maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and emphysema

Mode of Action

• Formoterol is a long-acting, selective β2 - adrenergic agonist with a rapid onset of action
• Budesonide is an anti-inflammatory corticosteroid with potent glucocorticoid activity

Precautions & Warnings

• Caution should be taken in patients with diabetes mellitus
• Caution should be taken in patients with untreated hypokalaemia
• Paradoxical bronchospasm may occur

Administration

• Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks
• Simple steps for using Inhaler effectively
• Instructions for cleaning Inhaler

Interaction

• Co-administration with strong cytochrome P450 3A4 inhibitors should be avoided
• Co-administration with Monoamine oxidase inhibitors and tricyclic antidepressants should be with extreme caution
• Beta-blockers should be use with caution

Contraindications

• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required
• Hypersensitivity to any of the ingredients in this preparation

Side Effects

• Tremor, palpitations, and headache are common adverse events
• Hoarseness, candida infection in the oropharynx, and throat irritation may occur

Pregnancy & Lactation

• No clinical data on exposed pregnancies are available
• Budesonide is excreted in breast milk
• Formoterol is excreted in small amounts in maternal milk

Use in Special Populations

• Recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored

Overdose Effects

• An overdose of Formoterol would likely lead to effects that are typical for adrenoceptor agonists

Related Brands

• Renafor-B 400 mcg+12 mcg (Inhalation Capsule) - renata-limited
• Renafor-B 200 mcg+6 mcg (Inhalation Capsule) - renata-limited
• Renafor-B 100 mcg+6 mcg (Inhalation Capsule) - renata-limited
• Renafor-B (160 mcg+4.5 mcg)/puff (Inhaler) - renata-limited
• Renafor-B (80 mcg+4.5 mcg)/puff (Inhaler) - renata-limited