Budetrol 400 mcg+12 mcg (Inhalation Capsule)

Title

• Dry Powder Inhaler
• Budesonide and Formoterol Combination Inhaler

Categories

• Medicine
• Respiratory
• Inhaler
• Asthma Treatment
• COPD Maintenance
• Bronchodilator

Formulation

• Combination of Formoterol Fumarate Dihydrate BP and Budesonide BP

Usage

• Oral inhalation only
• Twice-daily maintenance treatment for asthma
• Twice-daily maintenance treatment for COPD

Age Group

• Adults and adolescents (12 years and older)
• Children (4 years and older)

Dosage

• Recommended maintenance dose of 1 puff twice daily for adults and adolescents
• Alternative dosage regimens for children as per age groups
• Maximum daily maintenance dose
• Instructions for Inhalation Capsule usage for COPD

Mode of Action

• Budesonide: Potent glucocorticoid activity
• Budesonide: Anti-inflammatory action in the airways
• Formoterol: Long-acting, selective β2 - adrenergic agonist
• Formoterol: Bronchodilator with rapid onset of action

Pharmacological Effects

• Formoterol Fumarate Dihydrate: Acts locally in the lungs
• Budesonide: Reduction of symptoms and fewer asthma exacerbations

Administration Instructions

• Shake the inhaler vigorously before each use
• Breathe out fully before inhaling
• Hold breath for at least 10 seconds after inhaling
• Wait for 1 minute between puffs if prescribed multiple inhalations

Maintenance & Relief Doses

• Adults and adolescents: Budesonide and Formoterol 100 & 200 Inhalation Capsule maintenance
• Children: Budesonide and Formoterol 100 Inhalation Capsule once daily

Cleaning Instructions

• Clean the inhaler at least once a week
• Rinse plastic actuator and cap in warm water
• Replace the cap on the mouthpiece after use

Interactions

• Avoid co-administration with strong cytochrome P450 3A4 inhibitors
• Use beta-blockers with caution to avoid blocking bronchodilatory effects
• Exercise caution with diuretics

Contraindications

• Primary treatment of status asthmaticus
• Hypersensitivity to any of the ingredients

Side Effects

• Common adverse events associated with Formoterol Fumarate
• Common adverse events associated with Budesonide
• Potential adverse reactions from concurrent administration of the two compounds

Pregnancy & Lactation

• No clinical data on exposed pregnancies available
• Budesonide excreted in breast milk
• Use during breastfeeding only if expected benefit to the mother is greater than potential risk to the child

Precautions & Warnings

• Caution in patients with diabetes mellitus and severe cardiovascular disorders
• Monitor height of children receiving prolonged treatment with inhaled corticosteroids

Special Populations

• Regular monitoring of children's height during prolonged treatment
• Consideration for referral to a paediatric respiratory specialist

Overdose Effects

• Potential effects of Formoterol overdose
• Chronic excessive doses of Budesonide may lead to systemic glucocorticosteroid effects

Storage Conditions

• Capsules must not be swallowed, only used with inhalation device
• Store below 25°C temperature, away from light and moisture
• Remove capsule from blister pack immediately before use

Related Brands

• Pulmicort-F (160 mcg+4.5 mcg)/puff (Inhaler) - opsonin-pharma-ltd
• Budetrol 100 mcg+6 mcg (Inhalation Capsule) - drug-international-ltd
• Symbion (400 mcg+12 mcg)/puff (Inhaler) - beximco-pharmaceuticals-ltd
• Symbion (200 mcg+6 mcg)/puff (Inhaler) - beximco-pharmaceuticals-ltd
• Symbion (100 mcg+6 mcg)/puff (Inhaler) - beximco-pharmaceuticals-ltd