Symbion (160 mcg+4.5 mcg)/puff (Inhaler)

Title

• Formoterol Fumarate Dihydrate BP and Budesonide BP Inhalation Capsule

Categories

• Medicine
• Inhaler
• Respiratory Health
• Asthma Treatment
• COPD Treatment

Description

• Dry powder inhaler for oral inhalation only
• Combination of Formoterol Fumarate Dihydrate BP and Budesonide BP
• Anti-inflammatory action in the airways
• Long-acting relaxation of bronchial smooth muscle
• Selective β2 adrenoceptor agonist
• Rapid onset of action
• Duration of effect at least 12 hours after a single dose

Dimensions

• Standard inhaler size

Color Options

• Not applicable

Usability Features

• Simple and straightforward inhalation process

Materials

• Plastic
• Aluminum (for capsules)

Technical Specifications

• Recommended maintenance dose for adults and adolescents
• Recommended maintenance dose for children
• Alternative dosage regimens for the treatment of asthma with Budesonide and Formoterol combination
• Maximum daily maintenance dose
• Instructions for effective use of the inhaler
• Instructions for cleaning the inhaler
• Storage conditions

Design Elements

• Actuator
• Mouthpiece
• Plastic cap
• Blister pack

Functions

• Relief and maintenance treatment of asthma in patients 12 years and older
• Twice-daily maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and emphysema
• Prevention of asthma attacks
• Bronchodilator

Pharmacology

• Mechanism of action for Budesonide
• Mechanism of action for Formoterol Fumarate Dihydrate

Administration

• Steps for effective inhaler usage according to National Asthma Guidelines
• Instructions for cleaning the inhaler

Interactions

• Interactions with strong cytochrome P450 3A4 inhibitors
• Interactions with Monoamine oxidase inhibitors and tricyclic antidepressants
• Interactions with beta-blockers and diuretics

Contraindications

• Primary treatment of status asthmaticus or other acute episodes
• Hypersensitivity to any of the ingredients

Side Effects

• Common adverse events associated with Formoterol Fumarate
• Common adverse events associated with Budesonide

Dosage

• Recommended maintenance dose for adults and adolescents
• Recommended maintenance dose for children
• Alternative dosage regimens for the treatment of asthma with Budesonide and Formoterol combination
• Maximum daily maintenance dose for COPD

Pregnancy & Lactation

• No clinical data on exposed pregnancies
• Data from embryo-foetal development study in the rat
• Absence of evidence for additional effects from the combination
• Excretion of Budesonide in breast milk
• Potential passage of Formoterol into human breast milk

Precautions & Warnings

• Caution in patients with specific medical conditions
• Risk of paradoxical bronchospasm

Use in Special Populations

• Regular monitoring of children's height during prolonged treatment with inhaled corticosteroids

Overdose Effects

• Typical effects of overdose of Formoterol
• Expected effects of chronic excessive doses of Budesonide

Storage Conditions

• Inhalation capsules must not be swallowed
• Keep away from light and wet place
• Storage at or below 25°C temperature

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