Aroflo (25 mcg+125 mcg)/puff (Inhaler)

Indications

• Regular treatment of asthma
• Combination product for inadequately controlled patients
• Combination product for adequately controlled patients

Pharmacology

• Selective long-acting beta-2 agonist
• Corticosteroid with mainly glucocorticoid activity
• Protects against symptoms
• Improves lung function
• Prevents exacerbations

Dosage

• Dosage for adults and adolescents
• Dosage for children (4-12 years)
• Dosage for pediatric and adolescent patients
• Maxhaler dosage for adults and adolescents
• Maxhaler dosage for children
• Special patient group dosage

Administration

• Instructions for using Inhaler
• Cleaning instructions for Inhaler

Interaction

• Avoidance of non-selective and selective β-blockers
• Careful co-administration with strong CYP3A4 inhibitors

Contraindications

• Hypersensitivity to active ingredients or excipients
• Primary treatment of acute episodes of asthma

Side Effects

• Pharmacological side effects of beta-2-agonist treatment
• Adverse events associated with Salmeterol or Fluticasone Propionate

Pregnancy & Lactation

• Consideration during pregnancy and lactation
• Insufficient experience in human pregnancy and lactation

Precautions & Warnings

• Not to be initiated during exacerbation
• Serious asthma-related adverse events
• Paradoxical Bronchospasm
• Increased reporting of pneumonia in COPD patients
• Systemic effects of inhaled corticosteroids

Use in Special Populations

• Reduction in growth velocity in paediatric patients

Overdose Effects

• Signs and symptoms of Salmeterol overdose
• Signs and symptoms of Fluticasone Propionate overdose

Therapeutic Class

• Long-acting selective β-adrenoceptor stimulants
• Respiratory corticosteroids

Storage Conditions

• Pressurised canister precautions
• Storage temperature and sunlight exposure

Dimensions

Not available

Color Options

Not available

Material

Not available

Design Elements

Not available

Technical Specifications

Not available

Usability Features

Not available

Delivery Method

Inhalation

Age Group

• Adults
• Adolescents
• Children

Max Recommended Dosage

Salmeterol 50 µg & Fluticasone 500 µg twice daily

Patient Education

• Correct use of Inhaler
• Importance of regular use of Inhaler
• Cap and mouthpiece cleaning instructions

Adverse Reactions

Tremor, palpitations, headache, cardiac arrhythmia, arthralgia, hypersensitivity reactions, oropharyngeal irritation, muscle cramps, hoarseness, candidiasis, cutaneous hypersensitivity reactions, facial and oropharyngeal edema

Reproductive Toxicity

Revealed fetal effects at excessive systemic exposure levels

Animal Studies

Studies in lactating animals

Asthma Attack Management

Availability of fast and short-acting bronchodilator

Bronchospasm Treatment

Immediate treatment with a fast and short-acting inhaled bronchodilator

Adrenal Function Monitoring

Necessary in cases of chronic Fluticasone Propionate overdose

Mechanism of Action

• Long-acting beta-2-adrenoceptor agonist effect
• Topical glucocorticoid anti-inflammatory action within the lungs

Storage Precautions

• Avoid puncturing, breaking, or incinerating the canister
• Avoid storage in direct sunlight or heat

Patient Group Consideration

• Special dose considerations for pediatric and adolescent patients

Drug Class

• Long-acting selective β-adrenoceptor stimulants
• Respiratory corticosteroids

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