Aroflo 50 mcg+500 mcg (Inhalation Capsule)

Indications

• Regular treatment of asthma
• Combination product - long-acting β2-agonist and inhaled corticosteroid
• Asthma not adequately controlled with inhaled corticosteroids
• Regular treatment for patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist

Pharmacology

• Selective, long-acting beta-2 agonist
• Corticosteroid with mainly glucocorticoid activity
• Topical effect on the lungs without systematic effects at usual dose
• Selective long-acting (12-hour) beta-2-adrenoceptor agonist with long side chain

Dosage

• Different dosages for Adults, Adolescents (12 years and older) and Children (4-12 years)
• Inhalation capsule for asthma and COPD
• Maxhaler dosage for Asthma and COPD
• Instructions for maximum recommended dosage

Administration

• Instructions for using Inhaler
• Importance of correct and regular use for preventing or lessening severity of asthma attacks
• Guidelines for cleaning Inhaler

Interaction

• Avoidance of both non-selective and selective β-blockers in patients with asthma
• Care needed when co-administering known strong CYP3A4 inhibitors

Contraindications

• Hypersensitivity to salmeterol xinafoate, fluticasone propionate or any of the excipients
• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required

Side Effects

• Types and severity of adverse reactions associated with Salmeterol
• Adverse events associated with Fluticasone Propionate
• Incidence of adverse events following concurrent administration of the two compounds
• Relief of hoarseness and candidiasis by gargling with water after use of Inhaler

Pregnancy & Lactation

• Consideration of administration during pregnancy and lactation based on expected benefit to the mother and possible risk to the fetus or child
• Insufficient human experience of use in pregnancy and lactation
• Fetal effects expected at excessive systemic exposure levels
• Possible low concentrations in human breast milk

Precautions & Warnings

• Avoid initiation during an exacerbation or in case of unstable or acutely deteriorating asthma
• Not for relief of acute symptoms
• Paradoxical bronchospasm and its immediate treatment
• Increased reporting of pneumonia in patients with COPD receiving salmeterol/fluticasone inhaler
• Possible systemic effects of inhaled corticosteroid at high doses for long periods

Use in Special Populations

• Reduction in growth velocity when administered to pediatric patients
• Unknown long-term effects on final adult height

Overdose Effects

• Signs and symptoms of Salmeterol overdose
• Signs of overdosage may include hypokalemia and hyperglycemia
• Temporary suppression of adrenal function with excess inhalation of Fluticasone Propionate

Therapeutic Class

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

Storage Conditions

• Do not puncture, break or incinerate the pressurized canister
• Avoid storage in direct sunlight or heat
• Keep away from eyes and children

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