Fuxian Levosalbutamol Hydrochloride Nebuliser Solution

1. Indications and Usage
Bronchospasm: Treatment or prevention of bronchospasm in adult and adolescent patients (12 years of age and older) with reversible obstructive airway disease.
2. Dosage and Administration
Route of Administration: For Inhalation (Nebulization) ONLY.
Recommended Dosage:
Adults and Adolescents (≥12 years): The recommended initial dose is one vial (typically 0.63 mg) three times daily, with intervals of 6 to 8 hours between administrations.
Severe Asthma: For patients with severe asthma or those who do not respond adequately to the 0.63 mg dose, the dose may be increased to two vials (1.25 mg) three times daily. Systemic adverse effects should be closely monitored at higher doses.
Critical Administration Instructions:
Equipment: Use a standard nebulizer (with mask or mouthpiece) connected to an air compressor. Do not exceed the recommended dosage.
Hygiene: Open the vial immediately before use. Do not mix with other medications in the same nebulizer.
Missed Dose: If a scheduled dose is missed, take it as soon as remembered. Resume the regular schedule the next day; do not double the dose.
3. Mechanism of Action
β2-Agonism: Levosalbutamol is a selective β2-adrenergic receptor agonist.
Bronchodilation: It binds to and activates β2-receptors on airway smooth muscle cells, leading to increased intracellular cyclic AMP (cAMP).
Muscle Relaxation: This cascade results in the relaxation of bronchial smooth muscle, thereby reversing acute bronchospasm and improving airflow.
4. Safety and Warnings
Hypersensitivity: Contraindicated in patients with a history of hypersensitivity to levosalbutamol, racemic salbutamol, or any excipients.
Paradoxical Bronchospasm: May occur; if observed, the drug should be discontinued immediately.
Cardiovascular Effects: May cause clinically significant cardiovascular effects (e.g., increased heart rate, palpitations); caution is required in patients with cardiovascular disorders.
Hypokalemia: Large doses may cause a transient decrease in serum potassium levels.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Tremor, headache, tachycardia, palpitations, muscle cramps, and nervousness.
Other Adverse Reactions: Dizziness, nausea, throat irritation, dry mouth, and diarrhea.
Clinical Research Highlights: Levosalbutamol (the R-enantiomer of salbutamol) provides bronchodilatory efficacy comparable to racemic salbutamol, with a lower incidence of tremor and other systemic β2-adrenergic adverse effects.
6. Drug Interactions
Other β2-Agonists: Concomitant use with other short-acting sympathomimetics may increase adverse cardiovascular effects and should be avoided.
β-Blockers: May antagonize the therapeutic effect of levosalbutamol; non-selective β-blockers may precipitate severe bronchospasm.
Diuretics: Concomitant use with non-potassium-sparing diuretics (e.g., hydrochlorothiazide) may potentiate hypokalemia.
MAOIs or Tricyclic Antidepressants: May enhance the cardiovascular effects of levosalbutamol and should be used with extreme caution.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Levosalbutamol Hydrochloride. Excipients: Sodium chloride, disodium edetate, sulfuric acid, water for injection.
Appearance: Clear, colorless solution.
Packaging: Low-density polyethylene vials, sealed in aluminum/PE composite foil pouches (typically 3 ml/vial).
Storage: Store below 25°C, protected from light. Once the pouch is opened, the vial should be used immediately.