Ventolin Salbutamol Sulfate Inhalation Solution

Brand Name: 万托林®(Ventolin®)
Generic Name: Salbutamol Sulfate
Strength: 5 mg/mL, total 100 mg salbutamol per 20 mL bottle, 1 bottle per box
Manufacturer: GlaxoSmithKline Australia Pty Ltd
Marketing Authorization Holder: GlaxoSmithKline Trading Co., Ltd.
Approval Date in China: 2016
Registration Number: 国药准字H20160660
Storage: Store below 25°C, protected from light; do not freeze; keep out of reach of children, follow full storage guidance in package insert

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1. Indications and Usage
Bronchospasm: Treatment of acute bronchospasm in patients with reversible obstructive airway disease.
Prevention: Prevention of exercise-induced bronchospasm.
2. Dosage and Administration
Administration Route: Shall be administered only by inhalation via a nebulizer under medical guidance. It must not be injected or swallowed.
Adults: The usual dose is 2.5 mg to 5 mg, taken up to four times daily. In some cases, adult patients may require higher doses up to 10 mg.
Children: For patients under 12 years, the minimum starting dose is 2.5 mg, which may be increased to 5.0 mg if necessary.
Frequency: Prefer intermittent dosing to control the administration dose; continuous infusion may lead to uncontrolled dosing.
3. Mechanism of Action
β2-Receptor Agonism: Salbutamol is a selective β2-adrenergic receptor agonist.
Bronchodilation: It activates adenylyl cyclase, increasing intracellular cyclic AMP, which relaxes bronchial smooth muscle and relieves bronchospasm.
4. Safety and Warnings
Cardiovascular Effects: May cause palpitations, tachycardia, and arrhythmias. Use with caution in patients with cardiovascular disorders.
Hypokalemia: β2-agonist therapy has the potential to cause significant hypokalemia, especially when combined with xanthine derivatives or corticosteroids.
Paradoxical Bronchospasm: May cause paradoxical bronchospasm; if this occurs, the drug must be discontinued immediately.
Overdose: Overuse may lead to marked tachycardia, tremor, and metabolic effects including hypokalemia and lactic acidosis.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Tremor, headache, tachycardia, palpitations, and muscle cramps.
Rare Adverse Reactions: Hypokalemia, lactic acidosis, and hypersensitivity reactions (including angioedema and urticaria).
Clinical Research: Clinical trials have demonstrated rapid onset of action (within 5 minutes) and duration of effect lasting 4 to 6 hours.
6. Drug Interactions
Beta-Blockers: Non-selective beta-blockers (e.g., propranolol) should generally not be used concurrently.
Xanthine Derivatives/Corticosteroids: Concomitant use may increase the risk of hypokalemia.
MAOIs/Tricyclic Antidepressants: May potentiate the cardiovascular effects of salbutamol.
7. Pharmaceutical Information
Active Ingredient: Salbutamol Sulfate.
Appearance: Colorless or almost colorless clear solution.
Storage: Store at controlled room temperature, protected from light and moisture.

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