Salbutamol sulfate aerosol

Salbutamol is a selective beta 2-adrenergic receptor agonist. At therapeutic doses, it can treat reversible airway obstruction disease. It takes effect quickly within 5 minutes and the effect lasts for 4 to 6 hours. It mainly acts on the beta 2-adrenergic receptors located on bronchial smooth muscle.

The main ingredient of this product: Salbutamol, chemical name: 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol.

This product is mainly used to relieve bronchospasm in patients with asthma or chronic obstructive pulmonary disease (reversible airway obstructive disease), and to acutely prevent exercise-induced asthma or bronchospasm induced by other allergens.

This product can only be used by oral inhalation. Patients who have difficulty in synchronizing inhalation and inhalation can use a spacer. Adults: Relieve acute asthma attacks, including bronchospasm: 1 press of 100 micrograms is the minimum starting dose, which can be increased to 2 presses if necessary. For the prevention of symptoms caused by allergens or exercise: Administer 10-15 minutes before exercise or contact with allergens. For long-term treatment, the maximum dose is 2 presses 4 times a day. Medication for the elderly: The starting dose for elderly patients should be lower than the recommended dose for adult patients. If sufficient bronchodilator effect is not achieved, the dose should be gradually increased. Children: The recommended dose for the relief of acute asthma attacks, including bronchospasm or before contact with allergens and before exercise is 1 press, which can be increased to 2 presses if necessary. For long-term treatment, the maximum dose is 2 presses 4 times a day. This product can be administered to infants and children under 5 years old with the help of Babyhaler. Patients with impaired liver function: About 60% of oral salbutamol is metabolized into inactive forms (including not only tablets and syrups, but also about 90% of inhaled doses). Impaired liver function can cause accumulation of unchanged salbutamol. Patients with impaired renal function: About 60-70% of inhaled or intravenously injected salbutamol is excreted in the urine as the original form. Patients with impaired renal function need to reduce the dose to prevent excessive or prolonged drug effects. Use this product as needed, and the dose should not exceed 8 presses in any 24 hours. If the frequency of administration or the dose needs to be increased suddenly to relieve symptoms, it indicates that the patient's condition has worsened or the asthma is not properly controlled. Excessive medication can cause adverse reactions, so the dose or frequency of medication can only be increased under the guidance of a doctor. (See [Precautions]).

Adverse events are listed according to the system, organ and incidence. The incidence is defined as: very common (ge; 1/10), common (ge; 1/100 and 1/1O), uncommon (ge; 1/1000 and 1/100), rare (ge; 1/10000 and 1/1000), very rare (1/10000) including case reports. Very common and common are usually obtained from clinical trial data. Rare and very rare adverse events are usually spontaneous data. 1. Immune system Very rare: Allergic reactions including angioedema, urticaria, bronchospasm, hypotension and collapse 2. Metabolism and nutrition Rare: Hypokalemia Treatment with beta;2-receptor agonists has the potential to cause severe hypokalemia. 3. Nervous system Common: Tremor, headache Very rare: Hyperactivity 4. Cardiovascular system Common: Tachycardia Uncommon: Palpitations Very rare: Arrhythmias, including atrial fibrillation, supraventricular tachycardia and premature beats When the drug is used in excess of the recommended dose, or in patients who are susceptible to beta;-adrenergic agonists, dilation of peripheral arterioles may cause a slight decrease in blood pressure; this may cause a compensatory increase in cardiac output, and some patients may develop tachycardia. Rare: Peripheral vasodilation 5. Respiratory system, chest, mediastinum Very rare: Abnormal bronchospasm As with other inhaled treatments, abnormal bronchospasm may occur after medication and is immediately accompanied by an increase in wheezing. Immediately switch to alternative treatment or treat with other rapid-acting inhaled bronchodilators, and immediately stop using this product, evaluate the patient, and, if necessary, develop other alternative treatment plans. 6. Gastrointestinal reactions Uncommon: Oropharyngeal irritation Muscles. Bones and connective tissue Uncommon: Muscle spasms 7. This product may cause mild tremors in the patient's skeletal muscles. The hands are the most obvious affected area, and some patients will feel tense. This effect is dose-related and is caused by a direct effect on skeletal muscle rather than a direct excitation of the central nervous system. Note: The occurrence and severity of adverse reactions depend on the dose and route of administration. Inhaled salbutamol does not cause dysuria because its therapeutic dose does not produce the alpha-adrenergic receptor stimulant effect of other sympathomimetic drugs (such as ephedrine).

It is contraindicated for those who have a history of allergy to any ingredient in this product.

Precautions for children: See [Usage and Dosage]. Precautions for pregnancy and lactation: Pregnant women should consider using this product unless the expected benefits to the mother outweigh any possible harm to the fetus. Like most other drugs, there are only a few published data proving that salbutamol is safe for human use in early pregnancy. Animal studies have shown that very high doses can cause certain harm to the fetus. Large-scale animal reproductive toxicity experiments have shown that non-freon propellant HFA134a has no harm to fetal development. Teratogenicity studies of this product have shown that this product has no teratogenic effects at comparable high doses of beta;2-receptor agonists, but there is no test data on the use of this product during human pregnancy and lactation. Because salbutamol may be secreted into breast milk, it is not recommended for use by breastfeeding women unless the expected benefits to the mother outweigh the potential risks to the newborn. It is not clear whether salbutamol is harmful to newborns, and the pros and cons should be weighed before use. Intravenous salbutamol or occasional salbutamol tablets can be used to treat uncomplicated premature labor, but should not be used for threatened abortion within six months of pregnancy. Intravenous salbutamol is contraindicated for antepartum bleeding, as uterine relaxation can cause more bleeding. Similarly, the use of salbutamol to treat asthma in pregnant women also poses a risk of uterine bleeding. There have been reports of spontaneous abortions and heavy uterine bleeding after the use of salbutamol. Special attention should be paid to women with diabetes during pregnancy. Elderly precautions: See [Usage and Dosage].

Salbutamol should not be used in combination with non-selective beta-blockers such as propranolol. When used in combination with other sympathomimetics, caution should be exercised to prevent excessive sympathomimetic effects. Animal studies have shown that large amounts of salbutamol can interact with imipramine, chlordiazepoxide, and chlorpromazine, but the significance of this in humans has yet to be established.

Store at 30°C (86°F) away from light, freezing and direct sunlight. As with most other aerosol inhalers, freezing may reduce the efficacy of the drug. Whether empty or not, the can should not be broken, punctured or burned.

100 micrograms/press

24 months.