How Safe Is Albuterol for Children?

Salbutamol sulfate solution for inhalation, the indication is suitable for the routine treatment of chronic bronchospasm and the treatment of severe acute asthma attacks that are ineffective for traditional treatment methods.

Salbutamol sulfate solution for inhalation, the indication is suitable for the routine treatment of chronic bronchospasm and the treatment of severe acute asthma attacks that are ineffective for traditional treatment methods.

Drug Name

Salbutamol Sulfate Solution for Inhalation

Drug type

Prescription medicines, essential medicines, medicines for medical workers' injuries

Special medicine

Doping

Use classification

Uterine smooth muscle inhibitor

Ingredients of Salbutamol Sulfate Solution for Inhalation

The main ingredient of this product is: salbutamol, whose chemical name is 1- (4-hydroxy-3-hydroxymethylphenyl) -2- (tert-butylamino) ethanol. Its structural formula is:

Molecular formula: C ₁₃ H ₂₁ NO ₃
Molecular weight: 239.31

Properties of Salbutamol Sulfate Solution for Inhalation

This product is a colorless to pale yellow solution with a pH of 3.5. Each milliliter (ml) contains 5 milligrams (mg) of salbutamol (in the form of salbutamol sulfate).

Indications for Salbutamol Sulfate Solution for Inhalation

This product is suitable for the routine treatment of chronic bronchospasm and the treatment of severe acute asthma attacks that are ineffective for traditional treatment methods.

Specification for Salbutamol Sulfate Solution for Inhalation

100mg / 20ml, 50mg / 10ml

Dosage of salbutamol sulfate for inhalation

This product should be used through a sprayer and under the guidance of a doctor. It should not be injected or taken by mouth. Patients can be treated with intermittent or continuous therapy. Salbutamol lasts for 4 to 6 hours in most patients.
Calculate the dose in milliliters (ml) when taking the medication.
1. Intermittent therapy for adults:
Dilute 0.5ml of this product (containing 2.5mg albuterol) with physiological saline for injection to 2ml. 1ml of this product can also be diluted to 2.5ml. The diluted solution is inhaled by the patient through a suitable driven sprayer until no more aerosol is generated. If the sprayer and driver device are properly matched, the spray can be maintained for 10 minutes.
This product can be used intermittently without dilution. To this end, 2.0ml of this product (containing 10.0mg albuterol) can be placed in a nebulizer and the patient can inhale the atomized solution until the bronchi are dilated, which usually takes 3-5 minutes.
Some adult patients may require higher doses of salbutamol, up to 10 mg. In this case, the aerosol generated by the undiluted solution should be continuously inhaled until the aerosol stops producing.
child:
The minimum starting dose for children under 12 years is to dilute 0.5 ml of aerosolized solution (containing 2.5 mg salbutamol) to 2 to 2.5 ml with saline for injection. The medication is the same as for adults. However, some children may require up to 5.0 mg of salbutamol. Intermittent therapy can be repeated four times a day.
2. Continuous therapy Dilute this product with saline for injection to 50-100 g salbutamol per ml (1-2 ml of the drug solution is diluted to 100 ml). The diluted solution is treated with an aerosol in the form of an aerosol, and the commonly used rate is 1-2 mg per hour.
There are no data on the clinical efficacy of nebulized albuterol in children under 18 months of age. Since transient hypoxemia may occur, supplemental oxygen therapy should be considered.
How to use This product is for inhalation only and is equipped with a suitable nebulizer.
The aerosolized solution can be inhaled through a mask, T-shaped device or through a tracheal tube. Intermittent positive pressure ventilation can be used, but it is only necessary in rare cases. When there is a risk of hypoxia due to insufficient lung ventilation, oxygen should be added to the inhaled air.
Because the airflow produced by many nebulizers is continuous, the atomized medicine is likely to be released into the surrounding environment. Therefore, this product should be used in a well-ventilated room, especially when several patients use a nebulizer at the same time in a hospital.

Adverse reactions of salbutamol sulfate solution for inhalation

Adverse events are listed below according to the system, organ type and incidence. Incidence rate is defined as: very common (1 / 10), common (1 / 100 and <1/10), rare (1 / 10000 and <1/1000), very rare (<1/10000) including cases Report. Very rare and common adverse events are usually obtained from clinical trial data. Rare and very rare adverse events are usually obtained from spontaneous data.
Very rare allergic reactions to the immune system including angioedema, urticaria, bronchospasm, hypotension and hypometabolism, and nutritional rare hypokalemia. The treatment of ₂ -agonists has the potential to cause severe hypokalemia Sex.
Very rare lactic acidosis Lactic acidosis is very rarely reported in patients receiving intravenous and nebulized salbutamol for acute exacerbation of asthma.
Common nervous system tremors, headaches are very rare, hyperactive cardiac system is common, tachycardia is not common, arrhythmia is very rare, including atrial fibrillation, supraventricular tachycardia, and premature beats. Blood system is rare. Peripheral vasodilators, respiratory system, chest, mediastinum are very rare. Bronchial spasm, like other inhalation therapies, may also cause abnormal bronchospasm with immediate exacerbation of wheezing. When this occurs, another method of administration or another rapid-acting bronchodilator should be inhaled immediately, and the use of this preparation should be stopped immediately to evaluate the patient. The treatment should be changed if necessary.
The gastrointestinal tract is not common. The mouth and throat stimulate muscles, bones and connective tissues. The muscle spasms are not common. This product causes slight tremors of the epiphyseal muscles of patients. Usually, the hands are the most affected part: this effect is dose-related, Is a common feature of all -adrenergic receptor activators:
As with other ₂ -excitations, there are very few reports of ADHD in children.

Inhalation of Salbutamol Sulfate Solution

Those with a history of allergies to any of the ingredients in this product are prohibited.
Threatened abortion.

Precautions for Salbutamol Sulfate Solution for Inhalation

Asthma control should be routinely performed in accordance with the principle of step treatment, and patients' clinical response should be monitored through clinical and pulmonary function tests. Patients with severe or unstable asthma should not be treated solely or primarily with bronchodilators.
Severe asthma requires regular medical assessments, including pulmonary function tests, because patients are at risk of severe or even fatal attacks. Physicians should consider using the maximum recommended dose of inhaled steroids and / or administering oral steroid therapy to these patients.
Patients who use this product at home must be reminded to pay attention to the following conditions: If the symptoms are not relieved or the duration of the effect is shortened after the medication, do not increase the dose or increase the number of medications by yourself, because excessive medication can cause adverse reactions. Only under the guidance of a doctor can increase the dosage and frequency of medication.
If you need to increase the use of short-acting bronchodilators, especially short-acting inhaled ₂ -receptor agonists, to alleviate symptoms, it indicates that asthma is worsening. When sudden and progressive deterioration in asthma control is potentially life-threatening, the use or increase of hormone use should be considered. Patients considered to be at risk should monitor their daily peak flow. In this case, the patient should be re-evaluated and consideration should be given to adding anti-inflammatory therapy to the patient (eg, inhalation of a larger dose of corticosteroids or oral administration of a course of corticosteroids). Severely worsening asthma must be treated in a routine manner.
Patients receiving this product may also need to receive other short-acting bronchodilators to relieve symptoms:
Care should be taken in patients taking large doses of sympathomimetic drugs at the same time.
It should be used with caution in patients with thyroidism.
This product should be inhaled from the mouth through a respirator or sprayer and used under the guidance of a doctor. Not for injection or oral administration.
Non-isotonic or non-neutral solutions or solutions containing benzalkonium can cause abnormal bronchospasm in very few patients.
The use of ₂ -receptor agonists (mainly for parenteral and nebulized administration) has the potential to cause severe hypokalemia. People with severe acute asthma need to be particularly alert because taking xanthine derivatives, corticosteroids, diuretics, and hypoxia at the same time increases the likelihood of hypokalemia. In these cases, it is recommended that the patient's blood potassium level be monitored.
Like other beta-adrenergic agonists, salbutamol can cause reversible metabolic changes, such as increased blood glucose levels. Diabetic patients may be unable to compensate for this increase in blood glucose, and reports of developing ketoacidosis have been reported. Concomitant use of corticosteroids can exacerbate these effects.
Angle closure glaucoma has been reported in a small number of patients when receiving both aerosolized albuterol and ipratropium. Therefore, caution should be exercised when combining aerosolized albuterol with atomized anticholinergics. Patients should be instructed on the proper use of the drug and should be told not to get the liquid or nebulized solution in their eyes.
Reports of lactic acidosis associated with high-dose short-acting -receptor agonist intravenous and nebulization therapy are very rare, mainly in patients with acutely exacerbated asthma undergoing treatment (see [Adverse Reactions]). Elevated lactate levels can cause dyspnea and compensatory excessive courage, and these manifestations can be mistaken for treatment failure and do not appropriately enhance treatment with short-acting beta-agonists. Therefore, it is recommended to monitor patients on the spot for elevated serum lactic acid levels and associated metabolic acidosis.
No impact on the ability to drive and operate machines has been reported.
Use with caution by athletes.

Salbutamol sulfate solution for inhalation medication for pregnant and lactating women

Pregnancy: Use only if the expected benefit to the pregnant woman after the medication is greater than the risk to the fetus. As with most other drugs, research on the safety of salbutamol in humans during early pregnancy is very rare; however, studies in animals have shown that it can cause some harm to the fetus when doses are very high.
Breastfeeding: Since salbutamol may be secreted from milk, mothers who are breastfeeding should use it with caution. It is unclear whether salbutamol is harmful to newborns, and the pros and cons should be weighed before use. It is not recommended for breastfeeding women unless the expected benefit to the mother is greater than the potential danger to the newborn.

Salbutamol sulfate solution for inhalation for children

See [Dosage and Administration]

Salbutamol sulfate solution for inhalation

Same adult

Drug Interactions with Salbutamol Sulfate Solution for Inhalation

Under normal circumstances, this product should not be combined with non-selective -blockers, such as propranolol.

Salbutamol sulfate solution for inhalation drug overdose

The most common signs and symptoms of overdose of this product are events mediated by pharmacological effects of excessive -agonists. (See [Precautions] and [Adverse Reactions])
Overdose of salbutamol can cause hypokalemia, and blood potassium levels should be monitored.
For patients with cardiac symptoms (such as tachycardia, palpitations), consideration should be given to discontinuing the treatment of this product and giving appropriate symptomatic treatment, such as cardiac-selective beta-blockers. -blockers should be used with caution in patients with a history of bronchospasm.
With continuous inhalation of Ventolin® nebulizing solution, any signs of overdose can be relieved by stopping the medication.

Pharmacology and Toxicology of Salbutamol Sulfate Solution for Inhalation

Salbutamol is a selective ₂ -adrenergic receptor agonist, a fast-acting (within 5 minutes), short-acting (4 to 6 hours) bronchodilator for reversible airway obstruction. At the therapeutic dose, it acts on the ₂ -adrenergic receptor located on the bronchial smooth muscle, and because of its rapid action, it is particularly suitable for the treatment and prevention of acute attacks of asthma.

Pharmacokinetics of Salbutamol Sulfate Solution for Inhalation

The half-life of intravenous salbutamol is 4-6 hours, partially cleared by the kidneys, and partially metabolized to inactive 4'-O-sulfate (phenol sulfate), which is also mainly excreted from the urine. A small part is eliminated from the feces. Whether administered intravenously, orally or by inhalation, most drugs are excreted within 72 hours. The rate of salbutamol binding to plasma proteins was 10%.
After inhaling salbutamol, 10-20% of the drug reaches the lower respiratory tract, and the remaining part remains in the drug delivery system or is deposited in the throat and swallowed from then on. Drugs deposited in the airways are absorbed and circulated by the lung tissue, but are not metabolized in the lung. When it reaches the circulatory system, it can be metabolized by the liver and excreted into the urine in its original form or in the form of phenol sulfate.
After the swallowed drug is absorbed by the intestine, it is metabolized into phenol sulfate by the first pass effect of the liver, and all the original drugs and the combined metabolites are eliminated from the urine.

Storage of salbutamol sulfate for inhalation

Store below 25 ° C in the dark. Discard all remaining liquids one month after opening.

Packaging for salbutamol sulfate for inhalation

(1) 20ml glass ampoule with stopper, 1 bottle / box, each bottle contains 100mg salbutamol
(2) 10ml glass ampule with stopper, 1 bottle / box, each bottle contains 50mg salbutamol

Expiration Date of Salbutamol Sulfate Solution for Inhalation

36 months

Standard for Salbutamol Sulfate Solution for Inhalation

Import drug registration standard: JX20030229 ^[1]