What Factors Affect a Sufficient Albuterol Dose?
Salbutamol sulfate inhalation aerosol, the indication is mainly used to relieve bronchospasm in patients with asthma or chronic obstructive pulmonary disease (reversible airway obstruction disease), and acute prevention of exercise-induced asthma, or other allergen-induced Bronchospasm.
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- Drug Name
- Salbutamol Sulfate Inhalation Aerosol
- Drug type
- prescription
- Salbutamol sulfate inhalation aerosol, the indication is mainly used to relieve bronchospasm in patients with asthma or chronic obstructive pulmonary disease (reversible airway obstruction disease), and acute prevention of exercise-induced asthma or other allergen Bronchospasm.
Salbutamol Sulfate Inhalation Aerosol Ingredients
- The main ingredient of this product: Salbutamol Chemical name: 1- (4-hydroxy-3-hydroxymethylphenyl) -2- (tert-butylamino) ethanol Molecular formula: C 13 H 21 NO 3
Molecular weight: 239.31
This product contains HFC134a, a Freon-free propellant
Characteristics of Salbutamol Sulfate Inhalation Aerosol
- This product is an aerosol administered by a quantitative compression device, and its content is a white to off-white suspension.
Indications of Salbutamol Sulfate Inhalation Aerosol
- This product is mainly used to relieve bronchospasm in patients with asthma or chronic obstructive pulmonary disease (reversible airway obstruction disease), and acute prevention of exercise-induced asthma, or other allergen-induced bronchospasm.
Specifications of Salbutamol Sulfate Inhalation Aerosol
- 100ug / .
Salbutamol Sulfate Inhalation Aerosol
- This product can only be used by inhalation through the mouth. Patients who have difficulty in inhaling and inhaling drugs simultaneously can use the mist reservoir.
[u] Adult: [/ u]
Relieves acute exacerbations of asthma, including bronchospasm: Use a minimum starting dose of 1 to 100 micrograms and increase to 2 if necessary.
For the prevention of allergens or symptoms caused by exercise: dosing before exercise or 10-15 minutes before exposure to allergens. For long-term treatment, the maximum dose is 2 times per day, 4 times daily.
[u] Medication for the elderly: [/ u]
The starting dose for elderly patients should be lower than the recommended adult patient dose. If sufficient bronchiectasis is not achieved, the dose should be gradually increased.
[u] Children: [/ u]
The recommended dose for relieving an acute attack of asthma, including bronchospasm or before allergen exposure and before exercise, is 1 and can be increased to 2 if necessary.
Long-term treatment-the maximum dose is 4 times daily, 2 times each time.
This product can be administered to infants and young children under 5 years of age with the help of Babyhaler®.
[u] Patients with impaired liver function: [/ u]
About 60% of oral salbutamol is metabolized into inactive forms (not only tablets and syrups, but also about 90% of inhaled doses), and impairment of liver function can cause accumulation of the original salbutamol.
[u] Patients with impaired renal function: [/ u]
About 60-70% of the inhaled or intravenous salbutamol is excreted in the urine as a prototype. Patients with impaired renal function need to reduce the dose to prevent excessive or prolonged drug effects.
Use this product as needed, and the dosage in any 24 hours should not exceed 8%. If you need to increase the frequency of administration or abruptly increase the amount of medication to relieve symptoms, it indicates that the patient's condition is worsening or the asthma is not properly controlled. Excessive drugs can cause adverse reactions, so only increase the dose or the number of medications under the guidance of a doctor. (See [Precautions]).
Adverse effects of salbutamol sulfate inhalation aerosol
- Adverse events are listed according to the system, organ and incidence. Incidence is defined as: very rare (1 / 10), common (1 / 100 and <1/10), uncommon (1 / 1000 and <1/100), rare (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.
Immune system Very rare allergic reactions include angioedema, urticaria, bronchospasm, hypotension and depletion <br Metabolism and nutrition < br Treatment of rare hypokalemia 2-receptor agonists It has the potential to cause severe hypokalemia.
Nervous system < br Common tremors, headaches are very rare and hyperthyroidism <br Cardiovascular system < br Common tachycardia is not common Recommended doses of the drug, or for patients who are susceptible to beta-adrenergic agonists, the dilatation of the peripheral arterioles can cause a slight decrease in blood pressure; this may cause an increase in compensatory cardiac output, and some patients may experience cardiac events speed.
Rarely peripheral vasodilation <br Respiratory system, chest, mediastinum < br It is very rare Abnormal bronchospasm. Like other inhalation treatments, abnormal bronchospasm may occur after administration and immediately increase with wheezing. Switch to alternative treatment or other fast-acting inhaled bronchodilators immediately, discontinue use of this product, evaluate patients, and develop other alternative treatment options if necessary.
Gastrointestinal reactions < br Uncommon: Oropharyngeal irritation <br Muscles , bones, and connective tissues < br Uncommon: Muscle spasms This product may cause slight tremor in patients' skeletal muscles. Both hands are the most visible areas affected, and some patients may feel nervous. This effect is dose-dependent and is a direct effect of skeletal muscle rather than a direct excitatory effect of the central nervous system.
Note: The occurrence and severity of adverse reactions depend on the dose and route of administration. Inhalation of salbutamol will not cause dysuria, because its therapeutic dose will not produce alpha-adrenergic effects of other sympathomimetic drugs (such as ephedrine). Body agonism.
Salbutamol sulfate inhalation aerosol contraindications
- Those with a history of allergies to any of the ingredients in this product are prohibited.
Precautions for Salbutamol Sulfate Inhalation Aerosol
- 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. Bronchodilators should not be used as the sole or primary treatment for patients with severe asthma and unstable asthma. When sudden and progressive deterioration in asthma control indicates a potential for life threatening, the use or increase of hormone dosage should be considered. Patients considered to be at risk should monitor their daily peak flow rate. Physicians should consider treating these patients with the maximum recommended dose of inhaled corticosteroids and / or oral corticosteroids. If larger doses of short-acting bronchodilators are needed, especially short-acting inhaled beta 2 -agonists to relieve symptoms, this indicates worsening asthma control. Patients should be advised to consult a doctor if they find that the use of short-acting bronchodilators has decreased efficacy or that higher doses than usual should be used. In this case, the patient's condition should be re-evaluated and consideration should be given to strengthening anti-inflammatory treatments (such as increasing the dose of inhaled corticosteroids or taking a course of oral corticosteroids). Routine treatment of severely worsening asthma must be taken. If the patient is considered to be in a dangerous condition, the daily peak morning flow rate should be monitored instead.
Animal experiments have shown that some sympathomimetic drugs cause a cardiac response at high doses. Therefore, the possibility of myocardial damage caused by long-term use of such drugs can not be ruled out.
Attention should be paid to patients receiving high-dose albuterol or other sympathomimetic drugs, as well as patients with hypertension, hyperthyroidism, myocardial insufficiency, or diabetes.
The propellant contained in the salbutamol sulfate aerosol is a fluon-free formulation of Freon. Animal experiments have shown that the propellant has no obvious pharmacological effects, and its sensitization effect on the heart is still weaker than that of chloroform (even at very high exposure concentrations with coma and reduced sensitivity to catecholamines' arrhythmic effects) CFC-11).
Patients with thyrotoxicity should be careful when taking salbutamol.
Excessive use will induce a state of tolerance and lead to worsening of hypoxemia.
Parenteral or nebulized inhalation of 2-receptor agonists has the potential to cause severe hypokalemia. Patients with severe acute asthma need to be particularly vigilant, as taking xanthine derivatives, steroid hormones, diuretics, and hypoxia at the same time will increase the possibility of hypokalemia. In these cases, it is recommended to monitor the patient's blood potassium level.
It should be kept in mind that salbutamol may induce arrhythmias caused by hypokalemia, especially in patients with digitalis after injection of salbutamol.
Guidance should be given to the way the patient inhales the drug, ensuring that the inhalation is synchronized with the inhalation so that the drug reaches the lungs to the greatest extent. Patients should be informed that they may notice that the taste of this product is different from other previously used aerosols when inhaled.
Only under the guidance of a physician can the dosage or frequency of medication be increased. If the symptom relief lasts less than 3 hours at the previous effective dose, the patient is advised to seek the help of a physician to add any other necessary treatment.
No effects on driving and mechanical manipulation have been reported.
Use with caution by athletes.
Salbutamol sulfate inhalation aerosol for pregnant and lactating women
- Pregnant women should consider using this product only when the expected benefits to the mother outweigh any potential harm to the fetus.
As with most other drugs, only a small amount of published information has proven that humans can safely use salbutamol in early pregnancy. Studies on animals have shown that very high doses can cause some harm to the fetus. Large-scale animal reproductive toxicity experiments have shown that HFC134a, a Freon-free propellant, has no damage to fetal development.
Teratogenicity studies of this product have shown that this product has no teratogenic effects at comparable high doses of 2-receptor agonist teratogenic effects, but there is no test data for the use of this product in human pregnancy and lactation.
Because salbutamol may be lactated, it is not recommended for breastfeeding women unless the expected benefit to the mother outweighs the potential danger to the newborn. It is unclear whether salbutamol is harmful to newborns and the advantages and disadvantages should be weighed before use.
Intravenous salbutamol or occasional salbutamol tablets can be used to treat premature birth without comorbidities, but not for threatened abortion within six months of pregnancy. Intravenous salbutamol is contraindicated for prenatal bleeding, and factor uterine relaxation can cause more bleeding. The use of salbutamol in the treatment of asthma in pregnant women also creates a risk of uterine bleeding. Excessive uterine bleeding caused by spontaneous abortion after salbutamol has been reported. Special attention should be paid to women with diabetes during pregnancy.
Salbutamol Sulfate Inhalation Aerosol for Children
- See [Dosage and Administration].
Salbutamol Sulfate Inhalation Aerosol
- See [Dosage and Administration].
Salbutamol Sulfate Inhalation Aerosol Drug Interactions
- In general, salbutamol and non-selective beta-blockers such as propranolol cannot be combined.
When combined with other sympathomimetic drugs, attention should be paid to the occurrence of excessive sympathomimetic effects.
Animal studies have shown that a large amount of salbutamol can interact with imipramine, liming, and chlorpromazine, but its practical significance to humans has yet to be established.
Salbutamol Sulfate Inhalation Aerosol Drug Overdose
- The most common signs and symptoms of overdose of this product are events mediated by transient -agonist pharmacological effects. (See [Precautions] and [Adverse Reactions])
Salbutamol excess can cause hypokalemia, and blood potassium levels should be monitored. For patients with cardiac symptoms (such as tachycardia and palpitations), consideration should be given to discontinuing the treatment of this product and giving appropriate symptomatic treatment, such as heart-selective -blockers, Patients should use beta-blockers with caution.
Signs of salbutamol overdose are significant tachycardia and / or muscle tremor.
It should be noted that for 40 100ug this product contains salbutamol equivalent to 4mg salbutamol tablets.
Pharmacology and Toxicology of Salbutamol Sulfate Inhalation Aerosol
- Pharmacodynamics <br /> Salbutamol is a selective 2 -adrenergic receptor agonist. It cures reversible airway obstruction disease at a therapeutic dose. It takes effect within 5 minutes and the effect lasts 4 to 6 hours. It mainly acts on 2 -adrenergic receptors located on the bronchial smooth muscle.
Preclinical safety < br Similar to other selective 2-agonists, subcutaneous injection of salbutamol in mice shows teratogenicity. In a reproductive toxicity test, cleft palate occurred in 9.3% of fetuses at a dose of 2.5 mg / kg. In rat tests, rats were orally administered with 0.5, 2.32, 10.75, and 50 mg / kg / day salbutamol throughout pregnancy, and no abnormal fetal abnormalities occurred. Only in the highest dose group did an increase in the mortality of newborn pups result from negligent care of females. In the reproductive toxicity test in rabbits, at oral doses of 50 mg / kg / day (that is, much higher than conventional human doses), treatment-related changes occurred in the fetus, including open eyelids (no eyelids), secondary cleft palate (cleft palate ), Cranial prefrontal ossification (cranium), and limb bending. Changing the prescription of this product has no effect on the toxicity of salbutamol.
The HFC134a, a Freon-free propellant used in this product, has been exposed to animals of multiple species for a period of two years under very high gaseous concentrations (far exceeding the ejection dose in the patient's usual dose). See Toxicity.
Pharmacokinetics of Salbutamol Sulfate Inhalation Aerosol
- The half-life of intravenous salbutamol is 4-6 hours, which is partially cleared by the kidneys and partially metabolized to inactive 4'-O-sulfonate (phenolsulfonate), which is also mainly excreted from the urine. A small part of the metabolites are eliminated from the feces.
After inhaling salbutamol, 10-20% of the drug reaches the lower part of the airway, and the remaining part remains in the drug delivery system or is deposited in the throat, thereby swallowing. Drugs deposited in the airways are absorbed into the pulmonary circulation by the lung tissue, but are not metabolized in the lungs. When it reaches the systemic circulation, it can be metabolized by the liver and excreted mainly in the urine, either in its original form or as a phenolsulfonate.
Some drugs are absorbed by the intestine after swallowing, and metabolized into phenol sulfonates by the first pass effect of the liver. Prototype drugs and conjugates are mainly eliminated from the urine. Whether administered intravenously, orally or by inhalation, most of the dose is excreted within 72 hours. The rate of salbutamol binding to plasma proteins is about 10%.
Salbutamol Sulfate Inhalation Aerosol Storage
- Store in a dark place at 30 ° C (86 ° F) to avoid freezing and direct sunlight.
As with most other aerosol canister inhalants, when the canister is frozen, it may reduce the effectiveness of the medicine.
Regardless of whether the container is empty or not, it must not be broken, punctured, or fired.
Salbutamol Sulfate Inhalation Aerosol Packaging
- This product is composed of an aluminum alloy bottle and tank, a metering valve, a driver and a dust cap. Each jar contains 200 milliliters, each millet contains 100 micrograms of salbutamol (British Pharmacopoeia-grade salbutamol sulfate).
Expiration Date of Salbutamol Sulfate Inhalation Aerosol
- 24 months
Standard for Salbutamol Sulfate Inhalation Aerosol
- Import drug registration standard: JX20080307 [1]