The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, eg, angina, hypertension, tachycardia with rates up to 200 beats per minute, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, and insomnia. In addition, seizures, hypotension, arrhythmias, malaise, and hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of Levolin (albuterol sulfate syrup). Treatment consists of discontinuation of Levolin (albuterol sulfate syrup) together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Levolin (albuterol sulfate syrup).
The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 250 times the maximum recommended daily oral dose for adults on an mg/m basis).
Deterioration of Asthma
Asthma may deteriorate acutely over a period of hours, or chronically over several days or longer. If the patient needs more doses of Levolin (albuterol sulfate syrup) than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, eg, corticosteroids.
Use of Anti-Inflammatory Agents
The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, eg, corticosteroids.
Levolin (albuterol sulfate syrup), like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Levolin (albuterol sulfate syrup) at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Levolin (albuterol sulfate syrup), like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Levolin (albuterol sulfate syrup) can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Levolin (albuterol sulfate syrup) should be discontinued immediately and alternative therapy instituted.
Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema,.
Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of oral albuterol sulfate in children.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (eg, Proair® HFA) in children 4 years of age and older, albuterol inhalation powder (eg, Proair® Respiclick™) in children 12 years of age and older, and albuterol inhalation solution (eg, Accuneb®) in children 2 years of age and older. However, safety and efficacy have not been established for the albuterol inhalation aerosol in children younger than 4 years of age, albuterol inhalation powder in children younger than 12 years of age, and albuterol inhalation solution in children younger than 2 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (eg, Proair® HFA) and albuterol inhalation powder (eg, Proair® Respiclick™) in geriatric patients. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving albuterol inhalation aerosol and albuterol inhalation powder.
No information is available on the relationship of age to the effects of albuterol inhalation solution (eg, Accuneb®) in geriatric patients.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Rapidly increasing use of short-acting inhaled β2-agonists to relieve symptoms, indicates deterioration of asthma control (especially if peak expiratory flow rate value falls and/or becomes irregular). Patients should therefore be advised that in these cases the physician's advice should be obtained as soon as possible and therapeutic management should then be reassessed.
A regular anti-inflammatory controller medication taken on a daily basis is required, as soon as the patient needs inhaled β2-agonists more than twice a week. Levolin should be given with caution in patients suffering from thyrotoxicosis, cardiac insufficiency, hypokalaemia, myocardial ischemia, tachyarrhythmia and hypertrophic obstructive cardiomyopathy.
Potassium levels should be monitored in severe asthma as hypokalaemia potentially caused by Levolin may be potentiated by concomitant treatment and by hypoxia.
Rarely, inhalation therapy may cause bronchospasm after dosing. In this event, treatment with Levolin Easyhaler must be immediately discontinued and if needed, replace it with another therapy.
Cardiovascular effects may be seen with sympathomimetic drugs, including Levolin. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with Levolin. Patients with underlying severe heart disease (eg, ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Levolin should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms eg, dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
One (1) dose contains <10 mg lactose, which probably does not cause symptoms in lactose intolerant patients. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Levolin.
Effects on the Ability to Drive or Operate Machinery: The effect of Levolin Easyhaler on the ability to drive and use machines has not been directly studied. From the well-known pharmacological actions of Levolin and decades of clinical experience such effects are, however, regarded as unlikely.
Use in pregnancy: Administration of Levolin during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Use in lactation: As Levolin is excreted in breast milk, its use in nursing mothers requires careful consideration. As it is not known whether Levolin has harmful effects on the neonate, its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.
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Information checked by Dr. Sachin Kumar, MD Pharmacology