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Levosalbutamol

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Last Updated: 07 November 2020

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General | Latest Info

Levosalbutamol

Chemical and physical data
3D model ( JSmol )Interactive image
FormulaC 13 H 21 N O 3
Molar mass239.315 gmol 1
Clinical data
AHFS / Drugs.comInternational Drug Names
ATC codeR03AC02 ( WHO ) R03CC02 ( WHO )
Pregnancy categoryAU : A, US : C (Risk not ruled out),
Routes of administrationBy mouth ( tablets ), inhalational ( MDI )
Trade namesXopenex, other
Identifiers
CAS Number34391-04-3 N
ChEBICHEBI:8746 Y
ChEMBLChEMBL1002 Y
ChemSpider110192 Y
CompTox Dashboard ( EPA )DTXSID80187964
DrugBankDB01001 N
ECHA InfoCard100.113.688
KEGGD08124 N
PubChem CID123600
UNIIQF8SVZ843E
Legal status
Legal statusUS : -only
Pharmacokinetic data
Elimination half-life3.3-4 hours
ExcretionUrinary
MetabolismHepatic

With the exception of levosalbutamol, all of the 2-agonists that are currently in use are racemic mixtures that are composed of equal amounts of-and-enantiomers. Clinical and mechanistic studies have demonstrated that-salbutamol alone provides 2-agonist activity that is needed for relief of bronchoconstriction, as well as 2-adrenergically mediate side effects.-Salbutamol, on the other hand, has minimal binding affinity for 2-receptor, indicating that its effects are likely to be mediate through another site. Furthermore, there is evidence that-salbutamol opposes desirable effects of-salbutamol in racemic mixture and contributes to development of characteristic features of asthma, such as airway obstruction, physical hyperresponsiveness and airway inflammation. Evidence from clinical studies show delayed recovery from exacerbation of asthma by patients who are exposed to high concentrations of-salbutamol.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Adverse effects

Generally, levosalbutamol is well tolerate. Common mild side-effects include elevated heart rate, muscle cramps, and gastric upset. Symptoms of overdose in particular include: collapse into seizure; chest pain; fast, pounding heartbeat, which may cause raised blood pressure; irregular heartbeat, which may cause paradoxical lower blood pressure; nervousness and tremor; headache; dizziness and nausea / vomiting; weakness or exhaustion; dry mouth; and insomnia. Rarer side effects may indicate dangerous allergic reaction. These include: paradoxical bronchospasm; skin itching, rash, or hives; swelling of any part of face or throat, or swelling of extremities.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Pharmacology

The safety of levosalbutamol has been assessed in 211 children aged 2-5 years in a randomized, double-blind study. They receive either levosalbutamol, racemic salbutamol, or placebo over 3 weeks. Levosalbutamol was generally well tolerate. Racemic salbutamol and levosalbutamol 0. 63 mg, but not levosalbutamol 0. 31 mg or placebo, significantly increases the ventricular rate. There were no significant QT C interval changes in any treatment group. All groups experience hypokalemia and hyperglycemia 30-60 minutes after the last dose. In another study, levosalbutamol 1. 25 mg was compared with combined racemic salbutamol 5 mg + ipratropium bromide 0. 25 mg in 140 patients aged 6-18 years with acute asthma. The median increase in heart rate was greater with the salbutamol + ipratropium bromide group than with levosalbutamol. Other safety outcomes, including nervousness, nausea / vomiting, palpitation, or headache were similar in groups. Besides causing less tachycardia, levosalbutamol provides no advantage over combined salbutamol + ipratropium.


Actions of Levosalbutamol in details

This section provides information on proper use of a number of products that contain levalbuterol. It may not be specific to Levosalbutamol. Please read with care. Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor order. Also, do not stop using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance of breathing problems. Levalbuterol inhalation solution should be used with a jet nebulizer that is connected to an air compressor with good air flow. Inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. Open the pouch and remove one vial. Open vial and place inhalation solution in medicine reservoir or nebulizer cup on machine. Connect nebulizer to a face mask or mouthpiece. Use a face mask or mouthpiece to breathe in medicine. Use nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is go. Clean all parts of the nebulizer after each use. Do not use it if the solution becomes cloudy. Do not mix another inhalation medicine with levalbuterol in nebulizer, unless told to do so by your doctor. Levalbuterol aerosol canister provides about 200 inhalations, depending on the size of canister your doctor order. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot float in water to test its fullness. When you use an inhaler for the first time, or if you have not used it in a while, inhaler may not deliver the right amount of medicine with first puff. Therefore, before using inhaler, test or prime it. To test or prime inhaler: Shake inhaler well immediately before each use. Take the cap off the actuator. Inspect the actuator for the presence of foreign objects and make sure that the canister is seated in the actuator before each use. Prime inhaler by releasing 4 test sprays in air, away from your face. The Inhaler will now be ready to provide the right amount of medicine when you use it. To use inhaler: Shake inhaler well. Breathe out fully through your mouth, expelling as much air from your lungs as possible. Place the mouthpiece fully into your mouth, holding inhaler in a mouthpiece-down position and closing your lips around it. While breathing in deeply and slowly through your mouth, fully depress the top of the metal canister with your middle finger. Immediately after the puff is deliver, release your finger from the canister and remove the inhaler from your mouth. Hold your breath for 10 seconds, if possible. If your doctor has prescribed more than a single inhalation / puff, wait 1 minute between inhalations. Then, Shake inhaler well and repeat.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Levosalbutamol levalbuterol

Levosalbutamol is an R-enantiomer of beta 2-adrenoceptor agonist salbutamol. It has been suggested to have better therapeutic index than racemic salbutamol. As levosalbutamol has much higher receptor affinity than S-enantiomer, therapeutic effects of racemic salbutamol are assumed to be mediated by levosalbutamol. However, toxicity of levosalbutamol is unrelated to 2-receptor binding, and so S-enantiomer may significantly contribute to toxicity of racemic salbutamol. The issue of enantioselective efficacy and safety of salbutamol has been review. Interest in chiral switch, that is replacement of racemic formulation by pharmacologically active R-enantiomer levosalbutamol, may be hampered by enantiomeric interconversion in vivo and mark interindividual variation in salbutamol pharmacokinetics and pharmacodynamics, owing to complex interactions between genetic and environmental effects. Authors conclude that the advantages of levosalbutamol over racemic formulation appear to be small with respect to efficacy and controversial with respect to safety. Two large crossover studies with multiple inhaled doses of S-salbutamol in asthmatic patients show no evidence of adverse effects on FEV 1. The Effects of two doses of inhaled levosalbutamol and racemic salbutamol on FEV 1 have been studied in a randomized, double-blind trial in 362 asthmatic patients over 4 weeks. The average peak FEV 1 for levosalbutamol was significantly greater than that for racemic salbutamol after first dose but not at week 4. Possible superior bronchodilatation achieved with lower doses of levosalbutamol may be more cost-effective.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

General information

Expect symptoms with overdosage are those of excessive beta-adrenergic receptor stimulation, eg, seizures, angina, hypertension or hypotension, tachycardia with rates upto 200 beats / min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, cardiac arrest and sleeplessness. Hypokalaemia also may occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of levosalbutamol inhalation solution. Treatment consists of discontinuation of LEVOLIN Respules together with appropriate symptomatic therapy. Judicious use of cardioselective beta-receptor blockers may be consider, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of LEVOLIN Respules.


Undesirable Effects

In addition to adverse events reported in clinical trials, following adverse events have been observed in post approval use of levosalbutamol. These events have been chosen for inclusion due to their seriousness, their frequency of reporting, or their likely beta-mediate mechanism: angioedema, anaphylaxis, arrhythmias, asthma, chest pain, cough increase, dysphonia dyspnea, gastrooesophagial reflux disease, metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, and urticaria. Because these events have been reported spontaneously from population of unknown size, estimates of frequency cannot be make. In addition, levosalbutamol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of oropharynx. If you of any side effects, talk to your doctor or pharmacist or write to the drugsafety cipla. Com. You can also report side effects directly via the National Pharmacovigilance Programme of India by calling 1800 180 3024. By reporting side effects, you can help provide more information on the safety of this product.


Warnings and Precautions

LEVOLIN Respules, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and / or symptoms. Although such effects are uncommon after administration of LEVOLIN Respules at recommended doses, if they occur, drug may need to be discontinue. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of T wave, prolongation of QTc interval, and segment depression. The clinical significance of these findings is unknown. Therefore, levosalbutamol sulphate inhalation solution, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Age

Asthma is a complex syndrome that involves potentially permanent airway obstruction, airway hyperresponsiveness, and multicellular inflammation. It is characterized by dyspnea, cough, chest tightness, wheezing, variable airflow obstruction, and airway hyper-responsiveness. Clinical diagnosis of asthma can be corroborated by suggestive changes in pulmonary function tests. Chronic asthma is defined as asthma requiring maintenance treatment. When patients complain of symptoms more than once weekly but less than once daily with normal or near normal lung function, it is called mild persistent asthma. The prevalence of asthma has increased in most countries since the 1970s. About 300 million people worldwide have asthma and by 2025 it has been estimated that a further 100 million will be affect. There is a noticeable increase in health care burden from asthma in several areas of the world. There is also global concern about change in asthma epidemiology and clinical spectrum. Well-control asthma reduces the burden for patients and health services. Control of asthma may mean minimal symptoms and freedom from exacerbations for patients, normal peak flow or low scores on standard questionnaire for doctors, or composite measures in clinical trials. Aims of pharmacological management of asthma are control of symptoms, including nocturnal symptoms and exercise-induced asthma, prevention of exacerbations and achievement of best possible pulmonary function, with minimal side effects. Salbutamol, most widely used short-acting 2-agonist, consists of a racemic mixture of equal amounts of two enantiomers,-salbutamol and-salbutamol. Bronchodilator effects of salbutamol are attributed entirely to-salbutamol, while-salbutamol has been shown to possess bronchospastic and pro-inflammatory effects both in vitro and in vivo studies. R-salbutamol administered as a single enantiomer has better therapeutic ratio than racemic salbutamol. Handley et al report that nebulized levosalbutamol, in doses yielding comparable bronchodilatation, had fewer-agonist-mediated side effects than nebulized racemic salbutamol. Salbutamol is metabolized in human tissues by sulfation mainly in the liver, and inactive metabolites produce are rapidly excrete in urine. Rates of metabolism for the two isomers are different; R-isomer is metabolize about eight times faster than S-salbutamol, leading to longer half-life and increased accumulation of S-salbutamol in tissues. In outpatient studies, asthma patients who were treated with levosalbutamol experienced significantly greater increase in FEV 1, longer duration of action, and fewer side effects. Mild persistent asthma is usually treated with daily use of low dose inhaled corticosteroids along with short-acting 2-agonist. Use of regular short-acting 2-agonists without concurrent inhaled corticosteroids is now considered to be associated with increased exacerbations while it is relatively safe for short-term treatment. In this study we desire to explore the possibility of short-term monotherapy with levosalbutamol in mild persistent asthma. Justification for this study was the theoretical argument that levosalbutmol may cause less tachyphylaxis in comparison to recemic salbutamol and hence it may have a valuable role in persistent asthma.


Undesirable Effects

In addition to adverse events reported in clinical trials, following adverse events have been observed in post approval use of levosalbutamol. Because these reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to their seriousness, their frequency of reporting, or their likely beta-mediate mechanism: angioedema, anaphylaxis, arrhythmias, asthma, chest pain, cough increase, dysphonia, dyspnea, gastroesophageal reflux disease, metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, and urticaria. In addition, levosalbutamol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of oropharynx. If you experience any side-effects, talk to your doctor or pharmacist or write to the drugsafety cipla. Com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024. By reporting side-effects, you can help provide more information on the safety of this product.


Warnings and Precautions

Levosalbutamol has not been approved for management of preterm labor. Benefit: risk ratio when levosalbutamol is administered for tocolysis has not been establish. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta 2-agonists, including racemic salbutamol. During marketing experience of racemic salbutamol, various congenital anomalies, including cleft palate and limb defects, have been rarely reported in offspring of patients being treated with racemic salbutamol. Some mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discern, and relationship between racemic salbutamol use and congenital anomalies has not been establish.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Corticosteroids.

AEROCORT Inhaler is not for use in acute attacks, but for routine long-term management; so, some patients will require separate levosalbutamol Inhaler for relief of acute bronchospasm. For those patients who are steroid-dependent, it is advisable to commence therapy with beclomethasone dipropionate as separate Inhaler. Patients who have been wean in the previous few months from long-term systemic corticosteroids need special consideration until the hypothalamic-pituitary-adrenal system has recovered sufficiently to enable patient to cope with emergencies such as trauma, surgery or infections. These patients should also be given a supply of oral steroids to use in emergency when their airway obstruction worsens. Levosalbutamol can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, levosalbutamol should be discontinued immediately and alternative therapy institute. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with first use of new dosage. Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If a patient needs more doses of levosalbutamol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to possible need for anti-inflammatory treatment, eg, corticosteroids. Use of beta-adrenergic agonist alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, eg, corticosteroids, to therapeutic regimen. Levosalbutamol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular EFFECTS in some patients, as measured by heart rate, blood pressure, and symptoms. Although such EFFECTS are uncommon after administration of levosalbutamol at recommended doses, if they occur, drug may need to be discontinue. In addition, beta agonists have been reported to produce electrocardiogram changes, such as flattening of T-wave, prolongation of QTc interval, and segment depression. The clinical significance of these findings is unknown. Therefore, levosalbutamol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following unexpected development of severe acute asthmatic crisis and subsequent hypoxia is suspect. Immediate hypersensitivity reactions may occur after administration of racemic salbutamol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Potential for hypersensitivity must be considered in clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving levosalbutamol levosalbutamol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, hypertension, and cardiac arrhythmias; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Pulmonary and Respiratory Medications

Changes in heart rate before and after inhalation of nebulized salbutamol or levosalbutamol on days 1 and 3 have been retrospectively compared by chart review in 35 patients with acute airflow obstruction. On day 3, heart rate increased by 2. 7 bpm after inhalation of salbutamol compared with levosalbutamol. However, levosalbutamol does not provide clinical benefit with respect to drug-associate tachycardia. In a study of the effect of racemic nebulized salbutamol 2. 5 mg and nebulized levosalbutamol 1. 25 mg on heart rate in 20 intensive care patients with and without baseline tachycardia, Patients were randomized to receive at least two consecutive doses of salbutamol or levosalbutamol 4 hours apart. Patients with baseline tachycardia had a mean increase in heart rate of 1. 4 bpm with salbutamol and 2 bpm with levosalbutamol over following 2 hours after drug inhalation. Patients without baseline tachycardia had a mean increase in heart rate of 4. 4 bpm with salbutamol and 3. 6 bpm with levosalbutamol. Short-term use of nebulized salbutamol and levosalbutamol was therefore associated with similar changes in heart rates in intensive care patients with or without baseline tachycardia. Equipotent doses of salbutamol and levosalbutamol have been compared for their potassium-lowering effect in nine healthy volunteers in a double-blind, randomize, placebo-control study. Serum potassium concentration was significantly lower at 30 minutes and 60 minutes after inhalation of salbutamol and levosalbutamol compared with placebo. Levosalbutamol and salbutamol were equivalent with respect to their potassium-lowering effects. Levosalbutamol causes fewer adverse effects, such as tremor, palpitation, tachycardia, and nervousness, than salbutamol.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Home Management

31 mg. Available as respule of 2. 5 mL LEVOLIN Respules 0. 63 mg. Available as respule of 2. 5 mL LEVOLIN Respules 1. 25 mg. Available as respule of 2. 5 mL are allergic to levosalbutamol or any ingredients in LEVOLIN Inhaler are pregnant or are breastfeeding, without discussion with your doctor have kidney problems, without discussion with your doctor are taking medicines that interact with LEVOLIN, including: non-selective beta-blockers like propranolol, other beta 2 agonists like salmeterol, diuretics like hydrochlorothiazide for heart failure, digoxin for heart failure, monoamine oxidase or tricyclic antidepressants Drugs that can cause serious reaction with LEVOLIN Inhaler: other beta 2 agonists like salmeterol, diuretics like hydrochlorothiazide for heart failure, monoamine oxidase or tricyclic antidepressants, non-selective beta-blockers like propranolol Drugs that affect LEVOLIN Inhaler: non-selective beta-blockers like propranolol Drugs that are affect by LEVOLIN Inhaler: digoxin for heart failure remove mouthpiece cover and shake Inhaler. Breathe out as far as is comfortable and then place mouthpiece in your mouth. Start to inhale and press down on top of Inhaler to release dose of Salbutamol while still breathing in through your mouth until your lungs are full and then hold your breath for a few seconds. Remove the inhaler and breathe normally. Replace mouthpiece cover. Rinse your mouth after using

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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