Airlevo Adverse Reactions

Use of Levosalbutamol Tartrate Inhalation Aerosol may be associated with the following: Paradoxical bronchospasm; Cardiovascular effects; Immediate hypersensitivity reactions; Hypokalemia.
Clinical Trials Experience: Glenmark Phase-III Study No. GPL/CT/2018/003/III: Safety and tolerability - Adult patients (aged ≥18 to ≤65): A randomized cross-over three-period three-sequence placebo-controlled clinical study with open-label (non-blind) active comparator, intended to assess efficacy and safety of the medicinal product, Levosalbutamol tartrate, metered dose inhalation aerosol, 45 μg/dose (Glenmark Pharmaceuticals Limited, India) vs placebo and Ventolin (racemic Salbutamol 100 μg/dose), metered dose inhalation aerosol (GlaxoSmithKline Pharmaceuticals SIA) in adult patients with mild and moderate bronchial asthma, was conducted.
Over the study period, no SAEs arising after the use of the investigational product, no moderate and severe AEs arising after the use of the investigational product, no AEs/SAEs related to the use of the investigational product were reported. The study findings also demonstrated the good safety profile of the medicinal product, Levosalbutamol tartrate, metered dose inhalation aerosol, 45 μg/dose (Glenmark Pharmaceuticals Limited, India). All AEs (TEAEs) recorded during the study were mild and unrelated to the investigational product use.
During the study, 19/91 (20.9%) patients from the safety set reported the total of 24 AEs (TEAEs). Of them 2 AEs developed in 1/91 (1.1%) patients and resulted in his early withdrawal from the study.
The most frequent AEs that emerged post-administration of Levosalbutamol was cough from the class of Respiratory, Thoracic and Mediastinal Disorders: 3 cases of these AEs were seen in 3/90 (3.3%) patients.
Details of the prevalence of AEs (TEAEs) in treatment arms are shown in Table as follows. (See table.)

Click on icon to see table/diagram/image

Post-marketing Experience: In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been observed in post-approval use of levosalbutamol inhalation solution. Because these reactions are reported voluntarily from a 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-mediated mechanism: angioedema, anaphylaxis, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), asthma, chest pain, cough increased, dysphonia, dyspnea, gastrooesophageal reflux disease (GERD), metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, urticaria.
In addition, levosalbutamol tartrate inhalation aerosol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of the oropharynx.