TITLE:
Comparative toxicity assessment between generic salbutamol sulphate inhaler containing hydrofluoroalkane and Ventolin Evohaler
AUTHORS:
Suvas C. Singho Roy, M. A. Jalil, Nigar Sultana Tithi, Sajal K. Saha, Sheikh Zahir Raihan, Utpal K. Chanda, Chanchal K. Ghosh, Sitesh C. Bachar
KEYWORDS:
Salbutamol Sulphate; Hydrofluoroalkane; Toxicity Assessment; Adverse Drug Reaction; Asthma; Ventolin Evohaler
JOURNAL NAME:
Open Journal of Preventive Medicine,
Vol.3 No.3,
June
10,
2013
ABSTRACT: Salbutamol is a
short-acting β2-adrenergic
receptor agonist used for the relief of bronchospasm such as asthma and chronic
obstructive pulmonary disease (COPD). It is mostly taken through an inhaler
device. The comparative toxicity assessment between two salbutamol sulfate
preparations containing hydrofluoroalkane (HFA) metered dose inhalers with 100 μg
per puff was evaluated in selected patients with asthma and COPD after prescribing. An open label, non-randomized, non-interventional observational study was
designed. A large cohort of patients with asthma or related respiratory disorder
of the general population from Dhaka and Chittagong of Bangladesh were
recruited and treated with prescribed generic preparation Azmasol inhaler and
brand preparation Ventolin Evohaler. Total 508 patients with asthma and minor
obstructive airway disease were selected by the general medical practitioners
in Bangladesh those who visited out patient consultation center in hospitals
and physicians’ chambers and reported any
adverse side effects of inhaled medications. There were no significant
differences between the metered dose generic preparation Azmasol inhaler
and Ventolon Evohaler among the patients
treated with the medicines in asthma
and related respiratory diseases in terms of adverse effects like immune
system problem,dizziness,tremor,headache,nervousness,diarrhea,nausea,vomiting,heartburn,palpitation,skin rash,hypertension and
taste feeling. It is concluded that Azmasol Inhaler, the generic salbutamol
sulphate metered dose preparation containing HFA was as safe as the Ventolin
Evohaler,a salbutamol sulfate brand
preparation containing HFA when given to the patients in primary care after
their physicians’ visits. Both the preparations have shown the similar safety
profiles after regular use.