Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Pharmacotherapeutic group: Drugs for obstructive airway disease; Antiallergic agents, exclusive corticosteroids
ATC code: RO3BC01
Sodium cromoglicate inhibits the activation of many of the cell types involved in the development and progression of asthma. Thus, sodium cromoglicate inhibits the release of inflammatory mediators including cytokines from mast cells and reduces the chemotactic activity of eosinophils and neutrophils. Activation of and mediator release from monocytes and macrophages in vitro is also reduced by sodium cromoglicate.
The diverse range of activities of the drug may be explained by the ability of sodium cromoglicate to block chloride channels in different cell types which are important in cell activation.
In acute bronchial provocation tests in humans, sodium cromoglicate has been shown to inhibit or diminish the asthmatic reaction to antigen, exercise and to a range of non-specific triggers including cold air, sulphur dioxide, hypertonic saline and bradykinin. Antigen-induced increased bronchial hyperactivity to histamine is prevented and a reduction in bronchial mucus eosinophils and antigen-specific IgE occurs after 4 weeks treatment of asthmatic subjects with sodium cromoglicate.
After inhalation in man via a metered dose inhaler approximately 10% of a dose of sodium cromoglicate is absorbed from the respiratory tract. The remainder is either exhaled or deposited in the oropharynx, or swallowed and eliminated via the alimentary tract, as only a small amount (1%) of the dose is absorbed from the gastrointestinal tract. The rate of absorption of sodium cromoglicate from the respiratory tract is slower than the elimination rate (t½ of 1.5–2h). Hence, the drug remains effectively in the lungs to produce its local therapeutic effect and is then cleared rapidly from the systemic circulation. No substantial increase in plasma concentration occurs during repeated dose therapy.
Sodium cromoglicate is moderately and reversibly bound to plasma proteins (~65%) and is not metabolised in humans. It is excreted unchanged in both urine and bile in approximately equal proportions.
Pre-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
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