Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, G6 1PT, UK Trading as: anofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Tilade CFC-Free contains nedocromil sodium, a non-steroidal agent, which has anti-inflammatory properties when administered topically in the lung. In-vivo, ex-vivo and in-vitro studies have shown that nedocromil sodium has beneficial effects on cellular, humoral and neuronal mechanisms thought to be involved in the inflammation of bronchial asthma. In the treatment of bronchial asthma, nedocromil sodium reduces bronchospasm, cough and bronchial hyperreactivity and improves objective measurements of lung function.
After inhalation of nedocromil sodium (in common with other drugs inhaled using an MDI) a small fraction (generally 10%) reaches the lungs, while a major portion of the dose is deposited in the mouth or oropharynx and swallowed. The oral absorption of nedocromil sodium from the gastrointestinal tract is low, being approximately 2% of an orally administered dose. Hence, nedocromil sodium measured in plasma following inhalation is considered to represent mainly the drug absorbed by the airways. After inhalation, plasma concentrations of nedocromil sodium reach a maximum within one hour post-dosing and decline with a half-life of 1-2 hours.
Nedocromil sodium is moderately (80%) and reversibly bound to human plasma proteins, and is not metabolised in man or animals.
In man nedocromil sodium is excreted unchanged in the urine (approximately 70%) and in faeces (approximately 30%). The plasma profiles of nedocromil sodium are similar following inhalation of Tilade, Tilade Mint, or Tilade CFC-Free, and are also similar in healthy volunteers and in asthmatic patients.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
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