Home » Drug Information » Recently Approved Drugs » 1997
Medical Areas: Pediatrics/Neonatology | Pulmonary/Respiratory Diseases
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Rhone Poulenc Rorer
Approval Status: Approved April 1997
Treatment Area: asthma
Tilade has been approved to extend its application to children
ages six to eleven. It is an inhaled anti inflammatory drug
indicated as maintenance therapy for mild to moderate bronchial
asthma. Tilade was previously approved for patients 12 and
older.
Tilade can be used in conjunction with inhaled corticosteroids,
and inhaled and oral bronchodilators. It is not recommended for the
reversal of acute bronchospasm.
The results of an 8 week double blind, parallel group study
involving 146 children ages 6 11 demonstrated that Tilade
controlled asthma symptoms and reduced the need for patients to use
a rescue bronchodilator. There was also a statistically significant
difference, in favor of Tilade, for all symptom scores (daytime
asthma, sleep disturbance, daytime cough, morning asthma,
parent's opinion, clinician's opinion, and bronchodilator
use).
Adverse effects reported were unpleasant taste, rhinitis,
nausea, vomiting and abdominal pain.