Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Pediatrics/Neonatology | Pulmonary/Respiratory Diseases
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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: mild-to-moderate bronchial asthma in children ages six to eleven
The therapeutic benefits of Tilade (nedocromil sodium) inhaler
has been extended to children ages six to eleven. Tilade, an
inhaled anti-inflammatory drug indicated as maintenance therapy in
the management of patients with mild-to-moderate bronchial asthma,
was previously indicated for patients 12 and older.
The recommended starting dosage for patients six years of age
and older is two inhalations four times per day at regular
intervals. Less frequent administration may be effective once
patients achieve good control on this regimen. Tilade can be used
in conjunction with inhaled corticosteriods and inhaled and oral
bronchodilators. Tilade 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 demonstrate Tilade’s efficacy in
the treatment of pediatric asthma. The study showed that Tilade
controls asthma symptoms and reduces the need for patients to use a
rescue bronchodilator, with clinically and statistically
significant differences in favor of Tilade for all symptom scores
(daytime asthma, sleep disturbance, daytime cough, morning asthma,
parent’s opinion, clinician’s opinion), including a reduction in
bronchodilator use.
Adverse effects reported with statistically significant greater
frequency with Tilade than with placebo were unpleasant taste,
rhinitis, nausea, vomiting and abdominal pain.
Asthma is a chronic inflammatory condition that affects 4.8
million American children annually, and can be life threatening if
not properly managed. It is the number one cause of hospitalization
among children and the number one cause of absenteeism from
school.