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Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Pediatrics/Neonatology | Pulmonary/Respiratory Diseases | Family Medicine

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Tilade (nedocromil sodium)

The following drug 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

General Information

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.

Clinical Results

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.

Side Effects

Adverse effects reported with statistically significant greater frequency with Tilade than with placebo were unpleasant taste, rhinitis, nausea, vomiting and abdominal pain.

Additional Information

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.