FDA Expands Lansoprazole Usage to Teens

Nurse Practitioner, Oct 2004

TAP Pharmaceutical's lansoprazole (Prevacid) received FDA approval for the short-term treatment of symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis in children aged 12 to 17 years. The new approval also expands the use of lansoprazole to children aged 1 to 17 years.This drug is the only proton pump inhibitor approved for use by children as young as 1 year.

In a clinical study of once-daily lansoprazole (either 15 or 30 mg) in children with GERD who were 12 to 17 years of age, the drug was found to be safe and effective in treating patients with symptomatic GERD, including erosive esophagitis. The most frequently reported side effects of lansoprazole in patients aged 12 to 17 included headache, abdominal pain, nausea, and dizziness.

The FDA also approved lansoprazole for delivery as orally disintegrating tablets (Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets).They are administered using an oral syringe or nasogastric tube to patients who have difficulty swallowing tablets.The tablet should first be dissolved in water (4 mL for the 15 mg tablet and 10 mL for the 30 mg tablet) and administered within 15 minutes.