News - FDA Approves New Dosage Strength of Zantac (Ranitidine) EFFERdose Tablets

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FDA Approves New Dosage Strength of Zantac (Ranitidine) EFFERdose Tablets

A New Choice for Children With GERD

RESEARCH TRIANGLE PARK, NC -- April 12, 2004 -- GlaxoSmithKline (GSK) announced today the availability of a new dosage strength of Zantac® (ranitidine hydrochloride effervescent) EFFERdose® Tablets. New Zantac 25 EFFERdose(R) Tablets 25mg is indicated for the treatment of gastroesophageal reflux disease (GERD) in children one month and older.

Zantac EFFERdose has a preferred taste over Zantac SYRUP and the new 25mg tablet accommodates convenient dosing regimens for patients 11-22 lbs with GERD. Currently, Zantac (syrup plus tablet forms) is the #1 product prescribed by pediatricians for the treatment of GERD (Verispan PDDA, December 2003). In a recent single-centered study of 102 healthy children (4-8 years), 7 out of 10 preferred the taste of Zantac EFFERdose over Zantac SYRUP. The Zantac EFFERdose 25mg tablet is dissolved in at least 5 ml of water before administering the solution to the infant or child. It may be administered with a dosing cup, medicine dropper or oral syringe. Zantac EFFERdose Tablets are available in single-dose packets, do not require refrigeration and do not contain alcohol.

Zantac EFFERdose contains phenylalanine. The following have been reported as adverse events in clinical trials or in the routine management of patients treated with Zantac: headache, sometimes severe; abdominal discomfort/pain; nausea and vomiting; constipation; rash; and diarrhea. Safety and effectiveness in neonates (less than 1 month of age) have not been established. Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established. Use of Zantac in pediatric patients with GERD is supported by adequate and well controlled studies in adults with GERD, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature.

SOURCE: GlaxoSmithKline

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