Biltricide (Praziquantel) - Indications and Dosage

INDICATIONS AND USAGE

BILTRICIDE^® is indicated for the treatment of infections due to: all species of schistosoma (e.g. Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium), and infections due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated).

DOSAGE AND ADMINISTRATION

The dosage recommended for the treatment of schistosomiasis is: 20 mg/kg bodyweight three times a day as a one day treatment, at intervals of not less than 4 hours and not more than 6 hours. The recommended dose for clonorchiasis and opisthorchiasis is: 25 mg/kg bodyweight three times a day as a one day treatment, at intervals of not less than 4 hours and not more than 6 hours. The tablets should be washed down unchewed with water during meals. Keeping the tablets or segments thereof in the mouth can reveal a bitter taste which can promote gagging or vomiting.

HOW SUPPLIED

BILTRICIDE^® is supplied as a 600 mg white to orange tinged, film-coated, oblong tablet with three scores. The tablet is coded with “BAYER” on one side and “LG” on the reverse side. When broken, each of the four segments contains 150 mg of active ingredient so that the dosage can be easily adjusted to the patient’s bodyweight.

Segments are broken off by pressing the score (notch) with thumbnails. If 1/4 of a tablet is required, this is best achieved by breaking the segment from the outer end.

BILTRICIDE^® is available in bottles of 6 tablets.

Bottles of 6:	Strength 600 mg	NDC 0085-1747-01
Store below 86°F (30°C).

Manufactured by:

Bayer HealthCare Pharmaceuticals Inc.

Wayne, NJ 07470
Made in Germany

Distributed by:

Schering Corporation
Kenilworth, NJ 07033

BILTRICIDE is a registered trademark of Bayer Aktiengesellschaft and is used under license by Schering Corporation.

08918425, R.1

8/07      EMBAY      844013561

©2007 Bayer HealthCare Pharmaceuticals Inc.      Printed in USA