Kristalose (Lactulose) - Indications and Dosage

INDICATIONS AND USAGE

KRISTALOSE™ (LACTULOSE) For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

DOSAGE AND ADMINISTRATION

The usual adult dosage is 10 g to 20 g of lactulose daily. The dose may be increased to 40 g daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement.

DIRECTIONS FOR PREPARATION

Dissolve contents of packet in half a glass (4 ounces) of water.

When Lactulose for Oral Solution is dissolved in water, the resulting solution may be colorless to a slightly pale yellow color.

HOW SUPPLIED

KRISTALOSE™ (LACTULOSE) For Oral Solution is available in single dose packets of 10 g (NDC 62794-501-17) and single dose packets of 20 g (NDC 62794-502-17). The packets are supplied as follows:

   NDC 62794-501-93       Carton of thirty 10 g packets

   NDC 62794-502-93       Carton of thirty 20 g packets

STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F).

Distributed by

BERTEK PHARMACEUTICALS INC.

Sugar Land, TX 77478

Manufactured by

Inalco S.p.A.

Milan, Italy

089.1

REVISED OCTOBER 2003