Rx Item-Kristalose 20 G Packet 30X20Gm By Cumberland Pharma

KRISTALOSE- lactulose powder, for solution
Cumberland Pharmaceuticals Inc.

For Oral Solution

Rx only

DESCRIPTION

KRISTALOSE� (LACTULOSE) is a synthetic disaccharide in the form of crystals for reconstitution prior to use for oral administration. Each 10 g of lactulose contains less than 0.3 g galactose and lactose as a total sum. The pH range is 3.0 to 7.0.



Lactulose is a colonic acidifier which promotes laxation.

The chemical name for lactulose is 4-O-?-D-Galactopyranosyl-D-fructofuranose. It has the following structural formula:

Structural Formula
The molecular formula is C12 H22 O11 . The molecular weight is 342.30. It is freely soluble in water.

CLINICAL PHARMACOLOGY

KRISTALOSE� (LACTULOSE) is poorly absorbed from the gastrointestinal tract and no enzyme capable of hydrolysis of this disaccharide is present in human gastrointestinal tissue. As a result, oral doses of lactulose reach the colon virtually unchanged. In the colon, lactulose is broken down primarily to lactic acid, and also to small amounts of formic and acetic acids, by the action of colonic bacteria, which results in an increase in osmotic pressure and slight acidification of the colonic contents. This in turn causes an increase in stool water content and softens the stool.

Since lactulose does not exert its effect until it reaches the colon, and since transit time through the colon may be slow, 24 to 48 hours may be required to produce desired bowel movement.

Lactulose given orally to man and experimental animals resulted in only small amounts reaching the blood. Urinary excretion has been determined to be 3% or less and is essentially complete within 24 hours.

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.

RX ITEM-Kristalose 20 G Packet 30X20Gm B
NDC 66220-0729-30 UPC/GTIN No.3-66220-72930-6 Mfg.Part No.72930

Kristalose 20 G Packet 30X20Gm By Cumber
BRAND: KRISTALOSE NDC: 66220-0729-30,66220072930 UPC: 3-66220-72930-6,366220729306 Cumberland Pharmaceuticals

LACTULOSE ORAL PACKET 20
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