Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE)
Par Pharmaceutical
LACTULOSE
LACTULOSE 10 g in 15 mL
ORAL
PRESCRIPTION DRUG
For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur. Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
Abbreviated New Drug Application
LACTULOSE- LACTULOSE SOLUTION PAR PHARMACEUTICAL ---------- LACTULOSE SOLUTION, USP RX ONLY DESCRIPTION Lactulose solution, USP is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains FD&C Blue No. 1, FD&C Yellow No. 6, flavoring and purified water. A minimal quantity of sodium hydroxide is used to adjust pH, when necessary. The pH range is 2.5 to 6.5. Lactulose solution is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-_O-β_-D-galactopyranosyl-D-fructofuranose. It has the following structural formula: It has the molecular formula of C H O and the molecular weight is 342.30. It is freely soluble in water. CLINICAL PHARMACOLOGY Lactulose solution 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 solution reach the colon virtually unchanged. In the colon, lactulose solution 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 solution 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 the 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 12 22 11 For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day a Lue koko asiakirja