Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE)
Pharmaceutical Associates, Inc.
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.
Lactulose Solution, USP 10 g/15 mL is supplied as: NDC 0121-0873-08: 8 fl oz (237 mL) bottles NDC 0121-0873-16: 16 fl oz (473 mL) bottles NDC 0121-0873-32: 32 fl oz (946 mL) bottles NDC 0121-0873-15: 15 mL unit dose cup. Case contains 40 unit dose cups of 15 mL (NDC 0121-0873-40), packaged in 4 trays of 10 unit-dose cups each and 96 unit dose cups of 15 mL (NDC 0121-0873-06) packaged in a carton of 16 unit dose cups each. NDC 0121-1746-30: 30 mL unit dose cup. Case contains 40 unit dose cups of 30 mL (NDC 0121-1746-40), packaged in 4 trays of 10 unit-dose cups each, 100 unit dose cups of 30 mL (NDC 0121-1746-00), packaged in 10 trays of 10 unit-dose cups each and 96 unit dose cups of 30 mL (NDC 0121-1746-06) packaged in a carton of 16 unit dose cups each. Store at controlled room temperature, 20°to 25°C (68° to 77°F). [See USP] Do not freeze. Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 30°C (86°F) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use. Prolonged exposure to freezing temperatures may cause change to a semisolid, too viscous to pour. Viscosity will return to normal upon warming to room temperature. Dispense in original container or in a tight, light-resistant container with a child-resistant closure. To the Pharmacist: When ordering this product, include the NDC number in the description.
Abbreviated New Drug Application
LACTULOSE- LACTULOSE SOLUTION PHARMACEUTICAL ASSOCIATES, INC. ---------- LACTULOSE SOLUTION USP 10 G/15 ML CI08730222 R02/22 RX ONLY DESCRIPTION Lactulose 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). Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-0-ß-D-galactopyranosyl-D-fructofuranose. It has the following structural formula: The molecular weight is 342.30. It is freely soluble in water. CLINICAL PHARMACOLOGY 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 solution 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 the desired bowel movement. Lactulose solution 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 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. CONTRAINDICATIONS Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet. WARNINGS A theoretical hazar Olvassa el a teljes dokumentumot