देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE)
VistaPharm, Inc.
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.
Lactulose Solution is available as a cherry-flavored solution, 10 g/15 mL, supplied as follows: NDC 66689-039-01: 15 mL unit dose cup. NDC 66689-039-50: Case contains 50 unit dose cups of 15 mL (66689-039-01), packaged in 5 trays of 10 unit dose cups each. Lactulose Solution is available as a cherry-flavored solution, 20 g/30 mL, supplied as follows: NDC 66689-038-01: 30 mL unit dose cup. NDC 66689-038-50: Case contains 50 unit dose cups of 30 mL (66689-038-01), packaged in 5 trays of 10 unit dose cups each. NDC 66689-038-99: Case contains 100 unit dose cups of 30 mL (66689-038-01), packaged in 10 trays of 10 unit dose cups each. Lactulose Solution contains lactulose 667 mg/mL (10 g/15 mL). When ordering this product, include the product code number or NDC in the description. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Avoid subfreezing temperatures. 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 86°F (30°C) 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 semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
LACTULOSE- LACTULOSE SOLUTION VISTAPHARM, INC. ---------- LACTULOSE SOLUTION, USP 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 of other sugars). Also contains FD&C Yellow No. 6, purified water, USP and wild cherry flavoring. A minimal quantity of sodium hydroxide, NF is used to adjust pH when necessary. The pH range is 2.5 to 6.5. Lactulose 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: C H O 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 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 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 and the number of days on which bowel movements occur. CONTRAINDICATIONS Since lactulose solution contains galact पूरा दस्तावेज़ पढ़ें