Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED LACTULOSE For Oral Solution is available in single dose packets of 10 g (NDC 69067-010-15) andd single dose packets of 20 g (NDC 69067020-15). The packets are supplied as follows: NDC 69067-010-15 (Carton of fifteen 10 g packets) NDC 69067-020-14 (carton of fifteen 20g paclets) STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F).; PRINCIPAL DISPLAY PANEL - 10 Gram Packet Carton NDC 69067-010-15 Rx Only Lactulose 10 g packets For Oral Solution Fifteen Single Dose Packets Foxland Pharmaceuticals, Inc PRINCIPAL DISPLAY PANEL - 10 Gram Packet Carton; NDC 69067-020-15 Rx Only Lactulose, 20 g Packets Fifteen single dose packets Foxland, Pharmaceuticals, Inc. Carton 20g
- HOW SUPPLIED LACTULOSE For Oral Solution is available in single dose packets of 10 g (NDC 69067-010-15) andd single dose packets of 20 g (NDC 69067020-15). The packets are supplied as follows: NDC 69067-010-15 (Carton of fifteen 10 g packets) NDC 69067-020-14 (carton of fifteen 20g paclets) STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F).
- PRINCIPAL DISPLAY PANEL - 10 Gram Packet Carton NDC 69067-010-15 Rx Only Lactulose 10 g packets For Oral Solution Fifteen Single Dose Packets Foxland Pharmaceuticals, Inc PRINCIPAL DISPLAY PANEL - 10 Gram Packet Carton
- NDC 69067-020-15 Rx Only Lactulose, 20 g Packets Fifteen single dose packets Foxland, Pharmaceuticals, Inc. Carton 20g
Overview
LACTULOSE For Oral Solution 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-β-D-Galactopyranosyl-D-fructofuranose. It has the following structural formula: The molecular formula is C 12 H 22 O 11 . The molecular weight is 342.30. It is freely soluble in water. Chemical Structure
Indications & Usage
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 & 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.
Warnings & Precautions
WARNINGS A theoretical hazard may exist for patients being treated with lactulose who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H 2 gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. Although this complication has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution. Insufflation of CO 2 as an additional safeguard may be pursued but is considered to be a redundant measure.
Contraindications
Since LACTULOSE For Oral Solution contains galactose (less than 0.3 g/10 g as a total sum with lactose), it is contraindicated in patients who require a low galactose diet.
Adverse Reactions
Precise frequency data are not available. Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia. Nausea and vomiting have been reported.
Drug Interactions
Results of preliminary studies in humans and rats suggest that nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose.
Storage & Handling
STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F).
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.