Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Lactulose Solution, USP 10g/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.; PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0873-16 Lactulose Solution USP 10 g/15 mL Each 15 mL 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). Dispense in original container or tight, light-resistant container with a child-resistant closure. To the Pharmacist: When ordering this product, include the product number (or NDC) in the description. Rx ONLY 16 fl oz (473 mL) PAI Pharma 16 oz botttle label; PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label NDC 0121-0873-32 Lactulose Solution USP 10 g/15 mL Each 15 mL 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). Dispense in original container or tight, light-resistant container with a child-resistant closure. To the Pharmacist: When ordering this product, include the product number (or NDC) in the description. Rx ONLY 32 fl oz (946 mL) PAI Pharma 32 oz Bottle label; PRINCIPAL DISPLAY PANEL - 30 mL Cup Lid - NDC 0121-1746-30 UNIT DOSE Delivers 30 mL NDC 0121-1746-30 LACTULOSE SOLUTION USP 20 g/30 mL Indication: For the treatment of constipation. See Insert. Package Not Child-Resistant Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 30 mL UDC cup lidding
- HOW SUPPLIED Lactulose Solution, USP 10g/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.
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0873-16 Lactulose Solution USP 10 g/15 mL Each 15 mL 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). Dispense in original container or tight, light-resistant container with a child-resistant closure. To the Pharmacist: When ordering this product, include the product number (or NDC) in the description. Rx ONLY 16 fl oz (473 mL) PAI Pharma 16 oz botttle label
- PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label NDC 0121-0873-32 Lactulose Solution USP 10 g/15 mL Each 15 mL 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). Dispense in original container or tight, light-resistant container with a child-resistant closure. To the Pharmacist: When ordering this product, include the product number (or NDC) in the description. Rx ONLY 32 fl oz (946 mL) PAI Pharma 32 oz Bottle label
- PRINCIPAL DISPLAY PANEL - 30 mL Cup Lid - NDC 0121-1746-30 UNIT DOSE Delivers 30 mL NDC 0121-1746-30 LACTULOSE SOLUTION USP 20 g/30 mL Indication: For the treatment of constipation. See Insert. Package Not Child-Resistant Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 30 mL UDC cup lidding
Overview
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. Chemical Structure
Indications & 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.
Dosage & Administration
The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily. The dose may be increased to 60 mL daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement. Note: Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water or milk.
Warnings & Precautions
WARNINGS A theoretical hazard may exist for patients being treated with lactulose solution 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 solution contains galactose (less than 1.6 g/15 mL), 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. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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 solution.
Storage & Handling
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.
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