LACTULOSE by VistaPharm, Inc. LACTULOSE solution
LACTULOSE by
Drug Labeling and Warnings
LACTULOSE by is a Prescription medication manufactured, distributed, or labeled by VistaPharm, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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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:
C12H22O11
The molecular weight is 342.30. It is freely soluble in water.
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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
- CONTRAINDICATIONS
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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 H2 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 CO2 as an additional safeguard may be pursued but is considered to be a redundant measure.
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PRECAUTIONS
General
Since lactulose solution contains galactose (less than 1.6 g/15 mL) and lactose (less than 1.2 g/15 mL) it should be used with caution in diabetics.
Information for Patients
In the event that an unusual diarrheal condition occurs, contact your physician.
Laboratory Tests
Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically.
Drug Interactions
Results of preliminary studies in humans and rats suggest that non-absorbable 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.
There are no known animal data on long-term potential for mutagenicity.
Administration of lactulose solution in the diet of mice for 18 months in concentrations of 3 and 10 percent (v/w) did not produce any evidence of carcinogenicity.
In studies of mice, rats, and rabbits, doses of lactulose solution up to 6 or 12 mL/kg/day produced no deleterious effects in breeding, conception, or parturition.
Pregnancy
Teratogenic Effects
Pregnancy category B
Reproduction studies have been performed in mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
- ADVERSE REACTIONS
- OVERDOSAGE
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DOSAGE AND 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.
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HOW SUPPLIED
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.
Storage
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.
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PRINCIPAL DISPLAY PANEL - 20 g/30 mL cup label
Xact DOSE™
LACTULOSE
SOLUTION, USP
20 g/30 mLNDC: 66689-038-01
INDICATIONS AND DOSAGE: For the
treatment of constipation. See insert.
Avoid subfreezing temperatures.
Store at 20°–25°C (68°–77°F)
[See USP CONTROLLED RM TEMP]Rx Only This cup delivers 30 mL VP2050
Manufactured by VistaPharm, Inc.
Largo, FL 33771
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PRINCIPAL DISPLAY PANEL - 10 g/15 mL cup label
Xact DOSE™
LACTULOSE
SOLUTION, USP
10 g/15 mLNDC: 66689-039-01
INDICATIONS AND DOSAGE: For the
treatment of constipation. See insert.
Avoid subfreezing temperatures.
Store at 20°–25°C (68°–77°F)
[See USP CONTROLLED RM TEMP]Rx Only This cup delivers 15 mL VP2049
Manufactured by VistaPharm, Inc.
Largo, FL 33771
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INGREDIENTS AND APPEARANCE
LACTULOSE
lactulose solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 66689-039 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE) LACTULOSE 10 g in 15 mL Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Product Characteristics Color ORANGE Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 66689-039-50 5 in 1 CASE 05/10/2010 1 10 in 1 TRAY 1 NDC: 66689-039-01 15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074138 05/10/2010 LACTULOSE
lactulose solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 66689-038 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE) LACTULOSE 20 g in 30 mL Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Product Characteristics Color ORANGE Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 66689-038-50 5 in 1 CASE 05/10/2010 1 10 in 1 TRAY 1 NDC: 66689-038-01 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC: 66689-038-99 10 in 1 CASE 05/10/2010 2 10 in 1 TRAY 2 NDC: 66689-038-01 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074138 05/10/2010 Labeler - VistaPharm, Inc. (116743084)
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