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Lactulose (Hi-Tech Pharmacal Co., Inc.)

Available Formats

Dosage Form Package Information Links
SOLUTION 4 TRAY in 1 CASE (50383-779-17) > 10 CUP in 1 TRAY (50383-779-15) > 15 mL in 1 CUP Label Information
SOLUTION 10 TRAY in 1 CASE (50383-779-33) > 10 CUP in 1 TRAY > 30 mL in 1 CUP Label Information
SOLUTION 237 mL in 1 BOTTLE (50383-779-08) Label Information
SOLUTION 4 TRAY in 1 CASE (50383-779-31) > 10 CUP in 1 TRAY (50383-779-30) > 30 mL in 1 CUP Label Information
SOLUTION 473 mL in 1 BOTTLE (50383-779-16) Label Information
SOLUTION 946 mL in 1 BOTTLE (50383-779-32) Label Information

Complete Lactulose Information

  • FOR ORAL ADMINISTRATION


  • 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). Also contains water. The pH range is 4.8 to 6.0.

    Lactulose is a colonic acidifier which promotes laxation.

    The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula:

    Chemical Structure

    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

    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 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.


  • 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 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.

    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.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.


  • 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 Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


  • OVERDOSAGE

    Signs and Symptoms

    There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated.

    Oral LD50

    The acute oral LD50 of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats.

    Dialysis

    Dialysis data are not available for lactulose. Its molecular similarity to sucrose, however, would suggest that it should be dialyzable.


  • 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.


  • HOW SUPPLIED

    Lactulose Solution, USP 10 g/15 mL is available as follows:

    8 fl oz (237 mL) bottle

    16 fl oz (473 mL) bottle

    32 fl oz (946 mL) bottle

    15 mL unit dose in trays of 10 cups

    30 mL unit dose in trays of 10 cups

    Lactulose solution contains lactulose 667 mg/mL (10 g/15mL).

    Store at controlled room temperature 15° to 30°C (59° to 86° F). 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 semi-solid, 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 as defined in the USP, with a child-resistant closure.

    Rx only

    Distributed by:

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    Rev. 779:07 07/16


  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Display panel

    NDC 50383-779-26

    Lactulose Solution, USP

    10 g/15 mL

    INDICATIONS: For the treatment of constipation. See attached insert labeling foe full information.

    Rx only

    16 fl oz (473 mL)


  • INGREDIENTS AND APPEARANCE
    LACTULOSE 
    lactulose solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-779
    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
    GALACTOSE (UNII: X2RN3Q8DNE)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50383-779-17 4 in 1 CASE 09/04/2009
    1 NDC:50383-779-15 10 in 1 TRAY
    1 15 mL in 1 CUP; Type 0: Not a Combination Product
    2 NDC:50383-779-31 4 in 1 CASE 09/04/2009
    2 NDC:50383-779-30 10 in 1 TRAY
    2 30 mL in 1 CUP; Type 0: Not a Combination Product
    3 NDC:50383-779-33 10 in 1 CASE 09/04/2009
    3 10 in 1 TRAY
    3 30 mL in 1 CUP; Type 0: Not a Combination Product
    4 NDC:50383-779-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/03/1995
    5 NDC:50383-779-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/03/1995
    6 NDC:50383-779-32 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/03/1995
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074076 07/03/1995
    Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(50383-779)