LACTULOSE SOLUTION- lactulose solution usp, 10 g/15 ml solution

Lactulose Solution by

Drug Labeling and Warnings

Lactulose Solution by is a Prescription medication manufactured, distributed, or labeled by Kesin Pharma Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • DESCRIPTION

    Lactulose is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of Lactulose Solution USP contains 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). It also contains D&C Yellow No. 10, FD & C Yellow No. 6 and Purified Water.
    Lactulose is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy.
    The chemical name for lactulose is 4-0-ß-D-galactopyranos-D-fructofuranose. It has the following structural formula:

    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 solution 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 solution 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 H 2gas 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 2as an additional safeguard may be pursued but is considered to be a redundant measure.

  • PRECAUTIONS

    General
    Since lactulose solution contains galactose (less than1.6 g/15 mL) and lactose (less than 1.2 g/15 mL), it should be used with caution in diabetics. Infants receiving lactulose may develop hyponatremia and dehydration.

    Drug Interactions

    There have been conflicting reports about the concomitant use of neomycin and lactulose solution. Theoretically, the elimination of certain colonic bacteria by neomycin and possibly other anti-infective agents may interfere with the desired degradation of lactulose and thus prevent the acidification of colonic contents. Thus the status of the lactulose-treated patient should be closely monitored in the event of concomitant oral anti-infective therapy.
    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.

    Carcinogenesis, Mutagenesis, and Impairment of Fertility

    There are no known human data on log-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 2 or 4 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 is administered to a nursing woman.

    Pediatric Use

    Very little information on the use of lactulose in pediatric patients has been recorded (see DOSAGE AND ADMINISTRATION).

  • ADVERSE REACTIONS

    Precise frequency data are not available. Lactulose may produce gaseous distention with flatulence or belching and abdominal discomfort such as cramping in about 20% of patients. 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 Kesin Pharma at 1-833-537-4679 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 LD 50: The acute oral LD 50of 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

    Adult
    The usual adult oral dosage is 2 to 3 tablespoonfuls (30 to 45 mL, containing 20 g to 30 g of lactulose) three or four times daily. The dosage may be adjusted every day or two to produce 2 or 3 soft stools daily.
    Pediatric
    Very little information on the use of lactulose in young children and adolescents has been recorded. As with adults, the subjective goal in proper treatment is to produce 2 to 3 soft stools daily. On the basis of information available, the recommended initial daily oral dose in infants is 2.5 to 10 mL in divided doses. For older children and adolescents, the total daily dose is 40 to 90 mL. If the initial dose causes diarrhea, the dose should be reduced immediately. If diarrhea persists, lactulose should be discontinued.
    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 a clear, yellow to golden-yellow solution supplied as follows:
    NDC: 81033-241-15 - 15 mL Unit Dose Cup
    NDC: 81033-241-50 - Case containing 100 (15mL unit dose cups)
    NDC: 81033-241-30 - 30 mL Unit Dose Cup
    NDC: 81033-241-51 - Case containing 100 (30mL unit dose cups)

  • STORAGE

    Keep tightly closed. Do not freeze. Store at 20-25°C (68-77°F).
    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 semisolid, 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, with a child-resistant closure

  • PRINCIPAL DISPLAY PANEL

    Delivers 15ml

    NDC: 81033-241-15

    LACTULOSE SOLUTION, USP 10 g/15 mL

    FOR ORAL OR RECTAL ADMINISTRATION

    Store at 20-25°C (68-77°F)

    PKG By Kesin Pharma

    Oldsmar, FL

    Rx Only

    For Institutional Use Only| See Insert

    Foil Label

    Delivers 30ml

    NDC: 81033-241-30

    LACTULOSE SOLUTION, USP 20 g/35 mL

    FOR ORAL OR RECTAL ADMINISTRATION

    Store at 20-25°C (68-77°F)

    PKG By Kesin Pharma

    Oldsmar, FL

    Rx Only

    For Institutional Use Only

    See Insert

    81033-241-30

  • INGREDIENTS AND APPEARANCE
    LACTULOSE SOLUTION 
    lactulose solution usp, 10 g/15 ml solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 81033-241(NDC:61037-471)
    Route of AdministrationORAL, RECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE) LACTULOSE10 g  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (Yellow to Golden Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 81033-241-50100 in 1 CASE04/16/2024
    1NDC: 81033-241-1515 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC: 81033-241-51100 in 1 CASE04/16/2024
    2NDC: 81033-241-3030 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07664504/16/2021
    Labeler - Kesin Pharma Corporation (117447816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kesin Pharma Corporation117447816repack(81033-241)
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