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Lactulose

Lactulose(lactulose) – Various

OTHER BRAND NAMES

Constulose (Actavis)Generlac (Morton Grove)Enulose (Alpharma)

THERAPEUTIC CLASS

Osmotic laxative

INDICATIONS

Treatment of constipation. Prevention and treatment of portal-systemic encephalopathy, including stages of hepatic pre-coma and coma.

ADULT DOSAGE

Adults: Constipation: 15-30mL qd. Max 60mL/day. May mix with fruit juice, water, or milk. Portal-Systemic Encephalopathy: 30-45mL tid-qid. Adjust dose every 1 or 2 days to produce 2-3 soft stools daily. Rectal Use: Reversal of Coma: Mix 300mL with 700mL of water or saline and retain for 30-60 min. May repeat q4-6h. Oral doses should be started before completely stopping enema.

PEDIATRIC DOSAGE

Pediatrics: Portal-Systemic Encephalopathy: Older Children/Adolescents: 40-90mL/day divided tid-qid adjusted to produce 2-3 soft stools daily. Infants: 2.5-10mL in divided doses to produce 2-3 soft stools daily.

HOW SUPPLIED

Sol: 10g/15mL

CONTRAINDICATIONS

Patients who require a low galactose diet.

WARNINGS/PRECAUTIONS

Caution in DM due to galactose and lactose content. Monitor electrolytes periodically in elderly or debilitated if used >6 months. Potential for explosive reaction with electrocautery procedures during proctoscopy or colonoscopy.

ADVERSE REACTIONS

Flatulence, intestinal cramps, diarrhea, N/V.

DRUG INTERACTIONS

Decreased effect with nonabsorbable antacids.

PREGNANCY

Category B, caution in nursing.

MECHANISM OF ACTION

Synthetic disaccharide; broken down primarily to lactic acid, by the action of colonic bacteria, resulting in increased osmotic pressure and slight acidification of colonic content, causing an increase in stool water content and softens the stool. In portal-systemic encephalopathy, acidification of colonic contents results in retention of ammonia in colon as ammonium ion; ammonia then migrates from blood into colon to form ammonium ion, which traps and prevents absorption of ammonia; finally, laxative actions expels trapped ammonium ion from colon.

PHARMACOKINETICS

Absorption: Poor. Elimination: Urine (≤3%).

ASSESSMENT

Assess for DM. Assess patients requiring a low-galactose diet and those requiring electrocautery procedures.

MONITORING

Monitor serum electrolytes (potassium, sodium, chloride, carbon dioxide) periodically, diarrhea, vomiting.

PATIENT COUNSELING

Drug may be diluted with fruit juice, water, or milk. Report potential adverse effects.

ADMINISTRATION/STORAGE

Administration: Oral route. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Dispense in tight, light-resistant container with child-resistant closure.


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    Lactulose

    Lactulose

    Pronunciation Pronunciation: LAK-tyoo-lohs

    Class: Hyperosmotic agent

    For ProfessionalsSide EffectsInteractionsMore…

    Trade Names

    Cephulac

    – Solution 10 g lactulose/15 mL (less than 1.6 g galactose, less than 1.2 g galactose, and up to 1.2 g of other sugars)

    Chronulac

    – Solution 10 g lactulose/15 mL (less than 1.6 g galactose, less than 1.2 g galactose, and up to 1.2 g of other sugars)

    Constilac

    – Solution 10 g lactulose/15 mL (less than 1.6 g galactose, less than 1.2 g galactose, and up to 1.2 g of other sugars)

    Constulose

    – Solution 10 g lactulose/15mL (less than 1.6 g galactose, less than 1.2 g galactose, and up to 1.2 g of other sugars)

    Duphalac

    – Solution 10 g lactulose/15 mL (less than 1.6 g galactose, less than 1.2 g galactose up to 1.2 g of other sugars)

    Enulose

    – Solution 10 g lactulose per 15 mL (less than 1.6 g galactose, less than 1.2 g galactose, and up to 1.2 g of other sugars)

    Apo-Lactulose (Canada)

    PMS-Lactulose (Canada)

    ratio-Lactulose (Canada)

    Pharmacology

    Produces increased osmotic pressure within colon and acidifies its contents, resulting in increased stool water content and stool softening. Causes migration of ammonia from blood into colon, where it is converted to ammonium ion and expelled through laxative action.

    Pharmacokinetics

    Absorption

    Poorly absorbed from the GI tract when given PO and PR (no enzyme capable of hydrolysis of lactulose is present in GI tissue).

    Metabolism

    In the colon, lactulose is broken down primarily to lactic acid. Metabolized in the colon by bacteria.

    Elimination

    Less than 3% is excreted in the urine. Doses reach the colon virtually unchanged.

    Onset

    24 to 48 h.

    Indications and Usage

    Treatment of constipation; prevention and treatment of portal-systemic encephalopathy, including stages of hepatic precoma and coma.

    Contraindications

    Use in patients who require low-galactose diet.

    Dosage and Administration

    Constipation (Chronulac, Constilac, Duphalac)

    Adults PO 15 to 30 mL (10 to 20 g lactulose) daily; may increase to 60 mL/day.

    Portal-Systemic Encephalopathy (Cephulac, Cholac, Enulose)

    Adults PO 30 to 45 mL 3 to 4 times daily. Adjust dosage to produce 2 to 3 soft stools/day. Hourly doses of 30 to 45 mL may be used for rapid laxation initially; once achieved, reduce to recommended daily dose. PR 300 mL with 700 mL water or physiologic saline solution via rectal balloon catheter; retain for 30 to 60 min. May repeat every 4 to 6 h.

    Older Children and Adolescents PO 40 to 90 mL/day in divided doses to produce 2 to 3 soft stools/day.

    Infants PO 2.5 to 10 mL/day in divided doses to produce 2 to 3 soft stools/day.

    General Advice

    Mix with fruit juice, water, or milk to make oral solution more palatable.

    Storage/Stability

    Store at room temperature (below 86°F). Do not freeze.

    Drug Interactions

    Neomycin, other anti-infectives May interfere with desired degradation of lactulose and prevent acidification of colonic contents.

    Nonabsorbable antacids May inhibit colonic acidification.

    Laboratory Test Interactions

    None well documented.

    Adverse Reactions

    GI

    Gaseous distention with flatulence or belching, abdominal discomfort and cramping; diarrhea; nausea; vomiting.

    Precautions

    Pregnancy

    Category B .

    Lactation

    Undetermined.

    Children

    Safety and efficacy not established. Administer with caution. Infants receiving lactulose may develop hyponatremia and dehydration.

    Elderly

    With long-term therapy (more than 6 mo) at increased risk of dehydration and electrolyte imbalance.

    Concomitant laxative use

    Do not use other laxatives, especially during initial phase of therapy. Resultant loose stools may falsely suggest adequate lactulose dosage.

    Debilitated patients

    With long-term therapy (more than 6 mo) at increased risk of dehydration and electrolyte imbalance.

    Diabetic patients

    Lactulose syrup contains galactose and lactose. Use with caution.

    Electrocautery procedures

    Although not reported for lactulose, theoretical hazard exists for patients being treated with lactulose who may undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of hydrogen gas in presence of electrical spark may result in explosion. Therefore patients should have thorough bowel cleansing with nonfermentable solution before undergoing such procedures.

    Overdosage

    Symptoms

    Diarrhea, abdominal cramps.

    Patient Information

    • Advise patient that drug can be mixed with fruit juice, water, or milk to make it more palatable.
    • Inform patient that drug may cause belching, flatulence, or abdominal cramps. Instruct patient to notify health care provider if these symptoms become bothersome or if diarrhea occurs.
    • Instruct patient not to take other laxatives while receiving lactulose therapy.
    • Encourage patient to increase dietary fiber and fluid intake and participate in regular exercise.

    Copyright © 2009 Wolters Kluwer Health.

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    Lactulose

    Lactulose

    Pronunciation Dosage Form: oral solution

    For ProfessionalsSide EffectsInteractionsMore…

    Lactulose Solution USP

    10 g/15 mL

    Rx ONLY

    Lactulose 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 FD&C Yellow No. 6, purified water, and flavoring. Sodium hydroxide used to adjust pH. The pH range is 2.5 to 6.5.

    Lactulose is a colonic acidifier which promotes laxation.

    The chemical name for Lactulose is 4-0-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:

    The molecular weight is 342.30. It is freely soluble in water.

    Lactulose – 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 Lactulose

    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 solution 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 in 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.

    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.

    Lactulose 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 is Lactulose Supplied

    NDC 0121-0577-08

    Bottles of 8 fl oz (237 mL)

    NDC 0121-0577-16

    Bottles of 16 fl oz (473 mL)

    NDC 0121-0577-32

    Bottles of 32 fl oz (946 mL)

    NDC 0121-4577-15

    15 mL unit dose cups in trays of 10 cups

    NDC 0121-4577-30

    30 mL unit dose cups in trays of 10 cups

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

    Store at controlled room temperature, 20°-25°C (68°-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.

    Keep tightly closed.

    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.

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    R01/04

    PRINCIPAL DISPLAY PANEL – 473 mL Bottle Label

    NDC 0121-0577-16

    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). Also contains FD&C Yellow No. 6,

    purified water, and flavoring. Sodium hydroxide

    used to adjust pH. The pH range is 2.5 to 6.5.

    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

    Pharmaceutical

    Associates, Inc.

    Greenville, SC 29605

    Lactulose 

    Lactulose solution

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0121-0577
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Lactulose (Lactulose) Lactulose 10 g  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6  
    WATER  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description
    1 NDC:0121-0577-08 237 mL in 1 BOTTLE
    2 NDC:0121-0577-16 473 mL in 1 BOTTLE
    3 NDC:0121-0577-32 946 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074623 07/30/1966
    Lactulose 

    Lactulose solution

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0121-4577
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Lactulose (Lactulose) Lactulose 10 g  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6  
    WATER  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description
    1 NDC:0121-4577-15 4 TRAY in 1 CASE
    1 10 CUP, UNIT-DOSE in 1 TRAY
    1 15 mL in 1 CUP, UNIT-DOSE
    2 NDC:0121-4577-30 4 TRAY in 1 CASE
    2 10 CUP, UNIT-DOSE in 1 TRAY
    2 30 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074623 07/30/1966
    Labeler - Pharmaceutical Associates, Inc, (044940096)
    Establishment
    Name Address ID/FEI Operations
    Pharmaceutical Associates, Inc, 097630693 MANUFACTURE(0121-0577, 0121-4577)

    Revised: 07/2012   Pharmaceutical Associates, Inc,

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    Lactulose

    Lactulose

    Pronunciation Class: Ammonia Detoxicants

    VA Class: AD400

    CAS Number: 4618-18-2

    Brands: Cholac, Chronulac, Constilac, Constulose, Enulose, Generlac, Kristalose

    For ProfessionalsSide EffectsInteractionsMore…

    Introduction

    A synthetic derivative of lactose; an ammonia detoxicant and laxative.1 2

    Uses for Lactulose

    Portal-Systemic Encephalopathy

    Used as an adjunct to protein restriction and supportive therapy for prevention and treatment of portal-systemic encephalopathy (PSE), including hepatic pre-coma and coma.1

    Useful in the management of PSE resulting from surgical portacaval shunts or chronic hepatic diseases such as cirrhosis.1

    Reduces blood ammonia concentration, which usually leads to substantial improvement in patient’s mental state and EEG tracings.1

    Does not alter the course of underlying liver disease and therefore does not obviate treatment of such disease or PSE.1

    Since neomycin destroys bacteria and lactulose requires bacterial degradation for its effectiveness, concomitant therapy with these agents is theoretically counterproductive.1 (See Anti-infective Agents under Interactions.) However, some evidence suggests that concomitant therapy with lactulose and neomycin may be more effective than either drug alone.1

    Not useful in the management of non-nitrogenous types of encephalopathy such as those induced by drugs or metabolic or electrolyte disturbances.1 Not effective in the treatment of coma associated with infectious hepatitis or other acute liver disorders.1

    Chronic Constipation

    Useful as a laxative in the treatment of chronic constipation in adults,2 including geriatric patients.1 Superiority compared with conventional laxatives not established.1

    Used in the treatment of chronic constipation in children†; safety and efficacy in children not established.1

    Used to restore regular bowel movements following hemorrhoidectomy†.1

    Used to induce bowel evacuation in geriatric patients with colonic retention of barium and severe constipation following barium meal examination†.1

    Lactulose Dosage and Administration

    Administration

    Administer orally, via gastric tube, or rectally.1 2

    Oral Administration

    When solution is administered orally, may minimize sweet taste by diluting with water, fruit juice, milk or by adding to food (e.g., desserts).1

    When administering via gastric tube, dilute well to prevent induction of vomiting and possible aspiration pneumonia.1

    Reconstitution

    For oral administration, reconstitute powder by dissolving contents of a 10- or 20-g packet in approximately 120 mL of water.1

    Rectal Administration

    May administer rectally to adults with PSE during stages of hepatic pre-coma or coma when the possibility of aspiration exists or when necessary endoscopic or intubation procedures interfere with oral administration.1

    Reconstitution

    For rectal administration, dilute 200 g of powder in 700 mL of water or 0.9% sodium chloride solution and administer via a rectal balloon catheter.1

    Dosage

    Each 15 mL of commercially available lactulose solution provides approximately 10 g of the drug; corresponding doses provided by 2.5, 5, 7.5, 10, 30, 40, 45, 90, 150, and 300 mL of the commercial solution are approximately 1.67, 3.3, 5, 6.67, 20, 27, 30, 60, 100, and 200 g, respectively.1 Following reconstitution of the oral powder as directed, a 10- or 20-g dose is provided by administering the total volume.1

    Pediatric Patients

    Portal-Systemic Encephalopathy
    Oral

    Infants (limited data): Initially, 1.67–6.67 g daily in divided doses.1

    Older children and adolescents: Initially, 27–60 g daily recommended by manufacturer.1

    Adjust dosage every 1–2 days as necessary to produce 2–3 soft stools daily.1

    If the initial dose produces diarrhea, reduce dose immediately; if diarrhea persists, discontinue drug.1

    Chronic Constipation

    At least 5 g daily, usually given as a single dose after breakfast, has been used.1

    Adults

    Portal-Systemic Encephalopathy
    Oral

    20–30 g 3 or 4 times daily.1

    Adjust dosage every 1–2 days as necessary to produce 2 or 3 soft stools daily.1 Usually dosage is 60–100 g daily; some patients may require higher dosage.1

    Some clinicians recommend dosage adjustment according to acidity of colonic contents by measuring stool pH (with indicator paper) at initiation of therapy and adjusting dosage until stool pH is about 5.1 This pH is usually achieved when the patient has 2 or 3 soft stools daily during therapy.1

    In the management of acute PSE episodes, give 20–30 g orally at 1- to 2-hour intervals to induce rapid laxation.1 When the laxative effect has been achieved, reduce dosage to the amount required to produce 2 or 3 soft stools daily.1

    During treatment, improvement in patient’s clinical condition usually occurs within 1–3 days.1

    Continuous long-term therapy with lactulose may decrease severity and prevent recurrence of PSE.1

    Rectal

    For reversal of hepatic coma, 200 g is diluted with 700 mL of water or 0.9% sodium chloride solution and administered rectally via a rectal balloon catheter; solution is retained for 30–60 minutes.1

    Retention enemas may be administered every 4–6 hours.1 If enema retained for <30 minutes, may repeat administration immediately.1

    In some patients, reversal of hepatic coma may occur within 2 hours of the first enema.1 Before discontinuance of lactulose retention enemas, initiate recommended oral dosages of the drug.1

    Chronic Constipation
    Oral

    Usual initial dosage is 10–20 g daily.1 2 Dosage may be increased to 40 g daily if necessary.1

    Following oral administration, 24–48 hours may be required to restore normal bowel movements.1

    To facilitate bowel movements in patients undergoing hemorrhoidectomy†, administer 10 g twice daily on the day before surgery and twice daily for 5 days postoperatively.1

    To induce bowel evacuation in geriatric patients with colonic retention of barium and severe constipation following barium meal examination†, 3.3–6.7 g twice daily for 1–4 weeks has been administered.1

    Special Populations

    Hepatic Impairment

    Hepatic Impairment
    Oral

    No specific dosage recommendations for patients with hepatic impairment.1

    Renal Impairment

    Renal Impairment
    Oral

    No specific dosage recommendations for patients with renal impairment.1

    Geriatric Patients

    No specific dosage recommendations for geriatric patients.1

    Cautions for Lactulose

    Contraindications

    • Patients who require a low-galactose diet.1 2

    Warnings/Precautions

    Warnings

    Patients Who May Require Electrocautery Procedures

    Administer with caution to patients who may require electrocautery procedures during proctoscopy or colonoscopy; the drug can cause accumulation of hydrogen gas in high concentrations, which in the presence of an electrical spark may theoretically result in an explosive reaction.1 Although such events have not been reported to date, patients receiving lactulose therapy should have a thorough bowel cleansing with a nonfermentable solution prior to these procedures.1 Insufflation of carbon dioxide may be used but probably is unnecessary.1

    General Precautions

    Electrolyte Disturbances

    In the treatment of PSE, important to consider that serious underlying liver disease may produce complications such as electrolyte disturbances (e.g., hypokalemia) that require additional therapy.1 In addition, if diarrhea occurs, it may severely deplete fluids and potassium and may intensify symptoms of PSE.1 For these reasons, some clinicians recommend periodic determinations of serum potassium concentrations during long-term treatment with lactulose.1

    Diabetes Mellitus

    Since lactulose solution contains some free lactose and galactose, the drug should be used with caution in patients with diabetes mellitus.1

    Specific Populations

    Pregnancy

    Category B.2

    Lactation

    Not known if lactulose is distributed into milk.1 Use with caution in nursing women.1 2

    Pediatric Use

    Safety and efficacy for the treatment of chronic constipation in children not established.1 2

    Geriatric Use

    Determine serum electrolyte concentrations (e.g., potassium, chloride, carbon dioxide) periodically during therapy in geriatric, debilitated patients who receive lactulose for >6 months.1

    Common Adverse Effects

    Gaseous distention,1 belching,1 flatulence,1 2 borborygmi,1 abdominal discomfort (e.g., cramping).1 2 Dehydration and hyponatremia in infants.1

    Interactions for Lactulose

    Laxatives

    Do not administer laxatives concomitantly; resultant loose stools may be falsely interpreted as an indication that adequate dosage of lactulose has been achieved.1

    Anti-infective Agents

    Theoretical concern that concomitantly administered oral neomycin and possibly other anti-infective agents could eliminate colonic bacteria necessary to metabolize lactulose and thereby prevent acidification of the colon contents.1 However, lactulose appears to remain active when administered with neomycin to patients with PSE, and some reports suggest that such concomitant therapy may be more effective than either drug alone in the treatment of PSE.1

    Patients receiving lactulose and an oral anti-infective agent should be closely monitored for possible inadequate response to lactulose.1

    Antacids

    Limited data suggest that nonabsorbable antacids administered concomitantly with lactulose may inhibit the desired decrease in fecal pH in the colon.1

    The potential lack of desired effect of lactulose should be considered before concomitant use of a nonabsorbable antacid.1

    Lactulose Pharmacokinetics

    Absorption

    Extent

    Poorly absorbed from GI tract.1 2

    Onset

    Does not exert its effect until it reaches the colon.2

    Extent

    Less than 3% absorbed from small intestine following oral administration; negligible absorption from colon.1

    Elimination

    Metabolism

    Absorbed drug not metabolized.1 Unabsorbed drug reaches colon unchanged, where it is metabolized by bacteria to form lactic acid and small amounts of acetic and formic acids.1

    Elimination Route

    Absorbed drug excreted in urine unchanged within 24 hours.1

    Stability

    Storage

    Oral

    Powder and Solution

    15–30°C (powder and solution); avoid freezing of solution.1 Prolonged exposure to freezing temperatures may result in solution that is semisolid and too viscous to pour; viscosity returns to normal following warming to room temperature.1

    Although heat causes cloudiness and heat and light cause darkening of the solution, these changes do not indicate loss of potency.1

    Actions and Spectrum

    • A disaccharide containing one molecule each of galactose and fructose.1

    • Causes a decrease in blood ammonia concentration in patients with PSE and reduces the degree of PSE.1
    • Mechanism of action not clearly defined.1
    • Breakdown of lactulose to organic acids (i.e., lactic acid and small amounts of formic and acetic acids) by the saccharolytic bacteria in the colon acidifies colon contents.1
    • Acidification of colon contents inhibits the nonionic diffusion of ammonia from the colon into the blood.1 Since colon contents are more acidic than is blood, ammonia can diffuse from the blood into the colon.1
    • In the acidic colon, ammonia (NH3) is converted to ammonium ions (NH4+) thereby preventing its absorption.1 In a similar manner, the absorption of amines (which may also contribute to the development of PSE) also may be reduced.1
    • Finally, the cathartic action of lactulose (probably caused by the osmotic effect of its organic acid metabolites) expels the trapped ammonium ions and possibly other nitrogenous substances from the colon.1
    • The osmotic effect of the organic acid metabolites of lactulose causes an increase in water content of the stool and a softening of the stool; this effect on the stool may not be seen until 24–48 hours after administration of the drug.1
    • In patients with chronic constipation, the drug increases the number of bowel movements per day and the number of days when bowel movements occur.1

    Advice to Patients

    • Importance of not using cleansing enemas containing soapsuds or other alkaline agents concomitantly.1

    • Importance of contacting clinician if an unusual diarrheal condition occurs during therapy.1
    • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
    • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
    • Importance of informing patients of other important precautionary information. (See Cautions.)

    Preparations

    Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

    * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

    Lactulose
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Oral

    For solution

    10 g/packet

    Kristalose (with <0.3 g of galactose and lactose total)

    Bertek, (also promoted by Cumberland)

    20 g/packet

    Kristalose (with <0.3 g of galactose and lactose total)

    Bertek, (also promoted by Cumberland)

    Solution

    3.33 g/5 mL*

    Chronulac Syrup (with <733 mg of galactose, <400 mg of lactose, and ≤400 mg of other sugars)

    Aventis

    Constilac Syrup (with <733 mg of galactose, <400 mg of lactose, and ≤400 mg of other sugars)

    Alra

    Constulose (with <733 mg of galactose, <400 mg of lactose, and ≤400 mg of other sugars)

    Alpharma

    Oral or Rectal

    Solution

    3.33 g/5 mL*

    Cholac Syrup (with <733 mg of galactose, <400 mg of lactose, and ≤400 mg of other sugars)

    Alra

    Enulose (with <733 mg of galactose, <400 mg of lactose, and ≤400 mg of other sugars)

    Alpharma

    Generlac (with <733 mg of galactose, <400 mg of lactose, and ≤400 mg of other sugars)

    Morton Grove

    Comparative Pricing

    This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

    Kristalose 10GM Packet (CUMBERLAND PHARMACEUTICALS): 30/$55.99 or 90/$149.97

    Kristalose 20GM Packet (CUMBERLAND PHARMACEUTICALS): 30/$86.25 or 90/$240.95

    Lactulose Encephalopathy 10GM/15ML Solution (HI-TECH): 473/$19.98 or 1419/$59.94

    Disclaimer

    This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

    The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug’s actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

    AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions August 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

    † Use is not currently included in the labeling approved by the US Food and Drug Administration.

    References

    1. AHFS Drug Information 2003. McEvoy, GK, ed. Lactualose.Bethesda, MD: American Society of Health-System Pharmacists; 2003:2479-81.

    2. Bertek. Kristalose (lactulose) for oral solution prescribing information. In: Physicians’ desk reference. 58th ed. Montvale, NJ: Medical Economics Company Inc; 2004:962-3.

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    lactulose

    lactulose

    Pronunciation Generic Name: lactulose (oral) (LAK too lose)

    Brand Name: Constulose, Kristalose, …show all 11 brand names

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is lactulose?

    Lactulose is a type of sugar. It is broken down in the large intestine into mild acids that draw water into the colon, which helps soften the stools.

    Lactulose is used to treat chronic constipation.

    Lactulose is sometimes used to treat or prevent certain conditions of the brain that are caused by liver failure, which can lead to confusion, problems with memory or thinking, behavior changes, tremors, feeling irritable, sleep problems, loss of coordination, and loss of consciousness.

    Lactulose may also be used for purposes not listed in this medication guide.

    What is the most important information I should know about lactulose?

    You should not use this medication if you are on a special diet low in galactose (milk sugar).

    Before taking lactulose, tell your doctor if you have diabetes or if you need to have any type of intestinal test using a scope (such as a colonoscopy).

    It may take up to 48 hours before you have a bowel movement after taking lactulose.

    Stop using lactulose and call your doctor at once if you have severe or ongoing diarrhea.

    The liquid form of lactulose may become slightly darker in color, but this is a harmless effect. However, do not use the medicine if it becomes very dark, or if it gets thicker or thinner in texture.

    If you use lactulose over a long period of time, your doctor may want you to have occasional blood tests. Do not miss any scheduled appointments.

    What should I discuss with my healthcare provider before taking lactulose?

    You should not use this medication if you are on a special diet low in galactose (milk sugar).

    To make sure you can safely take lactulose, tell your doctor if you have other medical conditions, especially:

    • diabetes; or

    • if you need to have any type of intestinal test using a scope (such as a colonoscopy).

    FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

    It is not known whether lactulose passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    How should I take lactulose?

    Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

    Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

    The liquid form of lactulose may become slightly darker in color, but this is a harmless effect. However, do not use the medicine if it becomes very dark, or if it gets thicker or thinner in texture.

    Lactulose powder should be mixed with at least 4 ounces of water. You may also use fruit juice or milk to make the medication taste better.

    It may take up to 48 hours before you have a bowel movement after taking lactulose.

    If you use lactulose over a long period of time, your doctor may want you to have occasional blood tests. Do not miss any scheduled appointments.

    Store lactulose at room temperature away from moisture and heat.

    What happens if I miss a dose?

    Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

    What happens if I overdose?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

    Overdose symptoms may include confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, and muscle weakness or limp feeling.

    What should I avoid while taking lactulose?

    Avoid using antacids without your doctor’s advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb lactulose.

    Lactulose side effects

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

    Stop using lactulose and call your doctor at once if you have severe or ongoing diarrhea.

    Less serious side effects may include:

    • bloating, gas;

    • stomach pain;
    • diarrhea; or
    • nausea, vomiting.

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    See also: lactulose side effects (in more detail)

    Lactulose Dosing Information

    Usual Adult Dose for Constipation — Chronic:

    15 mL orally once a day.

    Usual Adult Dose for Constipation — Acute:

    Initial dose: 15 mL orally once a day. Therapy should be continued until normal bowel function resumes.

    Usual Adult Dose for Hepatic Encephalopathy:

    Initial dose: 30 mL orally 3 times a day or

    300 mL in 700 mL water or normal saline as an enema retained for 30 to 60 minutes every 4 to 6 hours.

    Maintenance dose: 30 to 45 mL orally 3 times a day.

    Usual Pediatric Dose for Hepatic Encephalopathy:

    Infants: 1.7 to 6.7 g/day (2.5 to 10 mL) orally daily divided in 3 to 4 doses. Adjust dosage to produce 2 to 3 soft stools per day.

    Children: 26.7 to 60 g/day (40 to 90 mL) orally daily divided in 3 to 4 doses. Adjust dosage to produce 2 to 3 soft stools per day.

    Usual Pediatric Dose for Constipation — Chronic:

    Children: 0.7 to 2 g/kg/day (1 to 3 mL/kg/day) orally in divided doses daily; generally recommended not to exceed the adult maximum of 40 g/day (60 mL/day).

    What other drugs will affect lactulose?

    There may be other drugs that can interact with lactulose. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

    Next Page → Side Effects

    More lactulose resources

    • Side Effects
    • Pregnancy Warnings
    • Drug Interactions
    • Support Group
    • 13 Reviews - Add your own review/rating
    • lactulose crystals MedFacts Consumer Leaflet (Wolters Kluwer)
    • Lactulose Prescribing Information (FDA)
    • Lactulose Monograph (AHFS DI)
    • Lactulose Professional Patient Advice (Wolters Kluwer)
    • Constulose solution MedFacts Consumer Leaflet (Wolters Kluwer)
    • Constulose Prescribing Information (FDA)
    • Enulose solution MedFacts Consumer Leaflet (Wolters Kluwer)
    • Enulose Prescribing Information (FDA)
    • Generlac Prescribing Information (FDA)
    • Kristalose Prescribing Information (FDA)

    Compare lactulose with other medications

    • Constipation, Acute
    • Constipation, Chronic
    • Hepatic Encephalopathy

    Where can I get more information?

    • Your pharmacist can provide more information about lactulose.

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