Generlac 10gm 15ml

Lactulose Solution

DOSAGE AND ADMINISTRATION

Oral

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.

Hourly doses of 30 to 45 mL of lactulose solution may be used to induce the rapid laxation indicated in the initial phase of the therapy of portal-systemic encephalopathy. When the laxative effect has been achieved, the dose of lactulose may then be reduced to the recommended daily dose. Improvement in the patient’s condition may occur within 24 hours but may not begin before 48 hours or even later.

Continuous long-term therapy is indicated to lessen the severity and prevent the recurrence of portal-systemic encephalopathy. The dose of lactulose for this purpose is the same as the recommended daily dose.

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 or 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.

Rectal

When the adult patient is in the impending coma or coma stage of portal- systemic encephalopathy and the danger of aspiration exists, or when the necessary endoscopic or intubation procedures physically interfere with the administration of the recommended oral doses, lactulose solution may be given as a retention enema via a rectal balloon catheter. Cleansing enemas containing soap suds or other alkaline agents should not be used.

Three hundred mL of lactulose solution should be mixed with 700 mL of water or physiologic saline and retained for 30 to 60 minutes. Lactulose enema may be repeated every 4 to 6 hours. If this lactulose enema is inadvertently evacuated too promptly, it may be repeated immediately.

The goal of treatment is reversal of the coma stage in order that the patient may be able to take oral medication. Reversal of coma may take place within 2 hours of the first enema in some patients. Lactulose given orally in the recommended doses, should be started before lactulose by enema is stopped entirely.

HOW SUPPLIED

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.

Lactulose

Identification

Are you a new drug developer? Contact us to learn more about our customized products and solutions. Stay in the know! As part of our commitment to providing the most up-to-date drug information, we will be releasing #DrugBankUpdates with our newly added curated drug pages. #DrugBankUpdates Name Lactulose Accession Number DB00581 (APRD01063) Type Small Molecule Groups Approved Description

Lactulose is a synthetic disaccharide derivative of lactose that is most commonly used as a laxative agent despite also being formally indicated to serve as an adjunct therapy in treating portal-systemic encephalopathy (PSE).Label,3,4 Despite being first synthesized in 19291, investigations regarding its possible use as a laxative for the treatment of chronic constipation did not occur until the 1960s and its first clinical use for treating PSE was not until 1966.4

Nevertheless, although lactulose received formal FDA approval in 1977 and has since become a readily available generic and brand-name non-prescription medication listed on the World Health Organization’s List of Essential Medicines as one of the most effective and safe medicines employed in a health system5, data regarding its optimal place in therapy is often ambiguous.4

Especially considering the use of lactulose as a laxative is typically only considered after lifestyle and dietary modifications fail and the fact that lactulose therapy cannot be ethically withheld from patients diagnosed with PSE in a placebo study, the substance may just be one of many options available for treating constipation and its efficacy in managing PSE may never be formally confirmed or refuted via clinical investigation.4

Structure 3D Download Similar Structures

Structure for Lactulose (DB00581)

× Close Synonyms

  • 4-O-beta-D-Galactopyranosyl-D-fructofuranose
  • 4-O-beta-D-Galactopyranosyl-D-fructose
  • Lactulosa
  • Lactulose
  • Lactulosum

Prescription Products

Name Dosage Strength Route Labeller Marketing Start Marketing End
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Lactulose Solution 10 g/15mL Oral ANI Pharmaceuticals Inc. 2009-05-21 2009-05-21 US
Lactulose Solution 10 g/15mL Oral; Rectal ANI Pharmaceuticals Inc. 2008-12-16 2008-12-16 US

Additional Data Available

  • Application Number Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code Product Code

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Generic Prescription Products

Name Dosage Strength Route Labeller Marketing Start Marketing End
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Constulose Solution 10 g/15mL Oral Actavis Pharma, Inc. 2011-02-28 Not applicable US
Constulose Solution 10 g/15mL Oral Actavis Mid Atlantic LLC, 2007-01-03 2012-02-29 US
Constulose Solution 10 g/15mL Oral A-S Medication Solutions 2011-02-28 Not applicable US
Enulose Solution 10 g/15mL Oral; Rectal Actavis Pharma, Inc. 2011-02-28 Not applicable US
Enulose Liquid 10 g/15mL Oral; Rectal Actavis Pharma, LLC 1990-10-31 2012-08-31 US
Generlac Solution 10 g/15mL Oral; Rectal Morton Grove Pharmaceuticals, Inc. 1996-10-31 Not applicable US
Kristalose Powder, for solution 10 g/10g Oral Cumberland Pharmaceuticals Inc. 2012-01-20 Not applicable US
Kristalose Powder, for solution 20 g/20g Oral Jones Contract Packaging Services 2018-01-24 2018-08-20 US
Kristalose Powder, for solution 20 g/20g Oral Cumberland Pharmaceuticals Inc. 2012-01-20 Not applicable US
Kristalose Powder, for solution 10 g/10g Oral Jones Contract Packaging Services 2018-01-24 2018-08-20 US

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  • Application Number Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code Product Code

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Over the Counter Products

Name Dosage Strength Route Labeller Marketing Start Marketing End
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Apo-lactulose Solution Oral Apotex Corporation 2001-02-19 Not applicable Canada
Cephulac Syr 667mg/ml Syrup Oral Hoechst Marion Roussel 1995-12-31 1998-08-12 Canada
Chronulac Syr Syrup Oral; Other Merrell Pharms Inc., Division Of Merrell Dow (Can) 1977-12-31 1996-09-09 Canada
Chronulac Syr 667mg/ml Syrup Oral Hoechst Marion Roussel 1996-12-31 1998-08-12 Canada
Comalose R Sirop 10gm/15ml Syrup Oral; Rectal Rougier Pharma Division Of Ratiopharm Inc 1987-12-31 1999-09-27 Canada
Duphalac Powder Oral Solvay Pharma Inc 1997-11-27 2001-02-12 Canada
Duphalac Dry Powder Oral Solvay Pharma Inc 1996-07-23 1998-08-04 Canada
Gen-lac – Liq 667mg/ml Liquid Oral Genpharm Ulc 1990-12-31 2009-08-05 Canada
Jamp-lactulose Syrup Oral Orbus Pharma Inc 2006-11-07 2010-03-31 Canada
Jamp-lactulose Solution Oral Jamp Pharma Corporation 2008-06-20 Not applicable Canada

Additional Data Available

  • Application Number Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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International/Other Brands Bifiteral (Abbott) / Cephulac / Cholac (Alra) / Chronulac / Constilac (Alra) / Laevolac (Roche) Categories UNII 9XH2P2N8EP CAS number 4618-18-2 Weight Average: 342.2965
Monoisotopic: 342.116211546 Chemical Formula C12H22O11 InChI Key JCQLYHFGKNRPGE-FCVZTGTOSA-N InChI InChI=1S/C12H22O11/c13-1-4-6(16)7(17)8(18)11(21-4)22-9-5(2-14)23-12(20,3-15)10(9)19/h4-11,13-20H,1-3H2/t4-,5-,6+,7+,8-,9-,10+,11+,12-/m1/s1 IUPAC Name (2S,3R,4S,5R,6R)-2-{oxy}-6-(hydroxymethyl)oxane-3,4,5-triol SMILES OC1O(O)(CO)(O)1O1O(CO)(O)(O)1O

Pharmacology

Indication

Lactulose is indicated for use as a laxative in the treatment of chronic constipation in adults and geriatric patients.Label,3,4

Additionally, lactulose is also employed as an adjunct to protein restriction and supportive therapy for the prevention and treatment of portal-systemic encephalopathy (PSE), including both the hepatic pre-coma and coma variations.Label,3,4 In particular, lactulose solution has been effective at managing PSE resulting from surgical portacaval shunts or from chronic hepatic diseases like cirrhosis.3

Moreover, there have also been studies demonstrating the capacity for lactulose to minimize the formation of gallstones and even some investigations regarding the experimental use of the agent in developing novel anticancer agents owing to its ability to bind galactin carbohydrates involved in various tumor progressions 4.

Associated Conditions

  • Constipation
  • Hepatic Encephalopathy

Pharmacodynamics

Lactulose formulations are most commonly administered via the oral route or the rectal route.4 Consequently, because the substance experiences minimal absorption by the gut it typically remains localized in the gastrointestinal tract environment and ultimately demonstrates almost all of its pharmacologic effects within the gut.Label,3,4 In particular, as lactulose elicits its laxative effects in enhancing stool amounts and softening stool, such biochemical and physiologic activities can cause increased bowel sounds (borborygmi), a feeling of bloatedness, belching, frequent flatus, and diarrhea.Label,3,4

Mechanism of action

Lactulose is a synthetic disaccharide derivative of lactose that consists of one molecule of galactose and one molecule of fructose.Label,3,4 Saccharolytic bacteria present in the large intestine subsequently break the substance down into organic acids like lactic acid and small amounts of formic and acetic acids.Label,3,4 Such resultant volatile fatty acid metabolites, in combination with hydrogen and methane that is also generated consequently enhance intraluminal gas formation, peristaltic gut motility, and elicit an osmotic effect that facilitates an increase in the water content of stool as well as associated stool softening.Label,3,4 All of these actions ultimately assist in facilitating and increasing the frequency of bowel movements in patients experiencing constipation, although it may take 24 to 48 hours after using the medication for this laxative effect to become evident.Label,3,4

At the same time, the formation of such acids via the metabolism of lactulose by colonic bacteria also acidifies the contents of the colon, thereby contributing to the treatment of portal-systemic encephalopathy (PSE).Label,3,4 As one of the principal features of PSE involves the accumulation of nitrogenous waste products like ammonia in the systemic circulation, a state in which the colonic contents become more acidic than blood allows ammonia in the circulation to diffuse into the colon.Label,3,4. Furthermore, ammonia that diffuses into the acidic colon is ionized to ammonium ions that are incapable of being absorbed back into the blood.Label,3,4 These effects, combined with the laxative action of lactulose facilitates the excretion of excess ammonia.Label,3,4 And finally, it is also believed that an acidic colonic environment results in the elimination of urease-producing bacteria that contribute to the formation of ammonia while surviving colonic bacteria use up any trapped ammonia in the colon as a source of nitrogen for protein synthesis.4

Target Actions Organism
UEvolved beta-galactosidase subunit alpha other Escherichia coli (strain K12)

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Learn more Absorption

After administration by the oral route, less than 3% of the given dose of lactulose solution is absorbed by the small intestine.3 The remaining unabsorbed lactulose reaches the large intestine where it is metabolized – but even then, negligible quantities of unchanged lactulose or its metabolites are absorbed across the colon.3,4

Volume of distribution

Negligible amounts of lactulose – metabolized or non-metabolized – are absorbed into the body.Label,3,4. Most lactulose that is administered subsequently remains predominantly around the gastrointestinal tract area.

Protein binding

Negligible amounts of lactulose – metabolized or non-metabolized – are absorbed into the body.Label,3,4. Regardless, data regarding the protein binding of lactulose is not readily available or accessible.

Metabolism

Lactulose is essentially only metabolized in the colon by saccharolytic bacteria that are present there.Label,3,4 In particular, the substance is broken down into lactic acid and small amounts of acetic and formic acid.Label,3,4 Specific examples of bacteria that normally inhabit the large intestine that are capable of lactulose metabolism include Lactobacilli, Bacteroides, Escherichia coli, and Clostridia.3

  • Lactulose Formic acid, Lactic acid, and Acetic acid

Route of elimination

The renal excretion of any lactulose that manages to be absorbed into the circulation has been determined to be 3% or less and is generally complete within 24 hours.Label Any unabsorbed lactulose is largely excreted with stool.Label,3,4

Half life

The data regarding the half-life of lactulose is not readily available or accessible.

Clearance

Negligible amounts of lactulose – metabolized or non-metabolized – are absorbed into the body.Label,3,4. Regardless, data regarding the clearance of lactulose is not readily available or accessible.

Toxicity

It has been documented that the oral LD50 of lactulose is 48.8 mL/kg in mice and more than 30 mL/ kg in rats.Label,3,4

It is expected that overdosage with lactulose would result in abdominal cramps and diarrhea, both of which should be treated with fluid and electrolyte replacement as required.Label,3,4

Considering the use of lactulose during pregnancy in humans has not been formally investigated, the agent should only be used during pregnancy only when clearly needed.Label,3,4 Similarly, it is unknown whether lactulose is distributed into human breastmilk.Label,3,4 Use of the medication in nursing women should subsequently be undertaken with caution.Label,3,4

Reproduction studies in rats, mice, and rabbits have not revealed any evidence of impaired fertility as a result of administering lactulose.Label,3,4

Data regarding the safety and efficacy of using lactulose in children for the treatment of chronic constipation or portal-systemic encephalopathy (PSE) is either very limited or yet to be established.Label,3,4

Information regarding the long-term mutagenic potential of lactulose solution in animals or humans and about the long-term carcinogenic potential in humans are not available.Label,3,4

Affected organisms

  • Humans and other mammals

Pathways Not Available Pharmacogenomic Effects/ADRs Not Available

Interactions

Drug Interactions This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

  • All Drugs
  • Approved
  • Vet approved
  • Nutraceutical
  • Illicit
  • Withdrawn
  • Investigational
  • Experimental
Drug Interaction
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(R)-warfarin The risk or severity of bleeding can be increased when Lactulose is combined with (R)-warfarin.
(S)-Warfarin The risk or severity of bleeding can be increased when Lactulose is combined with (S)-Warfarin.
25-desacetylrifapentine The therapeutic efficacy of Lactulose can be decreased when used in combination with 25-desacetylrifapentine.
6-Deoxyerythronolide B The therapeutic efficacy of Lactulose can be decreased when used in combination with 6-Deoxyerythronolide B.
Acenocoumarol The risk or severity of bleeding can be increased when Lactulose is combined with Acenocoumarol.
Acetazolamide The risk or severity of adverse effects can be increased when Acetazolamide is combined with Lactulose.
Acetyl sulfisoxazole The therapeutic efficacy of Lactulose can be decreased when used in combination with Acetyl sulfisoxazole.
Aclidinium The therapeutic efficacy of Lactulose can be decreased when used in combination with Aclidinium.
Agmatine The therapeutic efficacy of Lactulose can be decreased when used in combination with Agmatine.
Alcuronium The therapeutic efficacy of Lactulose can be decreased when used in combination with Alcuronium.

Additional Data Available

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Food Interactions

  • Take without regard to meals. Drink liberally.

Synthesis Reference

Renato Carobbi, Franco Innocenti, “Process for preparing high-purity lactulose syrup and the syrup obtained.” U.S. Patent US4978397, issued April, 1961.

US4978397 General References

  1. Schumann C: Medical, nutritional and technological properties of lactulose. An update. Eur J Nutr. 2002 Nov;41 Suppl 1:I17-25. doi: 10.1007/s00394-002-1103-6.
  2. Canadian Pharmacists Association (2019). Compendium of Pharmaceuticals and Specialties. Canadian Pharmacists Association.
  3. Lactulose Canadian Product Monograph
  4. NCBI StatPearls : Lactulose
  5. WHO Model List of Essential Medicines 19th List (April 2015 – Amended November 2015)

External Links Human Metabolome Database HMDB0000740 KEGG Drug D00352 KEGG Compound C07064 PubChem Compound 11333 PubChem Substance 46506757 ChemSpider 10856 BindingDB 50377984 ChEBI 6359 ChEMBL CHEMBL296306 PharmGKB PA164748762 HET W9T RxList RxList Drug Page Drugs.com Drugs.com Drug Page PDRhealth PDRhealth Drug Page Wikipedia Lactulose ATC Codes A06AD61 — Lactulose, combinations

  • A06AD — Osmotically acting laxatives
  • A06A — DRUGS FOR CONSTIPATION
  • A06 — DRUGS FOR CONSTIPATION
  • A — ALIMENTARY TRACT AND METABOLISM

A06AD11 — Lactulose

  • A06AD — Osmotically acting laxatives
  • A06A — DRUGS FOR CONSTIPATION
  • A06 — DRUGS FOR CONSTIPATION
  • A — ALIMENTARY TRACT AND METABOLISM

AHFS Codes

  • 40:10.00 — Ammonia Detoxicants
  • 56:12.00 — Cathartics and Laxatives

PDB Entries 3w9t / 6b8k / 6b94 / 6nwm FDA label (151 KB) MSDS (73.6 KB)

Clinical Trials

Clinical Trials

Phase Status Purpose Conditions Count
0 Recruiting Diagnostic Crohn’s Disease (CD) 1
1 Completed Basic Science Insulin Resistance / Prediabetic State 1
1 Completed Treatment Bowel Evacuant Prior to Colonoscopy 1
1 Completed Treatment Opiate Addiction 1
1 Recruiting Screening Infants, Premature / Intestinal Permeability 1
1 Recruiting Treatment Acute-On-Chronic Liver Failure / Hepatic Encephalopathy 1
2 Completed Prevention Necrotizing Enterocolitis / Sepsis 1
2 Completed Treatment Chronic Constipation 1
2 Completed Treatment Colonoscopy 1
2 Completed Treatment Colonoscopy Preparation 1
2 Completed Treatment Constipation 1
2 Completed Treatment Feces, Impacted 1
2 Completed Treatment Hepatic Encephalopathy 1
2 Completed Treatment Hepatic Encephalopathy / Liver Cirrhosis 1
2 Completed Treatment Hepatic Encephalopathy / Liver Cirrhosis / Portal Hypertension 1
2 Recruiting Treatment Overt Hepatic Encephalopathy 1
2 Terminated Treatment Minimal Hepatic Encephalopathy 1
2 Unknown Status Treatment Hepatic Encephalopathy 1
2, 3 Completed Treatment Atopic Dermatitis (AD) 1
2, 3 Completed Treatment Chronic Liver Diseases (CLD) / Hepatic Encephalopathy 1
2, 3 Recruiting Treatment Hepatic Encephalopathy 1
3 Completed Treatment Chronic Constipation 1
3 Not Yet Recruiting Treatment Constipation – Functional 1
3 Terminated Treatment Hepatic Encephalopathy 1
3 Unknown Status Prevention Encephalopathy, Hepatocerebral / Hepatic Encephalopathy / Portal-Systemic Encephalopathy 1
3 Withdrawn Treatment Hepatic Encephalopathy 1
4 Completed Not Available Osteopenia 1
4 Completed Basic Science Motility Disorder of Intestine / Ondansetron / Small Bowel Water 1
4 Completed Basic Science Type 2 Diabetes Mellitus 1
4 Completed Prevention Hepatic Encephalopathy 1
4 Completed Treatment Constipation 2
4 Completed Treatment Hepatic Encephalopathy / Liver Cirrhosis 1
4 Completed Treatment Hepatic Encephalopathy / Minimal Hepatic Encephalopathy 1
4 Not Yet Recruiting Prevention Hepatic Encephalopathy / Liver Cirrhosis / Liver Diseases / Pathological Processes / Portal Hypertension 1
4 Recruiting Treatment Acute-On-Chronic Liver Failure / Hepatic Encephalopathy 1
4 Recruiting Treatment Constipation 1
4 Recruiting Treatment Constipation / Peritoneal dialysis complication 1
4 Recruiting Treatment Hepatic Encephalopathy 1
4 Terminated Treatment Anal Fissures / Hemorrhoids 1
4 Terminated Treatment Hepatic Encephalopathy / Liver Cirrhosis / Portal Hypertension 1
4 Unknown Status Not Available Hepatic Encephalopathy 1
4 Unknown Status Treatment Hepatic Encephalopathy 2
4 Unknown Status Treatment Liver Cirrhosis / Renal Failure 1
Not Available Completed Basic Science Changes in Gut Microbiota Composition After Lactulose Exposure 1
Not Available Completed Diagnostic Hepatic Encephalopathy 1
Not Available Completed Diagnostic Hepatic Encephalopathy / Liver Cirrhosis 1
Not Available Completed Prevention Liver Cirrhosis 1
Not Available Completed Treatment Acute on Chronic Liver Failure With Hepatic Encephalopathy / Acute-On-Chronic Liver Failure 1
Not Available Completed Treatment Cirrhosis Related Parkinsonism / Hepatic/Cirrhosis Related Parkinsonism 1
Not Available Completed Treatment Hepatic Encephalopathy 2
Not Available Completed Treatment Hepatic Encephalopathy / Liver Cirrhosis / Portosystemic Encephalopathy / PSE 1
Not Available Recruiting Not Available Endometriosis 1
Not Available Recruiting Treatment Liver Cirrhosis 1
Not Available Unknown Status Diagnostic Hirschsprung’s Disease 1
Not Available Unknown Status Prevention Hospital Acquired Infections 1
Not Available Unknown Status Treatment Abdominal Pain / Constipation / Nausea / Vomiting 1
Not Available Unknown Status Treatment Constipation 1
Not Available Withdrawn Treatment Altered Mental Status / AMS / HE / Hepatic Encephalopathy / Liver Cirrhosis 1
Not Available Withdrawn Treatment Liver Cirrhosis 1
Not Available Withdrawn Treatment Refractory Hepatic Encephalopathy 1

Pharmacoeconomics

Manufacturers

  • Inalco spa
  • Sanofi aventis us llc
  • Alra laboratories inc
  • Actavis mid atlantic llc
  • Solvay pharmaceuticals
  • Teva pharmaceuticals usa
  • Ani pharmaceuticals inc
  • Hi tech pharmacal co inc
  • Morton grove pharmaceuticals inc
  • Novex pharma
  • Paco pharmaceutical services inc
  • Pharmaceutical assoc inc div beach products
  • Roxane laboratories inc
  • Vintage pharmaceuticals inc
  • Vistapharm inc
  • Nostrum laboratories inc

Packagers

  • Actavis Group
  • Advanced Pharmaceutical Services Inc.
  • Anip Acquisition Co.
  • Apotex Inc.
  • A-S Medication Solutions LLC
  • Bay Pharma Inc.
  • Cardinal Health
  • Cumberland Pharmaceuticals
  • Diversified Healthcare Services Inc.
  • DPT Laboratories Ltd.
  • Goldline Laboratories Inc.
  • H.J. Harkins Co. Inc.
  • Hi Tech Pharmacal Co. Inc.
  • Infra SRL
  • Innoviant Pharmacy Inc.
  • Ivers Lee Division Of Jones Packaging Inc.
  • Major Pharmaceuticals
  • Merrell Pharmaceuticals Inc.
  • Moeller Pharma GmbH and Co. KG
  • Novex Pharma
  • Palmetto Pharmaceuticals Inc.
  • Pharmaceutical Association
  • Pharmaceutical Packaging Center
  • Physicians Total Care Inc.
  • Precision Dose Inc.
  • Qualitest
  • Ratiopharm Inc.
  • Resolution Chemicals Ltd.
  • Roxane Labs
  • Solvay Pharmaceuticals
  • United Research Laboratories Inc.
  • Vintage Pharmaceuticals Inc.
  • Vistapharm Inc.
  • Watson Pharmaceuticals
  • Wockhardt Ltd.
  • Xactdose Inc.

Dosage forms

Form Route Strength
Syrup Oral
Syrup Oral; Other
Syrup Oral; Rectal
Powder Oral
Liquid Oral; Rectal 10 g/15mL
Liquid Oral
Solution Oral
Powder, for solution Oral 10 g/10g
Powder, for solution Oral 20 g/20g
Solution Oral 10 g/10g
Solution Oral 10 g/15mL
Solution Oral 20 g/30mL
Solution Oral 667 mg
Solution Oral; Rectal 10 g/15mL

Prices

Unit description Cost Unit
Kristalose 30 20 gm Packets Box 83.93USD box
Kristalose 30 10 gm Packets Box 57.57USD box
Enulose 10 gm/15ml Solution 473ml Bottle 37.83USD bottle
Kristalose 20 gm packet 2.04USD each
Kristalose 10 gm packet 1.67USD each
Constulose 10 gm/15 ml soln 0.09USD ml
Enulose 10 gm/15 ml solution 0.08USD ml
Lactulose Encephalopathy 10 gm/15ml Solution 0.08USD ml
Lactulose 10 gm/15ml Solution 0.07USD ml
Generlac 10 gm/15 ml solution 0.05USD ml
Apo-Lactulose 667 mg/ml Syrup 0.02USD ml
Jamp-Lactulose 667 mg/ml Syrup 0.02USD ml
Pms-Lactulose 667 mg/ml Syrup 0.02USD ml
Ratio-Lactulose 667 mg/ml Syrup 0.02USD ml

DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only. Patents Not Available

Properties

State Solid Experimental Properties Predicted Properties

Property Value Source
Water Solubility 792.0 mg/mL ALOGPS
logP -3.3 ALOGPS
logP -4.5 ChemAxon
logS 0.36 ALOGPS
pKa (Strongest Acidic) 10.28 ChemAxon
pKa (Strongest Basic) -3 ChemAxon
Physiological Charge 0 ChemAxon
Hydrogen Acceptor Count 11 ChemAxon
Hydrogen Donor Count 8 ChemAxon
Polar Surface Area 189.53 Å2 ChemAxon
Rotatable Bond Count 5 ChemAxon
Refractivity 68.77 m3·mol-1 ChemAxon
Polarizability 31.49 Å3 ChemAxon
Number of Rings 2 ChemAxon
Bioavailability 0 ChemAxon
Rule of Five No ChemAxon
Ghose Filter No ChemAxon
Veber’s Rule No ChemAxon
MDDR-like Rule No ChemAxon

Predicted ADMET features

Property Value Probability
Human Intestinal Absorption 0.8407
Blood Brain Barrier + 0.6609
Caco-2 permeable 0.8957
P-glycoprotein substrate Non-substrate 0.5805
P-glycoprotein inhibitor I Non-inhibitor 0.8575
P-glycoprotein inhibitor II Non-inhibitor 0.9425
Renal organic cation transporter Non-inhibitor 0.849
CYP450 2C9 substrate Non-substrate 0.8745
CYP450 2D6 substrate Non-substrate 0.854
CYP450 3A4 substrate Non-substrate 0.6605
CYP450 1A2 substrate Non-inhibitor 0.9472
CYP450 2C9 inhibitor Non-inhibitor 0.9556
CYP450 2D6 inhibitor Non-inhibitor 0.9386
CYP450 2C19 inhibitor Non-inhibitor 0.9134
CYP450 3A4 inhibitor Non-inhibitor 0.9774
CYP450 inhibitory promiscuity Low CYP Inhibitory Promiscuity 0.9619
Ames test Non AMES toxic 0.9421
Carcinogenicity Non-carcinogens 0.9569
Biodegradation Not ready biodegradable 0.6719
Rat acute toxicity 1.2563 LD50, mol/kg Not applicable
hERG inhibition (predictor I) Weak inhibitor 0.9692
hERG inhibition (predictor II) Non-inhibitor 0.8684

ADMET data is predicted using admetSAR, a free tool for evaluating chemical ADMET properties. (23092397)

Spectra

Mass Spec (NIST) Not Available Spectra

Taxonomy

Description This compound belongs to the class of organic compounds known as o-glycosyl compounds. These are glycoside in which a sugar group is bonded through one carbon to another group via a O-glycosidic bond. Kingdom Organic compounds Super Class Organic oxygen compounds Class Organooxygen compounds Sub Class Carbohydrates and carbohydrate conjugates Direct Parent O-glycosyl compounds Alternative Parents Disaccharides / C-glycosyl compounds / Oxanes / Tetrahydrofurans / Secondary alcohols / Hemiacetals / Polyols / Oxacyclic compounds / Acetals / Primary alcoholsHydrocarbon derivatives show 1 more Substituents O-glycosyl compound / Disaccharide / C-glycosyl compound / Oxane / Tetrahydrofuran / Secondary alcohol / Hemiacetal / Oxacycle / Organoheterocyclic compound / PolyolAcetal / Hydrocarbon derivative / Primary alcohol / Alcohol / Aliphatic heteromonocyclic compound show 5 more Molecular Framework Aliphatic heteromonocyclic compounds External Descriptors glycosylfructose (CHEBI:6359)

Targets

Kind Protein Organism Escherichia coli (strain K12) Pharmacological action Unknown Actions Other General Function Carbohydrate binding Specific Function The wild-type enzyme is an ineffective lactase. Two classes of point mutations dramatically improve activity of the enzyme. Gene Name ebgA Uniprot ID P06864 Uniprot Name Evolved beta-galactosidase subunit alpha Molecular Weight 117878.225 Da

  1. Overington JP, Al-Lazikani B, Hopkins AL: How many drug targets are there? Nat Rev Drug Discov. 2006 Dec;5(12):993-6.
  2. Imming P, Sinning C, Meyer A: Drugs, their targets and the nature and number of drug targets. Nat Rev Drug Discov. 2006 Oct;5(10):821-34.
  3. Bjarnason I, Batt R, Catt S, Macpherson A, Maxton D, Menzies IS: Evaluation of differential disaccharide excretion in urine for non-invasive investigation of altered intestinal disaccharidase activity caused by alpha-glucosidase inhibition, primary hypolactasia, and coeliac disease. Gut. 1996 Sep;39(3):374-81.
  4. Cook GC: Breath hydrogen concentrations after oral lactose and lactulose in tropical malabsorption and adult hypolactasia. Trans R Soc Trop Med Hyg. 1978;72(3):277-81.
  5. Noone C, Menzies IS, Banatvala JE, Scopes JW: Intestinal permeability and lactose hydrolysis in human rotaviral gastroenteritis assessed simultaneously by non-invasive differential sugar permeation. Eur J Clin Invest. 1986 Jun;16(3):217-25.
  6. Hall BG, Malik HS: Determining the evolutionary potential of a gene. Mol Biol Evol. 1998 Aug;15(8):1055-61.

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Drug created on June 13, 2005 07:24 / Updated on February 02, 2020 00:16

Over-the-Counter Laxative Beats Prescription Drug for Chronic Constipation

A treatment for chronic constipation that is now available over-the-counter was more effective that a drug that needs a doctor’s prescription in a review of ten studies comparing the two.

Both polyethylene glycol, which is marketed as Miralax®, and prescription lactulose, sold under a number of brand names including Cholac Syrup®, Kristalose®, and Enulose®, work by drawing water into the colon and softening stools making them easier to pass.

The two osmotic laxatives can help patients whose intestinal activity is slow because of illness or medicines. Cancer patients who take opiate pain relievers often have problems with this kind of constipation.

The Cochrane Collaborative reviewed all 10 randomized studies comparing polyethylene glycol to lactulose for chronic constipation. In all, 322 adults and 546 children were included in their analysis.

They found

Polyethylene glycol (PEG) was better than lactulose in

  • number of stools per week.
  • form of stool.
  • need for additional products to manage constipation.
  • for children, but not adults, amount of abdominal pain.

Authors Conclusion

Polyethylene Glycol should be used in preference to Lactulose in the treatment of Chronic Constipation.

SOURCE: Lee-Robichaud et al., Lactulose versus Polyethylene Glycol for Chronic Constipation, Cochrane Database of Systematic Reviews 2010, Issue 7.

I would like to see a comparison guide for common medications used for side-effect management, such as constipation, nausea, anxiety, etc. that includes a cost comparison—even if used a price range or one $ to four or five $ to reflect the cost. —Name withheld on request

Medications commonly used for managing each of these side effects are numerous. To make it easier to use this information, the editors are presenting each category of side-effect medication in separate charts.

This chart presents information on prescription, OTC, and consumer products for managing constipation. The list is not all-inclusive; medications indicated for opioid-induced constipation for noncancer-related pain are not included.

Future installments of this chart will present information on other side-effect management medications.

Product or generic (brand name) Contraindications Warnings/
Cautions
Interactions Adverse reactions Price
(OTC or Rx)
CONSTIPATION
Benefiber Children should not use caplet form Powder: not recommended for carbonated beverages
Kidney stones
Calcium-restricted diet
Pregnancy/Nursing mothers
$ (OTC)
bisacodyl (Dulcolax) Discontinue if rectal bleeding or no bowel movement occurs
Do not use if abdominal pain, nausea, or vomting present
Tablets: Do no take within at least 1 hour after antacids or milk Abdominal discomfort
Faintness
Cramps
Rectal burning (suppositories)
$-$$ (OTC)
docusate (Colace, Kaopectate, Phillips Milk of Magnesia) Discontinue if rectal bleeding or no bowel movement occurs
Pregnancy/Nursing mothers
May increase systemic absorption of mineral oil Glycerin sup. laxative: rectal discomfort, burning sensation $ (OTC)
docusate sodium (Peri-colace) Discontinue if rectal bleeding or no bowel movement occurs
Pregnancy/Nursing mothers
Docusate may increase systemic absorption of mineral oil $ (OTC)
Fibercon Discontinue if rectal bleeding or no bowel movement occurs $ (OTC)
Konsyl Psyllium Signs/symptoms of appendicitis
Intestinal obstruction
Fecal impaction
Rectal bleeding
Diabetes (sugar containing forms)
Tablets block tetracycline absorption (give at least 1 hr before or 2 hrs after tetracycline) Esophageal, gastric, enteral, rectal obstruction $ (OTC)
lactulose (Enulose, Generlac, Kristalose, generics) Not recommended for children Electrocautery in proctoscopy, colonoscopy
Reduce dose or discontinue if diarrhea persists
Monitor electrolytes if used >6 months in elderly or debilitated
Diabetes
Pregnancy (Category B)/Nursing mothers
May be antagonized by nonabsorbable antacids Flatulence
Intestinal cramps
Diarrhea
Nausea
Vomiting
Electrolyte imbalances
$$-$$$$ (Rx)
Metamucil Signs/symptoms of appendicitis
Intestinal obstruction
Fecal impaction
Dysphagia
Rectal bleeding
Esophageal narrowing
Diabetes (sugar-containing forms)
Separate dosing by a least 2 hours from other medications Esophageal, gastric, enteral, rectal obstruction $ (OTC)
polyethylene glycol 3350 (Glycolax, MiraLax, generic) Bowel obstruction (known or suspected) Nausea, vomiting, abdominal pain or distention: exclude bowel obstruction
Elderly (increased incidence of diarrhea)
Avoid prolonged, frequent, or excessive use
Pregnancy (Category C)
Nausea, abdominal bloating, cramping, flatulence, diarrhea $ (Rx)
$ (OTC)
senna (Ex-Lax, Senokot) Discontinue if rectal bleeding or no bowel movement occurs
Pregnancy/Nursing mothers
$ (OTC)

KEY: $, <$25; $$, $25-$49; $$$, $50-$74; $$$$, $75-$100; $$$$$ >$100; OTC, over-the-counter; Rx, prescription.

SOURCES: Prices were found via Internet search for the over-the-counter or consumer product. Prescription prices are from: Healthcare Bluebook. https://healthcarebluebook.com/page_Default.aspx. Accessed March 24, 2015.

Indications, contraindications, warnings/cautions, interactions, and adverse effects information is from MPR Drug Database, accessed via MPR app. Accessed December 1, 2014.

To access Part 2 of this series, Comparison of medications for managing nausea and vomiting, .

To access Part 3 of this series, Comparison of medications for managing anxiety, .

Cephulac/Enulose/Generlac/Lactulose Rectal Sol: 10g, 15mL To administer, dissolve dose (10 to 20 g) in 4 ounces of water. . Calcium Carbonate; Magnesium Hydroxide: (Minor) Oral, nonabsorbable antacids may interfere with the. Each 15 mL of Generlac Solution contains: 10 g lactulose (and less than g galactose, A theoretical hazard may exist for patients being treated with lactulose solution . solution containing 10 g of lactulose/15 mL ( mg lactulose/mL).

Each 15 mL of Lactulose Solution contains: 10 g lactulose (and less than g galactose, A theoretical hazard may exist for patients being treated with lactulose 40 unit dose cups of 15 mL () packaged in 4 trays of 10 unit dose cups each. Lactulose solution contains lactulose mg/mL (10 g/15 mL).

Mix the recommended amount of lactulose with milliliters (24 ounces) of If you are using this medication for constipation, it may take up to 48 hours to have .

Pictures of Lactulose Solution (Lactulose Solution), drug imprint information, side effects for the patient. Myths Slideshow Pictures · RxList. 10 Facts About the Amazing Brain Lactulose may also be used for purposes not listed in this medication guide. Lactulose powder should be mixed with at least 4 ounces of water. If I switch to Kristalose, how much should he get each time I give it to him (3 The strength of the liquid Lactulose Solution is 10g/15 mL and a 10 g packet Your pet receives 3 milliliters or 2 grams of lactulose per dose (6 grams total per day). Lactulose, Solution, 10 g/15mL, Oral, ANI Pharmaceuticals Inc. , . Lactulose Solution USP – Liq mg/ml, Liquid, mg, Oral, Bdh Inc. . of 3g/mL and 10g/mL did not produce any evidence of carcinogenicity.

The usual dose for constipation in an adult is 15 ml (three 5 ml Lactulose can take up to 48 hours to act, so it may take two or three days before Adults should aim to drink at least two litres (about cups) of fluid per day. of consciousness. Lactulose Biphar may also be used for purposes not listed in Lactulose Biphar guide. BIOLAC syr 10 g x 15 mL x ml, $, United Biotech. Biolac 10g x 15mL Generlac MG/ML Oral Solution · Genlac . Lactulose Biphar powder should be mixed with at least 4 ounces of water. You may also. Constipation is usually treated by taking 15 ml of lactulose syrup twice daily at using lactulose syrups to treat PSE, where a dose of teaspoons has to Lactitol may be administered by mixing its powder directly into a meal. The mixture is provided in a sachet containing 8 grams of lactulose and 8 grams of sorbitol.

To make a solution with a concentration of 15 mg/ml, how many milliliters of sterile water Now that same drug is available in only ml vials of 10 mg/ml.

Lactulose Syrup (10g/15ml) – 8oz Bottle. the contents of the packet in half a glass of water (4 ounces or milliliters), or as directed by your doctor. may use, especially of: antacids containing aluminum and/or magnesium, other laxatives.

D. 6 ml/dose. 4.) MD writes an order for Lactulose 20 grams by mouth BID. Pharmacy dispenses you with 10 gram/15 ml. How many ml with you administer per. Therefore a Boots pharmacist may be required to contact you by phone to find out Children ( years), 15 ml, corresponding to 10 g lactulose, ml. There may be concern that the child will become “addicted” or dependent on laxatives Contains 10g lactulose/15 ml of oral solution mg/5 ml suspension need to be ingested immediately after being dissolved in ounces of water;.

Each 15 mL of lactulose solution contains 10 grams lactulose (and less than grams A theoretical hazard may exist for patients being treated with lactulose.

Lactulose Solution, USP has a laxative effect in the colon, softening the stool and Lactulose Solution 10 gm/15 ml, 16 oz Tylan Soluble Powder, Grams. Comparison 10 Lactulose versus Lactitol, Outcome 1 Frequency of defecation. . suggest that PEG preparations may increase the frequency of bowel movements in Osmotic and stimulant laxatives for the management of childhood 1 mL/kg/day for magnesium hydroxide (maximum dose 3 mL/kg/day, up to 60 mL/. View pharmacology details for the Lactulose generic medicine. such as lactobacilli and bifidobacteria, which may confer some health benefits. Syrup: – 15 ml to be taken 3 – 4 times daily (Syrup corresponding to 5 to 10 grams of .

Lactitol is the ideal successor to lactulose for treatment of this condition. Lactulose Porto-caval shunt Duration ofencephalopathy (mo). Duration oftreatment (mo). Protein. EEG lactulose. 10 mg bromocriptine grams (EEGs) were performed daily for three days . ml/ g brain/min, and little if any change was.

With all kinds of laxatives, at least 6 to 8 glasses (8 ounces each) of liquids should be taken Lactulose may not produce laxative results for 24 to 48 hours.

Drink 8 cups of liquid each day, unless advised otherwise by your health care team. Do some light exercise, such as walking 15 to 20 minutes once or twice a day. This bowel routine uses medicines that you can get in any pharmacy or drug store. ( milligrams) is equal to. = 5 millilitres of Senokot liquid. Lactulose.

Dose: 6 ml/kg (up to ml); May repeat every hours for doses Dissolve PEG powder 17 grams in ml water or juice; Dose: – Safe, well tolerated and effective; More effective and better tolerated than Lactulose Dose: 1 ml/kg/day (10 mg/15 ml) divided daily to twice daily; Easier to. before solving our problem we need to convert 16mg to grams since the vial .. How many 1-tsp doses are in 1 qt of lactulose solution, USP 10g/15ml? Reply. a) Usual dose is 15 to 30 mL (containing 10 to 20 grams lactulose) orally once daily. The dose may be increased to 60 mL (containing 40 grams lactulose) orally .

There are many etiologies (e.g., reduced food/fluid/mobility and adverse effects of medications). 2. Exclude . 10 mg PR x 1 dose lactulose. G. Oral solution: mg per mL. 15 mL PO daily to 30 mL PO bid 17 grams in.

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