pharmacopeia
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/api/v1/drug/lactulose

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Acidifying Activity; Osmotic Activity.

Indications

Sourced from openFDA
  • For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns.

Contraindications

Sourced from openFDA
  • Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.contraindicated

Dosage & administration

Sourced from openFDA

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 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 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.

Warnings & precautions

Sourced from openFDA

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

Adverse reactions

Sourced from openFDA

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 EVENTS, contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

Use in specific populations

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

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 50 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.

Approval history

Sourced from openFDA
  • Jul 30, 1996ANDAANDA074623Pharm Assoc
  • Oct 31, 1996ANDAANDA074603Chartwell Rx
  • Dec 10, 1997ANDAANDA074712Cumberland Pharms
  • Jul 26, 2001ANDAANDA075993Lannett Co Inc
  • Feb 21, 2002ANDAANDA075911Pharmobedient
  • Jul 28, 2003ANDAANDA076645Bajaj
  • Jan 25, 2012ANDAANDA090502Fresenius Kabi
  • Jan 25, 2012ANDAANDA090503Fresenius Kabi

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
37,667 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea2,5796.8%
  2. 2Constipation2,5356.7%
  3. 3Fall2,2776.0%
  4. 4Vomiting2,0995.6%
  5. 5Fatigue2,0585.5%
  6. 6Death1,9705.2%
  7. 7Dyspnoea1,9405.2%
  8. 8Diarrhoea1,9345.1%
  9. 9Pain1,7374.6%
  10. 10Pneumonia1,7164.6%
  11. 11Off Label Use1,6074.3%
  12. 12Hypotension1,5514.1%
  13. 13Confusional State1,5024.0%
  14. 14Pyrexia1,4173.8%
  15. 15Asthenia1,3553.6%

Literature

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Recent PubMed references pinned to Lactulose as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 219 ClinicalTrials.gov registrations naming Lactulose as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Lactulose work?
Mechanism-of-action classes: Acidifying Activity; Osmotic Activity.
What is Lactulose used for?
According to FDA labeling, Lactulose carries indications including: For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Lactulose?
Lactulose is classified as Osmotically acting laxatives, Osmotic Laxative, Acidifying Activity, Osmotic Activity, Increased Large Intestinal Motility, Inhibition Large Intestine Fluid/Electrolyte Absorption, Stimulation Large Intestine Fluid/Electrolyte Secretion, Stimulation Small Intestine Fluid/Electrolyte Secretion.
What are the brand names for Lactulose?
Lactulose is marketed under brand names including Constulose, Enulose, Generlac, Kristalose.
What are the contraindications for Lactulose?
Lactulose labeling lists contraindications including: Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.. Always consult the full prescribing information and a clinician.
Note. Data for lactulose is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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