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Lactulose

Constipation, Hepatic Encephalopathy

DRUG STATUS

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Approvals

US(FDA), UK(BNF)

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Essential Medicine

YES

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Teratogenicity

Unlisted

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Pharmaceutical Class

Osmotic Laxative

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Drug Ingredient

Lactulose

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Summary

  • Lactulose is used to treat chronic or occasional constipation. It softens stools and improves bowel movements. It also reduces ammonia levels in patients with liver disease, preventing or treating confusion, drowsiness, or coma caused by Hepatic Encephalopathy.

  • Lactulose works locally in the gut. For constipation, it pulls water into the colon which softens the stool and promotes bowel movements. For hepatic encephalopathy, it reduces ammonia in the blood by converting it into a non-toxic form that is excreted in the stool.

  • For constipation, the initial dose is 15-30 mL daily and the maintenance dose is 10-20 mL daily, adjusted based on response. For hepatic encephalopathy, the initial dose is 30-45 mL 3-4 times daily, adjusted to produce 2-3 soft stools daily. Lactulose can be taken with or without food.

  • Common side effects of Lactulose include bloating, gas, abdominal cramping, and diarrhea with high doses. Serious adverse effects include severe dehydration or electrolyte imbalance due to prolonged diarrhea, and worsened abdominal pain or bloating.

  • Lactulose should not be used in cases of severe or unknown bowel obstruction or in patients with a rare inherited disorder called galactosemia. It should be used with caution in patients with gastrointestinal issues like irritable bowel syndrome (IBS) or galactose intolerance. Prolonged use or high doses may cause dehydration and imbalances in sodium and potassium.

Indications and Purpose

What is Lactulose used for?

Constipation:

  • Used to treat chronic or occasional constipation by softening stools and improving bowel movements.

Hepatic Encephalopathy (HE):

  • Helps reduce ammonia levels in patients with liver disease to prevent or treat confusion, drowsiness, or coma caused by HE.

Other Possible Uses (off-label):

  • Certain bowel disorders requiring stool softening, as determined by a doctor.

How does Lactulose work?

  1. Constipation: Pulls water into the colon, softening stool and promoting bowel movements.
  2. Hepatic Encephalopathy: Reduces ammonia in the blood by converting it into a non-toxic form excreted in stool.

Is Lactulose effective?

  1. Constipation: Clinical trials show Lactulose improves stool frequency and consistency within 24–48 hours, making it effective for chronic and acute cases.
  2. Hepatic Encephalopathy: Studies confirm Lactulose reduces ammonia levels, improves mental status, and prevents HE episodes in liver disease patients.
  3. Safety and Tolerability: Proven safe for long-term use, with mild side effects like gas or bloating.

How does one know if Lactulose is working?

For Constipation:

  • Frequency: Increased regular bowel movements.
  • Consistency: Softer stools, easier to pass.
  • Relief: Reduced discomfort from constipation symptoms.

For Hepatic Encephalopathy:

  • Ammonia Levels: Reduced ammonia in blood tests.
  • Cognitive Function: Improved mental clarity and reduced confusion.
  • Prevention: Fewer HE episodes.

Directions for Use

What is the usual dose of Lactulose?

The typical dose for adults is 15-30 mL daily, containing 10-20 g of lactulose. The dose may be increased to 60 mL daily if necessary. For children, specific dosage guidance is not detailed.

How do I take Lactulose?

  • Dosage: Follow the dose prescribed by your doctor. It is usually taken once or twice daily.
  • With or Without Food: Lactulose can be taken with or without food. If it upsets your stomach, take it with meals.
  • Food Restrictions: Generally, no specific food restrictions are required. However, maintain a balanced diet and drink plenty of fluids to aid its effects.
  • Other Tips: Avoid overuse as it may cause diarrhea. Contact a doctor if you experience severe side effects.

For how long do I take Lactulose?

Use Lactulose as directed by your physician. It may be used long-term for chronic constipation, but periodic monitoring is advised for prolonged use.

How long does it take for Lactulose to start working?

Lactulose typically takes 24 to 48 hours to produce a bowel movement when used for constipation. For hepatic encephalopathy, its effects may begin within 24 hours but may take longer to fully regulate ammonia levels. Ensure consistent dosing as prescribed for the best results.

How should I store Lactulose?

Lactulose should be stored at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze it. Keep the medicine away from heat and light. If the medicine turns dark, cloudy, or becomes too thick to pour, do not use it. Always ensure the bottle is tightly closed and store it in a cool, dry place, out of reach of children.

Warnings and Precautions

Who should avoid taking Lactulose?

  • Electrolyte Imbalance: Prolonged use or high doses may cause dehydration and imbalances in sodium and potassium.
  • Abdominal Issues: Use with caution in patients with gastrointestinal issues like bowel obstruction, irritable bowel syndrome (IBS), or galactose intolerance.
  • Monitor in Liver Disease: Adjust dosage carefully in hepatic encephalopathy patients to avoid overuse.

Contraindications:

  • Bowel Obstruction: Should not be used in cases of severe or unknown bowel obstruction.
  • Galactosemia: Contraindicated in patients with this rare inherited disorder.

Can I take Lactulose with other prescription drugs?

Lactulose may interact with diuretics (increasing the risk of electrolyte imbalances), antibiotics (affecting gut bacteria and Lactulose’s efficacy in treating hepatic encephalopathy), other laxatives (causing dehydration or excessive diarrhea), and corticosteroids (increasing electrolyte disturbances). Always inform your doctor about other medications to avoid harmful interactions and ensure proper use of Lactulose.

Can I take Lactulose with vitamins or supplements?

Electrolyte Supplements:

  • Lactulose can cause dehydration or electrolyte imbalances (low potassium or sodium). If taking supplements like potassium, monitor levels closely.

Magnesium:

  • Combining Lactulose with magnesium-containing supplements may increase the risk of diarrhea and dehydration.

Vitamins:

  • Long-term use may reduce absorption of certain vitamins (e.g., Vitamin K, calcium), especially if it causes diarrhea.

Can Lactulose be taken safely while pregnant?

Lactulose is generally considered safe during pregnancy, as it is not absorbed into the bloodstream and acts locally in the gut. There is no evidence of fetal harm from its use. However, it should only be used during pregnancy when clearly needed, and the benefits should be weighed against any potential risks. Always consult a healthcare provider before using Lactulose during pregnancy.

Can Lactulose be taken safely while breastfeeding?

Lactulose is considered safe during lactation. It is not absorbed into the bloodstream in significant amounts, so it is unlikely to affect breast milk or harm the baby. However, it's always best to consult a healthcare provider before using any medication while breastfeeding, to ensure it’s appropriate based on individual circumstances.

Is Lactulose safe for the elderly?

Elderly patients on Lactulose for over six months should have periodic serum electrolyte monitoring to prevent imbalances, their blood needs to be tested regularly to check the levels of potassium, chloride, and carbon dioxide. These tests are important because lactulose can sometimes affect these levels. Also, some antacids can stop lactulose from working properly.

Is it safe to exercise while taking Lactulose?

Yes, exercising while taking Lactulose is safe unless side effects such as diarrhea cause discomfort. Consult your doctor if symptoms interfere with activity.

Is it safe to drink alcohol while taking Lactulose?

Interactions with alcohol is not known, but general caution is advised.