Enulose 10gm/15ml Oral/rectal Sol
It is used to treat or prevent certain brain or mental problems caused by liver disease. It may be used by mouth or rectally.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Ammonia Detoxicant; Laxative, Osmotic
Pharmacologic Class
Synthetic disaccharide
Pregnancy Category
Category B
FDA Approved
Aug 1972
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lactulose is a type of sugar that helps treat constipation and a serious liver condition called hepatic encephalopathy. For constipation, it works by drawing water into your bowels to soften your stool. For liver conditions, it helps remove harmful ammonia from your body by making your stool more acidic and trapping the ammonia so it can be passed out.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
Oral Administration
Do not take antacids at the same time as your medication. Consult with your doctor for guidance.
When taking the liquid form, measure your dose accurately using the measuring device provided with the medication. If one is not included, ask your pharmacist for a suitable measuring device.
To improve the taste, you can mix the liquid with water, milk, or fruit juice.
Rectal Administration (Enema)
Some products may be administered rectally as an enema. If you are using this medication as an enema, it will be given by your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom.
Do not freeze your medication.
Protect it from heat and light to maintain its effectiveness.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
Oral Administration
Do not take antacids at the same time as your medication. Consult with your doctor for guidance.
When taking the liquid form, measure your dose accurately using the measuring device provided with the medication. If one is not included, ask your pharmacist for a suitable measuring device.
To improve the taste, you can mix the liquid with water, milk, or fruit juice.
Rectal Administration (Enema)
Some products may be administered rectally as an enema. If you are using this medication as an enema, it will be given by your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom.
Do not freeze your medication.
Protect it from heat and light to maintain its effectiveness.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Maintain adequate fluid intake to prevent dehydration, especially if experiencing diarrhea.
- Follow a low-protein diet as recommended by your doctor for hepatic encephalopathy.
- Do not use other laxatives unless directed by your doctor, as this can lead to severe diarrhea and electrolyte imbalance.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Hepatic Encephalopathy (Oral): Initially 30-45 mL (20-30 g) 3-4 times daily. Titrate to produce 2-3 soft stools per day. Hepatic Encephalopathy (Rectal): 300 mL (200 g) mixed with 700 mL water or saline, administered via rectal balloon catheter and retained for 30-60 minutes. May be repeated every 4-6 hours if needed.
Dose Range:
20 - 45 mg
Condition-Specific Dosing:
constipation:
Oral: 15-30 mL (10-20 g) once daily. May increase to 60 mL (40 g) daily if needed.
Pediatric Dosing
Neonatal:
Not established for routine use; consult specialist for hepatic encephalopathy (e.g., 2.5-10 mL/day divided doses, titrate to effect).
Infant:
Hepatic Encephalopathy: 2.5-10 mL/day (1.67-6.67 g/day) divided 3-4 times daily. Titrate to 2-3 soft stools/day. Constipation: 2.5-10 mL/day (1.67-6.67 g/day) once daily.
Child:
Hepatic Encephalopathy: 40-90 mL/day (26.7-60 g/day) divided 3-4 times daily. Titrate to 2-3 soft stools/day. Constipation: 40-90 mL/day (26.7-60 g/day) once daily.
Adolescent:
Hepatic Encephalopathy: 30-45 mL (20-30 g) 3-4 times daily. Titrate to 2-3 soft stools/day. Constipation: 15-30 mL (10-20 g) once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; not significantly dialyzable due to minimal absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed (primary indication for hepatic encephalopathy)
Pharmacology
Mechanism of Action
Lactulose is a synthetic disaccharide (galactose and fructose) that is not absorbed from the gastrointestinal tract. In the colon, it is metabolized by colonic bacteria into low molecular weight organic acids (lactic acid, acetic acid). This leads to: 1) An osmotic effect, drawing water into the colon, softening stool, and promoting defecation (laxative effect). 2) Acidification of the colonic contents, which converts ammonia (NH3) to ammonium (NH4+). Ammonium is polar and poorly absorbed, thus trapping it in the colon and promoting its excretion in feces. This reduces blood ammonia concentrations, which is beneficial in hepatic encephalopathy.
Pharmacokinetics
Absorption:
Bioavailability:
<3% (minimal)
Tmax:
Not applicable (minimal absorption)
FoodEffect:
Not significant
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Primarily fecal (as unabsorbed drug and metabolites)
Unchanged:
>97% (feces)
Pharmacodynamics
OnsetOfAction:
24-48 hours (for laxative effect and ammonia reduction)
PeakEffect:
24-72 hours
DurationOfAction:
Variable, depends on dosing frequency and patient response
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Diarrhea
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Burping
Stomach cramps
Gas
* Upset stomach or vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Diarrhea
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Burping
Stomach cramps
Gas
* Upset stomach or vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or watery diarrhea (contact doctor immediately)
- Severe abdominal pain or cramping that does not subside
- Signs of dehydration (e.g., extreme thirst, dry mouth, decreased urination, dizziness, lightheadedness)
- Worsening confusion, disorientation, or lethargy (for hepatic encephalopathy)
- Vomiting that prevents you from keeping the medication down
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are following a low-galactose or lactose-free diet.
If you are currently taking other laxatives.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of the following with your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your overall health and any existing medical conditions
Remember, before starting, stopping, or adjusting the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are following a low-galactose or lactose-free diet.
If you are currently taking other laxatives.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of the following with your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your overall health and any existing medical conditions
Remember, before starting, stopping, or adjusting the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.
If you have diabetes (high blood sugar), consult with your doctor before taking this medication, as some products may contain sugar.
Before undergoing certain medical procedures, such as a proctoscopy or colonoscopy, inform your doctor that you are taking this drug.
Prolonged diarrhea can lead to dehydration and electrolyte imbalances. If you experience diarrhea, consult with your doctor about preventive measures to avoid these complications.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.
If you have diabetes (high blood sugar), consult with your doctor before taking this medication, as some products may contain sugar.
Before undergoing certain medical procedures, such as a proctoscopy or colonoscopy, inform your doctor that you are taking this drug.
Prolonged diarrhea can lead to dehydration and electrolyte imbalances. If you experience diarrhea, consult with your doctor about preventive measures to avoid these complications.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe diarrhea
- Abdominal cramping
- Electrolyte imbalances (especially hypokalemia, hyponatremia)
- Dehydration
What to Do:
Discontinue lactulose. Provide supportive care, including fluid and electrolyte replacement. Monitor electrolyte levels closely. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Antacids (may reduce the desired pH-lowering effect of lactulose in the colon)
- Other laxatives (may lead to excessive diarrhea and electrolyte imbalance, making it difficult to titrate lactulose for hepatic encephalopathy)
Monitoring
Baseline Monitoring
Mental Status (e.g., Glasgow Coma Scale, West Haven Criteria)
Rationale: To assess baseline severity of hepatic encephalopathy and monitor treatment response.
Timing: Prior to initiation of therapy
Serum Ammonia Levels
Rationale: To assess baseline ammonia burden, though clinical response (mental status, bowel movements) is often more important for titration.
Timing: Prior to initiation of therapy
Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)
Rationale: To establish baseline and identify pre-existing imbalances, especially in patients with liver disease or those at risk of dehydration.
Timing: Prior to initiation of therapy
Fluid Status
Rationale: To assess baseline hydration status.
Timing: Prior to initiation of therapy
Routine Monitoring
Number and Consistency of Bowel Movements
Frequency: Daily
Target: 2-3 soft stools per day (for hepatic encephalopathy)
Action Threshold: If <2 or >3 stools/day, or if watery diarrhea, adjust dose.
Mental Status
Frequency: Daily (or more frequently in acute HE)
Target: Improvement in cognitive function, reduced asterixis, improved consciousness
Action Threshold: Lack of improvement or worsening may indicate need for dose adjustment or alternative therapy.
Serum Electrolytes (especially Potassium)
Frequency: Periodically, especially with prolonged use, excessive diarrhea, or concomitant diuretic use
Target: Within normal limits
Action Threshold: Hypokalemia or other electrolyte imbalances require intervention (e.g., potassium supplementation, dose adjustment of lactulose or other medications).
Fluid Status
Frequency: Daily
Target: Adequate hydration
Action Threshold: Signs of dehydration (e.g., dry mucous membranes, decreased urine output, orthostasis) require fluid replacement and dose adjustment.
Symptom Monitoring
- Abdominal cramping
- Bloating
- Flatulence
- Nausea
- Diarrhea (especially severe or watery)
- Vomiting
- Signs of dehydration (e.g., excessive thirst, decreased urination, dizziness)
- Worsening mental status (e.g., confusion, lethargy, disorientation)
Special Patient Groups
Pregnancy
Lactulose is minimally absorbed systemically and is generally considered safe for use during pregnancy. It is often used to treat constipation in pregnant women. No evidence of fetal harm has been reported.
Trimester-Specific Risks:
First Trimester:
Low risk
Second Trimester:
Low risk
Third Trimester:
Low risk
Lactation
Lactulose is minimally absorbed systemically by the mother and is not excreted into breast milk in significant amounts. It is considered compatible with breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Lactulose is used in pediatric patients for both constipation and hepatic encephalopathy. Dosing must be carefully titrated based on age, weight, and clinical response to avoid excessive diarrhea and electrolyte disturbances. Close monitoring of fluid and electrolyte status is crucial.
Geriatric Use
Geriatric patients may be more susceptible to dehydration and electrolyte imbalances due to excessive diarrhea. Close monitoring of fluid status, electrolytes, and renal function is recommended. Start with lower doses and titrate carefully.
Clinical Information
Clinical Pearls
- Lactulose is a viscous, sweet-tasting solution. It can be mixed with water, fruit juice, or milk to improve palatability.
- For hepatic encephalopathy, the goal is to achieve 2-3 soft bowel movements per day. The dose should be adjusted to meet this target, not necessarily to normalize ammonia levels.
- Rectal administration (enema) is typically used for acute hepatic encephalopathy when oral administration is not feasible (e.g., comatose patients) or for rapid initial ammonia reduction.
- Patients may experience flatulence, bloating, and abdominal cramping, especially at the beginning of therapy. These usually subside with continued use.
- Do not administer lactulose with other laxatives, as this can lead to severe diarrhea and make it difficult to assess the effectiveness of lactulose for hepatic encephalopathy.
- Monitor for signs of dehydration and electrolyte imbalance, particularly hypokalemia, especially in patients with prolonged diarrhea or those on diuretics.
Alternative Therapies
- Rifaximin (for hepatic encephalopathy, often used in combination with lactulose or as an alternative)
- Neomycin (older antibiotic for HE, less common due to ototoxicity/nephrotoxicity)
- Polyethylene glycol (PEG) (for constipation)
- Magnesium hydroxide (for constipation)
- Docusate sodium (for constipation)
Cost & Coverage
Average Cost:
$20 - $100 per 473 mL bottle (oral solution)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.