Constulose 10gm/15ml Solution
It is used to treat constipation.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Laxative, Ammonia Detoxicant
Pharmacologic Class
Synthetic disaccharide, Osmotic laxative
Pregnancy Category
Category B
FDA Approved
Aug 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lactulose is a type of sugar that helps you have bowel movements by drawing water into your intestines. It's also used to help people with liver problems by reducing a harmful substance called ammonia in their blood.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. It's essential to take your medication as directed by your doctor.
When taking this medication, avoid taking antacids at the same time. If you have any questions or concerns, discuss them with your doctor. To ensure accurate dosing, measure liquid medications carefully using the measuring device provided with your medication. If a measuring device is not included, ask your pharmacist for a suitable device to measure your medication.
To make the liquid medication more palatable, you can mix it with water, milk, or fruit juice.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Do not freeze your medication, and protect it from heat and light.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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 make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. It's essential to take your medication as directed by your doctor.
When taking this medication, avoid taking antacids at the same time. If you have any questions or concerns, discuss them with your doctor. To ensure accurate dosing, measure liquid medications carefully using the measuring device provided with your medication. If a measuring device is not included, ask your pharmacist for a suitable device to measure your medication.
To make the liquid medication more palatable, you can mix it with water, milk, or fruit juice.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Do not freeze your medication, and protect it from heat and light.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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 make up for a missed dose.
Lifestyle & Tips
- Drink plenty of fluids (water, juice) while taking lactulose to prevent dehydration and help the medication work effectively.
- Maintain a balanced diet rich in fiber (unless advised otherwise by your doctor) to support regular bowel movements.
- Engage in regular physical activity, if possible, to promote bowel regularity.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For constipation: 15-30 mL (10-20 g) orally once daily. For hepatic encephalopathy: 30-45 mL (20-30 g) orally 3-4 times daily, adjusted to produce 2-3 soft stools per day.
Dose Range:
15 - 180 mg
Condition-Specific Dosing:
constipation:
15-30 mL (10-20 g) orally once daily; may increase to 60 mL (40 g) daily if needed.
hepaticEncephalopathy:
Initial: 30-45 mL (20-30 g) orally 3-4 times daily. Maintenance: Adjust dose to produce 2-3 soft stools per day. May also be given via nasogastric tube or retention enema (300 mL lactulose with 700 mL water for 30-60 minutes, repeated every 4-6 hours if needed).
Pediatric Dosing
Neonatal:
Not established for routine use; consult specialist for specific conditions like neonatal cholestasis or hepatic encephalopathy (e.g., 2.5-10 mL/day divided doses).
Infant:
Constipation: 2.5-10 mL (1.67-6.7 g) orally daily, adjusted to produce 1-2 soft stools per day. Hepatic Encephalopathy: 2.5-10 mL (1.67-6.7 g) orally 3-4 times daily, adjusted to produce 2-3 soft stools per day.
Child:
Constipation: 7.5-15 mL (5-10 g) orally daily, adjusted to produce 1-2 soft stools per day. Hepatic Encephalopathy: 40-90 mL/day (26.7-60 g/day) orally divided 3-4 times daily, adjusted to produce 2-3 soft stools per day.
Adolescent:
Constipation: 15-30 mL (10-20 g) orally once daily. Hepatic Encephalopathy: 30-45 mL (20-30 g) orally 3-4 times daily, adjusted to produce 2-3 soft stools per day.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Dialysis:
No adjustment needed, as it is minimally absorbed and primarily acts locally in the colon.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed (used to treat hepatic encephalopathy).
Pharmacology
Mechanism of Action
Lactulose is a synthetic disaccharide that is not absorbed systemically. In the colon, it is metabolized by colonic bacteria into low molecular weight organic acids (primarily lactic acid and acetic acid). This leads to an osmotic effect, drawing water into the colon and softening the stool, thereby promoting defecation (laxative effect). In hepatic encephalopathy, the acidification of the colonic contents converts ammonia (NH3) to ammonium (NH4+), which is poorly absorbed and subsequently trapped in the colon and expelled in the feces. This reduces blood ammonia levels.
Pharmacokinetics
Absorption:
Bioavailability:
<3% (minimally absorbed)
Tmax:
Not applicable for systemic effect; onset of laxative action is 24-48 hours.
FoodEffect:
Can be taken with or without food.
Distribution:
Vd:
Not applicable (minimally absorbed)
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimally absorbed)
Clearance:
Not applicable
ExcretionRoute:
Fecal (as unchanged drug or bacterial metabolites)
Unchanged:
>97% (excreted unchanged or as metabolites in feces)
Pharmacodynamics
OnsetOfAction:
Constipation: 24-48 hours. Hepatic Encephalopathy: May take 24-48 hours for full therapeutic effect, but initial ammonia reduction can be seen sooner.
PeakEffect:
Not applicable for a typical peak effect; effect is continuous with regular dosing.
DurationOfAction:
Effect persists as long as dosing continues and bowel movements are maintained.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Burping
Stomach cramps
Gas
* Upset stomach or vomiting
Note: This is not an exhaustive list of all possible 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, this medication can cause severe and potentially life-threatening side effects. If you experience 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 may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Burping
Stomach cramps
Gas
* Upset stomach or vomiting
Note: This is not an exhaustive list of all possible 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 persistent diarrhea (more than 3-4 loose stools per day)
- Severe abdominal pain or cramping
- Nausea or vomiting that doesn't go away
- Signs of dehydration (e.g., extreme thirst, dry mouth, dizziness, decreased urination)
- Muscle weakness or cramps (may indicate electrolyte imbalance)
- Worsening confusion or mental status changes (if taking for liver disease)
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 list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
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 list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
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. To prevent these complications, discuss with your doctor the best ways to stay hydrated and maintain healthy electrolyte levels.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to weigh the benefits and risks of this medication for both you and your baby, and your doctor will help you make an informed decision.
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. To prevent these complications, discuss with your doctor the best ways to stay hydrated and maintain healthy electrolyte levels.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to weigh the benefits and risks of this medication for both you and your baby, and your doctor will help you make an informed decision.
Overdose Information
Overdose Symptoms:
- Diarrhea
- Abdominal cramps
- Electrolyte imbalance (especially hypokalemia, hyponatremia)
- Dehydration
What to Do:
Discontinue lactulose. Provide supportive care, including fluid and electrolyte replacement. Contact a poison control center or seek immediate medical attention. Call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Antacids (may reduce the desired pH-lowering effect of lactulose in the colon, potentially interfering with ammonia trapping in hepatic encephalopathy)
- Other laxatives (may lead to excessive diarrhea and electrolyte imbalance, especially hypokalemia)
- Non-absorbable antacids (e.g., aluminum hydroxide, magnesium hydroxide) - theoretical interaction, may raise colonic pH and counteract lactulose's effect.
Monitoring
Baseline Monitoring
Bowel habits/frequency
Rationale: To establish baseline for constipation treatment.
Timing: Prior to initiation.
Electrolyte levels (especially potassium, sodium, chloride)
Rationale: To assess baseline and monitor for potential imbalances, particularly in patients with hepatic encephalopathy or those at risk of dehydration.
Timing: Prior to initiation, especially in hepatic encephalopathy.
Mental status (hepatic encephalopathy)
Rationale: To assess baseline severity of encephalopathy.
Timing: Prior to initiation.
Routine Monitoring
Number and consistency of stools
Frequency: Daily
Target: Constipation: 1-2 soft stools/day; Hepatic Encephalopathy: 2-3 soft stools/day.
Action Threshold: Excessive diarrhea (more than 3-4 stools/day) or no bowel movement for 2-3 days.
Electrolyte levels (potassium, sodium, chloride)
Frequency: Periodically, especially with high doses or prolonged use, or in patients with hepatic encephalopathy.
Target: Within normal limits.
Action Threshold: Hypokalemia, hyponatremia, or other significant imbalances.
Blood ammonia levels (hepatic encephalopathy)
Frequency: Periodically, as clinically indicated, to guide dose titration.
Target: Reduction towards normal or improvement in clinical symptoms.
Action Threshold: Persistent elevated ammonia despite adequate stool output, or worsening encephalopathy.
Mental status (hepatic encephalopathy)
Frequency: Daily or as clinically indicated.
Target: Improvement in level of consciousness, orientation, and cognitive function.
Action Threshold: Worsening confusion, lethargy, or other signs of encephalopathy.
Symptom Monitoring
- Abdominal pain
- Bloating
- Flatulence
- Diarrhea (excessive)
- Nausea
- Vomiting
- Signs of dehydration (dry mouth, decreased urination, excessive thirst)
- Muscle weakness or cramps (signs of electrolyte imbalance)
- Confusion or changes in mental status (in hepatic encephalopathy)
Special Patient Groups
Pregnancy
Lactulose is generally considered safe for use during pregnancy (Pregnancy Category B). It is minimally absorbed systemically, reducing potential fetal exposure.
Trimester-Specific Risks:
First Trimester:
No known increased risk of congenital anomalies.
Second Trimester:
No known adverse effects.
Third Trimester:
No known adverse effects.
Lactation
Lactulose is considered safe for use during breastfeeding (Lactation Risk L1). It is minimally absorbed by the mother, and therefore, negligible amounts are expected to pass into breast milk. No adverse effects on the breastfed infant are expected.
Infant Risk:
Low to none.
Pediatric Use
Lactulose is commonly used in pediatric patients for chronic constipation and hepatic encephalopathy. Dosing must be carefully adjusted based on age, weight, and clinical response. Close monitoring for dehydration and electrolyte imbalances is crucial, especially in infants and young children.
Geriatric Use
No specific dose adjustments are typically required for elderly patients. However, geriatric patients may be more susceptible to dehydration and electrolyte imbalances due to excessive diarrhea. Close monitoring of fluid status and electrolytes is recommended.
Clinical Information
Clinical Pearls
- Lactulose may take 24-48 hours to produce a bowel movement; patients should be advised of this delay.
- The taste of lactulose can be very sweet and sometimes unpleasant. It can be mixed with water, fruit juice, or milk to improve palatability.
- For hepatic encephalopathy, the goal is 2-3 soft stools per day. Adjust the dose to achieve this target, not necessarily based on ammonia levels alone.
- Patients may experience flatulence and abdominal cramping, especially during the initial days of treatment. These side effects usually subside with continued use.
- Ensure adequate fluid intake to prevent dehydration, particularly with higher doses or prolonged use.
- Do not use other laxatives concurrently unless specifically directed by a healthcare provider, due to increased risk of severe diarrhea and electrolyte imbalance.
Alternative Therapies
- For constipation: Polyethylene glycol (PEG), magnesium hydroxide, docusate sodium, senna, bisacodyl, psyllium.
- For hepatic encephalopathy: Rifaximin, neomycin (less common due to systemic absorption and side effects), dietary protein restriction (in acute phases).
Cost & Coverage
Average Cost:
Varies widely, typically $15-$50 per 473 mL bottle
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.