Generlac 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
Laxative; Ammonia Detoxicant
Pharmacologic Class
Synthetic Disaccharide; Osmotic Laxative
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 by drawing water into your bowels, making stools softer and easier to pass. It's also used to treat a serious liver condition called hepatic encephalopathy by helping your body remove harmful substances like ammonia from your blood.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of 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
Some products may be administered as an enema. If your doctor prescribes this method, the medication will be given rectally by your healthcare provider.
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'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 the missed one.
To ensure you get the most out of 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
Some products may be administered as an enema. If your doctor prescribes this method, the medication will be given rectally by your healthcare provider.
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'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 the missed one.
Lifestyle & Tips
- Drink plenty of fluids (6-8 glasses of water daily) to help the medication work effectively and prevent dehydration.
- Maintain a balanced diet rich in fiber (fruits, vegetables, whole grains) to support bowel regularity.
- Engage in regular physical activity to promote healthy bowel function.
- Do not use other laxatives unless directed by your doctor, as this can make it difficult to adjust the lactulose dose.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For Hepatic Encephalopathy: Oral: 30-45 mL (20-30 g) 3-4 times daily. Rectal: 300 mL (200 g) in 700 mL water as a retention enema for 30-60 minutes, repeated every 4-6 hours if needed. For Constipation: Oral: 15-30 mL (10-20 g) once daily, may increase to 60 mL (40 g) daily if needed.
Dose Range:
15 - 60 mg
Condition-Specific Dosing:
hepaticEncephalopathy:
Oral: 30-45 mL 3-4 times daily, adjusted to produce 2-3 soft stools per day. Rectal: 300 mL in 700 mL water as retention enema.
constipation:
Oral: 15-30 mL once daily, adjusted to produce 1-2 soft stools per day.
Pediatric Dosing
Neonatal:
Not established for routine use, consult specialist for specific conditions.
Infant:
For Hepatic Encephalopathy: Oral: Initial 2.5-10 mL/day (1.67-6.67 g/day) in 3-4 divided doses, adjusted to produce 2-3 soft stools per day. For Constipation: Oral: 2.5-5 mL (1.67-3.33 g) once daily.
Child:
For Hepatic Encephalopathy: Oral: Initial 40-90 mL/day (26.7-60 g/day) in 3-4 divided doses, adjusted to produce 2-3 soft stools per day. For Constipation: Oral: 7.5-15 mL (5-10 g) once daily.
Adolescent:
For Hepatic Encephalopathy: Oral: Initial 40-90 mL/day (26.7-60 g/day) in 3-4 divided doses, adjusted to produce 2-3 soft stools per day. For Constipation: Oral: 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:
Not significantly dialyzable; no specific adjustment needed, but monitor electrolytes if significant diarrhea occurs.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
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 process lowers the pH of the colon, which then favors the formation of the nonabsorbable ammonium ion (NH4+) from ammonia (NH3). The trapped ammonium ions are then expelled in the feces. The osmotic effect of lactulose and its acidic metabolites also draws water into the colon, softening the stool and promoting peristalsis, leading to a laxative effect.
Pharmacokinetics
Absorption:
Bioavailability:
<3%
Tmax:
Not applicable (minimal systemic absorption); Onset of laxative action: 24-48 hours.
FoodEffect:
Minimal effect on absorption; can be taken with or without food.
Distribution:
Vd:
Not clinically relevant (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Fecal (primarily as unabsorbed drug and metabolites)
Unchanged:
>97% (excreted unchanged in feces or as bacterial metabolites)
Pharmacodynamics
OnsetOfAction:
24-48 hours (for laxative effect); for hepatic encephalopathy, clinical improvement may take several days.
PeakEffect:
Not a sharp peak; effect is sustained with continued administration.
DurationOfAction:
Continues as long as administered and bacterial metabolism occurs.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
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 side effects or only have mild ones, it's 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, contact your doctor for medical advice. 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 immediate medical attention:
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 side effects or only have mild ones, it's 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, contact your doctor for medical advice. 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
- Severe abdominal pain or cramping
- Nausea or vomiting that doesn't stop
- Signs of dehydration (e.g., extreme thirst, decreased urination, dizziness)
- Signs of electrolyte imbalance (e.g., muscle weakness, cramps, irregular heartbeat, confusion, extreme tiredness)
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 your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting 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 your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 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. 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 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. 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:
- Diarrhea
- Abdominal cramps
- Electrolyte disturbances (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)
- Non-absorbable antacids (e.g., aluminum hydroxide, magnesium hydroxide) - may inhibit the bacterial degradation of lactulose by raising colonic pH.
- Other laxatives (may obscure the clinical response to lactulose, especially in hepatic encephalopathy, making dose titration difficult)
- Diuretics (e.g., thiazides, loop diuretics) - increased risk of hypokalemia due to excessive fluid and electrolyte loss from diarrhea induced by lactulose.
Monitoring
Baseline Monitoring
Baseline mental status (for hepatic encephalopathy)
Rationale: To assess the severity of encephalopathy and establish a starting point for treatment efficacy.
Timing: Prior to initiation of therapy.
Electrolytes (Na, K, Cl, HCO3)
Rationale: To identify any pre-existing imbalances, especially if patient is dehydrated or has other comorbidities.
Timing: Prior to initiation of therapy, especially in patients at risk for electrolyte disturbances.
Routine Monitoring
Number and consistency of bowel movements
Frequency: Daily
Target: 2-3 soft stools per day (for hepatic encephalopathy); 1-2 soft stools per day (for constipation)
Action Threshold: If no bowel movement for 24-48 hours, or if excessive diarrhea (more than 3-4 stools/day) occurs, adjust dose.
Mental status (for hepatic encephalopathy)
Frequency: Daily or as clinically indicated
Target: Improvement in level of consciousness, reduction in asterixis, improved cognitive function.
Action Threshold: Lack of improvement or worsening of encephalopathy may indicate need for dose adjustment or alternative therapy.
Serum electrolytes (Na, K, Cl, HCO3)
Frequency: Periodically, especially with prolonged use, high doses, or significant diarrhea/vomiting.
Target: Within normal limits.
Action Threshold: Hypokalemia, hyponatremia, or other imbalances require intervention (e.g., electrolyte replacement, dose adjustment).
Ammonia levels (for hepatic encephalopathy)
Frequency: Periodically, though clinical response is often a better guide.
Target: Reduction towards normal range.
Action Threshold: Persistently high ammonia levels despite adequate stooling may indicate need for dose increase or alternative therapy.
Symptom Monitoring
- Abdominal pain
- Bloating
- Flatulence
- Diarrhea
- Nausea
- Vomiting
- Signs of dehydration (e.g., dry mouth, decreased urination)
- Signs of electrolyte imbalance (e.g., muscle weakness, cramps, irregular heartbeat, confusion)
Special Patient Groups
Pregnancy
Lactulose is minimally absorbed systemically, so maternal and fetal exposure is negligible. It is generally considered safe for use during pregnancy. Category B.
Trimester-Specific Risks:
First Trimester:
Low risk; minimal systemic absorption.
Second Trimester:
Low risk; minimal systemic absorption.
Third Trimester:
Low risk; minimal systemic absorption.
Lactation
Lactulose is minimally absorbed by the mother, and therefore, excretion into breast milk is negligible. It is considered compatible with breastfeeding (L1 - Safest).
Infant Risk:
Very low risk; unlikely to cause adverse effects in a breastfed infant.
Pediatric Use
Lactulose is used in pediatric patients for both constipation and hepatic encephalopathy. Dosing must be carefully adjusted based on age, weight, and clinical response. Monitor for dehydration and electrolyte imbalances, especially in infants and young children.
Geriatric Use
Lactulose is generally safe for use in geriatric patients. However, elderly patients may be more susceptible to dehydration and electrolyte imbalances from excessive diarrhea. Close monitoring of fluid status and electrolytes is recommended. Start with lower doses and titrate carefully.
Clinical Information
Clinical Pearls
- Lactulose solution has a very sweet taste; it can be mixed with water, fruit juice, or milk to improve palatability.
- The goal of lactulose therapy for hepatic encephalopathy is to produce 2-3 soft bowel movements per day. The dose should be titrated to achieve this.
- For rectal administration in hepatic encephalopathy, the enema should be retained for 30-60 minutes. If retention is difficult, it can be repeated.
- Patients should be advised that it may take 24-48 hours for the full laxative effect to be observed.
- Monitor for signs of dehydration and electrolyte imbalance, especially hypokalemia, with prolonged use or excessive diarrhea.
- Do not administer lactulose with non-absorbable antacids, as they may interfere with the desired colonic pH reduction.
Alternative Therapies
- For Constipation: Polyethylene glycol (PEG), magnesium hydroxide, docusate sodium, senna, bisacodyl, fiber supplements.
- For Hepatic Encephalopathy: Rifaximin (antibiotic to reduce ammonia-producing bacteria), neomycin (older antibiotic, less common due to systemic absorption), protein restriction (short-term), branched-chain amino acids.
Cost & Coverage
Average Cost:
$15 - $50 per 473 mL bottle (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.