Clinical medicine profile
Lactulose
Osmotic Laxative [EPC]
- Route
- ORAL, RECTAL
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- Hypersensitivity to the active substance or excipients.
- Additional absolute contraindications are indication- and product-specific — consult SmPC.
Precautions
- WARNINGS 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.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
DOSAGE AND ADMINISTRATION 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. Rectal When the adult patient is in the impending coma or coma stage of portal-systemic encephalopathy and the danger of aspiration exists, or when the necessary endoscopic or intubation procedures physically interfere with the administration of the recommended oral doses, lactulose solution may be given as a retention enema via a rectal balloon catheter. Cleansing enemas containing soapsuds or other alkaline agents should not be used. Three hundred ml of lactulose solution should be mixed with 700 mL of water or physiologic saline and retained for 30 to 60 minutes. Lactulose enema may be repeated every 4 to 6 hours. If the enema is inadvertently evacuated too promptly, it may be repeated immediately. The goal of treatment is reversal of the coma stage in order that the patient may be able to take oral medication. Reversal of coma may take place within 2 hours of the first enema in some patients. Lactulose, given orally in the recommended doses, should be started before Lactulose by enema is stopped entirely.
Pediatric Use Very little information on the use of lactulose in pediatric patients has been recorded (see DOSAGE AND ADMINISTRATION ).
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- INDICATIONS AND USAGE 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.
- The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy.
- An increase in patients' protein tolerance is also frequently observed with lactulose therapy.
- In the treatment of chronic portal-systemic encephalopathy, Lactulose has been given for over 2 years in controlled studies.
Adverse effects
- ADVERSE REACTIONS 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.
Drug interactions
Open multi-drug checker ↗- Professional use: confirm indication, dose, duration, monitoring and patient counselling points against current Kenya STG / EML and the product SmPC.
- Document allergy status and key interactions.
Mechanism & disposition
Mechanism is agent-specific.
Read complete mechanism
Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.
Product-specific
Product-specific
ORAL, RECTAL
has been determined to be 3% or less and is essentially complete within 24 hours. When incubated with extracts of human small intestinal mucosa, lactulose was not hydrolyzed during a 24-hour period and did not inhibit the activity of these extracts on lactose. Lactulose reaches t...
Pregnancy, lactation & diet
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.
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| B-LACT | Brookes Pharma Private Ltd | Syrup | Unavailable |
| DUPHALAC SP | Not recorded | 200ML | KES 1,046.35Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
| LACTITOSS | DAIMA BIASHARA / Wholesale Import | 100ML | KES 198.88Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
| LACTULAC SOLUTION | Not recorded | 100ML | KES 478.59Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
| LACTULIN SOL. | Not recorded | 100ML | KES 297.72Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
| Laxiwal Solution | Wallace Pharmaceuticals Pvt Ltd | Oral Solution | Unavailable |
| LAXULAC | ZAIN PHARMA LIMITED | Oral Solution | Unavailable |
| Livoluk solution | Panacea | tabs 100ml | Unavailable |
| Osmolax? | Afya Index product / manufacturer unverified | gm/ 15ml 200ml | Unavailable |
| OSMOLAX SOLUTION | Not recorded | 100ML | KES 301.00Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
| OSMOLAX SOLUTION3. | Not recorded | 5MG/5ML 200ML | KES 662.20Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
| Osmowin | Win-Medicare | tabs 100ml | Unavailable |
| Osmowin | Win-Medicare | tabs 200mL | Unavailable |
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.