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New search Medicine profile Lactulose

Clinical medicine profile

Lactulose

Osmotic Laxative [EPC]

POM
Evidence state Source-linked Review date not recorded
Route
ORAL, RECTAL
Schedule
POM
ATC
Not assigned
PPB status
registered
Patient advice Check interactions
01 Risk first

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.
02 Point of care

Dosing matrix

Population and organ-function guidance, shown together for faster comparison.

Adult

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.

Paediatric

Pediatric Use Very little information on the use of lactulose in pediatric patients has been recorded (see DOSAGE AND ADMINISTRATION ).

Renal

Review renal impairment dosing; many agents need CrCl/eGFR adjustment.

  • CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic

Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.

03 Clinical use

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.
  • 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.
04 Pharmacology

Mechanism & disposition

Mechanism is agent-specific.

Mechanism is agent-specific.At receptor, enzyme, ion channel, transpor…Confirm precise molecular mechanism in cur…
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.

Onset

Product-specific

Duration

Product-specific

Route

ORAL, RECTAL

Elimination

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...

05 Special populations

Pregnancy, lactation & diet

Pregnancy

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.

Lactation

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.

06 Kenya market

Brands & loaded prices

FromKES 199
MedianKES 301
Listings13
BrandManufacturerPackObserved 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
07 Provenance

Sources & review state

Primary sourceLocal active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Professional class pharmacology (Therapeutic agent (verify pharmacological class))
Last reviewedNot recorded
EvidenceSource-linked
Open source document ↗

Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.