Lactulose

What it is and how it works

Mechanism class: Osmotic Activity · Acidifying Activity

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 solution therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose solution has been given for over 2 years in controlled studies.

Dosage and administration (summary)

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 Generlac Solution) 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 Generlac Solution 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 Generlac Solution 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.

Contraindications

CONTRAINDICATIONS Since Generlac Solution (Lactulose Solution, USP) contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.

Warnings and 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.

Storage and supply

HOW SUPPLIED Generlac Solution (Lactulose Solution, USP, 10 g/15 mL) is a colorless to yellow, unflavored solution containing 10 g of lactulose/15 mL (667 mg lactulose/mL). It is available in the following container sizes: 1 Pint (473 mL) bottles (NDC 62135-892-47) 2 Pints (946 mL) bottles (NDC 62135-892-94) STORAGE AND HANDLING Store at 20° to 25°…

Source: Lactulose (Generlac) — US FDA prescribing information, 2024-07-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.