API

Lactulose (10gm)

Drug classification

Lactulose is an osmotic laxative; specific subclass: synthetic disaccharide laxative.

Dosage form

Lactopil Oral Solution is an oral liquid formulation containing lactulose.

API strength per dosage

Dose

Lactulose oral solution dosing for adults typically starts at 15–30 mL daily, adjusted to produce 2–3 soft stools per day. Paediatric dosing is weight-based and lower. Dose adjustments are generally not required for renal or hepatic impairment. Titrate to effect, monitoring for electrolyte imbalance and dehydration, especially in elderly or paediatric patients.

Mechanism of action

Lactulose is a synthetic disaccharide metabolized by colonic bacteria into organic acids, primarily lactic and acetic acids. These acids lower colonic pH, promoting ammonia ionization and trapping (NH4+), reducing ammonia absorption, and increasing osmotic pressure, which enhances water retention and stimulates peristalsis, resulting in a laxative effect.

Indications

Treatment of ConstipationTreatment of Hepatic encephalopathy

Side effects

Abdominal pain Nausea Vomiting Diarrhea

Pregnancy category

Lactulose is generally considered safe in pregnancy; limited data suggest low risk, but use only if clearly needed and under medical supervision.

Precautions

Monitor for electrolyte imbalance, dehydration, especially in elderly or debilitated patients, use caution in diabetes mellitus, avoid in galactosemia, assess for abdominal pain of unknown origin, monitor bowel movement frequency, adjust dose to avoid diarrhea, monitor serum electrolytes with prolonged use.

Contraindications

Galactosemia, intestinal obstruction, hypersensitivity to lactulose or any component of the formulation.