Lactulose STELLA

OTC

Indications

• Chronic constipation.
• Treatment of hepatic encephalopathy (HE), hepatic coma.

Dosage

Chronic constipation:

• Adults: 15 – 30 ml daily, given in a single dose or in 2 divided doses, increase 60 ml daily if necessary, adjust doses to the needs of the individual.
• Children 1 month – 1 years: 2,5 ml twice daily,
  1 – 5 years: 5 ml twice daily,
  5 – 10 years: 10 ml twice daily,
  10 – 18 years: 15 ml twice daily, adjust doses according to response;
• To restore bowel movements in hemorrhoidectomy patients: 15 ml twice during the day before surgery and twice daily for 5 days postoperatively;
  Geriatric patients with colonic retention of barium and severe constipation: 5 – 10 ml twice daily for 1 – 4 weeks.

Hepatic encephalopathy:

• Initial 30 – 45 ml, 3 times daily, subsequently adjust the dose every 1 – 2 days as necessary to produce two or three soft stools each day or measuring stool pH (with indicator paper) at the start of therapy and adjusting the dosage until stool pH is about 5;
• Acute episodes of hepatic encephalopathy:
  30 – 45 ml, given at 1 to 2 hour intervals to induce rapid laxation,
  Reduce to the amount required to produce 2 or 3 soft stools daily;
• Hepatic pre-coma or coma:
  Lactulose is used rectally, and other preparation is recommended;
  Newborn to 18 years of age: The safety and efficacy have not been established.

Usage

• Lactulose STELLA is administered orally.
• In case of single daily dose, this should be taken at the same time.
• During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5 – 2 litres, equal to 6 – 8 glasses) during the day.

• Known hypersensitivity to any of the active substance or excipients.
• Patients with galactosemia or requiring a low lactose diet.

Common

• Flatulence, diarrhoea.

Uncommon

• Abdominal discomfort, nausea, vomiting, hypematremia.

• Painful abdominal symptoms of undetermined cause before starting the treatment.
• Insufficient therapeutic effect after several days.
• The dose used in the treatment of hepatic encephalopathy is usually much higher and may need to be taken into consideration for diabetics.
• Unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance.
• Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption: should not use.
• Use of laxatives in children should be exceptional and under medical supervision.