📌 COMPOSITION

Each 100 ml contains: Lactulose 67 g (as Lactulose concentrate USP).

📌 DESCRIPTION

Normalax Syrup (Lactulose) is a synthetic disaccharide analog of lactose. It is metabolised in the colon by bacteria, resulting in the formation of lactic acid, formic acid, acetic acid and carbon dioxide. These products produce an increased osmotic pressure and slightly acidify the colonic contents, resulting in an increase in stool water content and stool softening. Further, ammonia migrates from the blood into the colon where it is converted to the ammonium ion, preventing its absorption. Lactulose is poorly absorbed. Urinary excretion is ≤ 3% and is essentially complete within 24 hours. Lactulose does not exert its effects until it reaches the colon. 24-48 hours may be required to produce a normal bowel movement.

📌 INDICATIONS

Normalax Syrup is indicated for:

• Treatment of constipation.
• Prevention and treatment of portal‑systemic encephalopathy, including hepatic pre‑coma and hepatic coma.

📌 DOSAGE & ADMINISTRATION

Constipation:

• Adults: 15-30 ml (10-20 g Lactulose) daily in a single dose or two divided doses, increased to 60 ml/day if necessary.
• Children 5-10 years: 10 ml twice daily.
• Children 1-5 years: 5 ml twice daily.
• Children under 1 year: 2.5 ml twice daily.

Encephalopathy:

• Adults: 30-45 ml three or four times daily. Adjust dosage every day or two days to produce 2 or 3 soft stools daily.

Normalax Syrup may be mixed with fruit juice, water or milk to increase palatability.

📌 RESTRICTIONS ON USE

Contraindications

• Patients who require a low galactose diet.

Precautions

• Use with caution in diabetic patients.
• Do not use other laxatives concomitantly with lactulose, especially during the initial phase of therapy for portal‑systemic encephalopathy.
• Monitor periodically the levels of electrolytes and carbon dioxide in debilitated patients who receive lactulose for more than 6 months.
• Should not be given to patients with intestinal obstruction.

📌 DRUG INTERACTIONS

Concomitant administration with non‑absorbable antacids may inhibit the acidification of colonic contents.

📌 ADVERSE EFFECTS

• Lactulose may cause abdominal discomfort associated with flatulence or cramps.
• Excessive dosage can lead to diarrhoea.

📌 OVERDOSAGE

Excessive dosage can lead to diarrhoea. If this occurs, treatment should be discontinued. Fluid and electrolyte loss may require correction.

📌 STORAGE INSTRUCTIONS

Store below 30°C. Do not refrigerate.

📌 PHARMACEUTICAL FORMS

• Normalax Syrup: Bottle of 100 ml and 150 ml.