Normalax

COMPOSITION :

Each 100 ml contains :

Lactulose 67 gm (as Lactulose concentrate USP)

DESCRIPTION :

Normalax Syrup (Lactulose) is a synthetic disaccharide analog of lactose . It is metabolized 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 hrs. 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 gm 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, 1- 5 years : 5ml twice daily, 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 diarrhea.

STORAGE INSTRUCTIONS :

Store below 30oC . Do not refrigerate.

PRESENTATION* :

Normalax Syrup : Bottle of 100 ml and150 ml.

* Other presentations may be available in some countries.