NORMASE ® Lactulose

NORMASE ® is a drug based on Lactulose

THERAPEUTIC GROUP: Laxatives - Osmotic laxative

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Directions NORMASE ® Lattulosio

NORMASE ® is indicated for the treatment of chronic constipation, dyspepsias due to eating disorders, putrefactive syndromes in infants, during weaning and as an adjunct in intestinal bacterial diseases.

Mechanism of action NORMASE ® Lattulosio

NORMASE ® is a drug based on lactulose, a synthetic disaccharide originating from the association of a molecule of sucrose and one of galactose. Taken orally, it exceeds unchanged both the gastric and duodenal environment (given the absence of specific sucrases), and thanks to its osmotic activity it retains important quantities of liquids and minerals, accelerating intestinal transit.

The imposing volume of liquids rapidly reaches the colon, stretching the walls, increasing peristalsis, and facilitating evacuation, sometimes characterized by abdominal pain. At the same time, lactulose is fermented by the intestinal flora in the large intestine, with the production of organic acids such as acetic acid and lactic acid, with a prebiotic effect useful to stimulate the growth of the resident flora at the expense of the pathogenic one (an important action in counteracting some consequences, clinically relevant, of liver diseases such as cirrhosis) and with an osmotic effect.

Studies carried out and clinical efficacy

LACTULOSE: NOT JUST A laxative

Although lactulose is known above all for its important laxative action, the latest studies are focusing on the other functional characteristics of this disaccharide. Recent evidence, in fact, hypothesizes an important antioxidant role of lactulose at the enteric level, which could prove to be important in the prevention of inflammatory bowel diseases.

2. THE PREBIOTIC EFFECTS OF LACTULOSE

In addition to being an excellent osmotic laxative, lactulose has also proved useful for its prebiotic actions. In fact, being effectively hydrolyzed by the intestinal microflora into acetic acid and lactic acid, it can guarantee an important growth of the resident flora. This important ability has allowed lactulose to re-enter as a fortifying element in various foods, particularly in milk.

3. LACTULOSE AND CHRONIC CONSTIPATION

Chronic constipation is one of the most common problems in the western population, and is often associated with a poor diet. Among the most used treatments for this pathology it is possible to include osmotic laxatives, in particular lactulose and polyethylene glycol.

Despite the excellent effectiveness of lactulose, polyethylene glycol has proved particularly useful in reducing abdominal pain and increasing the weekly frequency of evacuations.

Method of use and dosage

NORMASE ® 200 ml syrup with 66.7 g of lactulose every 100 ml : the therapeutic procedure for the treatment of chronic constipation should include the intake of 20 ml on the first day, followed by daily administration of 10 ml.

Any adjustment of the dosage should be decided by the doctor, following the evaluation of the patient's health conditions.

The therapeutic protocol used as an adjuvant for intestinal bacterial infections, instead, requires the intake of 10-20ml of NORMASE ® ciroppo per day, for a maximum of 7 days.

In all the aforementioned cases, and especially in the case of patients under the age of 10, medical advice and supervision is required.

Warnings NORMASE ® Lattulosio

NORMASE ® should be taken under strict medical supervision, especially for patients suffering from diabetes, cardiovascular diseases, acute diseases of the gastro-intestinal tract, nausea, vomiting and intestinal obstructions.

Excessive dosages of this drug could be associated with electrolyte imbalances and gastro-intestinal disorders.

PREGNANCY AND BREASTFEEDING

The various clinical trials and post-marketing monitoring did not show toxic effects on the health of the fetus or newborn, following the use of NORMASE ® during the period of pregnancy and lactation.

Interactions

The effectiveness of NORMASE ® can be reduced by the concomitant administration of broad-spectrum antibiotics and antacids.

Possible interactions, not entirely characterized and clinically irrelevant, were observed following the concomitant administration of lactulose and digitalis.

Contraindications NORMASE ® Lattulosio

NORMASE ® is contraindicated in case of galactosemia and hypersensitivity to one of its components.

Undesirable effects - Side effects

The administration of NORMASE ® was detected, both from clinical trials and from post-marketing experience, well tolerated, with occasional episodes of meteorism and abdominal cramps.

The presence of intense diarrheal discharges should be accompanied by a reduction in dosage or suspension of therapy.