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Oralax (Lactulose)

Pharmacology:

Oralax (lactulose) is a disaccharide which is not hydrolysed in the small intestine. Therefore it cannot be absorbed and is transported to the colon with water to retain the osmotic balance. In the colon, several species of bacteria can degrade lactulose to Lactic acid, Formic acid and Acetic acid, this in turn supports the growth of intestinal bacteria. By enhancing this normal activity of the bacteria, the osmotic pressure of the colonic contents is doubled and more water is drawn in to the bowel.

Lactulose improves the transfer of Calcium salts and Phosphates from the intestine. It also leads to healing and improvement in gum diseases through normalization of matabolic processes in the parodontal region.

Composition:

Oralax Oral Solution: Each 5 ml oral solution contains Lactulose USP 3.35 gm.

Indication:

1. Constipation (chronic constipation): In every case of chronic constipation, initial treatment should consists of a diet rich in fiber (vegetables, salads, fruits, supplements of linseeds, wheat germ, etc.) a generous amount of liquids and much physical exercise. Lactulose is only to be taken when these measures prove insufficient.

2. Intestinal flora disturbances: In damage to intestinal flora, following therapy with broad spectrum antibiotics, gall bladder diseases, intestinal disease (colitis, diverticulosis, megacolon)

3. Increased blood ammonia level (hyperammoniemia in hepatopathy, portal systemic encephalopathy, precoma, coma)

4. Disease of the gums and the parodontic apparatus (paradonotosis, bleeding from the gums, inflammation, dystrophy)

Dosage and Administration:

1. Constipation (chronic constipation): Due to the fact that every organism responds differently to lactulose, each patient must determine his/her own optimal dose in the course of time.

                                                                        Initial                                      In long-term therapy

Adults   :                                                           3 - 6 tea-spoons daily                1.5 - 6 tea spoons daily

Children up to 14 years  :                                   3 tea spoons daily                      1- 2 tea spoons daily

Infants and toddlers       :                                   1 - 2 tea spoons daily                 1 tea spoon daily

With lactulose a prompt laxative effect may be achieved by drinking a mixture of 3 - 9 tea spoons in 1/8 - 1/4 liter water, coffee, tea, fruit juice, or milk on an empty stomach after getting up in the morning. Normally defecation takes place approximately 2 hours later in the form of a fluid mass (increased defecation reflex).

2. In damage intestinal flora (e.g. following long term antibiotic treatment):

                Adults                  : 1 - 2 tea spoons daily

                Children               : 1 tea spoon daily

3. For reduction of blood ammonia level ( in hepatopathy):

                A maximum of 60 - 100 g lactulose daily, that is 18 - 30 tea spoons

4. In precoma:

                A maximum of 100 g lactulose daily, that is 30 tea spoons lactulose spread over the course of the day.

5. Disease of the gums and the parodontic apparatus (paradontopathy)

                Adults : 3 - 6 tea spoons lactulose daily.

Contraindication:

Hypersensitivity to either galactose and/or lactose, galactose free diet. Gastro-cardial symptom complex (heart problems stemming from the gastro-intestinal tract), suspected intestinal obstruction.

Pregnancy & Lactation:

Studies show that lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by a registered physician.

Side Effect:

Occasionally flatulence can occur at the beginning of treatment, this is rapidly   eliminated by reducing the dose and/or taking the daily dose in several smaller individual portions spread over the course of the day. Over doses can result in diarrhoea. In abuse: loss of electrolytes (primarily Potassium).

Drug Interaction:

The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse.

Storage:

Oralax Oral Solution should be protected from light, stored in cool and dry place.

Keep out of reach of children

Packaging:

Oralax Oral Solution : 100 ml & 200 ml in each glass bottle.

 

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