Composition:
Each Sachet Contains:
Lactitol Monohydrate BP10g or 20g
Clinical Pharmacology:
Lactitol is a synthetic lactulose-like disaccharide. It is derived from lactose and is minimally absorbed following oral administration. It is more palatable, better tolerated and produces a more predictable cathartic activity than lactulose. Lactitol monohydrate has calorific value of 2 kcal/g (8.5KJ/g) and has no effect on blood glucose levels. It can therefore be given to diabetes patients.
Mechanism of Action
Lactitol is a disaccharide derivative consisting of galactose and sorbitol which is only minimally absorbed and is not hydrolysed by the disaccharidases of the gastrointestinal tract and thus reaches the colon unchanged. In the colon it is broken down to short chain organic acids, mainly acetic, propionic and butyric acid, by the intestinal flora, in particular by the bacteroides and lactobacilli, thus acidifying the contents of the colon. The effect of this acidification is to reduce the absorption of ammonia. The transformation of lactitol into low molecular weight organic acids results in an increase in osmotic pressure in the colon, thereby causing an increase in the stool water content and stool volume which explains the laxative effect.
Pharmacokinetics
Lactitol is not significantly absorbed in the small intestine; only 0.5% to 2% of a dose is partially absorbed as unchanged lactitol. Upon reaching the colon, lactitol is rapidly and extensively metabolized to volatile fatty acids by the bacterial flora of the colon. Absorbed volatile fatty acids are either metabolized in the liver to carbon dioxide or incorporated into tissues.
In one study, it was calculated that 2% of a radio labeled dose of lactitol was passively absorbed in the small bowel with the remaining 98% entering the colon. In the colon, it was assumed that first-pass bacterial metabolism resulted in carbon dtoxide formation and loss of 27.4% of the dose; 64% of the dose was calculated to be absorbed by the colonic mucosa as volatile fatty acids, with 6.5% excreted in the feces. Small amounts of unchanged lactitol appear in the urine (2% or less of a dose).
Indications:
Lactitol is indicated for the treatment of constipation.
Centra-indications:
•Appendicitis.
•Patients with intestinal obstruction, where an underlying organic lesion of the gastrointestinal tract is suspected, or in cases of unexplained abdominal pain or bleeding.
•Hypersensitivity to the drug or any other component of the formulation.
•Galactosemia
Warnings and Precautions:
Absorption of lactate from colonic metabolism of lactitol can potentially result in acid-base disturbances, and diarrhea induced by lactitol can be associated with hypokalemia and hypernatremia. Potassium deficiency may increase the risk of toxic effects of glycosides in patients receiving concomitant therapy.
Periodic monitoring of serum electrolytes, blood glucose and blood lactate is suggested. If watery stools are noticed, one should either reduce the quantity of administration or suspend administration. As with all laxatives, any pre-existing electrolyte or water balance abnormalities must be corrected. Blood electrolyte levels should be monitored regularly in elderly or debilitated patients on long term treatment.
Patients who complain of nausea should be advised to take lactitol with meal.
Lactitol is not recommended in case of ileostomy or colostomy. Fecal impaction should be treated by alternative methods prior to using lactitol.
Following treatment with lactitol, hydrogen may accumulate in the bowel. Patients who need to undergo electrocauterisation procedures should therefore have a thorough bowel cleansing with a non fermentable solution.
All cases of chronic constipation should first be treated by a fibre rich diet, intake of liquids or physical activity. Prolonged use of laxatives without interruption should be avoided.
Typical symptoms of laxative abuse include abdominal pain, weakness, fatigue, thirst, vomiting, edema, bone pain (due to osteomalacia), fluid and electrolyte imbalance, hypoalbuminemia (due to protein losing gastroenteropathy), and syndromes that mimic colitis. If the bowel has not been permanently damaged, it may require several months to retrain the bowel without the assistance of laxatives.
Pregnancy & Lactation
Available evidence is inconclusive or is inadequate for determining fetal risk when used in pregnant women or women of childbearing potential and nursing mothers. Therefore, lactitol can be prescribed only if the potential benefits justify the potential risk to the fetus.
Although there have been no studies on the elimination of lactitol in breast milk, it is unlikely that the use of lactitol while breastfeeding could have any clinical effect on the child, because its absorption is minimal. But the potential benefits of drug treatment should be weighed against potential risks before prescribing this drug during lactation.
Drug Interactions:
Lactitol can increase the potassium losses caused by other medicines (e.g., thiazide diuretics, corticosteroids, carbenoxolone, amphotericin B). Potassium deficiency may increase the risk of toxic effects of glycosides in patients receiving concomitant therapy.
Side effects:
Abdominal distension or cramp and flatulence have occurred most frequently (30% to 100% of patients); these effects are most prevalent during the first 10 days of treatment and tend to subside continued administration. Other less frequent side effects include abdominal discomfort, nausea, dyspepsia, epigastric pain, urgency of defecation, borborygmi or anal pruritus and vomiting in rare cases. Diarrhea occurs generally with excessive doses of lactitol; but some patients may experience diarrhea at the recommended dosage. A reduction in dosage will overcome this. Severe flatulence, nausea, and epigastric pain have occasionally necessitated withdrawal of lactitol therapy.
Absorption of lactate resulting from colonic metabolism of lactitol can potentially result in acid-base disturbances, and diarrhea induced by lactitol can be associated with hypokalemia and. hypernatremia.
Over dosage:
The appearance of diarrhea is a sign of over dosage which requires dose reduction. Over dosage may also cause a shift in serum electrolytes which may require corrective therapy. In case of over dosage, periodic monitoring of serum electrolytes, blood glucose and blood lactate is suggested.
Dosage and Administration:
Lactitol should be administered once daily, in the morning or evening, at mealtimes, preferably mixed with food or any liquid (such as hot or cold beverages, fresh or preserved fruit, puddings, cereals, yoghurt, etc). The choice between morning and evening should be left to the patient, depending on his or her individual response to the product. It is recommended that lactitol should be taken with 1 or 2 glasses of liquid. The laxative effect usually occurs a few hours after taking lactitol. The patient should be told that in some cases the laxative action may not begin until the 2 or 3 day after the initial dose. Patients should be advised to maintain an adequate daily fluid intake.
Adult patients (including the elderly): The recommended daily starting dose, for the first 4-5 days, is 20 gm, to be taken as a single dose, with breakfast or the evening meal. In most cases the starting dose can be followed by a maintenance dose of 10 gm daily.
Pediatric patients: The mean dosage for children is usually 0.25 gm/kg/day. For children 12-16 years of age the usually recommended dosage is 10 gm to 20 gm daily; for children 6-12 years of age the dosage is 5 gm to 10 gm; for children under 6 years, the usually recommended dosage is 2.5 gm to 5 gm. For infants, the maximum recommended dose is 1 -2 gm/daily.
The individual dose should be adjusted to obtain one bowel movement per day and according to patients response and tolerability. Once the correct dose is determined, there is rarely any need to change it, as the laxative effect is generally predicted.
Incompatibilities:
None reported.
Storage:
Store in a cool dry place, protected from lightKeetfout of reach of children.
Presentation:
Lactihep is available as sachet containing 10 gm or20 gm lactitol monohydrate.
Instruction for patients:
1. Take Lactihep as advised by your Doctor.
2. Lactihep is available as sachets containing a powder that is sweet tasting and induces a regular bowel movement.
3. Mix the entire contents of one sachet with food or any liquid (such as hot or cold beverages, fresh or preserved fruit, cereals, puddings, yogurt, etc) and take it as a single dose, either in the morning or evening, with breakfast orthe evening meal.
4. Always take 1-2 glasses of liquid alongwith Lactihep.
5. The laxative effect of Lactihep will be usually seen afterfew hours of taking the medicine.
6. In some patients, the laxative effect may be produced only after 2" or 3" day from the initial dose. So, do not take any extra dose to induce laxative effect.
7. For children under 12 years of age, your doctor might recommend a much lower dose (e.g., half the sachet or a quarter of the sachet content). Follow your doctors instructions.
8. Consult your doctor if any undesirable effects are observed.
9. Maintain adequate fluid intake and a fibre rich diet alongwith regular physical activity so as to enable faster relief of your condition.
For further details, please write to
sun pharmaceutical Ind. ltd. |
Acme Plaza, Andheri-Kuda Road
Andheri (East), Mumbai-400 05