Osilax

Osilax Uses, Dosage, Side Effects, Food Interaction and all others data.

Lactulose causes a decrease in blood ammonia concentration and reduces the degree of portal-systemic encephalopathy. These actions are considered to be results of the following:

Bacterial degradation of lactulose in the colon acidifies the colonic contents.This acidification of colonic contents results in the retention of ammonia in the colon as the ammonium ion. Since the colonic contents are then more acid than the blood, ammonia can be expected to migrate from the blood into the colon to form the ammonium ion.The acid colonic contents convert NH3 to the ammonium ion (NH4)+, trapping it and preventing its absorption.The laxative action of the metabolites of lactulose then expels the trapped ammonium ion from the colon.Experimental data indicate that lactulose is poorly absorbed. Lactulose given orally to man and experimental animals resulted in only small amounts reaching the blood. Urinary excretion has been determined to be 3% or less and is essentially complete within 24 hours.When incubated with extracts of human small intestinal mucosa, lactulose was not hydrolyzed during a 24-hour period and did not inhibit the activity of these extracts on lactose. Lactulose reaches the colon essentially unchanged. There it is metabolized by bacteria with the formation of low molecular weight acids that acidify the colon contents.Lactulose formulations are most commonly administered via the oral route or the rectal route. Consequently, because the substance experiences minimal absorption by the gut it typically remains localized in the gastrointestinal tract environment and ultimately demonstrates almost all of its pharmacologic effects within the gut. In particular, as lactulose elicits its laxative effects in enhancing stool amounts and softening stool, such biochemical and physiologic activities can cause increased bowel sounds (borborygmi), a feeling of bloatedness, belching, frequent flatus, and diarrhea.

Lactulose formulations are most commonly administered via the oral route or the rectal route. Consequently, because the substance experiences minimal absorption by the gut it typically remains localized in the gastrointestinal tract environment and ultimately demonstrates almost all of its pharmacologic effects within the gut. In particular, as lactulose elicits its laxative effects in enhancing stool amounts and softening stool, such biochemical and physiologic activities can cause increased bowel sounds (borborygmi), a feeling of bloatedness, belching, frequent flatus, and diarrhea.

Osilax
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Osilax
Generic	Ispaghula + Lactulose
Type	Syrup
Therapeutic Class
Manufacturer	Ozone Pharmaceuticals Ltd
Available Country	India
Last Updated:	September 19, 2023 at 7:00 am

Uses

Lactulose is used in the treatment of chronic and habitual constipation, treatment of acute and the prevention and treatment of chronic Portal-systemic encephalopathy including the stages of hepatic pre-coma and coma.

Lactulose is a hyperosmolar laxative which is used as an effective treatment approach for constipation. It is a non-absorbable disaccharide which draws water into the bowel; causes distention through fluid accumulation, thus promotes soft stool and accelerates bowel motion.

Osilax is also used to associated treatment for these conditions: Constipation, Hepatic Encephalopathy (HE)

How Osilax works

Lactulose is a synthetic disaccharide derivative of lactose that consists of one molecule of galactose and one molecule of fructose. Saccharolytic bacteria present in the large intestine subsequently break the substance down into organic acids like lactic acid and small amounts of formic and acetic acids. Such resultant volatile fatty acid metabolites, in combination with hydrogen and methane that is also generated consequently enhance intraluminal gas formation, peristaltic gut motility, and elicit an osmotic effect that facilitates an increase in the water content of stool as well as associated stool softening. All of these actions ultimately assist in facilitating and increasing the frequency of bowel movements in patients experiencing constipation, although it may take 24 to 48 hours after using the medication for this laxative effect to become evident.

At the same time, the formation of such acids via the metabolism of lactulose by colonic bacteria also acidifies the contents of the colon, thereby contributing to the treatment of portal-systemic encephalopathy (PSE). As one of the principal features of PSE involves the accumulation of nitrogenous waste products like ammonia in the systemic circulation, a state in which the colonic contents become more acidic than blood allows ammonia in the circulation to diffuse into the colon.. Furthermore, ammonia that diffuses into the acidic colon is ionized to ammonium ions that are incapable of being absorbed back into the blood. These effects, combined with the laxative action of lactulose facilitates the excretion of excess ammonia. And finally, it is also believed that an acidic colonic environment results in the elimination of urease-producing bacteria that contribute to the formation of ammonia while surviving colonic bacteria use up any trapped ammonia in the colon as a source of nitrogen for protein synthesis.

Dosage

Osilax dosage

Adults (including elderly): 3 tea spoonful or 15 ml twice daily

Children 5 to 10 years: 2 tea spoonful or 10 ml twice daily

Children under 5 years: 1 tea spoonful or 5 ml twice daily

Babies under 1 year: ½ tea spoonful or 2.5 ml twice daily (paediatric dose should be given after breakfast)

Each dose of Lactulosemay, if necessary, be taken with water or fruit juices, usually once a day, preferably in the morning. If a dose is forgotten it should be taken as soon as one remembers up to 8 hours before bedtime. If later, wait for next scheduled dose (don’t double this dose). Don’t take at bedtime. Usual time lapse before drug works is 30 minutes to 3 hours.

Side Effects

Life threatening: None expected

Common: Increased thirst, cramps, nausea, diarrhoea, flatulence

Infrequent: Irregular heart beat, muscle cramps

Rare: Dizziness, confusion, fatigue, weakness.

Toxicity

It has been documented that the oral LD50 of lactulose is 48.8 mL/kg in mice and more than 30 mL/ kg in rats.

It is expected that overdosage with lactulose would result in abdominal cramps and diarrhea, both of which should be treated with fluid and electrolyte replacement as required.

Considering the use of lactulose during pregnancy in humans has not been formally investigated, the agent should only be used during pregnancy only when clearly needed. Similarly, it is unknown whether lactulose is distributed into human breastmilk. Use of the medication in nursing women should subsequently be undertaken with caution.

Reproduction studies in rats, mice, and rabbits have not revealed any evidence of impaired fertility as a result of administering lactulose.

Data regarding the safety and efficacy of using lactulose in children for the treatment of chronic constipation or portal-systemic encephalopathy (PSE) is either very limited or yet to be established.

Information regarding the long-term mutagenic potential of lactulose solution in animals or humans and about the long-term carcinogenic potential in humans are not available.

Precaution

It should be avoided if one is allergic to any hyperosmotic laxative, have symptoms of appendicitis, inflammatory bowel diseases or intestinal blockage, have missed a bowel movement for only 1 or 2 days. Adverse reactions over age 60 year may be more frequent and severe than in younger persons.

Interaction

Reduced effect with non-absorbable antacids, neomycin and other oral anti-infectives. Concomitant use with other laxatives may falsely suggest that adequate lactulose dosage has been achieved.

Volume of Distribution

Negligible amounts of lactulose - metabolized or non-metabolized - are absorbed into the body.. Most lactulose that is administered subsequently remains predominantly around the gastrointestinal tract area.

Elimination Route

After administration by the oral route, less than 3% of the given dose of lactulose solution is absorbed by the small intestine. The remaining unabsorbed lactulose reaches the large intestine where it is metabolized - but even then, negligible quantities of unchanged lactulose or its metabolites are absorbed across the colon.

Half Life

The data regarding the half-life of lactulose is not readily available or accessible.

Clearance

Negligible amounts of lactulose - metabolized or non-metabolized - are absorbed into the body.. Regardless, data regarding the clearance of lactulose is not readily available or accessible.

Elimination Route

The renal excretion of any lactulose that manages to be absorbed into the circulation has been determined to be 3% or less and is generally complete within 24 hours. Any unabsorbed lactulose is largely excreted with stool.

Pregnancy & Breastfeeding use

In pregnancy no proven problems were detected. Avoid the drug if possible. Consultation with physician is required. It has no side effect during breast feeding. Lactulose oral solution could be used in infants and children only under medical supervision. It should not be used to ‘flush out’ the system or as a ‘tonic'.

Contraindication

Lactulose is contraindicated in patients with galactosaemia and intestinal obstruction.

Acute Overdose

There have been no reports of accidental overdosage. In the event of acute overdosage it is expected that diarrhoea and abdominal cramps would be the major symptoms.