Darix
Darix Uses, Dosage, Side Effects, Food Interaction and all others data.
Darix 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. Darix 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. Darix reaches the colon essentially unchanged. There it is metabolized by bacteria with the formation of low molecular weight acids that acidify the colon contents.Darix 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.
Darix 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.
| Trade Name | Darix |
| Availability | Prescription only |
| Generic | Lactulose |
| Lactulose Other Names | Lactulosa, Lactulose, Lactulosum |
| Related Drugs | MiraLAX, Linzess, polyethylene glycol 3350, Xifaxan, Amitiza, rifaximin, neomycin, Movantik, linaclotide, lubiprostone |
| Type | Solution |
| Formula | C12H22O11 |
| Weight | Average: 342.2965 Monoisotopic: 342.116211546 |
| Protein binding | Negligible amounts of lactulose - metabolized or non-metabolized - are absorbed into the body.. Regardless, data regarding the protein binding of lactulose is not readily available or accessible. |
| Groups | Approved |
| Therapeutic Class | Osmotic purgatives |
| Manufacturer | Little Greave Pharmaceuticals Pvt Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Darix 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.
Darix 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.
Darix is also used to associated treatment for these conditions: Constipation, Hepatic Encephalopathy (HE)
How Darix works
Darix 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
Darix 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 Darixmay, 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.
Food Interaction
- Drink plenty of fluids. This drug may cause fluid loss.
- Take with or without food.
Darix Drug Interaction
Moderate: docusate, docusate, furosemide, furosemide, polyethylene glycol 3350, polyethylene glycol 3350, ondansetron, ondansetronUnknown: acetaminophen, acetaminophen, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, rifaximin, rifaximin
Darix Disease Interaction
Major: galactosemia, inflammatory bowel disease, intestinal obstruction disordersModerate: diabetes
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. Darix 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
Darix 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.
Storage Condition
Store between 15-30° C.
Innovators Monograph
You find simplified version here Darix
Darix contains Lactulose see full prescribing information from innovator Darix Monograph, Darix MSDS, Darix FDA label
FAQ
What is Darix used for?
Darix is a non-absorbable sugar used in the treatment of constipation and hepatic encephalopathy. Darix is used by mouth for constipation and either by mouth or in the rectum for hepatic encephalopathy.Darix is a laxative taken to treat constipation. It is also taken to help a severe liver disease called hepatic encephalopathy.
How safe is Darix?
You should only take Darix occasionally and for a few days at a time. Using laxatives like Darix for longer can lead to prolonged diarrhoea. It can also cause an electrolyte imbalance, where levels of substances like sodium, potassium and magnesium in your body get too high or too low.
How does Darix work?
Darix is broken down in the bowel into products that pull water out from the body and into the bowel to soften poo and make it easier to pass.
What is the mechanism of action of Darix?
Darix is chief mechanism of action is by decreasing the intestinal production and absorption of ammonia.
What are the common side effects of Darix?
The most common side effects are diarrhoea, bloating and wind. These are usually mild and shortlived.Darix takes at least 48 hours to work. If you find the taste of Darix too sweet, you can dilute it with fruit juice or water.
Is Darix safe during pregnancy?
Darix is generally safe to take during pregnancy.
Is Darix safe during breastfeeding?
Lactulose is generally safe to take during pregnancy and while breastfeeding.If you're breastfeeding, it's always better to try to safely treat constipation without taking a medicine.
Can I drink alcohol with Darix?
Yes, you can drink alcohol with Darix.
Is it safe to take Darix every day?
Typical dosage: 2,3 tablespoons three or four times per day.Your doctor may adjust your dosage every day or every other day until you can produce two or three soft stools per day.
When shouId be taken Darix ?
Darix usually is taken once a day for treatment of constipation and three or four times a day for liver disease.
Can I take Darix on an empty stomach?
Take lactulose once or twice a day. You can take it with or without food.
Can I take Darix on an empty stomach?
Take Darix once or twice a day. You can take it with or without food.
How long does Darix take to work?
Darix takes at least 48 hours to work.
How long does Darix stay in my system?
The half-life of Darix is about 2 hours while the half-life of bisacodyl is 16 hours. Bulk-forming laxatives don't have a half-life, because they're eliminated with your next bowel movement.
Can I take Darix for a long time?
This will usually be for up to a week.You should only take Darix occasionally and for a few days at a time.
Who should not take Darix?
Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.
What happens if I overdose?
Seek emergency medical attention.Overdose may cause nausea, vomiting, diarrhea, and stomach cramps, or symptoms of low blood potassium or low blood sodium (confusion, weakness, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling).
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Does Darix make me gain weight?
Ingestion of Darix does not cause a weight gain because it is not digestible, with no nutritional value.
What does Darix do for the liver?
Darix is also used to reduce the amount of ammonia in the blood of patients with liver disease. It works by drawing ammonia from the blood into the colon where it is removed from the body.
Is Darix safe for kidney patients?
Darix is generally a safe medication for patients with chronic kidney disease
