Duphalac

Constipation, Hepatic Encephalopathy, Hepatic Encephalopathy

Treatment

6 FDA approvals

16 Active Studies for Duphalac

Treatment for

Constipation

What is Duphalac

LactuloseThe Generic name of this drug

Treatment SummaryLactulose is a synthetic sugar used to treat constipation. It was developed in 1929 but didn't become a common treatment until the 1960s. Lactulose became an FDA-approved drug in 1977 and is now available over-the-counter. It is considered a safe and effective medicine according to the World Health Organization. Lactulose is usually prescribed after lifestyle and dietary changes have failed to help constipation. While it is a common treatment for constipation and portal-systemic encephalopathy (PSE), its effectiveness in treating PSE has not been scientifically proven.

Lactuloseis the brand name

image of different drug pills on a surface

Duphalac Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Lactulose

1966

Approved as Treatment by the FDA

Lactulose, also known as Lactulose, is approved by the FDA for 6 uses which include Hepatic Encephalopathy (HE) and Constipation .

Hepatic Encephalopathy (HE)

Constipation

prophylaxis of Hepatic encephalopathy

Constipation

Hepatic Encephalopathy

Effectiveness

How Duphalac Affects PatientsLactulose is usually taken by mouth or by rectal administration. Since it is not absorbed by the gut, it stays in the gastrointestinal tract and has its main effects in the gut. These effects include improved bowel movements and softer stools. Taking lactulose can also lead to increased bowel sounds, feeling bloated, belching, passing gas more often, and diarrhea.

How Duphalac works in the bodyLactulose is a sugar-based medication that helps soften stool and increase bowel movements. It also works to reduce the amount of ammonia in the body by making the contents of the colon more acidic. This causes ammonia present in the bloodstream to move into the colon, where it is ionized and unable to be absorbed back into the blood. Bacteria in the colon then use the ammonia as a source of protein for synthesis. All of these effects help reduce the amount of ammonia in the body, which can help treat portal-systemic encephalopathy. It can take up to 48 hours for this medication to take effect.

When to interrupt dosage

The suggested dosage of Duphalac is contingent upon the diagnosed condition, such as Hepatic Encephalopathy, Chronic Constipation and Hepatic Encephalopathy. The quantity of dosage may differ, in accordance with the delivery system (e.g. Oral or Solution) demonstrated in the table hereunder.

Condition

Dosage

Administration

Constipation

, 1000.0 mg/mL, 2000.0 mg/mL, 1.0 mg/mg, 2.0 mg/mg, 667.0 mg, 667.0 mg/mL, 3300.0 mg/mL, 0.95 mg/mg

, Oral, Solution, Solution - Oral, Oral; Rectal, Solution - Oral; Rectal, Powder, for solution - Oral, Powder, for solution, Liquid, Liquid - Oral, Syrup, Syrup - Oral, Powder, Powder - Oral, Syrup - Oral; Rectal, Liquid - Oral; Rectal

Hepatic Encephalopathy

, 1000.0 mg/mL, 2000.0 mg/mL, 1.0 mg/mg, 2.0 mg/mg, 667.0 mg, 667.0 mg/mL, 3300.0 mg/mL, 0.95 mg/mg

Hepatic Encephalopathy

, 1000.0 mg/mL, 2000.0 mg/mL, 1.0 mg/mg, 2.0 mg/mg, 667.0 mg, 667.0 mg/mL, 3300.0 mg/mL, 0.95 mg/mg

Warnings

Duphalac Contraindications

Condition

Risk Level

Notes

low galactose diet

Do Not Combine

Pulse Frequency

Do Not Combine

There are 20 known major drug interactions with Duphalac.

Common Duphalac Drug Interactions

Drug Name

Risk Level

Description

Alloin

Minor

The risk or severity of adverse effects can be increased when Lactulose is combined with Alloin.

Bisacodyl

Minor

The risk or severity of adverse effects can be increased when Lactulose is combined with Bisacodyl.

Bisoxatin

Minor

The risk or severity of adverse effects can be increased when Lactulose is combined with Bisoxatin.

Calcium polycarbophil

Minor

The risk or severity of adverse effects can be increased when Lactulose is combined with Calcium polycarbophil.

Carboxymethylcellulose

Minor

The risk or severity of adverse effects can be increased when Lactulose is combined with Carboxymethylcellulose.

Duphalac Toxicity & Overdose RiskThe toxic dose of lactulose in mice is 48.8mL/kg and higher than 30mL/kg in rats. Taking too much lactulose can cause stomach cramps and diarrhea, so it's important to stay hydrated and replenish electrolytes. The effects of lactulose in pregnant or breastfeeding women are not known, so caution should be used in these cases. Animal studies have not shown any effects on fertility, but there is not enough data to assess the safety and efficacy of lactulose in children. The long-term effects of lactulose on mutagenicity or cancer in humans is unknown.

image of a doctor in a lab doing drug, clinical research

Duphalac Novel Uses: Which Conditions Have a Clinical Trial Featuring Duphalac?

25 active clinical trials are currently exploring the potential of Duphalac to ameliorate Hepatic Encephalopathy, Chronic Constipation and Hepatic Encephalopathy-related conditions.

Condition

Clinical Trials

Trial Phases

Hepatic Encephalopathy

0 Actively Recruiting

Constipation

16 Actively Recruiting

Phase 2, Not Applicable, Phase 4, Phase 3

Hepatic Encephalopathy

0 Actively Recruiting