FDA label

What is Enulose used for?

Enulose contains lactulose. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label says: “For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma.”

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Enulose, solution

Indications and Usage, quoted from the label by Actavis Pharma, Inc. (ANDA090502). Cross-references to other label sections are left out.

For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma.

Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients' protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, Lactulose has been given for over 2 years in controlled studies.

Source: DailyMed label, set id 00c42c5c-d19e-4130-aa08-a8bbd47d3e5b, version 8, effective June 1, 2022. NDC 45963-438, one of 2 listings for this product.

Questions

What is Enulose used for?

The FDA label says: “For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma.”

What drug class is Enulose?

FDA lists lactulose in the Osmotic Laxative established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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