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NDC 45963-0438-64

Lactulose 10 g/15mL SOLUTION

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NDC
45963-0438-64
Generic Name
Lactulose
Brand Name
Enulose
Strength
10 g/15mL
Dosage Form
SOLUTION
Route
ORAL, RECTAL
Package Size
—
Labeler
Actavis Pharma, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE 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 th…

Important Warnings

WARNINGS A theoretical hazard may exist for patients being treated with lactulose solution who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H 2 gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. Although this complication has not been reported with lactulose, patients on lactulose t…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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