lactulose
lactulose is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including KRISTALOSE, LACTULOSE Crystalline. Available dosage form: powder, for solution.
Drug Details
- Generic Name
- lactulose
- Brand Names
- KRISTALOSE, LACTULOSE Crystalline
- Application Number
- ANDA074712
- Sponsor
- Cumberland Pharmaceuticals Inc.
- NDC Codes
- 4
- Dosage Forms
- POWDER, FOR SOLUTION
- Routes
- ORAL
- Active Ingredients
- LACTULOSE
Indications and Usage
1 INDICATIONS & 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 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.