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Basic Drug Info
Drug Name:Lactulose
Manufacturer:ANI Pharmaceuticals Inc.
Other Info:(For Oral or Rectal Administration for the prevention and treatment of Portal-Systemic Encephalopathy)10g/15mLRx Only



Clinical Trials:


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 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.
Hepatic Encephalopathy -- A syndrome characterized by central nervous system dysfunction in association with LIVER FAILURE, including portal-systemic shunts. Clinical features include lethargy and CONFUSION (frequently progressing to COMA); ASTERIXIS; NYSTAGMUS, PATHOLOGIC; brisk oculovestibular reflexes; decorticate and decerebrate posturing; MUSCLE SPASTICITY; and bilateral extensor plantar reflexes (see REFLEX, BABINSKI). ELECTROENCEPHALOGRAPHY may demonstrate triphasic waves. (From Adams et al., Principles of Neurology, 6th ed, pp1117-20; Plum & Posner, Diagnosis of Stupor and Coma, 3rd ed, p222-5)

Hepatic Coma --

comatose -- A profound state of unconsciousness associated with depressed cerebral activity from which the individual cannot be aroused. Coma generally occurs when there is dysfunction or injury involving both cerebral hemispheres or the brain stem RETICULAR FORMATION.

Immune Tolerance -- The specific failure of a normally responsive individual to make an immune response to a known antigen. It results from previous contact with the antigen by an immunologically immature individual (fetus or neonate) or by an adult exposed to extreme high-dose or low-dose antigen, or by exposure to radiation, antimetabolites, antilymphocytic serum, etc.

Contraindications
Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
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 H2 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 therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution.

Insufflation of CO2 as an additional safeguard may be pursued but is considered to be a redundant measure.
Branded Drugs
The following US Branded drugs contain Lactulose


CHRONULAC -- SANOFI AVENTIS US LLC

CONSTILAC -- ALRA LABORATORIES INC

CONSTULOSE -- ACTAVIS MID ATLANTIC LLC

DUPHALAC -- SOLVAY PHARMACEUTICALS

EVALOSE -- TEVA PHARMACEUTICALS USA

LAXILOSE -- NOSTRUM LABORATORIES INC

ACILAC -- NOSTRUM LABORATORIES INC

CEPHULAC -- SANOFI AVENTIS US LLC

CHOLAC -- ALRA LABORATORIES INC

ENULOSE -- ACTAVIS MID ATLANTIC LLC

GENERLAC -- MORTON GROVE PHARMACEUTICALS INC

HEPTALAC -- TEVA PHARMACEUTICALS USA

PORTALAC -- SOLVAY PHARMACEUTICALS


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