Generlac

Generlac

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Questions & Answers

Side Effects & Adverse Reactions

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 nonfermentable solution. Insufflation of CO2 as an additional safeguard may be pursued but is considered to be a redundant measure.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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

Controlled studies have shown that lactulose therapy reduces the blood ammonia levels by 25–50%; 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 solution therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose solution has been given for over 2 years in controlled studies.

History

There is currently no drug history available for this drug.

Other Information

Generlac Solution (Lactulose Solution, USP) is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of Generlac Solution contains: 10 g lactulose (and not more than 1.6 g galactose, not more than 1.2 g lactose, not more than 0.8 g epilactose, and not more than 0.1 g fructose). The pH range is between 2.5 and 6.5.

Generlac Solution is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy.

The chemical name for lactulose is 4-0-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:

                C12H22O11   Chemical Structure

The molecular weight is 342.30. It is freely soluble in water.

Generlac Manufacturers


  • Morton Grove Pharmaceuticals, Inc.
    Generlac (Lactulose) Solution [Morton Grove Pharmaceuticals, Inc.]

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