Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 11 January 2017
PRECAUTIONS General Since Generlac Solution contains galactose (not more than 1.6 g/15 mL) and lactose (not more than 1.2 g/15 mL), it should be used with
In the overall management of portal-systemic encephalopathy, it should be recognized that there is
Drug Interactions There have been
Results of preliminary studies in humans and
Therefore, a possible
Other laxatives should not be used, especially during the initial phase of therapy for portalsystemic encephalopathy, because the
Administration of lactulose in the diet of mice for 18 months in concentrations of 3 % and 10 % (V/W) did not produce any evidence of carcinogenicity.
In studies in mice,
Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in mice,
There are, however,
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk,
DOSAGE AND ADMINISTRATION Oral Adult The usual adult oral dosage is 30 to 45 mL (2 to 3 tablespoonfuls, containing 20 g to 30 g of Generlac Solution) three or four times daily.
Hourly doses of 30 to 45 mL of Generlac Solution may be used to induce the
When the laxative effect has been achieved,
The dose of Generlac Solution for this purpose is the same as the
As with adults, the subjective goal in
For older pediatric patients, the total daily dose is 40 to 90 mL.
If the initial dose causes diarrhea,
If diarrhea persists,
Three hundred mL of Generlac Solution should be mixed with 700 mL of water or physiologic saline and retained for 30 to 60 minutes.
The goal of treatment is reversal of the
Generlac Solution, given orally in the
|Agency product number||9U7D5QH5AE|
|Date Last Revised||21-01-2014|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Do Not Freeze Under
Such darkening is characteristic of sugar solutions and does not affect therapeutic action.
Prolonged exposure to temperatures above 30°C (86°F) or to direct light may cause
If this condition
Prolonged exposure to freezing temperatures may cause change to a semisolid, too
Viscosity will return to normal upon
Dispense in original container or in a
To The Pharmacist: When ordering this product, include the product number (or NDC) in the description.
|Marketing authorisation holder||Morton Grove Pharmaceuticals, Inc.|