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Lactulose
Overview
What is Enulose?
Lactulose is a synthetic disaccharide in solution form for oral or rectal administration.
Each 15 mL of lactulose solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose).
Lactulose is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy.
The chemical name for lactulose is 4-O--D-galactopyranosyl-D-fructofuranose. It has the following structural formula:
The molecular weight is 342.30. It is freely soluble in water.
What does Enulose look like?


What are the available doses of Enulose?
Sorry No records found.
What should I talk to my health care provider before I take Enulose?
Sorry No records found
How should I use Enulose?
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.
Oral
Adult: The usual adult, oral dosage is 2 to 3 tablespoonfuls (30 to 45 ml, containing 20 g to 30 g of lactulose) three or four times daily. The dosage may be adjusted every day or two to produce 2 or 3 soft stools daily.
Hourly doses of 30 to 45 ml of Lactulose may be used to induce the rapid laxation indicated in the initial phase of the therapy of portal-systemic encephalopathy. When the laxative effect has been achieved, the dose of lactulose may then be reduced to the recommended daily dose.
Improvement in the patient's condition may occur within 24 hours but may not begin before 48 hours or even later.
Continuous long-term therapy is indicated to lessen the severity and prevent the recurrence of portal-systemic encephalopathy. The dose of lactulose for this purpose is the same as the recommended daily dose.
Pediatric
Very little information on the use of lactulose in young children and adolescents has been recorded. As with adults, the subjective goal in proper treatment is to produce 2 to 3 soft stools daily. On the basis of information available, the recommended initial daily oral dose in infants is 2.5 to 10 ml in divided doses.
For older children and adolescents, the total daily dose is 40 to 90 ml. If the initial dose causes diarrhea, the dose should be reduced immediately. If diarrhea persists, lactulose should be discontinued.
Rectal
When the adult patient is in the impending coma or coma stage of portal-systemic encephalopathy and the danger of aspiration exists, or when the necessary endoscopic or intubation procedures physically interfere with the administration of the recommended oral doses, lactulose solution may be given as a retention enema via a rectal balloon catheter. Cleansing enemas containing soapsuds or other alkaline agents should not be used.
Three hundred ml of lactulose solution should be mixed with 700 mL of water or physiologic saline and retained for 30 to 60 minutes. Lactulose enema may be repeated every 4 to 6 hours. If the enema is inadvertently evacuated too promptly, it may be repeated immediately.
The goal of treatment is reversal of the coma stage in order that the patient may be able to take oral medication. Reversal of coma may take place within 2 hours of the first enema in some patients. Lactulose, given orally in the recommended doses, should be started before Lactulose by enema is stopped entirely.
What interacts with Enulose?
Sorry No Records found
What are the warnings of Enulose?
Sorry No Records found
What are the precautions of Enulose?
Sorry No Records found
What are the side effects of Enulose?
Sorry No records found
What should I look out for while using Enulose?
Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
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 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 CO as an additional safeguard may be pursued but is considered to be a redundant measure.
What might happen if I take too much Enulose?
Signs and Symptoms
There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated.
Oral LD
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Dialysis:
How should I store and handle Enulose?
Store at USP controlled room temperature 68°F to 77°F (20°C to 25°C) with excursions permitted between 15°C (59°F) and 30°C (86°F). Contents under pressure. Do not puncture or incinerate. Avoid contact with eyes or other mucous membranes. Keep out of reach of children. Lactulose Solution USP, 10 g/15 ml, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles.Lactulose solution, USP contains lactulose 670 mg/mL (10 g/15 mL).Store between 36° to 86°F (2° to 30°C). Do not freeze.Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Manufactured and packaged by:Fresenius Kabi Austria GmbHEstermannstraße 174020 Linz AustriaDistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised - March 2016Lactulose Solution USP, 10 g/15 ml, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles.Lactulose solution, USP contains lactulose 670 mg/mL (10 g/15 mL).Store between 36° to 86°F (2° to 30°C). Do not freeze.Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Manufactured and packaged by:Fresenius Kabi Austria GmbHEstermannstraße 174020 Linz AustriaDistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised - March 2016Lactulose Solution USP, 10 g/15 ml, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles.Lactulose solution, USP contains lactulose 670 mg/mL (10 g/15 mL).Store between 36° to 86°F (2° to 30°C). Do not freeze.Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Manufactured and packaged by:Fresenius Kabi Austria GmbHEstermannstraße 174020 Linz AustriaDistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised - March 2016Lactulose Solution USP, 10 g/15 ml, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles.Lactulose solution, USP contains lactulose 670 mg/mL (10 g/15 mL).Store between 36° to 86°F (2° to 30°C). Do not freeze.Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Manufactured and packaged by:Fresenius Kabi Austria GmbHEstermannstraße 174020 Linz AustriaDistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised - March 2016Lactulose Solution USP, 10 g/15 ml, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles.Lactulose solution, USP contains lactulose 670 mg/mL (10 g/15 mL).Store between 36° to 86°F (2° to 30°C). Do not freeze.Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Manufactured and packaged by:Fresenius Kabi Austria GmbHEstermannstraße 174020 Linz AustriaDistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised - March 2016Lactulose Solution USP, 10 g/15 ml, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles.Lactulose solution, USP contains lactulose 670 mg/mL (10 g/15 mL).Store between 36° to 86°F (2° to 30°C). Do not freeze.Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Manufactured and packaged by:Fresenius Kabi Austria GmbHEstermannstraße 174020 Linz AustriaDistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised - March 2016Lactulose Solution USP, 10 g/15 ml, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles.Lactulose solution, USP contains lactulose 670 mg/mL (10 g/15 mL).Store between 36° to 86°F (2° to 30°C). Do not freeze.Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Manufactured and packaged by:Fresenius Kabi Austria GmbHEstermannstraße 174020 Linz AustriaDistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised - March 2016Lactulose Solution USP, 10 g/15 ml, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles.Lactulose solution, USP contains lactulose 670 mg/mL (10 g/15 mL).Store between 36° to 86°F (2° to 30°C). Do not freeze.Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Manufactured and packaged by:Fresenius Kabi Austria GmbHEstermannstraße 174020 Linz AustriaDistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised - March 2016Lactulose Solution USP, 10 g/15 ml, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles.Lactulose solution, USP contains lactulose 670 mg/mL (10 g/15 mL).Store between 36° to 86°F (2° to 30°C). Do not freeze.Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Manufactured and packaged by:Fresenius Kabi Austria GmbHEstermannstraße 174020 Linz AustriaDistributed by: Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised - March 2016