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Components:
Lactulose
Method of action:
Detoxifying, Hypoazotemic, Laxative, Ph-Lowering Of Intestinal Contents, Stimulating Peristalsis Of The Intestine
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Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 2020.01.22

Name of the medicinal product

Kristalose

Qualitative and quantitative composition

KRISTALOSE® (Lactulose) For Oral Solution is available in single dose packets of 10 g (NDC 66220-719-01) and single dose packets of 20 g (NDC 66220-729-01). The packets are supplied as follows:

NDC 66220-719-30 (Carton of thirty 10 g packets)
NDC 66220-729-30 (Carton of thirty 20 g packets)

STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F).

To report adverse events associated with this product, please call 1 -877-484-2700.

Distributed by : Cumberland Pharmaceuticals Inc. Nashville,TN37203. Revised: Sep 2012

Therapeutic indications

KRISTALOSE® (Lactulose) For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

Dosage (Posology) and method of administration

The usual adult dosage is 10 g to 20 g of lactulose daily. The dose may be increased to 40 g daily if necessary. Twenty-four to 48 hours may be required to produce a normalbowel movement.

Directions For Preparation

Dissolve contents of packet in half a glass (4 ounces) of water.

When Lactulose For Oral Solution is dissolved in water, the resulting solution may be colorless to a slightly pale yellow color.

Contraindications

Since KRISTALOSE ® (LACTULOSE) For Oral Solution contains galactose (less than 0.3 g/10 g as a total sum with lactose), it is contraindicated in patients who require a low galactose diet.

Special warnings and precautions for use

WARNINGS

A theoretical hazard may exist for patients being treated with lactulose 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 C02 as an additional safeguard may be pursued but is considered to be a redundant measure.

PRECAUTIONS

General

Since KRISTALOSE® (Lactulose) For Oral Solution contains galactose and lactose (less than 0.3 g/10 g as a total sum), it should be used with caution in diabetics.

Laboratory Tests

Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.

There are no known animal data on long-term potential for mutagenicity.

Administration of lactulose syrup in the diet of mice for 18 months in concentrations of 3 and 10 percent (v/w) did not produce any evidence of carcinogenicity.

In studies in mice, rats, and rabbits, doses of lactulose syrup up to 6 or 12 mL/kg/day produced no deleterious effects in breeding, conception, or parturition.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose. There are, however, no adequate and wellcontrolled studies in pregnant women. 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, caution should be exercised when lactulose is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Interaction with other medicinal products and other forms of interaction

SIDE EFFECTS

Precise frequency data are not available.

Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia.

Nausea and vomiting have been reported.

DRUG INTERACTIONS

Results of preliminary studies in humans and rats suggest that nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose.

Fertility, pregnancy and lactation

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose. There are, however, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Undesirable effects

Precise frequency data are not available.

Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia.

Nausea and vomiting have been reported.

Overdose

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 LD50

The acute oral LD50 of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats.

Dialysis

Dialysis data are not available for lactulose. Its molecular similarity to sucrose, however, would suggest that it should be dialyzable.

Date of revision of the text

Sep 2012
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