Document
DailyMed Label: LACTULOSE
Title
DailyMed Label: Lactulose
Date
2009
Document type
DailyMed Prescription
Name
Lactulose
Generic name
lactulose
Manufacturer
Physicians Total Care, Inc.
Product information
NDC: 54868-3101
Product information
NDC: 54868-3101
Description
Lactulose is a synthetic disaccharide in solution form for oral
administration. Each 15 mL of Lactulose Solution contains: 10 g lactulose (and
less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other
sugars). Also contains FD&C Yellow No. 6, purified water, and flavoring.
Sodium hydroxide used to adjust pH . The pH range is 2.5 to 6.5.
Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.
It has the following structural formula:
The molecular weight is 342.30. It is freely soluble in water.
image of Lactulose chemical structure
Indications
For the treatment of constipation. In patients with a history of chronic
constipation, lactulose solution therapy increases the number of bowel movements
per day and the number of days on which bowel movements occur.
Dosage
The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing
10 g to 20 g of lactulose) daily. The dose may be increased to 60 mL daily if
necessary. Twenty-four to 48 hours may be required to produce a normal bowel
movement.
Note: Some patients have found that lactulose solution may be more acceptable
when mixed with fruit juice, water or milk.
Contraindications
Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is
contraindicated in patients who require a low galactose diet.
Precautions
General Since lactulose solution contains galactose (less than 1.6 g/15
mL) and lactose (less than 1.2 g/15 mL), it should be used with caution in
diabetics.
Information for Patients In the event that an unusual diarrheal condition occurs, contact
your physician.
Laboratory Tests Elderly, debilitated patients who receive lactulose solution for
more than six months should have serum electrolytes (potassium, chloride, carbon
dioxide) measured periodically.
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 solution.
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 solution 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 solution 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 well-controlled 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 solution is administered to a nursing woman.
Pediatric Use Safety and effectiveness in pediatric patients have not been
established.
Adverse reactions
Precise frequency data are not available.
How supplied
NDC 54868-3101-0 Bottles of 8 fl oz (237 mL)
NDC 54868-3101-1 Bottles of 16 fl oz (473 mL)
NDC 54868-3101-2 Bottles of 32 fl oz (946 mL)
Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL )
Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP] 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 30ºC (86ºF) 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 semisolid,
too viscous to pour. Viscosity will return to normal upon warming to room
temperature.
Keep tightly closed.
Dispense in original container or tight, light-resistant container with a
child-resistant closure.
Clinical pharmacology
Lactulose is poorly absorbed from the gastrointestinal tract, and
no enzyme capable of hydrolysis of this disaccharide is present in human
gastrointestinal tissue. As a result, oral doses of lactulose solution reach the
colon virtually unchanged. In the colon, lactulose is broken down primarily to
lactic acid, and also to small amounts of formic and acetic acids, by the action
of colonic bacteria, which results in an increase in osmotic pressure and slight
acidification of the colonic contents. This in turn causes an increase in stool
water content and softens the stool.
Since lactulose does not exert its effect until it reaches the colon, and
since transit time through the colon may be slow, 24 to 48 hours may be required
to produce the desired bowel movement.
Lactulose solution given orally to man and experimental animals resulted in
only small amounts reaching the blood.
Urinary excretion has been determined to be 3% or less and is essentially
complete within 24 hours.
Package label
Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL )
image of Lactulose Solution Package Label
14 organizations
2 products
Product
LactuloseOrganization
NuCare Pharmaceuticals, Inc.Organization
Akorn - Strides LLC Organization
Foxland Pharmaceuticals, Inc.Organization
Chartwell RX, LLC.Organization
Xttrium Laboratories, Inc.Organization
Cardinal Health 107, LLCOrganization
Quality Care Products, LLCProduct
Lactulose SolutionOrganization
PAI Holdings, LLCOrganization
Pharmaceutical Associates, Inc.Organization
Lannett Company, Inc.Organization
Proficient Rx LPOrganization
Chartwell RX, LLCOrganization
PAI Holdings, LLC dba PAI PharmaOrganization
Physicians Total Care, Inc.