A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Cephulac Warnings, Precautions, Pregnancy, Nursing, Abuse - Lactulose
Cephulac Warnings, Precautions, Pregnancy, Nursing, Abuse - Lactulose
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 H 2 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 2 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.
Information for patients
In the event that an unusual diarrheal condition occurs, contact your physician.
Laboratory Tests
Elderly, debilitated patients who receive lactulose 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.
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 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 is administered
to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
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