LACTULOSE solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Lactulose (UNII: 9U7D5QH5AE) (Lactulose - UNII:9U7D5QH5AE)

Disponibbli minn:

Cardinal Health

INN (Isem Internazzjonali):

Lactulose

Kompożizzjoni:

Lactulose 10 g in 15 mL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

LACTULOSE- LACTULOSE SOLUTION
CARDINAL HEALTH
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LACTULOSE SOLUTION USP
10 G/15 ML
RX ONLY
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.
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.
INDICATIONS AND USAGE
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.
CONTRAINDICATIONS
Since lactulose solution contains galactose (less than 1.6 g/15 mL),
i